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news brief<br />
Forecast:<br />
robust Market For<br />
Molecular Diagnostics<br />
A new report released by Kalorama<br />
In<strong>for</strong>mation predicts <strong>the</strong> world market<br />
<strong>for</strong> molecular diagnostic tests will grow<br />
11% annually, reaching $8.085 billion<br />
U.S. dollars in 2015. Back in 1995, <strong>the</strong><br />
market <strong>for</strong> <strong>the</strong>se nascent tests was estimated<br />
to comprise just 2% of <strong>the</strong> total<br />
in vitro diagnostic (IVD) market or<br />
$360 billion. Today that number stands<br />
at $4.765 billion.<br />
The report, “The World Market <strong>for</strong><br />
Molecular Diagnostics,” highlights <strong>the</strong><br />
primary growth drivers <strong>for</strong> molecular<br />
diagnostics, and describes challenges<br />
facing <strong>the</strong> IVD industry in <strong>the</strong> future.<br />
The authors call <strong>the</strong> track record <strong>for</strong><br />
molecular diagnostic testing a testament<br />
to innovation.<br />
The report attributes <strong>the</strong> continued<br />
growth in <strong>the</strong> market to <strong>the</strong> introduction<br />
of numerous assays over <strong>the</strong> past 5<br />
years, as well as publication of <strong>the</strong> Human<br />
Genome Project and advances in<br />
functional genomics, bioin<strong>for</strong>matics,<br />
miniaturization, and microelectronics.<br />
At <strong>the</strong> same time, demand <strong>for</strong> testing<br />
snaPshoT<br />
2010 Molecular Diagnostics Market<br />
Siemens<br />
6%<br />
BD, 4%<br />
Qiagen/Digene<br />
5%<br />
has been fueled by an increase in<br />
cancer patients, proliferation of infectious<br />
diseases and growing interest in<br />
parental gene carrier analysis.<br />
Especially notable is <strong>the</strong> fact that<br />
many of <strong>the</strong>se complex tests have<br />
been commercialized as proprietary<br />
lab-developed tests offered by reference<br />
labs and company-sponsored lab<br />
services.<br />
But major challenges obstruct use of<br />
molecular diagnostic assays, including<br />
getting stakeholders, payers, physicians,<br />
researchers, and regulators to<br />
work toge<strong>the</strong>r to close <strong>the</strong> gap between<br />
research and clinical applicability.<br />
Physician education is also lacking,<br />
and reimbursement problems threaten<br />
fur<strong>the</strong>r implementation of <strong>the</strong>se tests.<br />
The report also provides a snapshot<br />
of today’s market share. While some 350<br />
companies are actively involved in molecular<br />
diagnostics, most hold tiny fractions<br />
of <strong>the</strong> market. The major players<br />
are Roche Diagnostics with an estimated<br />
15% market share, followed by Abbott<br />
and Gen-Probe with 8% each.<br />
The full report is available <strong>for</strong><br />
purchase at www.kaloramain<strong>for</strong>mation.com.<br />
nonprofit org.<br />
u.s. postage<br />
Paid<br />
greenfield, oH<br />
permit no. 436<br />
Qiagen IVDs, 6%<br />
O<strong>the</strong>r<br />
48%<br />
Gen-Probe<br />
8%<br />
Source: Kalorama In<strong>for</strong>mation.<br />
Used with permission.<br />
2 0 1 1 a a C C a n n u a l M e e t i n G i s s u e<br />
Roche<br />
Diagnostics<br />
15%<br />
Abbott<br />
8%<br />
<strong>Clinical</strong><br />
Laboratory<br />
News<br />
A Decade of Lab Tests Online<br />
What Are Millions of Users Searching For?<br />
By Bill Malone<br />
This year hospitals and physicians begin marching into<br />
<strong>the</strong> age of electronic health records under a new paradigm<br />
of in<strong>for</strong>mation sharing and patient access, chasing<br />
government financial incentives now coming into<br />
effect. However, it looks like patients are already one<br />
step ahead. An estimated 80% of Web users now search online <strong>for</strong><br />
health in<strong>for</strong>mation, or about 59% of all adults in <strong>the</strong> U.S. Already<br />
one in four Internet users have tracked some aspect of <strong>the</strong>ir health<br />
online and 16% report looking online <strong>for</strong> in<strong>for</strong>mation about medical<br />
test results, according to a new report from <strong>the</strong> Pew Internet<br />
& <strong>American</strong> Life Project, “The Social Life of Health In<strong>for</strong>mation,<br />
2011.”<br />
When it comes to patient-oriented in<strong>for</strong>mation about lab testing,<br />
Lab Tests Online, AACC’s public resource on clinical lab testing,<br />
has represented <strong>the</strong> lab community <strong>for</strong> 10 years, evolving to<br />
meet <strong>the</strong> needs of 2 million visitors a month (www.labtestsonline.<br />
org). The Pew report underscores just how important sites like Lab<br />
Tests Online can be at a time when patients increasingly receive<br />
direct electronic access to <strong>the</strong>ir lab results. With more online access to personal records like lab tests, health<br />
in<strong>for</strong>mation sites will act as intermediaries that help patients cope with all this new data, said Susannah Fox, an<br />
associate director at <strong>the</strong> Pew Internet & <strong>American</strong> Life Project and author of <strong>the</strong> recent report.<br />
“There is a critical role <strong>for</strong> <strong>the</strong> Internet to fill in <strong>the</strong> gap of understanding that we all know exists between <strong>the</strong><br />
moment that a health professional gives in<strong>for</strong>mation to someone and how that person deals with that in<strong>for</strong>ma-<br />
See lab Tests online, continued on page 3<br />
Low-Risk Chest Pain Patients<br />
Can a Two-Hour Assessment Protocol<br />
Send Them Home Safely?<br />
By Genna Rollins<br />
emergency department overcrowding has confounded hospital administrators and clinicians <strong>for</strong><br />
years, with no simple solution in sight. In fact, emergency visits increased at twice <strong>the</strong> rate of growth<br />
of <strong>the</strong> U.S. population between 1997 and 2007, and a recent Government Accountability Office report<br />
found that it took more than double <strong>the</strong> recommended time to see patients with immediate<br />
care needs. Given <strong>the</strong>se strains on <strong>the</strong> healthcare system, <strong>the</strong> idea of being able to quickly assess and<br />
safely discharge even a modest segment of <strong>the</strong> emergency population is quite appealing.<br />
That’s why a provocative protocol put <strong>for</strong>th by a consortium of Pacific Rim researchers has generated discussion<br />
internationally. The protocol, which involves a 2-hour accelerated diagnostic protocol using a point-of-care<br />
(POC) biomarker panel, a risk score, and electrocardiography (ECG) to identify and safely discharge patients<br />
with symptoms suggestive of acute coronary syndrome (ACS), one day could lead to much shorter assessment<br />
times <strong>for</strong> a substantial and resource-intensive segment of <strong>the</strong> emergency population, low-risk chest pain patients<br />
(Lancet 2011;377:1077–84). This approach has piqued interest in both<br />
<strong>the</strong> cardiology and emergency medicine fields because each year, patients<br />
presenting with symptoms suggestive of ACS account <strong>for</strong> as<br />
many as 10% of hospital emergency cases and up to one-quarter of<br />
admissions. Most undergo hours-long assessments, although 75–85%<br />
turn out not to have ACS, according to lead investigator Martin Than,<br />
MBBS.<br />
“We have to take people who present with chest pain very seriously,<br />
because <strong>the</strong> consequences of getting it wrong are significant.<br />
<strong>Clinical</strong> Laboratory News<br />
The <strong>American</strong> <strong>Association</strong><br />
<strong>for</strong> <strong>Clinical</strong> Chemistry, Inc.<br />
1850 K Street, NW, Suite 625<br />
Washington, DC 20006<br />
Concern about <strong>the</strong> possibility of sending someone home to harm is<br />
a key driver of clinician behavior, which is essentially to investigate<br />
See chest Pain Protocol, continued on page 6<br />
The auThoriTaTive<br />
source <strong>for</strong> The<br />
clinical laboraTorian<br />
july 2011<br />
volume 37, number 7<br />
www.aacc.org<br />
in This <strong>issue</strong><br />
Lab 2011<br />
10 Thyroglobulin—<br />
Analytical Pitfalls<br />
14<br />
Patient Safety Focus<br />
Designing Processes<br />
<strong>for</strong> Patient Safety<br />
15 Overcoming<br />
Disruptive Behavior<br />
16<br />
17<br />
18<br />
Confronting Conflict<br />
in <strong>the</strong> Lab<br />
Ensuring a Safety Culture<br />
Expert Access—<br />
The Delta Check in Action<br />
2011 AACC Annual Meeting<br />
20<br />
22<br />
44<br />
47<br />
List of Exhibitors<br />
2011 New Products<br />
Review<br />
Regulatory, Industry,<br />
& Diagnostic Profiles<br />
News from <strong>the</strong> FDA
COBAS and LIFE NEEDS ANSWERS are trademarks of Roche. © 2011 Roche Diagnostics. All rights reserved 467-50568-0611<br />
I want to think about<br />
- Uptime instead of downtime<br />
- Working instead of waiting<br />
- support I have, but don’t always need<br />
Then it’s time to talk to Roche about <strong>the</strong> cobas ® total solution.<br />
Visit us at <strong>the</strong> AACC <strong>Clinical</strong> Lab Expo - Booth #2205<br />
The cobas ® Total Solution - inspiring confidence
Most Adults Check Online <strong>for</strong> Health Info<br />
lab Tests online, continued from page 1<br />
tion,” she said. “As healthcare providers rush<br />
to implement electronic health records and<br />
patients get greater access, this is going to be<br />
an important opportunity <strong>for</strong> better patient<br />
education and communication.”<br />
The New Health In<strong>for</strong>mation Seekers<br />
Even though health professionals remain<br />
<strong>the</strong> primary source of in<strong>for</strong>mation when<br />
people need an accurate medical diagnosis<br />
or have o<strong>the</strong>r serious health concerns, Pew<br />
survey data from <strong>the</strong> past decade consistently<br />
show that people use online sources as a<br />
significant supplement to <strong>the</strong>ir interactions<br />
with healthcare professionals. Young college<br />
graduates with higher-than-average household<br />
income still search online <strong>the</strong> most,<br />
but significant numbers of o<strong>the</strong>r groups are<br />
emerging as active users as well (See Health<br />
In<strong>for</strong>mation Seekers Box, right).<br />
The Internet has fundamentally changed<br />
<strong>American</strong>s’ relationships to in<strong>for</strong>mation,<br />
Fox said. “One of <strong>the</strong> first changes that we<br />
saw really broadly was with <strong>the</strong> advent of<br />
high speed Internet access. We found that<br />
broadband users are more likely to turn to<br />
<strong>the</strong> Internet first when <strong>the</strong>y have a question,<br />
whe<strong>the</strong>r it’s a question about <strong>the</strong> wea<strong>the</strong>r,<br />
what movie is playing, or a new medical<br />
diagnosis—an important qualitative difference,”<br />
she said. “There is something about<br />
<strong>the</strong> always-on access that makes people<br />
think of <strong>the</strong> Internet as a first-line in<strong>for</strong>mation<br />
resource far more often than be<strong>for</strong>e.”<br />
Mobile access, along with social media,<br />
is <strong>the</strong> third wave in this trend, especially<br />
among younger demographic groups. In<br />
user comments demonstrate a<br />
broad spectrum of site visitors<br />
Lab Tests Online invites user comments.<br />
Here is a sampling.<br />
My wife and I are RN’s. Your site is, excuse <strong>the</strong> pun, “bloody good.”<br />
Thanks so much.<br />
This site is excellent. It explained my laboratory blood work results.<br />
Once you understand what <strong>the</strong> medical terms—like B-U-N, W-B-C,<br />
and NEUTROPHILS—are, mentally it clears up worries as to what<br />
<strong>the</strong> test results mean and eliminates unnecessary stress. Thank<br />
you so much <strong>for</strong> this site.<br />
Excellent site! In<strong>for</strong>mation is clear, concise and helps you research<br />
fur<strong>the</strong>r if needed. I work in healthcare as a phlebotomist and I<br />
have found this site to help me and my patients more than anything<br />
else. Thank you.<br />
My doctor ordered many tests and I did not know what <strong>the</strong>y were<br />
all <strong>for</strong>. Reading your descriptions made me feel secure and gave<br />
me a clue about what <strong>the</strong> doctor was looking <strong>for</strong> or trying to rule<br />
out. Now he seems pretty smart!<br />
Thank you <strong>for</strong> providing such comprehensive and excellent in<strong>for</strong>mation<br />
in lay terms. It has helped me better understand my—and<br />
my elderly parents’—health conditions as well as all our lab tests<br />
results.<br />
This site has been a wonderful help to me in understanding my<br />
health status and my doctor’s thinking. It has helped me to be a<br />
more responsible and active partner in <strong>the</strong> maintenance of my<br />
health and treatment. Thanks.<br />
It is Friday afternoon and I received test results that I did not<br />
understand. I won’t see my doctor until Monday afternoon. The in<strong>for</strong>mation<br />
on this site helped ease my anxieties about <strong>the</strong> results.<br />
It was easy to understand and relevant to my needs.<br />
I am very glad to have stumbled upon this site. It is so much more<br />
easily searchable <strong>for</strong> clinical lab tests than o<strong>the</strong>rs. It is also more<br />
helpful getting to <strong>the</strong> succinct facts about your test, your results<br />
versus normal, and potential things that can affect <strong>the</strong> results. I<br />
appreciate <strong>the</strong> public service mission of this site.<br />
Quite a useful reference when I need a reminder about <strong>the</strong> differences<br />
and uses of specific lab tests. Thanks.<br />
I am a lab director and I LOVE this site.<br />
This site was VERY helpful. My husband has cancer and <strong>the</strong> doctor<br />
gave us a print-out of all his blood tests and a graph showing low,<br />
high and where his results were. I found <strong>the</strong> tests on your site and<br />
was able to understand what <strong>the</strong> doctor was testing <strong>for</strong>.<br />
Fox’s report, about a third of those age<br />
18–29 reported using a cell phone to look<br />
<strong>for</strong> health in<strong>for</strong>mation, compared to 15%<br />
overall. “With mobile, now it’s <strong>the</strong> alwayson,<br />
always-with-you access, and that is<br />
changing us as Internet users,” Fox said.<br />
“We have been able to see in many sectors,<br />
including health, what we call <strong>the</strong> mobile<br />
difference. That means that people are<br />
not only more likely to look <strong>for</strong> in<strong>for</strong>mation<br />
online if <strong>the</strong>y have a mobile device,<br />
but <strong>the</strong>y are more likely to share it.” In <strong>the</strong><br />
Pew survey, 34% of Internet users said <strong>the</strong>y<br />
had read someone else’s commentary or<br />
experience about health or medical <strong>issue</strong>s<br />
See lab Tests online, continued on page 4<br />
health in<strong>for</strong>mation seekers<br />
according to <strong>the</strong> pew internet & american life project’s recent report,<br />
“<strong>the</strong> social life of Health in<strong>for</strong>mation, 2011,” 80% of internet users have<br />
gone online <strong>for</strong> health in<strong>for</strong>mation. that is almost 60% of all adults in<br />
<strong>the</strong> u.s.<br />
looking online <strong>for</strong> health in<strong>for</strong>mation: demographics<br />
Percentage<br />
who go online<br />
Percentage who<br />
look online <strong>for</strong><br />
health in<strong>for</strong>mation<br />
all adults in <strong>the</strong> u.s. 74 59<br />
Gender<br />
Male 73 53<br />
female 75 65<br />
race<br />
white 77 63<br />
african american 66 47<br />
latino 62 45<br />
age<br />
18–29 92 71<br />
30–49 79 66<br />
50–64 71 58<br />
65+ 40 29<br />
education<br />
some high school 38 24<br />
High school graduate 64 45<br />
some college 84 70<br />
College graduate 91<br />
household income<br />
81<br />
< $30,000 57 41<br />
$30,000–49,999 80 66<br />
$50,000–74,999 86 71<br />
$75,000+ 95 83<br />
overall, 16% of all internet users in <strong>the</strong> telephone survey say <strong>the</strong>y’ve<br />
searched online <strong>for</strong> in<strong>for</strong>mation about medical test results. while much<br />
of <strong>the</strong> demographics are similar to those searching <strong>for</strong> o<strong>the</strong>r types of<br />
health in<strong>for</strong>mation, certain groups are more likely than o<strong>the</strong>rs to search<br />
<strong>for</strong> test in<strong>for</strong>mation.<br />
27% currently caring <strong>for</strong> a loved one with a health problem<br />
23% experienced a medical crisis within <strong>the</strong> past year,<br />
self or someone close<br />
22% experienced a personal health change in <strong>the</strong> past year<br />
21% have at least one chronic condition,<br />
such as high blood pressure or diabetes<br />
0 10% 20% 30%<br />
7% less than high<br />
school education<br />
11% high school education<br />
16% some college<br />
23% college graduates<br />
0 10% 20% 30%<br />
Source: Fox, Susannah. The Social Life of Health In<strong>for</strong>mation, 2011. Pew Internet and<br />
<strong>American</strong> Life Project, May 12, 2011, www.pewinternet.org/Reports/2011/Social-Life-of-<br />
Health-Info.aspx.<br />
CliniCal laboratory news July 2011 3
<strong>Clinical</strong><br />
Laboratory<br />
News<br />
ediTorial sTaff<br />
editor—Nancy Sasavage, PhD<br />
senior editor—Genna Rollins<br />
associate editor—Bill Malone<br />
editorial assistant—Laura Kachin<br />
contributor—Carole Spencer, MT, PhD, FACB<br />
board of ediTors<br />
chair—Elia Mears, MS, MT (ASCP), SM<br />
Independent Laboratory Consultant<br />
Houma, La.<br />
members—Nikola Baumann, PhD<br />
Mayo Clinic, Rochester, Minn.<br />
Andrew Don-Wauchope, MD<br />
McMaster University Medical Center<br />
Hamilton, Ontario<br />
Steven Goss, PhD<br />
Siemens Healthcare Diagnostics, Newark, Del.<br />
Mary Kimberly, PhD<br />
CDC, Atlanta, Ga.<br />
Amy Saenger, PhD<br />
Mayo Clinic, Rochester, Minn.<br />
aacc officers<br />
President— Ann Gronowski, PhD<br />
President-elect— W. Greg Miller, PhD,<br />
DABCC, FACB<br />
Treasurer—D. Robert Dufour, MD<br />
secretary—Elizabeth L. Frank, PhD, DABCC,<br />
FACB<br />
Past-President—Ca<strong>the</strong>rine Hammett-Stabler,<br />
PhD<br />
adverTisinG sales<br />
Scherago International, Inc.<br />
525 Washington Blvd, Ste. 3310<br />
Jersey City, NJ 07310<br />
Phone: (201) 653-4777, Fax: (201) 653-5705<br />
E-mail: aacc@scherago.com<br />
President—H.L. Burklund<br />
sr. v.P. of sales & marketing—Jack Ryan<br />
v.P. of sales—Mike Minakowski<br />
sr. director of sales & marketing<br />
—Steven A. Hamburger<br />
Traffic manager—Qien Porter<br />
subscriPTions<br />
<strong>American</strong> <strong>Association</strong> <strong>for</strong> <strong>Clinical</strong> Chemistry, Inc.<br />
1850 K Street, NW, Suite 625<br />
Washington, DC 20006<br />
Phone: (202) 857-0717 or (800) 892-1400<br />
Fax: (202) 887-5093<br />
E-mail: custserv@aacc.org<br />
Subscriptions to <strong>Clinical</strong> Laboratory News are<br />
free to qualified laboratory professionals in<br />
<strong>the</strong> United States. AACC members outside<br />
<strong>the</strong> U.S. pay $84 <strong>for</strong> postage. The subscription<br />
price <strong>for</strong> those who do not qualify <strong>for</strong> a free<br />
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contact <strong>the</strong> AACC Customer Service Department<br />
at (800) 892-1400 or (202) 857-0717 or<br />
custserv@aacc.org.<br />
ediTorial corresPondence<br />
Nancy Sasavage, PhD, Editor<br />
<strong>Clinical</strong> Laboratory News<br />
1850 K Street, NW, Suite 625<br />
Washington, DC 20006<br />
Phone: (202) 835-8725 or (800) 892-1400<br />
Fax: (202) 835-8725<br />
E-mail: nsasavage@aacc.org<br />
Contents copyright © 2011 by <strong>the</strong> <strong>American</strong><br />
<strong>Association</strong> <strong>for</strong> <strong>Clinical</strong> Chemistry, Inc.,<br />
except as noted. Printed in <strong>the</strong> U.S.A.<br />
<strong>Clinical</strong> laboratory news (issn 0161-9640)<br />
is <strong>the</strong> authoritative source <strong>for</strong> timely analysis<br />
of <strong>issue</strong>s and trends affecting clinical<br />
laboratories, clinical laboratorians, and <strong>the</strong><br />
practice of clinical laboratory science.<br />
4 CliniCal laboratory news July 2011<br />
Few Sites Meet Quality Criteria<br />
lab Tests online, continued from page 3<br />
on an online news group, website, or blog,<br />
and 18% seek out o<strong>the</strong>rs online who share<br />
similar health concerns.<br />
Compared to o<strong>the</strong>r types of websites,<br />
social networking sites like Facebook and<br />
MySpace are still not yet widely used <strong>for</strong><br />
health in<strong>for</strong>mation searches. But with<br />
<strong>the</strong> notably higher use of mobile searches<br />
among <strong>the</strong> young, health in<strong>for</strong>mation seeking<br />
on social networking sites is likely to increase.<br />
“Now that <strong>the</strong>y have <strong>the</strong>se devices<br />
with <strong>the</strong>m that are like Swiss army knives<br />
of participation, what’s really neat is that in<br />
healthcare, we are tapping into an ancient<br />
instinct to share,” Fox commented. “People<br />
have always gotten toge<strong>the</strong>r to talk about<br />
<strong>the</strong>ir health, to talk with loved ones about<br />
what <strong>the</strong>y’re facing, or to share with people<br />
who might have a similar diagnosis. But<br />
now we can widen our networks and speed<br />
up those conversations, and that’s <strong>the</strong> difference<br />
that <strong>the</strong> Internet makes.”<br />
Ano<strong>the</strong>r notable trend revealed in <strong>the</strong><br />
Pew survey is that many people searching<br />
<strong>for</strong> health in<strong>for</strong>mation are caregivers. Almost<br />
half of Internet users seeking health<br />
in<strong>for</strong>mation report that <strong>the</strong>ir most recent<br />
search was <strong>for</strong> ano<strong>the</strong>r person, and overall,<br />
70% of all adults in <strong>the</strong> U.S. caring <strong>for</strong><br />
a loved one have looked online <strong>for</strong> health<br />
in<strong>for</strong>mation. This is a significant number,<br />
considering that one in four adults provides<br />
unpaid care <strong>for</strong> a friend or family<br />
member.<br />
Specifically <strong>for</strong> medical test in<strong>for</strong>mation,<br />
<strong>the</strong> Pew survey found that those who<br />
are caregivers, have recently experienced a<br />
medical crisis, or have a chronic condition,<br />
are more likely to search <strong>for</strong> lab-related in<strong>for</strong>mation<br />
online (See Health In<strong>for</strong>mation<br />
Seekers Box, p. 3).<br />
The Quality Conundrum<br />
Even a decade ago, when most Internet<br />
users still depended on slow, dial-up connections<br />
and blogging and social networks<br />
were in <strong>the</strong>ir infancy, people already had<br />
strong doubts about <strong>the</strong> quality of health<br />
in<strong>for</strong>mation that was finding its way onto<br />
<strong>the</strong> Web. This is one of <strong>the</strong> reasons that<br />
AACC and o<strong>the</strong>r collaborating lab organizations<br />
felt so strongly about creating a<br />
site like Lab Tests Online. Pew found in a<br />
2006 survey that only one in four Internet<br />
users always look <strong>for</strong> <strong>the</strong> source and date<br />
of health in<strong>for</strong>mation online. However,<br />
<strong>the</strong> vast majority of websites do not display<br />
such in<strong>for</strong>mation, Fox noted. “I think you<br />
can <strong>for</strong>give consumers <strong>for</strong> giving up searching<br />
<strong>for</strong> a needle in a haystack,” she said. “If<br />
<strong>the</strong>y’re expected to look <strong>for</strong> <strong>the</strong> source and<br />
date of health in<strong>for</strong>mation, <strong>the</strong>n it’s up to<br />
<strong>the</strong> websites to display that.”<br />
The largest ever study on <strong>the</strong> quality of<br />
health in<strong>for</strong>mation online comes from <strong>the</strong><br />
U.S. Department of Health and Human<br />
Services’ Office of Disease Prevention and<br />
Health Promotion. The 2006 study selected<br />
a sample of 102 health-oriented websites<br />
out of 3,608 identified at <strong>the</strong> time and reviewed<br />
<strong>the</strong>m <strong>for</strong> six criteria established<br />
by <strong>the</strong> agency as hallmarks of quality and<br />
completeness: in<strong>for</strong>mation on <strong>the</strong> identity<br />
of <strong>the</strong> website sponsor; <strong>the</strong> purpose of <strong>the</strong><br />
site; <strong>the</strong> source; <strong>the</strong> site’s privacy policy;<br />
how <strong>the</strong> site is evaluated; and how often<br />
content is updated.<br />
The results paint a bleak picture. Not<br />
one of <strong>the</strong> 102 sites in <strong>the</strong> sample, which<br />
did not include Lab Tests Online, met all six<br />
of <strong>the</strong> criteria. And though 90% complied<br />
with at least one, only 3% complied with<br />
more than three. More concerning, 10%<br />
complied with none. The report also noted<br />
that <strong>the</strong>re was a lack of consistency in how<br />
or where websites disclosed in<strong>for</strong>mation.<br />
While concerns about <strong>the</strong> quality of<br />
health in<strong>for</strong>mation online seem to be<br />
justified, Fox suggested a more nuanced<br />
perspective. For instance, even <strong>the</strong> most<br />
highly respected sites that meet criteria like<br />
disclosing a source and date, such as those<br />
from <strong>the</strong> government, are not often <strong>the</strong> first<br />
choice of <strong>the</strong> average Internet user. In fact,<br />
only 6% of adults were even aware of <strong>the</strong><br />
Hospital Compare Tool created by <strong>the</strong> Centers<br />
<strong>for</strong> Medicare and Medicaid Services.<br />
There are several reasons <strong>for</strong> this, according<br />
to Fox. “For better or <strong>for</strong> worse,<br />
Internet users by and large are not going to<br />
sites like PubMed [<strong>the</strong> National Library of<br />
Medicine’s online citation database of biomedical<br />
literature],” she said. “People have<br />
questions that are about all <strong>the</strong> aspects of<br />
health that surround <strong>the</strong> diagnosis—like<br />
what to expect and how <strong>the</strong>y fit into <strong>the</strong><br />
universe of people going through <strong>the</strong> same<br />
illness. So it’s not a rejection of going to see<br />
<strong>the</strong> doctor: it’s actually that <strong>the</strong>y continue<br />
to embrace that, but <strong>the</strong>y want to augment<br />
what <strong>the</strong>y’re learning from health professionals.”<br />
The Lab’s Voice in Cyberspace<br />
Since it’s inception in 2001, AACC and<br />
o<strong>the</strong>r stakeholders intended Lab Tests Online<br />
to fill <strong>the</strong> apparent in<strong>for</strong>mation gap<br />
online <strong>for</strong> <strong>the</strong> public and garner visibility<br />
and esteem <strong>for</strong> <strong>the</strong> practice of lab medicine<br />
at <strong>the</strong> same time. The site’s rapid climb in<br />
lab Tests online<br />
celebrates 10 years<br />
in <strong>the</strong> past 5 years alone, <strong>the</strong> number of visitors to lab tests online has<br />
tripled, a testament to <strong>the</strong> quality of <strong>the</strong> site and <strong>the</strong> high demand <strong>for</strong><br />
online health in<strong>for</strong>mation. <strong>the</strong> u.s. site was launched in July 2001, and<br />
had had 1 million visitors by <strong>the</strong> next year. Visitors to <strong>the</strong> site soared to<br />
25 million in 2006, and hit ano<strong>the</strong>r milestone, 100 million, in february,<br />
2011.<br />
this month, <strong>the</strong> site launches an app <strong>for</strong> mobile devices in <strong>the</strong> itunes<br />
store and android market. once downloaded, <strong>the</strong> app will not require<br />
an internet connection to be used. an internet connection will only be<br />
needed to obtain content updates.<br />
Growth of <strong>the</strong> u.s. site<br />
annual Traffic<br />
increasing Global visibility<br />
lab tests online is now available in 17 countries and 14 languages.<br />
<strong>the</strong> first non-u.s. site was launched in <strong>the</strong> uK in 2004. Just 3 years later,<br />
spain, germany, poland, australia, Hungary, and italy launched localized<br />
sites. Currently, greece, Czech republic, China, france, portugal, brazil,<br />
and turkey also have sites up and running, with two more—Korea and<br />
romania—expected to launch soon.<br />
Total non-u.s. site visitors
visitors and <strong>the</strong> hundreds of thousands<br />
of questions answered by lab volunteers<br />
demonstrate <strong>the</strong> real public demand <strong>for</strong><br />
high-quality lab-related in<strong>for</strong>mation. The<br />
site has also maintained its original commitment<br />
to rigorous peer review, usability,<br />
and a non-commercial viewpoint, even as<br />
17 o<strong>the</strong>r countries have developed localized<br />
versions in 14 languages (See Lab Tests<br />
Online Box, left). Lab Tests Online has<br />
earned numerous awards <strong>for</strong> content and<br />
reliability, as well as praise from national<br />
news media such as <strong>the</strong> Washington Post,<br />
U.S. News and World Report, and Prevention<br />
magazine.<br />
Because of <strong>the</strong> hurried and fragmented<br />
care <strong>the</strong>y often receive, patients need a site<br />
like Lab Tests Online, emphasized Elisa<br />
Passiment, CLS, executive vice president of<br />
<strong>American</strong> Society <strong>for</strong> <strong>Clinical</strong> Laboratory<br />
Science (ASCLS) and a member of <strong>the</strong> site’s<br />
editorial board. “There are so many benefits<br />
to us as laboratorians offering this kind of<br />
in<strong>for</strong>mation to our patient-customers,”<br />
she said. “It is always interesting to me how<br />
concerned people are about <strong>the</strong>ir health<br />
status, yet how little <strong>the</strong>y seem to understand<br />
about that status, even though <strong>the</strong>y’re<br />
under a physician’s care. It’s not because<br />
<strong>the</strong> physician is not doing his or her job,<br />
it’s because <strong>the</strong>re is just not enough time to<br />
explain everything in <strong>the</strong> depth that people<br />
need. So Lab Tests Online is <strong>the</strong> next round<br />
of education and understanding <strong>for</strong> people,<br />
and we as laboratorians can tell <strong>the</strong>m much<br />
more about what lab tests mean than anyone<br />
else that <strong>the</strong>y encounter.”<br />
The Internet has not only changed our<br />
relationship to in<strong>for</strong>mation, but also <strong>the</strong><br />
patient-physician relationship, noted Murilo<br />
Melo, MD, PhD, editor of <strong>the</strong> Brazilian Lab<br />
Tests Online site that was launched in 2010.<br />
“Patients are taking more control of <strong>the</strong>ir<br />
health and it is now customary to per<strong>for</strong>m<br />
an Internet search be<strong>for</strong>e and after a medical<br />
visit. Physicians are still trying to adapt to<br />
this new reality,” he said. “What is disturbing<br />
to most physicians is that since patients<br />
often get most of <strong>the</strong>ir in<strong>for</strong>mation on sites<br />
that have poor quality content, <strong>the</strong>y must<br />
spend extra time educating <strong>the</strong>m. Lab Tests<br />
Online-Brazil aims to help both patients and<br />
physicians by providing reliable content that<br />
empowers patients while directing <strong>the</strong>m to<br />
<strong>the</strong> most important aspects of each lab test.”<br />
Melo is associate professor of molecular<br />
medicine at Santa Casa Medical School in<br />
São Paulo and vice-scientific director of <strong>the</strong><br />
Brazilian Society <strong>for</strong> <strong>Clinical</strong> Pathology and<br />
Laboratory Medicine (SBPC/ML).<br />
The need <strong>for</strong> a trustworthy source of lab<br />
test in<strong>for</strong>mation can also be seen in how<br />
Lab Tests Online has evolved over <strong>the</strong> past<br />
decade, Passiment commented. “When we<br />
first started out, we thought that it was going<br />
to be pretty basic in<strong>for</strong>mation, written<br />
only <strong>for</strong> <strong>the</strong> consumer, just to give people<br />
an appreciation of what laboratory testing<br />
was all about,” she said. “We have now realized<br />
that <strong>the</strong>re are many kinds of patients<br />
and caregivers that are using <strong>the</strong> site. So we<br />
are way past just <strong>the</strong> routine tests. We always<br />
keep in mind that we’re helping a broad<br />
spectrum of caregivers and healthcare professionals,<br />
so we’re incredibly careful that<br />
everything is totally clear and accurate.”<br />
The balancing act between technically<br />
complete content and <strong>the</strong> clarity patients<br />
need takes <strong>the</strong> most time and ef<strong>for</strong>t, said<br />
ano<strong>the</strong>r long-time editorial board member,<br />
Patrick St. Louis, PhD, laboratory director<br />
at Clearstone Central Laboratorie in Mississauga,<br />
Ontario. “In terms of content, it<br />
comes back to our target audience,” he said.<br />
“It’s a mixture of ordinary patients and professionals<br />
as well as people like ourselves. So<br />
we need something understandable to <strong>the</strong><br />
guy next door who may be a laborer, an engineer,<br />
or a lawyer, or <strong>the</strong>n someone who is<br />
a physician or a lab professional. The content<br />
must be sufficiently technical but also<br />
readable.”<br />
Now that Lab Tests Online has developed<br />
so many international sites, with<br />
more on <strong>the</strong> way, its staff and editors face<br />
new challenges that highlight <strong>the</strong> variety<br />
of ways lab testing is utilized around <strong>the</strong><br />
world. “Initially, we looked at this primarily<br />
as an ef<strong>for</strong>t to translate <strong>the</strong> site, but in fact<br />
what we’re discovering is that international<br />
sites must be adapted in o<strong>the</strong>r ways,” said<br />
D. Robert Dufour, MD, executive editor of<br />
Lab Tests Online. “Once you develop content,<br />
it can’t just be left static. You have to<br />
constantly review it and bring it up-to-date,<br />
whe<strong>the</strong>r it’s new guidelines, new evidence,<br />
or new ways of using <strong>the</strong> test. We spend in<br />
<strong>the</strong> U.S. about 80 percent of our time, not<br />
creating new content, but reviewing <strong>the</strong> existing<br />
content. So this we see as <strong>the</strong> challenge<br />
<strong>for</strong> our international colleagues, where <strong>the</strong>y<br />
generally do not have as large an editorial<br />
team.” Dufour is emeritus professor of pathology<br />
at George Washington University<br />
Medical Center, and a consultant in pathology<br />
and hepatology at <strong>the</strong> Veterans Affairs<br />
Medical Center in Washington, D.C.<br />
As <strong>the</strong> site continues to expand and refine<br />
content to keep up with new methods,<br />
guidelines, and patient needs, <strong>the</strong>re will be<br />
opportunities <strong>for</strong> more volunteers to con-<br />
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tribute, Dufour emphasized. Lab experts<br />
are needed to answer <strong>the</strong> questions that<br />
visitors to <strong>the</strong> site submit, a responsibility<br />
that ASCLS until recently has managed, but<br />
now includes AACC members as well. “It’s<br />
important to note that this is a huge ef<strong>for</strong>t.<br />
We have hundreds of people all over <strong>the</strong><br />
world who are participating in this, both in<br />
developing and adapting content, answering<br />
<strong>the</strong> questions, and this is something<br />
that could not have happened without<br />
<strong>the</strong> ef<strong>for</strong>ts of all of <strong>the</strong>se volunteers, many<br />
of whom have devoted years and years to<br />
working on this project,” Dufour said. “It<br />
also could not have happened without <strong>the</strong><br />
support of <strong>the</strong> professional societies who<br />
recruit those volunteers, or without <strong>the</strong><br />
support of <strong>the</strong> companies who give financial<br />
support, or AACC that continues to<br />
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CliniCal laboratory news July 2011 5
More Data Needed <strong>for</strong> Protocol Change<br />
chest Pain Protocol, continued from page 1<br />
chest pain patients to get <strong>the</strong> risk as low<br />
as possible,” Than explained. “Given that<br />
only 20 to 25 percent have acute myocardial<br />
infarction, that’s a lot of people being<br />
investigated. That, paired with <strong>the</strong> fact that<br />
hospitals have an immense problem with<br />
overcrowding, is one of <strong>the</strong> challenges of<br />
<strong>the</strong> healthcare system <strong>for</strong> <strong>the</strong> next decade,<br />
if not longer.” He is director of emergency<br />
medicine research at Christchurch Hospital<br />
in Christchurch, New Zealand.<br />
The Details of ASPECT<br />
Than and his colleagues at 14 emergency<br />
departments in nine countries in <strong>the</strong> Asia-<br />
Pacific region launched <strong>the</strong> Asia-Pacific<br />
Evaluation of Chest Pain Trial (ASPECT)<br />
to assess whe<strong>the</strong>r a pre-defined protocol<br />
could identify patients presenting to<br />
<strong>the</strong> emergency department with chest<br />
pain who would be at low risk of harm if<br />
<strong>the</strong>y were discharged early. The protocol’s<br />
POC panel consisted of cardiac troponin I<br />
(cTn), creatine kinase MB (CK-MB), and<br />
myoglobin. Researchers combined biomarker<br />
results with <strong>the</strong> Thrombolysis in<br />
Myocardial Infarction (TIMI) risk score<br />
and electrocardiograph (ECG) to establish<br />
patient risk.<br />
ASPECT involved 3,582 consecutive<br />
adult patients who reported at least 5 minutes<br />
of chest pain suggestive of ACS. Patients<br />
received normal care, and attending physicians<br />
had access to central lab cTn results<br />
but were blinded to TIMI score and results<br />
from <strong>the</strong> POC panel, samples <strong>for</strong> which were<br />
drawn at admission and after 2-hours. The<br />
researchers combined <strong>the</strong> ASPECT protocol<br />
with medical records and telephone followup<br />
to determine <strong>the</strong> study’s primary endpoint,<br />
major adverse cardiac events within<br />
30 days after initial presentation.<br />
The POC panel results were considered<br />
positive when cTn was ≥0.05µg/L, CK MB<br />
was ≥4.3 µg/L or had an increase ≥1.6 µg/L<br />
within 2 hours, or myoglobin was ≥108<br />
µg/L or increased ≥25% within 2 hours.<br />
Patients were deemed low risk if <strong>the</strong>y had a<br />
TIMI score of 0, no new ischemic changes<br />
on ECG, and normal results from <strong>the</strong> POC<br />
biomarker panel, at both admission and<br />
2-hours. The researchers found that 9.8%<br />
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of patients were at low risk and would have<br />
been eligible <strong>for</strong> early discharge. Following<br />
release from <strong>the</strong> hospital, a major cardiac<br />
event occurred in three (0.9%) low-risk<br />
patients, giving <strong>the</strong> protocol a sensitivity<br />
of 99.3%, specificity of 11%, and negative<br />
predictive value of 99.1%.<br />
Practice Changes Desired but Difficult<br />
Observers agreed that a system which<br />
would lead to as many as 10% of suspected<br />
ACS patients being discharged quickly<br />
and safely would have considerable merit.<br />
“There’s overcrowding in emergency departments<br />
in <strong>the</strong> U.S. and world wide, so<br />
even a nine or 10 percent discharge rate<br />
that wasn’t <strong>the</strong>re be<strong>for</strong>e would make a big<br />
difference in work flow,” said Alan Wu,<br />
PhD, director of clinical chemistry and<br />
toxicology at <strong>the</strong> University of Cali<strong>for</strong>nia-<br />
San Francisco.<br />
However, Wu was not alone in cautioning<br />
that as intriguing as <strong>the</strong> ASPECT results<br />
may be, a 2-hour assessment protocol is<br />
unlikely to be adopted in practice anytime<br />
soon. “It’s not a simple thing to change protocols.<br />
No single study would be <strong>the</strong> driving<br />
<strong>for</strong>ce to elicit such a change, but this will<br />
contribute to it,” he said. “Every institution<br />
would have to look at its own resources,<br />
needs, and turnaround times, and determine<br />
if it would be com<strong>for</strong>table with a twohour<br />
rule-out. A lot of hospitals in <strong>the</strong> U.S.<br />
will not be ready to adopt this today, especially<br />
where <strong>the</strong> medicolegal aspects are so<br />
different and we don’t have <strong>the</strong> luxury of<br />
missing an MI.”<br />
Hospitals worldwide adhere to guidelines<br />
on <strong>the</strong> universal definition of MI <strong>issue</strong>d<br />
in 2007 by <strong>the</strong> European Society of<br />
Cardiology, <strong>American</strong> College of Cardiology<br />
Foundation, <strong>American</strong> Heart <strong>Association</strong>,<br />
and World Heart Foundation. These<br />
guidelines call <strong>for</strong> a cTn measurement<br />
exceeding <strong>the</strong> 99th percentile of a normal<br />
reference population with a coefficient of<br />
variation ≤10% as an element of diagnosing<br />
MI, along with at least one additional criterion:<br />
symptoms or ECG changes indicative<br />
of ischemia; development of pathological Q<br />
waves in <strong>the</strong> ECG; or imaging evidence of<br />
new loss of viable myocardium or regional<br />
wall motion abnormality. The guidelines<br />
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also note <strong>the</strong> importance of rising and/or<br />
falling cTn values in discerning MI. Measurements<br />
should be taken at <strong>the</strong> time of<br />
first assessment and 6–9 hours later to detect<br />
any pattern. CK-MB by mass assay is an<br />
acceptable alternative when cTn values are<br />
not available, according to <strong>the</strong> guidelines.<br />
Cutting Down Assessment Times<br />
Healthcare systems have adopted various<br />
strategies to adhere to <strong>the</strong> universal definition<br />
of MI while not keeping chest pain patients<br />
in emergency department beds per se.<br />
For example, many have chest pain or observation<br />
units where <strong>the</strong>y transfer suspected<br />
ACS patients <strong>for</strong> continued work up.<br />
However, depending on how <strong>the</strong> units are<br />
staffed and where <strong>the</strong>y’re located, <strong>the</strong>y may<br />
still demand attention and resources from<br />
<strong>the</strong> emergency department <strong>for</strong> 6–8 hours,<br />
and in some instances, up to 12 hours.<br />
Widespread adoption of <strong>the</strong> universal<br />
definition of MI and use of strategies like<br />
observation units reflect how far <strong>the</strong> fields<br />
of emergency medicine and cardiology<br />
have come over <strong>the</strong> past three decades in<br />
discerning MI from o<strong>the</strong>r sources of chest<br />
pain and moving towards shorter, more efficient<br />
assessment processes, according to<br />
Ezra Amsterdam, MD, associate chief of<br />
cardiovascular medicine at UC Davis Medical<br />
Center in Sacramento, Calif. “There’s<br />
been an evolution over <strong>the</strong> past 30 years.<br />
K-ASSAY ®<br />
We’ve gone from admitting every adult<br />
patient with chest pain, and putting <strong>the</strong>m<br />
through <strong>the</strong>se rule-out procedures with serial<br />
cardiac enzymes and ECGs over several<br />
days until you finally decided it was OK<br />
to discharge <strong>the</strong> patient. That’s accelerated<br />
into protocols where a majority of patients<br />
are not admitted, and it’s done safely,” he<br />
explained. “So <strong>the</strong> ASPECT protocol is not<br />
new per se. What’s new is <strong>the</strong>ir systematic<br />
approach to a two-hour assessment.”<br />
An Objective Method<br />
Such a systematic approach to identifying<br />
patients at low risk has been a missing ingredient<br />
in emergency medicine, according<br />
to W. Frank Peacock, MD, vice chair<br />
of emergency medicine at <strong>the</strong> Cleveland<br />
Clinic Foundation. “Chest pain is <strong>the</strong> emergency<br />
department’s first or second most<br />
common presentation. The likelihood of<br />
an emergency doctor having a bad outcome<br />
in patients with chest pain occurs in<br />
<strong>the</strong> first five years of practice, so that tells<br />
you it’s really subjective,” he said. “What<br />
Martin did was to validate an accelerated<br />
diagnostic protocol with completely objective<br />
measures. There’s nothing subjective<br />
about it, and that’s <strong>the</strong> advantage.” Peacock<br />
helped analyze data and write <strong>the</strong> ASPECT<br />
report, but no Cleveland Clinic patients<br />
were part of <strong>the</strong> study.<br />
See chest Pain Protocol, continued on page 8<br />
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hs-cTn Assays: A Game Changer?<br />
chest Pain Protocol, continued from page 6<br />
Than added that demonstrating <strong>the</strong><br />
value of a structured risk assessment was<br />
a key objective of ASPECT. “A lot of literature<br />
shows that assessments of pre-test<br />
probabilities are done extremely poorly<br />
by clinicians,” he observed. “In general, we<br />
tend to overestimate <strong>the</strong> risks because we’re<br />
concerned about <strong>the</strong> possibility of getting<br />
it wrong. We also tend not to agree with<br />
each o<strong>the</strong>r in assessing risk. That’s why we<br />
thought some sort of structured risk assessment<br />
was important.”<br />
The Role of High-Sensitivity cTn Assays<br />
While experts agreed that <strong>the</strong> ASPECT protocol<br />
broke ground by laying out objective<br />
assessment criteria <strong>for</strong> ACS, several observers<br />
questioned <strong>the</strong> relevancy of a POC panel<br />
employing CK-MB, myoglobin, and a<br />
contemporary—but not high-sensitivity—<br />
cTnI assay, given that both high-sensitivity<br />
cTnT and cTnI assays with limits of detection<br />
10 times lower than conventional assays<br />
are about to hit <strong>the</strong> U.S. market (CLN<br />
Feb 2011). In addition, <strong>the</strong> cTnI assay used<br />
in ASPECT, <strong>the</strong> Alere Triage CardioProfiler,<br />
is not approved <strong>for</strong> use in <strong>the</strong> U.S.<br />
“There’s no question that ASPECT adds<br />
to <strong>the</strong> argument that myoglobin and CK-<br />
8 CliniCal laboratory news July 2011<br />
MB are no longer necessary,” said Wu. “In<br />
my opinion that conclusion was reached<br />
years ago, even be<strong>for</strong>e <strong>the</strong> advent of <strong>the</strong><br />
current generation of troponin assays, but<br />
this reaffirms even more so that labs should<br />
move away from <strong>the</strong> <strong>for</strong>mer two.”<br />
Than explained that in his own clinical<br />
practice, he has not used myoglobin or<br />
CK-MB <strong>for</strong> at least a decade, but that <strong>the</strong><br />
ASPECT investigators specifically wanted<br />
to evaluate a POC biomarker panel. “We<br />
were interested in <strong>the</strong> point-of-care concept,<br />
but we also felt that by using a slightly<br />
inferior troponin assay, one can say you<br />
can do this with any troponin assay you<br />
like—ei<strong>the</strong>r point-of-care or central lab—<br />
because even a less-sensitive assay works<br />
just fine,” he explained. “The main message<br />
of <strong>the</strong> paper was that <strong>the</strong> combination<br />
of this risk/pre-test probability tool, with<br />
ECG and troponin or combinations of<br />
biomarkers can be used <strong>for</strong> safe, early discharge<br />
of some patients.<br />
Whe<strong>the</strong>r <strong>the</strong> new high-sensitivity cTn<br />
assays will hinder or harm ef<strong>for</strong>ts to speed<br />
emergency department assessment of chest<br />
pain patients remains unclear. Some observers,<br />
like Michael Kontos, MD, argued<br />
that <strong>the</strong> assays will help quickly identify <strong>the</strong><br />
lowest of low-risk patients but contribute<br />
Guidelines <strong>for</strong><br />
managing acute coronary<br />
syndrome Patients<br />
Key professional organizations have published guidelines on<br />
<strong>the</strong> use and interpretation of cardiac biomarkers in aCs.<br />
acc/aha 2007 Guidelines <strong>for</strong> <strong>the</strong> management of Patients<br />
with unstable angina/non-sT-elevation myocardial<br />
infarction, J am Coll Cardiol 2007;50:e1–157.<br />
clinical Policy: critical <strong>issue</strong>s in <strong>the</strong> evaluation and<br />
management of adult Patients with non-sT-segment<br />
elevation acute coronary syndromes,<br />
annals of emergency Medicine 2006;48:270–301.<br />
nacb laboratory medicine Practice Guidelines <strong>for</strong><br />
utilization of biochemical markers in acute coronary<br />
syndromes and heart failure, Clin Chem 2007;53:2086–2096.<br />
Testing of low-risk Patients Presenting to <strong>the</strong> emergency<br />
department with chest Pain: a scientific statement from<br />
<strong>the</strong> american heart association, Circulation 2010;122;1756–76.<br />
universal definition of myocardial infarction,<br />
J am Coll Cardiol 2007;50:2173–2195.<br />
in o<strong>the</strong>r ways to slower emergency department<br />
processing times. “You’ll have <strong>the</strong> really<br />
low-risk cohort where <strong>the</strong> troponin will<br />
be so sensitive that once you do <strong>the</strong> test and<br />
clinical assessment, you’ll essentially be able<br />
to exclude an acute coronary syndrome,”<br />
he said. “But <strong>the</strong>n you’ll have a more intermediate<br />
risk group that will have detectible<br />
troponin levels—not necessarily with serial<br />
changes or highly suggestive of acute<br />
coronary syndrome—but <strong>the</strong>y clearly need<br />
some sort of fur<strong>the</strong>r evaluation.” Kontos is<br />
associate professor of internal medicine at<br />
Virginia Commonwealth University’s Pauley<br />
Heart Center in Richmond.<br />
While high-sensitivity cTnI and cTnT<br />
assays might pose challenges in understanding<br />
just what very low levels of circulating<br />
cTn mean, Than suggested that<br />
when used with o<strong>the</strong>r components of <strong>the</strong><br />
ASPECT protocol, <strong>the</strong> tests still would<br />
bring clarity and speed to emergency department-based<br />
chest pain evaluations.<br />
“There are far more patients who need to<br />
be ruled-out than ruled-in, and <strong>the</strong> way<br />
I see <strong>the</strong> high-sensitivity troponin assays<br />
working is that you’ll be able to set a slightly<br />
higher pretest probability to your risk score<br />
because <strong>the</strong> assay will be more sensitive,” he<br />
said. “This will enable you to incorporate<br />
a broader group of patients in a potential<br />
early rule-out group. There needs to be a<br />
greater awareness of rule-out and <strong>the</strong> benefits<br />
it can have on <strong>the</strong> healthcare system.”<br />
A Glimpse of <strong>the</strong> Future<br />
Most experts agreed that <strong>the</strong> high-sensitivity<br />
cTnT and cTnI assays eventually would<br />
lead <strong>the</strong> way towards shorter chest pain assessment<br />
protocols. “Conceptually, this a<br />
great model to consider, and it’s a good first<br />
step in thinking about whe<strong>the</strong>r assays will<br />
be able to differentiate chest pain patients<br />
this early in <strong>the</strong> process. The high-sensitivity<br />
troponin assays will narrow <strong>the</strong> window,”<br />
predicted Fred Apple, PhD, professor<br />
of laboratory medicine and pathology<br />
at <strong>the</strong> University of Minnesota School of<br />
Medicine, and medical director of clinical<br />
laboratories at Hennepin County Medical<br />
Center in Minneapolis.<br />
However, Apple cautioned that considerably<br />
more research would be needed<br />
be<strong>for</strong>e 2-hour chest pain work-ups become<br />
standard-of-care. “We’ll need a wealth of<br />
more in<strong>for</strong>mation be<strong>for</strong>e we start changing<br />
practice patterns. The high-sensitivity troponin<br />
assays will need to be looked at <strong>for</strong><br />
baseline and two hours <strong>for</strong> every person<br />
who walks in <strong>the</strong> emergency department<br />
with suspected acute coronary syndrome,<br />
and determine whe<strong>the</strong>r an absolute value<br />
or delta change percent is best <strong>for</strong> patient<br />
triage. This is not ready <strong>for</strong> primetime just<br />
yet.”<br />
Research ef<strong>for</strong>ts that might trans<strong>for</strong>m<br />
chest pain assessment standards already are<br />
underway. For example, a team of British<br />
researchers recently reported that patients<br />
with suspected MI who were tested at presentation<br />
and after 90 minutes with a POC<br />
biomarker panel consisting of cTn, CK-<br />
MB, and myoglobin had shorter median,<br />
but not mean, lengths of stay in <strong>the</strong> emergency<br />
department and were discharged<br />
more frequently without inpatient admission<br />
(Heart 2011;97:190–196).<br />
In addition, Amsterdam and his colleagues<br />
at UC Davis are preparing to<br />
publish results from an accelerated assessment<br />
process <strong>for</strong> very low risk patients.<br />
“We’ve been investigating a protocol<br />
that involves a clinical assessment,<br />
biomarkers, and ECG with a two-to-four<br />
hour period,” he said. “It’s a minority<br />
of our population, but we’ve found<br />
<strong>the</strong> patients we’re doing this with to be<br />
very safe with no events at 30-days.”<br />
Than also has initiated a randomized<br />
controlled trial using <strong>the</strong> ASPECT protocol<br />
but with a central lab-based cTn assay.<br />
“I wouldn’t expect anyone to change <strong>the</strong>ir<br />
practice necessarily based on <strong>the</strong> ASPECT<br />
study, but I might expect <strong>the</strong>m to take more<br />
interest when results from this second study<br />
become available,” he said. “We expect that<br />
we’ll demonstrate that you can send 15<br />
to 20 percent of patients home early and<br />
safely, with an economic benefit in terms of<br />
bed days saved.” CLN
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10 CliniCal laboratory news July 2011<br />
Thyroglobulin<br />
Solutions to Analytical Pitfalls in<br />
Differentiated Thyroid Cancer Monitoring<br />
By CaRole spenCeR, Mt, phD, FaCB<br />
differentiated thyroid cancer (dtC), <strong>the</strong> most common endocrine malignancy, is a highly curable<br />
disease with 5-year survival rates in excess of 95%. treatment <strong>for</strong> dtC typically involves thyroidectomy<br />
followed by, in certain cases, radioactive iodine ablation, as well as thyroid-stimulating<br />
hormone (tsH) suppression. serum thyroglobulin (tg) measurement is a cornerstone of postoperative<br />
monitoring and long-term surveillance of dtC patients.<br />
a radioimmunoassay (ria) <strong>for</strong> measuring serum tg measurement was first developed in <strong>the</strong> 1970s, but since<br />
<strong>the</strong>n, several different immunometric assay (iMa) methods have been introduced and gained in popularity over<br />
time. in concert with <strong>the</strong>se changes, clinicians now use serum tg primarily <strong>for</strong> dtC monitoring, whereas in <strong>the</strong> past<br />
<strong>the</strong>y also relied on it to investigate non-neoplastic pathologies such as hyperthyroidism, thyroiditis, and goiter.<br />
Despite <strong>the</strong> fact that serum Tg measurement<br />
is a well-accepted test that has been in<br />
common use <strong>for</strong> 4 decades, it still is subject<br />
to a variety of analytical challenges, including<br />
insensitivity, wide between-method<br />
variability, and Tg autoantibody (TgAb)<br />
interference, among o<strong>the</strong>rs. This review<br />
will contrast <strong>the</strong> clinical utility of Tg testing<br />
in DTC with <strong>the</strong> technical limitations related<br />
to <strong>the</strong> test and provide laboratorians<br />
with suggested remedies <strong>for</strong> <strong>the</strong>se analytical<br />
challenges.<br />
The Role of Tg in DTC<br />
Following thyroidectomy, DTC patients<br />
need life-long surveillance to monitor <strong>for</strong><br />
tumor recurrence. An estimated 10% experience<br />
recurrence during <strong>the</strong> first decade after<br />
surgery, and an additional 5% have late<br />
recurrences that may develop decades after<br />
<strong>the</strong> initial treatment. Serum Tg measurement<br />
and periodic cervical ultrasound are<br />
<strong>the</strong> main tools <strong>for</strong> long-term surveillance<br />
(1).<br />
The reason serum Tg measurement<br />
has such value as a tumor-marker <strong>for</strong><br />
DTC is that Tg protein is syn<strong>the</strong>sized<br />
uniquely in thyroid follicular cells. Even<br />
though <strong>the</strong> pre-operative Tg concentra-<br />
tion is not in<strong>for</strong>mative as a biomarker <strong>for</strong><br />
DTC, preoperative values can provide a<br />
gauge of <strong>the</strong> tumor’s efficiency <strong>for</strong> Tg secretion<br />
and validate <strong>the</strong> utility of postoperative<br />
Tg monitoring. Postoperative Tg<br />
measurement is likely to be most sensitive<br />
when small tumors are associated with a<br />
high preoperative Tg concentration, as<br />
compared to large tumors being associated<br />
with low preoperative serum Tg values.<br />
The latter suggests <strong>the</strong> tumor is not<br />
capable of secreting appreciable amounts<br />
of Tg.<br />
Staging and risk-stratification are critical<br />
<strong>for</strong> determining both <strong>the</strong> frequency of<br />
Tg monitoring and <strong>the</strong> need <strong>for</strong> additional<br />
imaging modalities (CT, MRI, PET) or<br />
radioiodine treatment. Most Tg testing is<br />
done with serum. However, in recent years<br />
it has become common to measure Tg in<br />
saline wash-outs of <strong>the</strong> needles used to biopsy<br />
suspicious lymph nodes (2).<br />
Because Tg is thyroid- but not tumorspecific,<br />
patient-related factors influence<br />
<strong>the</strong> interpretation of serum Tg concentrations.<br />
Examples include <strong>the</strong> mass of remaining<br />
thyroid t<strong>issue</strong> after thyroidectomy,<br />
recent injury, and <strong>the</strong> TSH status of <strong>the</strong><br />
patient.<br />
Tg Assay Limitations<br />
The technical pitfalls of Tg measurement<br />
include between-method variability, inappropriate<br />
reference ranges, suboptimal<br />
functional sensitivity (FS), hook effects, and<br />
human anti-mouse antibody (HAMA), as<br />
well as TgAb interferences. Table 1 summarizes<br />
<strong>the</strong> characteristics of nine current Tg<br />
assays, which include several different IMA<br />
methods, an enzyme-linked immunosorbent<br />
assay, and an RIA. First-generation<br />
IMA methods have two particularly serious<br />
limitations, including insensitivity and<br />
TgAb interference. Second-generation IMA<br />
methods have a ten-fold higher FS that facilitates<br />
monitoring of basal Tg levels and<br />
may eliminate <strong>the</strong> need <strong>for</strong> expensive and<br />
inconvenient recombinant human TSH<br />
(rhTSH) stimulation. However, secondgeneration<br />
IMAs are still prone to TgAb<br />
and HAMA interferences.<br />
Method and Biological Variability<br />
Although a Tg reference preparation<br />
(CRM-457) has been available <strong>for</strong> at least<br />
15 years, method-related variabilities in Tg<br />
measurement persist (3). Some disparities<br />
reflect TgAb interference, which will be<br />
discussed more fully later in this review.<br />
However, even in <strong>the</strong> absence of interfering<br />
TgAb, <strong>the</strong> between-method coefficient of<br />
variation is about 30%, more than twice <strong>the</strong><br />
within-person biologic variability (3–5).<br />
Complicating matters, serum Tg obtained<br />
from DTC patients is very heterogeneous,<br />
and different from <strong>the</strong> glandular Tg preparations<br />
used as standards. Abnormalities<br />
in <strong>the</strong> post-translational maturation of Tg<br />
protein involving glycosylation, phosphorylation,<br />
sulfation, and iodination cause this<br />
heterogeneity. Indeed, some tumors secrete<br />
immature, poorly iodinated, and/or con<strong>for</strong>mationally<br />
abnormal Tg molecules that<br />
are detected with different specificities by<br />
different assays depending on <strong>the</strong> monoclonal<br />
antibody reagents <strong>the</strong>y use (3).<br />
Between-method variability—whe<strong>the</strong>r<br />
caused by TgAb interferences or patientrelated<br />
Tg heterogeneity compounded by<br />
differences in assay sensitivity and specificity—require<br />
serial Tg monitoring <strong>for</strong><br />
each patient using <strong>the</strong> same method over<br />
time. This is a challenge because DTC patients<br />
need lifelong Tg monitoring and may<br />
move, change physicians, and/or insurance<br />
plans that result in a change in contract<br />
laboratory. When a change in Tg method is<br />
necessary, it is critical to re-baseline <strong>the</strong> patient’s<br />
Tg level to prevent disrupting patient
care. Un<strong>for</strong>tunately, most laboratories are<br />
not able to do this because archived unused<br />
specimens usually are not available.<br />
Setting <strong>the</strong> Reference Range<br />
Biochemical test results are typically reported<br />
relative to a reference range established<br />
from measurements made on individuals<br />
without conditions likely to affect<br />
<strong>the</strong> test. Any Tg assay reference range established<br />
using normal euthyroid subjects will<br />
be influenced by <strong>the</strong> rigor used to exclude<br />
individuals with thyroid pathologies such<br />
as goiter and thyroiditis. Regardless of <strong>the</strong>se<br />
factors, Tg reference ranges established <strong>for</strong><br />
normal euthyroid subjects have little relevance<br />
when interpreting serum Tg concentrations<br />
in thyroidectomized DTC patients.<br />
In <strong>the</strong>se patients, it is better to interpret<br />
serum Tg levels relative to <strong>the</strong> degree of<br />
surgery (lobectomy versus near-total thyroidectomy),<br />
<strong>the</strong> TSH status of <strong>the</strong> patient,<br />
and <strong>the</strong> technical benchmarks of <strong>the</strong> assay<br />
used (Figure 1).<br />
Ano<strong>the</strong>r factor in interpreting postoperative<br />
Tg values is that Tg is thyroid- but<br />
not tumor-specific, so <strong>the</strong> serum Tg concentration<br />
represents <strong>the</strong> contribution from<br />
normal and any residual tumor t<strong>issue</strong>. For<br />
example, <strong>the</strong> typical 1–2 g normal thyroid<br />
remnant left after thyroidectomy contributes<br />
1–2 µg/L Tg to <strong>the</strong> serum concentration<br />
in <strong>the</strong> absence of TSH stimulation.<br />
Additionally, some tumors are not efficient<br />
Tg secretors. In extreme cases, tumors may<br />
not secrete a detectable Tg concentration<br />
or may secrete abnormal Tg iso<strong>for</strong>ms that<br />
are not detected by <strong>the</strong> monoclonal antibodies<br />
employed as IMA reagents. Lastly,<br />
<strong>the</strong>re typically is a 10 to 20-fold difference<br />
between Tg measured in <strong>the</strong> absence versus<br />
<strong>the</strong> presence of TSH stimulation with ei<strong>the</strong>r<br />
rhTSH or <strong>the</strong> high endogenous TSH associated<br />
with thyroid hormone withdrawal.<br />
The Benefits of Functional Sensitivity<br />
A realistic determination of Tg assay sensitivity<br />
is critical <strong>for</strong> <strong>the</strong> effective management<br />
of DTC patients following thyroidectomy,<br />
when very little Tg-producing t<strong>issue</strong> is left.<br />
Current guidelines recommend using FS as<br />
a means of determining Tg assay sensitivity<br />
(6). FS is a clinically relevant parameter<br />
based on low-end, between-run precision.<br />
The guidelines define it as <strong>the</strong> Tg concentra-<br />
figure 1<br />
factors that influence Tg reference intervals<br />
schematic diagram of how <strong>the</strong> tg reference range is influenced by <strong>the</strong> degree of surgery: lobectomy<br />
(center panel) or near-total thyroidectomy (right panel), tsH status (on abscissa), and assay functional<br />
sensitivity (first- versus second-generation).<br />
Adapted from reference 6.<br />
tion that can be measured with 20% coefficient<br />
of variation determined from multiple<br />
measurements of a human serum pool containing<br />
a low Tg level made across a clinically-relevant<br />
time-span (6–12 months) and<br />
employing at least two calibrator lots and<br />
two reagent lots. The guidelines committee<br />
developed this definition to realistically represent<br />
<strong>the</strong> sensitivity of <strong>the</strong> test used in clinical<br />
practice, and to replace descriptive terms<br />
like “ultrasensitive” and “supersensitive”<br />
that manufacturers favor <strong>for</strong> marketing.<br />
First- Versus Second-Generation FS<br />
RIA methodology is only capable of firstgeneration<br />
FS ranging from 0.5–1.0 µg/L<br />
(3). Laboratorians hoped that replacing<br />
RIA with IMA methodology would improve<br />
FS by an order of magnitude, as was<br />
<strong>the</strong> case in <strong>the</strong> 1980s <strong>for</strong> TSH. Un<strong>for</strong>tunately,<br />
most current Tg IMA methods still only<br />
have first-generation FS, with a detection<br />
limit only marginally below <strong>the</strong> lower reference<br />
limit <strong>for</strong> control subjects with intact<br />
thyroid glands (Figure 1 and Table 1).<br />
First-generation assays are too insensitive<br />
clinically to use <strong>for</strong> basal Tg monitoring<br />
without TSH stimulation. As a result,<br />
it is customary to measure serum Tg after<br />
rhTSH stimulation, a maneuver analogous<br />
to <strong>the</strong> use of thyrotropin-releasing hormone<br />
stimulation to overcome <strong>the</strong> insensitivity<br />
of <strong>the</strong> TSH assays used be<strong>for</strong>e <strong>the</strong><br />
1990s (7). By consensus, a 72-hour rhTSHstimulated<br />
Tg above 2.0 µg/L is considered<br />
a risk factor <strong>for</strong> disease (7). In reality, this<br />
fixed rhTSH-Tg cutoff has a low positive<br />
predictive value <strong>for</strong> disease of about 50%.<br />
Fur<strong>the</strong>rmore, depending on <strong>the</strong> method<br />
used, a Tg value of 2.0 µg/L could be reported<br />
as being anywhere between 1.5 and<br />
3.2 µg/L using different methods (8).<br />
More recently, second-generation IMAs<br />
have become available with FS ranging<br />
table 1<br />
characteristics of current Tg assays<br />
from 0.05–0.1 µg/L (9). These more sensitive<br />
assays show that <strong>the</strong>re is a strong 10fold<br />
difference between basal and rhTSHstimulated<br />
Tg values, <strong>the</strong>reby obviating<br />
<strong>the</strong> need <strong>for</strong> expensive and inconvenient<br />
rhTSH-stimulated Tg testing <strong>for</strong> most patients<br />
(Figure 3) (8). Second generation<br />
IMAs also facilitate <strong>the</strong> monitoring of basal<br />
Tg trends that improve positive and negative<br />
predictive values <strong>for</strong> assessing risk <strong>for</strong><br />
disease, as compared with <strong>the</strong> rhTSH-Tg<br />
cutoff value of 2.0 µg/L (1,10,11).<br />
Notably, when TgAb is present, rhTSH<br />
stimulation offers no diagnostic benefit. This<br />
is because rhTSH-Tg responses are paradoxically<br />
blunted or absent in <strong>the</strong> presence<br />
of TgAb, possibly because of increased metabolic<br />
clearance of Tg-TgAb complexes (9).<br />
The Hook Effect<br />
A high-dose hook effect can occur when<br />
using IMA to measure exceedingly high Tg<br />
Assay # 1 2 3 4 5 6 7 8 9<br />
Assay Name Access Tg Tg-Plus TgIRMA Immulite 2000 Tg TgRIA Elecsys Tg Tg Wallac Delfia Tg<br />
Manufacturer<br />
Beckman Coulter,<br />
US<br />
BRAHMS<br />
diagnostica,<br />
Germany<br />
CISbio-Schering,<br />
Germany<br />
Siemens, US<br />
Genesis<br />
Diagnostics, UK<br />
University<br />
Sou<strong>the</strong>rn<br />
Cali<strong>for</strong>nia, US<br />
Roche,<br />
Germany<br />
Sanofi Pasteur,<br />
France<br />
Perkin-Elmer,<br />
Finland<br />
Assay Type<br />
non-competitive<br />
ICMA<br />
competitive<br />
IRMA<br />
competitive<br />
IRMA<br />
competitive<br />
ICMA<br />
non-competitive<br />
ELISA<br />
competitive<br />
RIA<br />
competitive<br />
IECMA<br />
competitive<br />
IRMA<br />
competitive<br />
IFMA<br />
Capture Antibody 4xMab pab (rabbit) 4xMab Mab pab (rabbit) pab (rabbit) Mab 4xMab Mab<br />
Tracer ap-Mab 125-iMab 125-iMab (sheep) ap-pab (rabbit) 125-itg Mab 125-iMab eu-Mab<br />
Sample Size µL 40 100 100 50 50 200 20 100 50<br />
1:1 CRM-457<br />
Standardization<br />
Functional<br />
yes<br />
no<br />
(factor of 2)<br />
yes yes no yes yes no no<br />
Sensitivity ng/mL<br />
(µg/L)*#<br />
Reference<br />
0.1 [5,1] 0.4* 0.7 0.9 na 0.5 1.0 na na<br />
Range ng/mL<br />
(µg/L)*<br />
3–32 [3] 2–34 [3] 2.1–43 [3] 1.6–60 2.0–50 3.0-40 1.4–78 1.5–50 1.7–35<br />
*expressed relative to 1:1 CrM-457 standardization; # defined by naCb guidelines (6); [ ] literature citation, no manufacturer data<br />
CliniCal laboratory news July 2011 11
concentrations characteristic of patients<br />
with metastatic disease. These high Tg levels<br />
overwhelm <strong>the</strong> assay’s reagent binding<br />
capacities, which yields inappropriately low<br />
values. Although adoption of a two-step<br />
assay design has reduced this problem, a<br />
hook effect still can occur when measuring<br />
saline wash-outs of <strong>the</strong> needles used to biopsy<br />
metastatic lymph nodes. In such cases,<br />
Tg levels often exceed 10,000 µg/L. Because<br />
of <strong>the</strong>se challenges, laboratories need to use<br />
linearity studies to check <strong>the</strong> high range <strong>for</strong><br />
hooking and <strong>the</strong> potential <strong>for</strong> carry-over<br />
contamination of specimens.<br />
Countering Interferences<br />
Un<strong>for</strong>tunately, <strong>the</strong> Tg IMA methodology<br />
favored by most laboratories is more prone<br />
to interferences from both human antimouse<br />
antibody (HAMA) and TgAb than<br />
is Tg RIA methodology (3,12,13). HAMA<br />
interference usually results in a falsely high<br />
serum Tg that may prompt unnecessary<br />
imaging or radioiodine treatment <strong>for</strong> presumed<br />
disease. In contrast, TgAb interference<br />
causes falsely low or undetectable<br />
serum Tg that can have more serious consequences<br />
because it can mask <strong>the</strong> presence<br />
of disease. Whereas contemporary IMA<br />
methods routinely include blocker reagents<br />
to minimize HAMA interference to around<br />
0.5%, currently <strong>the</strong>re are no effective measures<br />
to overcome TgAb interference encountered<br />
with Tg IMA methodology (8).<br />
12 CliniCal laboratory news July 2011<br />
HAMA in <strong>the</strong> specimen can interact<br />
with one of <strong>the</strong> monoclonal antibody reagents<br />
to create a false signal that simulates<br />
<strong>the</strong> presence of a high antigen (Tg) concentration<br />
(12). Rarely, HAMA can block <strong>the</strong><br />
participation of <strong>the</strong> antibody reagents and<br />
cause a falsely low Tg value (13). Physicians<br />
should suspect HAMA when <strong>the</strong> serum Tg<br />
level appears inappropriate in <strong>the</strong> context<br />
of <strong>the</strong> patient’s clinical status, or fails to<br />
respond appropriately to changes in TSH.<br />
An example would be when Tg levels rise<br />
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so <strong>for</strong> <strong>the</strong> approximately 20% of DTC patients<br />
with detectable TgAb, <strong>the</strong> TgAb concentration<br />
can be used to monitor changes<br />
in tumor mass in preference to measuring<br />
Tg by IMA (14). Specifically, when <strong>the</strong> antigenic<br />
stimulus is removed by thyroidectomy,<br />
TgAb concentrations typically decline<br />
by approximately 50% within <strong>the</strong> first year<br />
and eventually disappear within a median<br />
of 3 years when patients are rendered disease-free<br />
(14). Conversely, TgAb concentrations<br />
rise in response to increased antigen<br />
concentrations following second surgeries,<br />
fine needle biopsy, or radioiodine <strong>the</strong>rapy<br />
as well as with recurrence. Serial monitoring<br />
of TgAb concentrations can overcome<br />
<strong>the</strong> problem of unreliable Tg IMA measurements.<br />
TgAb Interference in IMA<br />
TgAb interference with Tg IMA measurements<br />
can cause Tg underestimation and<br />
<strong>the</strong> reporting of falsely low or undetectable<br />
values that can mask <strong>the</strong> presence of<br />
disease (3,6). Although RIA methods tend<br />
to be more resistant to TgAb interference,<br />
<strong>the</strong>y too can produce falsely low or high<br />
values, depending on <strong>the</strong> characteristics<br />
of <strong>the</strong> assay reagents and <strong>the</strong> endogenous<br />
TgAb in <strong>the</strong> specimen. There<strong>for</strong>e, reliable<br />
TgAb detection is critical <strong>for</strong> au<strong>the</strong>nticating<br />
all Tg measurements. Although <strong>the</strong><br />
propensity <strong>for</strong> interference is related to <strong>the</strong><br />
TgAb concentration, high TgAb levels do<br />
not necessarily produce interference, and in<br />
some cases, low TgAb concentrations may<br />
profoundly interfere (3).<br />
Manufacturer-recommended assay cutoffs<br />
<strong>for</strong> detecting TgAb are typically set in<br />
<strong>the</strong> detectable range and relate to <strong>the</strong> diagnosis<br />
of autoimmune thyroid disease, not<br />
<strong>the</strong> detection of interfering TgAb. Inappropriate<br />
cutoffs, toge<strong>the</strong>r with differences in<br />
assay sensitivity and specificity, cause some<br />
specimens to be classified as TgAb-positive<br />
by one method and TgAb-negative by ano<strong>the</strong>r<br />
(5). Laboratorians should be aware<br />
that any TgAb detected above <strong>the</strong> analytic<br />
sensitivity limit has <strong>the</strong> potential to interfere<br />
with Tg measurement. Notably, <strong>the</strong>se<br />
between-method disparities exist despite<br />
<strong>the</strong> methods’ purported standardization<br />
with <strong>the</strong> same international reference<br />
preparation (WHO 1st IRP 65/93). TgAb<br />
method-related disparities are difficult to<br />
eliminate because <strong>the</strong>y reflect patient-related<br />
TgAb heterogeneity compounded by<br />
differences in assay sensitivity and specificity<br />
(5).<br />
Labs on <strong>the</strong> Front Lines<br />
Given <strong>the</strong> importance of life-long postoperative<br />
monitoring of DTC patients, labs<br />
have a vital responsibility to ensure that Tg<br />
measurements are as accurate as possible,<br />
and that <strong>the</strong>y keep abreast of and address<br />
<strong>the</strong> analytical limitations of <strong>the</strong>ir Tg assay<br />
methods. Ongoing dialogue with endocrinologists<br />
and oncologists likewise is essential,<br />
so <strong>the</strong>se clinicians can be well-in<strong>for</strong>med<br />
of any method changes and confer readily<br />
with laboratorians about any discrepant<br />
results. CLN<br />
REFERENCES<br />
1. Cooper DS, Doherty GM, Haugen BR,<br />
Kloos RT, et al. Revised <strong>American</strong> Thyroid<br />
<strong>Association</strong> management guidelines <strong>for</strong> patients<br />
with thyroid nodules and differentiated<br />
thyroid cancer. Thyroid 2009;19:1–48.<br />
2. Snozek CL, Chambers EP, Reading CC,<br />
Sebo TJ, et al. Serum thyroglobulin, highresolution<br />
ultrasound, and lymph node<br />
thyroglobulin in diagnosis of differentiated<br />
thyroid carcinoma nodal metastases. J Clin<br />
Endocrinol Metab 2007;1992:4278–4281.<br />
3. Spencer CA, Bergoglio LM, Kazarosyan<br />
M, Fatemi S, et al. <strong>Clinical</strong> impact of thyroglobulin<br />
(Tg) and Tg autoantibody method<br />
differences on <strong>the</strong> management of patients<br />
with differentiated thyroid carcinomas.<br />
J Clin Endocrinol Metab 2005;1990:5566–<br />
5575.<br />
4. Jensen E, Petersen PH, Blaabjerg O, Hegedüs<br />
L. Biological variation of thyroid autoantibodies<br />
and thyroglobulin. Clin Chem<br />
Lab Med 2007;45:1058–1064.<br />
5. Spencer C, Petrovic I, Fatemi S. Current<br />
thyroglobulin autoantibody (TgAb)<br />
assays often fail to detect interfering TgAb<br />
that can result in <strong>the</strong> reporting of falsely<br />
low/undetectable serum Tg IMA values <strong>for</strong><br />
patients with differentiated thyroid cancer.<br />
J Clin Endocrinol Metab 96:1283–91, 2011.<br />
6. Baloch Z, Carayon P, Conte-Devolx B,<br />
Demers LM, et al. Laboratory medicine<br />
practice guidelines: laboratory support <strong>for</strong><br />
<strong>the</strong> diagnosis and monitoring of thyroid<br />
disease. Thyroid 2003;13:3–126.<br />
7. Mazzaferri EL, Robbins RJ, Spencer<br />
CA, Braverman LE, et al. A consensus report<br />
of <strong>the</strong> role of serum thyroglobulin as<br />
a monitoring method <strong>for</strong> low-risk patients<br />
with papillary thyroid carcinoma. J Clin<br />
Endocrinol Metab 2003;88:1433–1441.<br />
8. Spencer CA, Fatemi S, Singer P, Nicoloff<br />
JT, et al. Serum basal thyroglobulin measured<br />
by a 2nd generation assay correlates<br />
with <strong>the</strong> recombinant human tsh-stimulated<br />
thyroglobulin response in patients<br />
treated <strong>for</strong> differentiated thyroid cancer.<br />
Thyroid 2010;20:587–95.<br />
9. Spencer CA, Lopresti JS. Measuring<br />
thyroglobulin and thyroglobulin autoantibody<br />
in patients with differentiated thyroid<br />
cancer. Nat Clin Pract Endocrinol Metab<br />
2008;4:223–233.<br />
10. Tuttle RM, Leboeuf R. Follow up approaches<br />
in thyroid cancer: a risk adapted<br />
paradigm. Endocrinol Metab Clin North<br />
Am 2008;37:419–435.<br />
11. Giovanella L, Ceriani L, Suriano S,<br />
Ghelfo A, et al. Thyroglobulin measurement<br />
be<strong>for</strong>e rhTSH-aided (131)I ablation<br />
in detecting metastases from differentiated<br />
thyroid carcinoma. Clin Endocrinol (Oxf)<br />
2008;69:659–663.<br />
12. Preissner CM, O’Kane DJ, Singh RJ,<br />
Morris JC, et al. Phantoms in <strong>the</strong> assay<br />
tube: heterophile antibody interferences in<br />
serum thyroglobulin assays. J Clin Endocrinol<br />
Metab 2003; 88:3069–3074.<br />
13. Giovanella L, Ghelfo A. Undetectable<br />
serum thyroglobulin due to negative<br />
interference of heterophile antibodies in<br />
relapsing thyroid carcinoma. Clin Chem<br />
2007;53:1871–1872.<br />
14. Chiovato L, Latrofa F, Braverman LE,<br />
Pacini F, et al. Disappearance of humoral<br />
thyroid autoimmunity after complete removal<br />
of thyroid antigens. Ann Intern Med<br />
2003;139:346–351.<br />
Carole Spencer, MT, PhD,<br />
FACB, is a professor of<br />
medicine in <strong>the</strong> Department<br />
of Medicine at <strong>the</strong> University<br />
of Sou<strong>the</strong>rn Cali<strong>for</strong>nia.<br />
Email: cspencer@usc.edu
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What are <strong>the</strong> three most important<br />
elements of safe process design?<br />
The first is accounting <strong>for</strong> human factors.<br />
It is important to recognize that processes<br />
which rely on perfect human per<strong>for</strong>mance<br />
are incapable of high reliability. The second<br />
is standardization with limited discretionary<br />
variability (See “Examples,” below).<br />
Fur<strong>the</strong>rmore, reasons <strong>for</strong> appropriate variation<br />
should be captured and fed into <strong>the</strong><br />
process design. The third is organizational<br />
culture. It is essential to have a positive reporting<br />
culture that exposes misses and<br />
near misses, because no process or procedure<br />
is failure-proof. Successful reporting<br />
cultures also identify key vulnerabilities.<br />
How do attitudes about safety in <strong>the</strong><br />
laboratory affect process design?<br />
All processes that rely on vigilance and hard<br />
work are incapable of per<strong>for</strong>ming at a high<br />
level of reliability. If leadership and/or <strong>the</strong><br />
front line worker do not understand <strong>the</strong><br />
limitations of human per<strong>for</strong>mance, <strong>the</strong>n<br />
high levels of reliability will not be possible.<br />
Also, a positive reporting culture is essential.<br />
Punishment <strong>for</strong> human error will impede<br />
process improvement and make <strong>the</strong><br />
organization less safe and less reliable.<br />
14 CliniCal laboratory news July 2011<br />
PATIENT SAFETY FOCUS<br />
TAkING AIM AT REDuCING LAB ERRORS<br />
Designing Processes <strong>for</strong> Patient Safety<br />
The Key is Finding <strong>the</strong> Vulnerabilities and Fixing Them<br />
richard gitomer, Md, Mba, is chief quality<br />
officer <strong>for</strong> emory university Hospital<br />
Midtown and is a general internist by<br />
training. He has led numerous improvement<br />
projects related to access, efficiency,<br />
and innovation in <strong>the</strong> ambulatory setting<br />
and care of patients with chronic conditions.<br />
dr. gitomer is a recognized leader<br />
in process improvement through his collaborations<br />
with <strong>the</strong> institute <strong>for</strong> Healthcare<br />
improvement and <strong>the</strong> association of<br />
american Medical Colleges.<br />
this inteRview was ConDuCteD By CoRinne Fantz, phD.<br />
<strong>Clinical</strong> laboratories routinely monitor<br />
key processes. Is it not enough to know<br />
what errors occur and why <strong>the</strong>y occur?<br />
Measurement alone does not result in improvement,<br />
but it is essential <strong>for</strong> identifying<br />
areas that need improvement and <strong>for</strong> monitoring<br />
improvement. There is a saying, “You<br />
don’t fatten <strong>the</strong> chicken by weighing it.” (See<br />
Figure, above).<br />
What opportunities and challenges do<br />
new technology bring to old processes?<br />
New technologies increase <strong>the</strong> capability of<br />
systems. For example, autoverification in<br />
<strong>the</strong> lab is faster and more reproducible than<br />
manual verification of results. But technology<br />
comes with some inherent risks. For<br />
those technologies that still require human<br />
intervention, <strong>the</strong> interface between humans<br />
and <strong>the</strong> technology remains <strong>the</strong> most<br />
vulnerable point. These vulnerabilities<br />
include incorrect human operation, due<br />
ei<strong>the</strong>r to human error or errors that result<br />
from interacting with <strong>the</strong> new technology.<br />
All systems will fail at some point. With<br />
older technology, we know those failure<br />
modes and have designed processes to limit<br />
<strong>the</strong>ir impact. We do not have <strong>the</strong> same understanding<br />
of new technologies. So, until<br />
lab examples of standardization<br />
with limited variability<br />
® standardized procedures across all sites<br />
® standardized phlebotomy trays<br />
® one type of point- of-care glucometer in <strong>the</strong> health system<br />
® automation that limits <strong>the</strong> care providers choice of tube types<br />
® selection of a primary referral laboratory<br />
® use of templates <strong>for</strong> interpretative reports<br />
Prothrombin Time<br />
90% Turn around Time<br />
measurement is important to quality improvement, but by itself<br />
will not significantly improve quality.<br />
those vulnerabilities are fully understood,<br />
<strong>the</strong>re will be safety and reliability shortfalls.<br />
Communication errors are a major<br />
contributor of preventable harm to<br />
patients. How can laboratory staff make<br />
change-of-shift hand-offs safer?<br />
Handoffs, like all processes, benefit from<br />
standardization, which increases <strong>the</strong> likelihood<br />
that key in<strong>for</strong>mation will not be<br />
missed. Standardization also creates an<br />
opportunity to measure and improve <strong>the</strong><br />
process. The standard process should include<br />
a template, or checklist (See “Checklist,”<br />
opposite), which highlights key in<strong>for</strong>mation<br />
that should be exchanged.<br />
While every laboratory has a process<br />
<strong>for</strong> communicating critical values,<br />
could you elaborate on a few design<br />
elements that make one process safer<br />
than ano<strong>the</strong>r?<br />
Communicating critical lab values is a process<br />
that is heavily reliant on humans with<br />
all <strong>the</strong>ir inherent vulnerabilities. In addition,<br />
creating a first-level communication<br />
process that includes all <strong>the</strong> eventualities<br />
and exceptions necessary to respond to<br />
every situation would result in a process<br />
so complex that <strong>the</strong> staff would be unable<br />
to execute it in a reliable fashion. Using a<br />
reliable approach to design as described by<br />
Roger Resar, per<strong>for</strong>mance levels in <strong>the</strong> high<br />
90 percentages can be achieved with a series<br />
of simple processes (See “Designing a<br />
Process,” opposite).<br />
The first step is to create a standardized<br />
process that effectively communicates at<br />
least 80% of <strong>the</strong> critical lab values on <strong>the</strong><br />
first attempt. For all <strong>the</strong> failures, <strong>the</strong>re is a<br />
second process that ensures appropriate<br />
communication. This second process usually<br />
is more resource-intensive, but it is able<br />
to handle <strong>the</strong> complexities not addressed in<br />
<strong>the</strong> first process. The benefit of this strategy<br />
is more effective use of resources. The risk is<br />
that failure of <strong>the</strong> initial standard process to<br />
function at an 80% level of reliability or better<br />
can overwhelm <strong>the</strong> redundant process.<br />
By design, <strong>the</strong> redundant process is more<br />
resource-intensive but has limited capacity.<br />
As a physician consumer of laboratory<br />
services, could you provide an example<br />
of a laboratory process that directly<br />
impacts <strong>the</strong> safety of your patients?<br />
I am a general internist who sees ambulatory<br />
patients. Reliable communication of critical<br />
lab results directly impacts <strong>the</strong> safety of<br />
my patients. By definition, <strong>the</strong>se patients are<br />
mostly healthy, so <strong>the</strong> incidence of critical<br />
lab values is very low. Being an infrequent<br />
event makes <strong>the</strong> likelihood that any process<br />
designed to remedy <strong>the</strong> notification barriers<br />
has a greater likelihood of failing. There<strong>for</strong>e,<br />
in my case, because receiving prompt and<br />
accurate notification of critical lab results is<br />
a rare event, it has a higher failure rate than<br />
a process that occurs regularly.<br />
Positive patient identification is essential<br />
to ensuring patient safety. Do errors<br />
in patient identification always mean<br />
<strong>the</strong> process is bad?<br />
Process failure is expected <strong>for</strong> all processes.<br />
Since identifying patients is a process carried<br />
out by humans, it will fail at some<br />
measurable rate. Based on <strong>the</strong> specifications<br />
of <strong>the</strong> clinical team, <strong>the</strong>se error rates<br />
could be well below <strong>the</strong> needs of <strong>the</strong> users
checklist <strong>for</strong> structured<br />
handoffs at shift change<br />
o Current staffing __________________________________<br />
_______________________________________________<br />
o problem cases still pending ________________________<br />
_______________________________________________<br />
o instrument/method <strong>issue</strong>s _________________________<br />
_______________________________________________<br />
o inventory/supplies _______________________________<br />
_______________________________________________<br />
o Computer <strong>issue</strong>s _________________________________<br />
_______________________________________________<br />
o o<strong>the</strong>r <strong>issue</strong>s _____________________________________<br />
_______________________________________________<br />
structured communication will reduce <strong>the</strong> likelihood of missing key elements.<br />
of <strong>the</strong> in<strong>for</strong>mation and <strong>the</strong>re<strong>for</strong>e considered<br />
a good process. But if <strong>the</strong> error rate is<br />
such that it significantly impedes <strong>the</strong> care<br />
of <strong>the</strong> patient, <strong>the</strong> process does not meet<br />
specifications and must be improved.<br />
Would you provide examples of a few<br />
good questions to ask when assessing<br />
how well a process is working?<br />
The first question to ask is: does <strong>the</strong> process<br />
meet <strong>the</strong> needs of <strong>the</strong> customer of <strong>the</strong><br />
process? If it is not meeting <strong>the</strong> specifications<br />
of <strong>the</strong> customer, <strong>the</strong>n <strong>the</strong>re are three<br />
possibilities to assess. First, if <strong>the</strong>re is no<br />
standard process to do <strong>the</strong> task, <strong>the</strong>n <strong>the</strong><br />
standard process must be developed. The<br />
second possibility is that <strong>the</strong>re is a standard<br />
process, but it is not being followed.<br />
designing a Process <strong>for</strong><br />
handling critical values<br />
step 1<br />
® standardize critical value list throughout <strong>the</strong> system<br />
® employ templates <strong>for</strong> communication and documentation<br />
step 2<br />
If critical value communication is unsuccessful after <strong>the</strong> first attempt:<br />
® pass calls from busy technologist to call center with access to many<br />
o<strong>the</strong>r data feeds that help overcome problems, such as a patient<br />
being registered to wrong <strong>the</strong> physician.<br />
® use a clear escalation plan, such as licensed practitioner, ordering<br />
provider, on-call physician, chief-of-service.<br />
® Call patient at home if an outpatient.<br />
By design, <strong>the</strong> redundant process is more resource-intensive but has limited<br />
capacity.<br />
In this case, it is important to understand<br />
why <strong>the</strong> process is not being followed and<br />
redesign <strong>the</strong> process if necessary. Monitors<br />
have to be put in place to detect <strong>the</strong> decline<br />
in per<strong>for</strong>mance and allow <strong>for</strong> <strong>the</strong> appropriate<br />
response. Last, if <strong>the</strong> standard process is<br />
being followed, and customer need is not<br />
met, <strong>the</strong>n <strong>the</strong> standard process must be improved.<br />
How can laboratories design processes<br />
that integrate clinical teams and<br />
patients?<br />
Laboratories are frequently accused of optimizing<br />
<strong>the</strong>ir processes at <strong>the</strong> expense of<br />
<strong>the</strong> patient and <strong>the</strong> clinical team. Part of<br />
<strong>the</strong> problem is that we tend to measure and<br />
Disruptive Behavior<br />
How Labs Can Recognize and Overcome Its Negative Effects<br />
By MiChael astion, MD, phD<br />
In <strong>the</strong> laboratory, producing accurate and<br />
timely patient test results depends on teamwork,<br />
communication, and a collaborative<br />
work environment. However, laboratory<br />
staff who display intimidating and disruptive<br />
behaviors can quickly destabilize this<br />
cooperative environment and negatively<br />
impact patient safety. The Joint Commis-<br />
examples of disruptive behavior<br />
Disruptive Behavior Potential Effect on Patient Safety<br />
physical and verbal intimidation of<br />
a coworker, leading to decreased<br />
communication.<br />
refusal to communicate with<br />
coworkers regarding a problem<br />
testing situation in <strong>the</strong> lab, such as<br />
an intermittent problem with lab<br />
reagents or instruments.<br />
refusal to per<strong>for</strong>m a laboratory<br />
task, such as processing a specimen<br />
or per<strong>for</strong>ming a laboratory test.<br />
refusal to make an outgoing<br />
phone call or answer an incoming<br />
phone call related to patient care.<br />
refusal to come to work despite<br />
being on-call.<br />
perpetrator makes a harmful lab<br />
error because victim, who suspects<br />
<strong>the</strong> error, refuses to speak up.<br />
problem goes unresolved, leading<br />
to erroneous results, delays, and<br />
patient harm.<br />
delay in testing that harms patient.<br />
Critical/urgent test results not<br />
communicated to care provider in<br />
timely fashion leading to patient<br />
harm.<br />
lab understaffing leads to delays in<br />
testing.<br />
verbal abuse negatively impacts patient safety.<br />
sion advises health care organizations to<br />
confront behavior problems in order to<br />
promote a culture of safety and efficient<br />
team per<strong>for</strong>mance (1).<br />
To overcome <strong>the</strong> negative effects of<br />
disruptive employee behaviors, labs first<br />
need to recognize inappropriate conduct.<br />
The Joint Commission developed<br />
assess each section independently ra<strong>the</strong>r<br />
than <strong>the</strong> <strong>entire</strong> care process that results in<br />
healing <strong>the</strong> patient. There may be times,<br />
however, when efficiency in <strong>the</strong> lab may<br />
need to be subordinate to <strong>the</strong> efficiency of<br />
<strong>the</strong> <strong>entire</strong> process of care.<br />
SuGGESTED READING<br />
Grimm E. Shift-to-Shift communication:<br />
what can labs learn from NASA and o<strong>the</strong>r<br />
highly reliable organizations? <strong>Clinical</strong><br />
Laboratory News 2011 (January).<br />
Resar RK. Making non-catastrophic health<br />
care processes more reliable: learning to<br />
walk be<strong>for</strong>e running in creating highreliability<br />
organizations. Health Serv Res<br />
2006; 41:1677–1689.<br />
a list of workplace behaviors considered<br />
both disruptive and threatening to patient<br />
safety (1), including verbal abuse, physical<br />
threats, and intimidation, all of which can<br />
compromise laboratories’ ability to operate<br />
efficiently and effectively. Passive, uncooperative<br />
behavior, such as refusing to per<strong>for</strong>m<br />
assigned tasks and not communicat-<br />
CliniCal laboratory news July 2011 15
ing with coworkers, also negatively affect<br />
laboratories’ day-to-day operations.<br />
These disruptive behaviors are relatively<br />
common and have a significant impact on<br />
medical errors, according to oncology nurse<br />
and author, Theresa Brown. In a recent New<br />
York Times article, she explained how such<br />
inappropriate workplace conduct adversely<br />
affects patient safety (2). For example, out<br />
of fear, a nurse being bullied by a doctor<br />
would be less likely to question <strong>the</strong> doctor’s<br />
orders, despite suspecting an error. Brown<br />
contended that a healthcare worker being<br />
abused or intimated by a co-worker often<br />
avoids communicating with <strong>the</strong> perpetrator,<br />
<strong>the</strong>reby increasing <strong>the</strong> probability of a medical<br />
error. In addition, she observed that any<br />
type of disruptive behavior negatively affects<br />
patient safety because it distracts and upsets<br />
<strong>the</strong> people involved. When staff members<br />
are not able to concentrate on <strong>the</strong>ir assigned<br />
Confronting Conflict in <strong>the</strong> Lab<br />
How Lab Managers Can Curb <strong>the</strong> Effects of Disruptive Behavior<br />
By JaMes s. heRnanDez, MD, Ms<br />
We all probably have known one: <strong>the</strong> lab<br />
staff member whose disruptive behavior<br />
affects not only her own per<strong>for</strong>mance, but<br />
also keeps her co-workers from doing <strong>the</strong>ir<br />
best.<br />
Disruptive behavior can include verbal<br />
abuse, sexual harassment, yelling, profanity,<br />
vulgarity, and threatening words or actions,<br />
according to Gerald B. Hickson, MD,<br />
director of <strong>the</strong> Center <strong>for</strong> Patient and Professional<br />
Advocacy at Vanderbilt University<br />
Medical Center in Nashville, Tenn. He says<br />
disruptive behavior can negatively affect<br />
both lab operations and <strong>the</strong> level of respect<br />
and camaraderie among lab staff (1).<br />
Why is it so important to stop disruptive<br />
behavior? Because such conduct not<br />
only can lead to medical errors, but failure<br />
to curb it also can cause team members to<br />
adopt <strong>the</strong> disruptive person’s negative behavior,<br />
which in turn can reduce <strong>the</strong> level<br />
of trust and respect among co-workers,<br />
says Hickson. Inappropriate attitudes and<br />
actions also reduce productivity in <strong>the</strong> lab<br />
sources of<br />
conflict in <strong>the</strong><br />
Workplace<br />
® goals and/or values conflict<br />
® ambiguous jurisdictions;<br />
role ambiguity<br />
® Competitively fueled reward<br />
systems yielding divisiveness<br />
® weak communication<br />
capabilities<br />
® perceived power imbalances<br />
® personality style differences<br />
® difficult behavior patterns<br />
Adapted from reference 3.<br />
16 CliniCal laboratory news July 2011<br />
tasks, <strong>the</strong>y are more likely to commit noncognitive<br />
errors, meaning <strong>the</strong>y make mistakes<br />
in a process that is normally automatic.<br />
Bad Behavior Leads to Lab Errors<br />
How serious is <strong>the</strong> disruptive behavior<br />
problem in healthcare systems today?<br />
Rosenstein and O’Daniel recently described<br />
<strong>the</strong> scope of <strong>the</strong> problem based on<br />
a survey involving more than 100 Veteran’s<br />
Health Administration Hospitals (3). In<br />
<strong>the</strong>ir study, approximately 4,500 physicians,<br />
nurses, and o<strong>the</strong>r healthcare workers<br />
responded to questions about <strong>the</strong> frequency<br />
of disruptive behavior and its effect on<br />
patient safety. More than three-quarters of<br />
participants reported witnessing disruptive<br />
behavior by physicians, while two-thirds<br />
had observed disruptive behavior by nurses.<br />
Fur<strong>the</strong>rmore, 71% said <strong>the</strong>y believed<br />
<strong>the</strong>re is a link between disruptive behaviors<br />
because staff are distracted by <strong>the</strong> perpetrator’s<br />
behavior. As this environment affects<br />
how efficiently a lab operates and has negative<br />
repercussions <strong>for</strong> all involved, lab managers<br />
should continuously monitor <strong>the</strong> offender’s<br />
disruptive behavior (2).<br />
Multiple sources of conflict in <strong>the</strong> workplace<br />
exist, according to management expert<br />
Louellen Essex, president of Louellen<br />
Essex & Associates (See “Sources of Conflict,”<br />
below). Essex has worked extensively<br />
with healthcare organizations, including<br />
laboratories.<br />
When Conflict is Good<br />
Not all conflict is dysfunctional, according<br />
to management guru Charles Dwyer, PhD,<br />
academic director <strong>for</strong> <strong>the</strong> Aresty Institute’s<br />
Leading and Managing People Program at<br />
<strong>the</strong> University of Pennsylvania Wharton<br />
School of Business. Although some people<br />
actually enjoy conflict, <strong>the</strong> lab director’s<br />
goal should be to manage, ra<strong>the</strong>r than<br />
squelch, conflict. (4). In fact, getting to <strong>the</strong><br />
Tips <strong>for</strong><br />
confronting<br />
disruptive<br />
behavior<br />
® prepare by writing down and<br />
practicing what you are going<br />
to say.<br />
® Make sure you are in <strong>the</strong> right<br />
mindset.<br />
® document and stay calm at all<br />
times.<br />
® be objective, not judgmental.<br />
® get help when you need it.<br />
Adapted from reference 5.<br />
and medical errors, and 18% indicated that<br />
<strong>the</strong>y were aware of specific adverse events<br />
related to disruptive behavior.<br />
Policies and Procedures<br />
Given <strong>the</strong> possible dire consequences of<br />
medical errors, clinical laboratories should<br />
not hesitate to take action against employees<br />
who display disruptive behaviors (See<br />
Table, p. 15). The first step is to develop and<br />
en<strong>for</strong>ce policies and procedures based on<br />
a professional code of conduct (4). These<br />
policies and procedures must include a protocol<br />
<strong>for</strong> reporting and managing disruptive<br />
behavior without fear of retaliation. A successful<br />
workplace environment depends on<br />
encouraging lab workers to confront <strong>the</strong>se<br />
behaviors at all levels of <strong>the</strong> organization.<br />
Removing intimidators and disruptors from<br />
<strong>the</strong> laboratory not only boosts productivity<br />
but also helps ensure patient safety.<br />
disruptive behaviors, such as sexual harassment, create tension in <strong>the</strong><br />
laboratory and threaten its safe operation.<br />
root of <strong>the</strong> conflict has several benefits <strong>for</strong><br />
laboratories, including raising important<br />
and unresolved <strong>issue</strong>s, resolving deep-seated<br />
problems, and helping <strong>the</strong> lab to evolve<br />
better group cohesion. Overall, such resolution<br />
can lead to productive changes in lab<br />
culture and output.<br />
Managing Conflict<br />
As unsettling as disruptive behavior can be,<br />
some individuals thrive on conflict. Today,<br />
it seems that conflict among co-workers is<br />
rooted in <strong>American</strong> culture, which often<br />
times rewards and encourages bad behavior.<br />
In fact, some co-workers may even instigate<br />
or encourage conflict. It takes courage, discipline,<br />
and practice <strong>for</strong> lab managers to learn<br />
how to de-escalate conflict in a healthy way.<br />
What should lab managers do when<br />
<strong>the</strong>y observe conflict in <strong>the</strong> laboratory?<br />
Barbara Linney, vice president of career<br />
development at <strong>the</strong> <strong>American</strong> College of<br />
Physician Executives in Tampa, Fla., offers<br />
a few pointers (5). First, avoid teasing<br />
REFERENCES<br />
1. Behaviors that undermine a culture<br />
of safety. The Joint Commission Sentinel<br />
Event Alert. Issue 40. July 9, 2008. Available<br />
at: www.jointcommission.org/assets/1/18/<br />
SEA_40.PDF, accessed May 26, 2011.<br />
2. Brown T. Physician, Heel Thyself. New<br />
York Times. May 7, 2011. Available at:<br />
www.nytimes.com/2011/05/08/, accessed<br />
May 26, 2011.<br />
3. Rosenstein AH, O’Daniel M. A survey<br />
of <strong>the</strong> impact of disruptive behaviors and<br />
communication defects on patient safety.<br />
Jt Comm J Qual Patient Saf 2008:34;464–<br />
71.<br />
4. Saxton RS, Hines T, Enriquez M. The<br />
negative impact of nurse-physician disruptive<br />
behavior on patient safety: A<br />
review of <strong>the</strong> literature. J Patient Saf<br />
2009;5:180–183.<br />
subordinates about <strong>the</strong> behavior. This only<br />
makes <strong>the</strong> lab manager an equal with <strong>the</strong><br />
disruptive staff member. Second, avoid<br />
big shows of emotions, such as angry outbursts<br />
or crying. This merely escalates <strong>the</strong><br />
problem. Linney also advises lab professionals<br />
to be mindful of <strong>the</strong>ir body language,<br />
since 55% of what we communicate<br />
is through body language, 38% is from <strong>the</strong><br />
tone of our voice, and only 7% is due to<br />
<strong>the</strong> words we are speaking (6) (See “Tips,”<br />
left).<br />
Listening skills are essential to resolving<br />
conflict, according to Essex (3). Lab<br />
managers should listen and avoid being<br />
defensive when managing conflict. It helps<br />
to paraphrase <strong>the</strong> concerns of <strong>the</strong> o<strong>the</strong>r<br />
person or team members and to ask questions<br />
to clarify your understanding. If you<br />
are at fault, don’t be afraid to admit it, and<br />
if you’re not at fault, explain your point of<br />
view to clear up <strong>the</strong> misunderstanding. Finally,<br />
thank <strong>the</strong> person or team <strong>for</strong> bringing<br />
<strong>the</strong> matter to your attention.
Being Prepared<br />
Hickson urges laboratories to have an<br />
infrastructure in place <strong>for</strong> addressing<br />
unprofessional behavior (7). Key components<br />
of such a system include commitment<br />
from <strong>the</strong> organization’s leadership,<br />
supportive institutional policies, surveillance<br />
tools to capture complaints, a model<br />
to guide graduated interventions, and<br />
a process <strong>for</strong> reviewing allegations. It also<br />
may help to institute a training program<br />
<strong>for</strong> employees and develop resources to<br />
aid both those being disruptive and <strong>the</strong><br />
The Slippery Slope of Errors<br />
Steps Labs Can Take to Avoid <strong>the</strong> Normalization of Deviance<br />
By KaRen appolD anD MiChael astion, MD, phD<br />
People who prefer to sleep in are often<br />
in <strong>the</strong> habit of rushing to get to work on<br />
time. In <strong>the</strong>ir rush, <strong>the</strong>y may multitask to<br />
make up <strong>for</strong> <strong>the</strong> lack of time by combing<br />
<strong>the</strong>ir hair and using <strong>the</strong>ir mobile devices<br />
while driving. Obviously, <strong>the</strong>se behaviors<br />
increase <strong>the</strong> chances of a serious accident.<br />
But late sleepers who have never been in a<br />
wreck gradually adopt <strong>the</strong>se risky actions<br />
as part of <strong>the</strong>ir normal routine to compensate<br />
<strong>for</strong> sleeping in. They may even<br />
rationalize that more sleep improves <strong>the</strong>ir<br />
work per<strong>for</strong>mance. Despite that little voice<br />
telling <strong>the</strong>m <strong>the</strong>y should go to bed earlier<br />
instead of risking an accident, <strong>the</strong>ir unsafe<br />
morning routine has become acceptable to<br />
<strong>the</strong>m. This is an example of <strong>the</strong> normalization<br />
of deviance.<br />
In <strong>the</strong> workplace, <strong>the</strong> normalization of<br />
deviance refers to <strong>the</strong> gradual acceptance<br />
of incidents or activities that were initially<br />
defined as deviant and unacceptable. Typically<br />
this occurs because organizations fail<br />
to deploy <strong>the</strong>ir mission, vision, and goals at<br />
<strong>the</strong> ground level with employees. Factors<br />
that favor <strong>the</strong> normalization of deviance<br />
include inadequate or incompetent supervision,<br />
time pressure, and resource scarcity.<br />
Lessons Learned from The Challenger<br />
Diane Vaughan, PhD, coined <strong>the</strong> term<br />
“normalization of deviance” in her book,<br />
“The Challenger Launch Decision: Risky<br />
Technology, Culture, and Deviance at<br />
NASA.” Vaughan is a professor in <strong>the</strong> Departments<br />
of International and Public Affairs<br />
and Sociology at Columbia University<br />
in New York.<br />
She concluded that <strong>the</strong> Space Shuttle<br />
Challenger disaster on January 28, 1986,<br />
which killed all seven crew members, occurred<br />
due to normalization of deviance,<br />
ra<strong>the</strong>r than misconduct. The events leading<br />
up to this tragic accident are a good exam-<br />
looking <strong>for</strong> The joint<br />
commission standards?<br />
<strong>the</strong> Joint Commission standards<br />
are available in print and electronic<br />
<strong>for</strong>mats and can be purchased<br />
from Joint Commission resources.<br />
www.jointcommission.org/<br />
standards_in<strong>for</strong>mation/standards.<br />
aspx<br />
staff members affected by <strong>the</strong> behavior.<br />
Even with limited resources, by taking<br />
tips from o<strong>the</strong>r areas in healthcare to guide<br />
policies and procedures, laboratorians can<br />
confront and combat disruptive behavior.<br />
In <strong>the</strong> end, experts agree that <strong>the</strong> ultimate<br />
goal is to eliminate poor behavior in <strong>the</strong><br />
clinical laboratory in order to ensure patient<br />
safety.<br />
REFERENCES<br />
1. Hickson G. Dealing with Disruptive Behavior<br />
among Health Care Professionals,<br />
ple of how normalization of deviance transpires.<br />
Organizations typically accept an<br />
initial deviant occurrence or two because<br />
it was unintended and little or no harm<br />
occurred. However, <strong>the</strong> initial incidents establish<br />
a precedent <strong>for</strong> accepting more and<br />
more deviance.<br />
In <strong>the</strong> case of <strong>the</strong> Challenger, when <strong>the</strong><br />
first deviation from <strong>the</strong> expected per<strong>for</strong>mance<br />
happened involving O-ring pressure<br />
seals during flight, <strong>the</strong> problem was<br />
fixed. Overtime, more damage took place<br />
on subsequent flights. Eventually, more serious<br />
damage became acceptable to NASA.<br />
“Because failure did not occur and <strong>the</strong><br />
causes of <strong>the</strong> problem continued to change,<br />
<strong>the</strong> pattern continued,” Vaughan explained.<br />
“It became normal to fly with <strong>the</strong> flawed<br />
design.” Eventually though, problems with<br />
<strong>the</strong> O-rings caused <strong>the</strong> Challenger disaster.<br />
The normalization of deviance often<br />
results from patterns of in<strong>for</strong>mation that<br />
disguise <strong>the</strong> seriousness of <strong>the</strong> problem.<br />
For example, as NASA moved <strong>for</strong>ward<br />
with launches, each decision seemed rational.<br />
“Technical deviations indicating something<br />
was wrong were interspersed with in<strong>for</strong>mation<br />
that all was well,” Vaughan said.<br />
“What in retrospect seemed like strong<br />
warning signals of danger prior to <strong>the</strong> accident<br />
did not have <strong>the</strong> same meaning to<br />
insiders at <strong>the</strong> time events were occurring.<br />
Signals were mixed, weak, and routine.”<br />
Don’t Let Deviance Become <strong>the</strong> Norm<br />
In <strong>the</strong> laboratory, normalization of deviance<br />
tends to occur when employees become<br />
less sensitive to slight changes or<br />
take small shortcuts to improve work per<strong>for</strong>mance,<br />
according to Mark R. Chassin,<br />
MD, president of The Joint Commission<br />
in Oak Brook Terrace, Ill. The problem is<br />
that laboratory professionals don’t realize<br />
this behavior can cause unsafe situations<br />
that eventually can harm patients. Chassin<br />
believes <strong>the</strong>y fall into this behavior when<br />
strong safety systems aren’t in place and <strong>the</strong><br />
lab doesn’t have a clear commitment to follow<br />
safety protocols without fail.<br />
As a <strong>for</strong>mer commissioner of <strong>the</strong> New<br />
York State Department of Health, Chassin<br />
oversaw medical institutions’ quality programs<br />
and had <strong>the</strong> opportunity to observe<br />
normalization of deviance events in clinical<br />
laboratories. He recalled one instance in<br />
which patient and specimen identification<br />
CLMA audioconference, Gerald B. Hickson,<br />
MD, director, Center <strong>for</strong> Patient and<br />
Professional Advocacy, Vanderbilt University<br />
Medical Center.<br />
2. Felps W, et al. How, when, and why bad<br />
apples spoil <strong>the</strong> barrel: negative group<br />
members and dysfunctional groups. Res<br />
Organ Behav 2006;27:175–222.<br />
3. Louellen Essex and Associates, www.<br />
louellenessex.com/contact.html, accessed<br />
May 12, 2011.<br />
4. Dwyer C. The Shifting Source of Power<br />
and Influence, ACPE Publication, 1991<br />
labels were slightly cut off as <strong>the</strong>y were dispensed<br />
from <strong>the</strong> label maker. As <strong>the</strong> problem<br />
worsened, some letters and numbers<br />
were omitted. “That small abnormality<br />
went unreported until it caused several patient<br />
misidentifications,” Chassin said. “If<br />
people would have been more attentive to<br />
that slight change earlier and called it to <strong>the</strong><br />
attention of <strong>the</strong> right individuals sooner,<br />
<strong>the</strong>n it wouldn’t have led to <strong>the</strong> misidentifications<br />
of patients and specimens.”<br />
Ano<strong>the</strong>r example involved reporting of<br />
highly abnormal test results. A technologist<br />
had difficulty reaching clinicians when<br />
reporting critical lab values. He became<br />
satisfied with leaving <strong>the</strong> in<strong>for</strong>mation with<br />
a clerk or non-clinician, even though <strong>the</strong><br />
protocol called <strong>for</strong> leaving it with a nurse<br />
or doctor. Since nothing bad resulted from<br />
<strong>the</strong> technologist’s actions, this deviation<br />
continued. He eventually developed a habit<br />
of being less careful about adhering to <strong>the</strong><br />
critical value policy, even though this increased<br />
<strong>the</strong> likelihood of an adverse event.<br />
Taking Action<br />
The Joint Commission has put in place<br />
several standards to help labs combat <strong>the</strong><br />
normalization of deviance, and it has es-<br />
Patient safety focus editorial board<br />
chair<br />
michael astion, md, Phd<br />
seattle Children’s Hospital<br />
seattle, wash.<br />
members<br />
Peggy a. ahlin, bs, mT(ascP)<br />
Consultant<br />
salf lake City, utah<br />
5. Linney, Barbara, Conflict and Cooperation,<br />
<strong>American</strong> College of Physician Executive<br />
course, 2008.<br />
6. Malandro, LA, Barker, LL, Barker, DA<br />
Nonverbal Communication, 2nd Edition,<br />
New York, Random House (1989).<br />
7. Hickson GB, Pichert JW, Webb LE,<br />
Gabbe SG. A Complementary Approach<br />
to Promoting Professionalism: Identifying,<br />
Measuring and Addressing Unprofessional<br />
Behaviors. Acad Med. 2007; 82:<br />
1040–48.<br />
lab examples of <strong>the</strong><br />
normalization of deviance<br />
® repeating quality control until it is in range<br />
® allowing relabeling of mislabeled specimens that are replaceable<br />
® allowing physicians to opt out of a critical value policy<br />
® accepting outdated specimens<br />
® labeling specimens in batch at <strong>the</strong> nurses’ station<br />
® accepting a culture of rudeness on <strong>the</strong> phone<br />
® ordering a CbC, tsH, and basic metabolic panel on all ambulatory<br />
patients<br />
tablished safety guidelines, which identify<br />
situations that increase <strong>the</strong> likelihood of<br />
patient harm.<br />
“If <strong>the</strong>re is a problem, no one should feel<br />
intimidated about identifying it, regardless<br />
of how junior an individual may be,” Chassin<br />
said. “For example, a lab technologist<br />
asks a doctor, ‘Are you sure you want to order<br />
this test?’ The doctor replies, ‘That’s a<br />
really stupid question; it is on <strong>the</strong> ordering<br />
sheet.’ This kind of intimidating behavior,<br />
although subtle, is likely to result in <strong>the</strong><br />
technologist not questioning <strong>the</strong> doctor<br />
again, even if he or she feels that <strong>the</strong> doctor<br />
is creating an unsafe situation <strong>for</strong> patients.<br />
Behavior that diminishes communication<br />
needs to be eliminated when building a<br />
safety culture. O<strong>the</strong>rwise, such behavior<br />
promotes <strong>the</strong> normalization of deviance.”<br />
SuGGESTED READING<br />
Vaughan, D. The Challenger Launch Decision:<br />
Risky Technology, Culture, and Deviance<br />
at NASA. Chicago, Ill: University of<br />
Chicago Press 1996.<br />
Karen Appold is an editorial consultant<br />
<strong>for</strong> <strong>the</strong> clinical laboratory industry.<br />
Email: karenappold@comcast.net<br />
corrine fantz, Phd<br />
emory university<br />
atlanta, ga.<br />
james s. hernandez, md, ms<br />
Mayo Clinic arizona<br />
scottsdale and phoenix, ariz.<br />
brian r. jackson, md, ms<br />
arup laboratories<br />
salt lake City, utah<br />
CliniCal laboratory news July 2011 17
AACC’S ExPERT ACCESS<br />
The Delta Check in Action<br />
Causes and Consequences of Discrepant Laboratory Results<br />
Each month, AACC’s Expert Access Live Online Program features a<br />
different topic of importance to clinical laboratory practice.<br />
Visit AACC’s website, www.aacc.org/events/expert_access, <strong>for</strong> more<br />
in<strong>for</strong>mation and an archive of past presentations.<br />
<strong>the</strong> following is an excerpt from <strong>the</strong> March 2011<br />
presentation by Joely straseski, phd, Mt(asCp),<br />
dabCC, medical director of endocrinology at arup<br />
laboratories in salt lake City, utah, and assistant<br />
professor of pathology at <strong>the</strong> university of utah<br />
school of Medicine.<br />
Should results identified by delta<br />
checking be flagged in <strong>the</strong> laboratory<br />
in<strong>for</strong>mation system? What comments<br />
do you recommend?<br />
When first identified, delta check flags<br />
should indicate to <strong>the</strong> technologist that this<br />
result exceeds <strong>the</strong> established delta limits<br />
<strong>for</strong> this analyte and should be investigated,<br />
<strong>for</strong> example, by repeating <strong>the</strong> test or calling<br />
<strong>the</strong> clinician. This keeps <strong>the</strong> result from<br />
being autoverified. Beyond that, if an investigation<br />
reveals a sample integrity error,<br />
results should be cancelled with a comment<br />
describing <strong>the</strong> error, such as IV dilution<br />
or EDTA contamination. It may be<br />
helpful to document <strong>the</strong>se types of <strong>issue</strong>s,<br />
since trends in sampling errors may be revealed<br />
this way. If an investigation reveals<br />
a misidentified specimen, results should be<br />
cancelled with a comment describing that<br />
<strong>issue</strong> as well. If a provider is contacted during<br />
an investigation to confirm whe<strong>the</strong>r<br />
<strong>the</strong> discrepant results are expected, and <strong>the</strong><br />
results fit with <strong>the</strong> clinical picture of <strong>the</strong><br />
patient, you might add a comment stating<br />
that <strong>the</strong> clinician was contacted and results<br />
were discussed. Then, upon review of <strong>the</strong><br />
patient chart, explanations <strong>for</strong> any large<br />
fluctuations would be documented. A simple<br />
comment such as “results repeated and<br />
verified” is commonly added to repeated<br />
18 CliniCal laboratory news July 2011<br />
specimens and may be used <strong>for</strong> delta check<br />
failures as well. If a result is “questionable,”<br />
an investigation should be conducted to<br />
clarify any <strong>issue</strong>s be<strong>for</strong>e reporting.<br />
Do delta checks alert only medically<br />
significant discrepancies?<br />
While labs traditionally use delta checks to<br />
highlight medically important analyte concentrations,<br />
<strong>the</strong>y can be tailored to whatever<br />
your needs may be. You can set up alert<br />
limits specifically <strong>for</strong> your patient population<br />
to highlight only likely misidentified<br />
specimens, typically a large delta value, or<br />
to highlight medically relevant changes in<br />
analyte concentrations.<br />
What is your perspective on delta checks<br />
as it relates to autoverification?<br />
Delta checks can certainly become part of<br />
autoverification procedures. They are simply<br />
ano<strong>the</strong>r step in <strong>the</strong> autoverification process,<br />
one that provides yet ano<strong>the</strong>r layer of<br />
confidence in your results be<strong>for</strong>e you send<br />
<strong>the</strong>m to <strong>the</strong> provider. The delta limits, once<br />
determined, become additional rules that a<br />
sample must follow in order to be autoverified.<br />
For example, a rule involving sodium<br />
levels would state: Is <strong>the</strong> sodium <strong>for</strong> this<br />
patient less than 13 mEq/L different from<br />
<strong>the</strong>ir sodium results over <strong>the</strong> past 3 days?<br />
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atlanta, Georgia<br />
Site of <strong>the</strong> 2011 AACC Annual Meeting<br />
and <strong>Clinical</strong> Lab Expo<br />
® population: 486,411<br />
® City-owned parks: 277<br />
® Churches: 1,500<br />
® <strong>for</strong>tune 500 Companies: 13<br />
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Sources: U.S. Census Bureau and Atlanta.net<br />
If so, and if all o<strong>the</strong>r autoverification rules<br />
have passed, autoverify <strong>the</strong> results. If not,<br />
flag <strong>for</strong> fur<strong>the</strong>r review or repeated analysis.<br />
Do you recommend delta checks <strong>for</strong><br />
enzymes or o<strong>the</strong>r disease markers like<br />
carcinoembryonic antigen (CEA)?<br />
Yes, several institutions follow tumor<br />
markers such as CEA. Delta checks <strong>for</strong><br />
<strong>the</strong>se markers can be helpful, but you may<br />
see fluctuations as patients go through<br />
treatment, remission, etc. Although <strong>the</strong>se<br />
deltas will trigger a discrepant results investigation,<br />
tumor markers are a valuable<br />
analyte <strong>for</strong> delta checks. Alerting a clinician<br />
to a large change in a tumor marker value<br />
may be extremely important in <strong>the</strong> care<br />
and management of that particular patient.<br />
With <strong>the</strong> reliability of automated instruments,<br />
is it truly necessary to repeat a<br />
delta check?<br />
This will vary depending on <strong>the</strong> analyte<br />
and <strong>the</strong> methodologies and/or analyzers in<br />
question. Review of quality control values<br />
and a historical review of repeated values<br />
within your institution may give you a better<br />
indication of <strong>the</strong> analytical per<strong>for</strong>mance<br />
of each specific analyte. This will help you<br />
determine whe<strong>the</strong>r repeating delta check<br />
failures is necessary.<br />
I need help with percent difference<br />
<strong>for</strong> delta checks between hematology<br />
parameters.<br />
Hematology was one of <strong>the</strong> first areas to<br />
use delta checks, so <strong>the</strong>re are several parameters<br />
that may be helpful <strong>for</strong> you. Most notably,<br />
<strong>the</strong> mean corpuscular value (MCV)<br />
is a commonly used delta check, as this is<br />
a value that should not change appreciably<br />
within an individual. An examples of delta<br />
check limits <strong>for</strong> MCV include: 4 fL over 2<br />
days; 5 fL over any period of time; and 10 fL<br />
over one day. Mean corpuscular hemoglobin<br />
concentration (MCHC) is ano<strong>the</strong>r<br />
parameter with little biological variation<br />
in <strong>the</strong> short term. Calculating <strong>the</strong> Index<br />
of Individuality (II) <strong>for</strong> hematology tests<br />
will help you identify good delta check<br />
candidates. Beyond MCV and MCHC,<br />
o<strong>the</strong>r hematology tests with low II include<br />
hemoglobin, hematocrit, and platelet volume.<br />
However, care should be used when<br />
setting up delta checks on <strong>the</strong>se measures,<br />
since <strong>the</strong>y can vary depending on <strong>the</strong> patient<br />
population, <strong>for</strong> instance, in acute care<br />
patients with hemorrhage.<br />
How do you handle results that look<br />
as though <strong>the</strong> sample might have been<br />
contaminated with IV fluid?<br />
The biological ramifications of reporting<br />
results that have been diluted cannot be<br />
stressed strongly enough. Each institution<br />
may have <strong>the</strong>ir own procedure <strong>for</strong> dealing<br />
with <strong>the</strong>se types of specimens, and each<br />
case is different. Although only one analyte<br />
may be in question, such as absurdly elevated<br />
glucose level possibly coming from <strong>the</strong><br />
IV, <strong>the</strong> chance that o<strong>the</strong>r analytes have been<br />
similarly diluted is high. The safest course<br />
of action is to redraw <strong>the</strong> patient; however,<br />
that isn’t always possible. In <strong>the</strong> case where<br />
only one analyte appears to be diluted, but<br />
o<strong>the</strong>rs were also ordered from <strong>the</strong> same<br />
specimen, do a careful investigation of <strong>the</strong><br />
o<strong>the</strong>r analytes if <strong>the</strong>re are recent results <strong>for</strong><br />
comparison. If any analytes are reported, a<br />
comment regarding <strong>the</strong> possible dilution<br />
with IV fluid should accompany <strong>the</strong> results.<br />
Clinicians also should be alerted to interpret<br />
results with caution. Generally speaking,<br />
institutions’ policies vary as to <strong>the</strong> best<br />
way to handle <strong>the</strong>se types of situations.<br />
How many days back should we include<br />
in our delta checks?<br />
Every analyte will be different. As you can<br />
imagine, a difference in sodium may be<br />
checked over a period of a few days, while<br />
an ABO blood type could be stable over a<br />
lifetime. An exaggerated example, but you<br />
see <strong>the</strong> difference. Shorter timeframes are<br />
usually more specific; as time goes on, differences<br />
in an analyte may be attributed to<br />
normal changes and not an acute process<br />
or sampling <strong>issue</strong>.<br />
Sampson and colleagues used time intervals<br />
to optimize error detection with<br />
delta checks (Sampson et al. Journal of<br />
<strong>Clinical</strong> Ligand Assay 30:44–54, 2007).<br />
They looked at 20 different analytes and<br />
found that <strong>the</strong> optimal delta time interval<br />
was generally between 2 and 5 days. Again,<br />
this is extremely analyte-specific, and this<br />
time interval is simply a general guide. Using<br />
rate changes is ano<strong>the</strong>r way to evaluate<br />
delta values over time. However, <strong>the</strong> most<br />
common way to determine <strong>the</strong> number of<br />
days to use <strong>for</strong> delta check limits is experience<br />
over time. Adjusting time limits will<br />
allow you to balance lab staff investigations<br />
and error detection. CLN<br />
Disclaimer—The opinions and in<strong>for</strong>mation<br />
are <strong>the</strong> sole responsibility of <strong>the</strong> presenter.<br />
AACC reviews <strong>the</strong> presentation <strong>for</strong> overall<br />
appropriateness, but this should not be construed<br />
as an endorsement by <strong>the</strong> association<br />
or its employees of <strong>the</strong> opinions and in<strong>for</strong>mation<br />
offered here.<br />
visit aacc.org<br />
<strong>for</strong> professional<br />
development,<br />
meeting<br />
registrations,<br />
books,<br />
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aafp–proficiency testing ..............1315<br />
aalto scientific, ltd. ...................1503<br />
ab sCieX ..............................2450<br />
abaxis .................................223<br />
abbott diagnostics ...................2531<br />
abd serotec ..........................2361<br />
abnova Corporation ...................4340<br />
accel biotech, inc. ......................353<br />
access bio, inc. .........................114<br />
access biologicals, llC .................3455<br />
accubiotech Co., ltd. ..................3074<br />
accumetrics, inc. .......................440<br />
acon laboratories, inc. ................3737<br />
ac<strong>the</strong>rm inc. ..........................3469<br />
adaltis/i.s.e. s.r.l. .....................3860<br />
adaptive Mfg. technologies, inc. .......2146<br />
adeMteCH ............................448<br />
adhesives research, inc. ...............2760<br />
adicon <strong>Clinical</strong> laboratory .............1602<br />
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advanced instruments, inc. ............3422<br />
advanced Microdevices pvt. ltd. .......3160<br />
advandx ..............................2257<br />
aesku diagnostics .....................2551<br />
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switzerland gmbH ..................3573<br />
agilent technologies ..................3743<br />
ahlstrom ...............................334<br />
aid gmbH ............................4002<br />
akonni biosystems .....................460<br />
alere-inverness Medical ...............1931<br />
alfa scientific designs, inc. ..............315<br />
alifaX spa ............................4031<br />
alpCo diagnostics ....................2944<br />
amano enzyme usa Co., ltd. ..........1760<br />
amedica biotech, inc. ..................221<br />
american board of <strong>Clinical</strong> Chemistry ..2137<br />
american diagnostica inc. .............2609<br />
american Medical technologists .......2456<br />
american proficiency institute .........3005<br />
american society <strong>for</strong> <strong>Clinical</strong> pathology ..202<br />
anaerobe systems. ....................4111<br />
analis .................................3622<br />
analyticon biotechnologies ag ........3051<br />
ani biotech oy/ani labsystems ltd. ...2770<br />
aperio .................................245<br />
applied biocode, inc. ..................2573<br />
aries filterworks ......................2357<br />
arista biologicals inc. ..................2667<br />
arK diagnostics, inc. ..................3753<br />
arKraY, inc. ..........................3251<br />
arlington scientific inc. ................352<br />
artel ..................................1020<br />
arup laboratories ....................1831<br />
arup laboratories/Careers ............1940<br />
asahi Kasei pharma Corporation .......3611<br />
asCo numatics .......................2661<br />
a<strong>the</strong>ns research & tech., inc. ..........3366<br />
atlas link, inc. ........................3167<br />
atom scientific ltd. ...................4406<br />
audit MicroControls, inc. . . . . . . . . . . . . . . . 747<br />
autobio diagnostics Co. ltd. ............35<br />
autogenomics inc. .....................409<br />
aVe science & technology industrial Co. 311<br />
awareness technology, inc. ............1203<br />
aweX .................................3523<br />
axxin .................................1548<br />
azer scientific .........................4404<br />
aZog, inc. . . . . . . . . . . . . . . . . . . . . . . . . . . . .4424<br />
bangs laboratories/polysciences ......3062<br />
bay state biologicals inc. ..............2673<br />
baytree national bank & trust Company ... 9<br />
bb international . ......................2461<br />
bd .....................................820<br />
beau<strong>for</strong>t, llC ..........................3450<br />
beckman Coulter .......................603<br />
beijing Chemclin biotech Co., ltd. ......3952<br />
beijing Kinghawk<br />
pharmaceutical Co. ltd ...............354<br />
20 CliniCal laboratory news July 2011<br />
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beijing strong biotechnologies, inc. ...3852<br />
berthold detection systems gmbH ....2568<br />
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bertin technologies ...................4344<br />
bg Medicine ..........................1662<br />
big C/dino-lite scopes ..................308<br />
binding site inc., <strong>the</strong> ...................641<br />
binding site inc., <strong>the</strong> (oeM) ............2861<br />
bioassay works, llC ...................4020<br />
biobase biodustry (shandong) Co. ltd. 3570<br />
bio-Chem fluidics inc. .................1211<br />
bioCrates life sciences ag ...........4144<br />
biodot, inc. ............................131<br />
bioHit, inc. ............................3438<br />
biokit s.a. .............................2231<br />
biolabo ...............................4001<br />
biolYpH, llC ..........................3919<br />
bioMedica diagnostics inc. ............3569<br />
biometrix technology inc. .............3563<br />
bioneer Corporation ...................2153<br />
bionostics inc./rna Medical. ...........2666<br />
bioporto diagnostics a/s ..............2809<br />
bioprocessing, inc. .......................39<br />
bio-rad laboratories ..................1631<br />
biosearch technologies ................1415<br />
biospacific.............................3556<br />
bio-syn<strong>the</strong>sis, inc. .....................3267<br />
biotechniques .........................4241<br />
biotek instruments ....................2871<br />
biotix .................................4211<br />
biotron diagnostiCs usa ...........4348<br />
bit analytical instruments .............2951<br />
blood systems laboratories. ...........3954<br />
blue ocean biomedical llC .............304<br />
boditeCH Med inc. ....................123<br />
bomi group ...........................4100<br />
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bruker daltonics ......................3853<br />
buHlMann laboratories ag ...........350<br />
burkert fluid Control system ...........841<br />
C & a scientific Co., inc. . . . . . . . . . . . . . . . .4104<br />
C s i ...................................341<br />
Cadence, inc. ..........................3909<br />
Calbioreagents ........................2471<br />
Calbiotech, inc. .......................1414<br />
Calzyme laboratories, inc. ..............915<br />
Cambridge Consultants .................43<br />
Cambridge isotope labs ..............4248<br />
Capitalbio Corporation ................3362<br />
Capralogics inc. .......................3848<br />
Capricorn products llC ...............2149<br />
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Care diagnostica international ........3061<br />
Caretium Medical instruments Co, ltd. ...203<br />
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Carville ltd. ............................415<br />
Cedarlane laboratories, ltd. ...........4319<br />
CellaVision .............................847<br />
Center <strong>for</strong> disease Control<br />
& prevention ........................4335<br />
Centers <strong>for</strong> Medicare,<br />
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Cepheid ...............................431<br />
Ceragem Medisys, inc. .................3155<br />
Cerilliant ..............................2856<br />
Certest bioteC s.l. ..................2048<br />
CetaC technologies ...................4148<br />
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Chromsystems gmbH .................2839<br />
Chungdo pharm. Co. ltd. ..............3561<br />
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Cisbio us inc. .........................2817<br />
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Clearbridge bioloc. .....................217<br />
Cleveland Clinic laboratories ..........3442<br />
Clindiag systems usa .................4243<br />
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Contec Medical systems Co., ltd. ......3663<br />
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Copan diagnostics, inc. ................2945<br />
Corgenix ...............................444<br />
Coris bioconcept ......................3425<br />
CorMaY & orphee ....................2849<br />
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Creative laboratory products inc. ......2971<br />
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desert biologicals/omega biologicals ..3710<br />
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diagnostic Consulting network, inc. ...2960<br />
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diagnostica stago, inc. .................731<br />
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diamond diagnostics inc. ..............322<br />
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diasys diagnostic systems ............3211<br />
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diazyme laboratories .................4023<br />
diba industries, inc. ...................1213<br />
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egemin automation, inc. ..............3551<br />
electronic imaging Materials, inc. .......134<br />
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elitech group Company ................542<br />
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enigma diagnostics ....................116<br />
entrocomponent solutions (eCs) .......452<br />
entrogen .............................4412<br />
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eppendorf .............................430<br />
epson robots ..........................106<br />
equal access to scientific excellence ....122<br />
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erba diagnostics Mannheim gmbH ...3705<br />
escalon <strong>Clinical</strong> diagnostics ............753<br />
eurogentec north america, inc. ........4418<br />
eurospital spa ........................4339<br />
eurotrol, inc. ..........................2835<br />
eVergreen sCientifiC ................1541<br />
excel scientific, inc. ....................2967<br />
express diagnostics int’l, inc. ..........4317<br />
fapon biotech inc. . . . . . . . . . . . . . . . . . . . .2049<br />
fenin .................................1947<br />
filtrona porous technologies . . . . . . . . . .3161<br />
fine Care biosystems ..................4013<br />
finetek Co., ltd. ........................349<br />
fitzgerald industries int’l ..............2914<br />
flexlink systems, inc. ..................138<br />
fluid Metering, inc. ....................2561<br />
focus diagnostic, inc. .................4131<br />
foliage ...............................4115<br />
freezerworks .........................4105<br />
fresenius Medical Care-renal products 2870<br />
fujirebio diagnostics, inc. .............2221<br />
g&l precision die Cutting, inc. .........4022<br />
gale <strong>for</strong>ce software Corporation ......3653<br />
ge Healthcare .........................3078<br />
gems Medical sciences ...............1610<br />
general biologicals Corporation .......4440<br />
genMark diagnostics, inc. .............1455<br />
genprime, inc. .........................351<br />
gen-probe ............................1021<br />
gentura dx ...........................1606<br />
gilson, inc. ............................2774<br />
globe scientific inc. ....................911<br />
gold standard diagnostics ............1310<br />
golden west biologicals, inc. ..........4244<br />
greiner bio-one, inc. . . . . . . . . . . . . . . . . . .2243<br />
grifols ................................3719<br />
guangzhou improve Medical, inc. .....3409<br />
H & H system, inc. .....................4106<br />
Hamamatsu Corporation ...............120<br />
Hamilton Company ...................1441<br />
Hanlab Corporation ...................3446<br />
Harlan bioproducts <strong>for</strong> science, inc. ...2863<br />
Haydon Kerk Motion solutions, inc. ....2248<br />
Hb optical technology Co., ltd. ..........11<br />
Healgen scientific llC ...................31<br />
Heathrow scientific ....................320<br />
Hedwin Corporation ..................4212<br />
Helena laboratories ...................1006<br />
HelMer ..............................2819<br />
Hemagen diagnostics, inc. ............4315<br />
HemoCue, inc.<br />
a Quest diagnostic Company .......3339<br />
Hemosure inc. ........................3949<br />
Hoover precision products, llC ........2121<br />
Horiba Medical .......................2249<br />
Htl-strefa inc. ........................1648<br />
Human gmbH. ........................3764<br />
Hycor biomedical. .....................3545<br />
Hytest ltd. ..............................27<br />
i.C.a. Corporation ......................1762<br />
ibl - america ..........................2906<br />
ibl- international Corp. ...............4049<br />
iCubate, inc. ............................346<br />
ideX Health & science .................2120<br />
ifCC—intl federation of <strong>Clinical</strong><br />
Chemistry & laboratory Medicine ...2238<br />
ils .....................................235<br />
iMMCo diagnostics ...................4038<br />
immucor, inc. .........................2931<br />
immundiagnostik ag ..................3461<br />
immuno Concepts. ....................3939<br />
immuno probe Co. ltd. ................4307<br />
immunodiagnostic systems ...........3731<br />
immunostics inc. ......................1556<br />
immunoVision ........................3072<br />
inbios international, inc. ...............4010<br />
ind diagnostic inc. ....................3364<br />
innova biosciences .....................314<br />
innovize ...............................220<br />
inoVa diagnostics, inc. ................2235<br />
instatests ..............................115<br />
instru-med inc. ........................343<br />
instrumentation laboratory (il) ........2331<br />
intec products, inc. .....................741<br />
integra biosciences .....................242<br />
integrated laboratory automation. ....3325<br />
inteplast - Healthcare ..................3751<br />
inter bio-lab, inc. ......................4110<br />
international immuno-diagnostics .....214<br />
international immunology Corporation . .414<br />
inverness Medical innovation ..........3778<br />
invetech ..............................2803<br />
ionics Mass spectrometry group .......111<br />
iQuum, inc. ............................649<br />
iris international inc. ..................419<br />
isensix, inc. ...........................1306<br />
it4ip ..................................3526
itC ...................................3231<br />
iVaX diagnostics, inc. ..................3805<br />
iVd research, inc. .....................4012<br />
iVd technologies .......................201<br />
iVd technology/ubM Canon ...........2767<br />
iVeK Corp. .............................1560<br />
iwaki america inc. .....................2660<br />
Jackson immunoresearch<br />
laboratories, inc. ...................3557<br />
Japanese association of<br />
<strong>Clinical</strong> laboratory automation .....1451<br />
JenoptiK 1 optical systems ...........2968<br />
Jeol ltd. .............................3484<br />
Jiangsu audicom Medical<br />
technology Co. .....................4310<br />
Jiangsu Zhengji instruments Co. ltd. ..2969<br />
Joint Commission, <strong>the</strong> ..................207<br />
Jokoh Co., ltd. ........................4341<br />
Jsr Corporation .......................2762<br />
K & K Consultant group, inc. ............249<br />
Kaiser permanente .....................312<br />
Kamiya biomedical Company ..........2220<br />
Kem-en-tec diagnostics ...............1554<br />
Key tech ...............................345<br />
KiKKoMan Corporation ..............110<br />
Kinematic automation inc. ............2761<br />
Kingmed diagnostics ..................3511<br />
KMC systems, inc. .....................3351<br />
Knf neuberger inc. . . . . . . . . . . . . . . . . . . .4331<br />
Kpl, inc. ..............................3262<br />
Kronus, inc. ..........................1622<br />
lab Medica ...........................2356<br />
lab safety supply .....................4149<br />
labCorp - esoterix .....................3431<br />
labitec gmbH ........................2845<br />
labnovation technologies, inc. ........4215<br />
laboratory data systems, inc. .........3321<br />
labotix automation, inc. ..............2351<br />
labproducts, inc. . . . . . . . . . . . . . . . . . . . . . . . 147<br />
labs are Vital ..........................2431<br />
labtest ...............................3560<br />
lampire biological laboratories, inc. ...2212<br />
lasX industries, inc. ...................4316<br />
lathrop engineering inc. ..............2908<br />
lead Care .............................1920<br />
lee Company, <strong>the</strong> .....................2954<br />
life technologies .......................919<br />
lifesign llC ...........................3149<br />
linear Chemicals, s.l. .................2046<br />
liposcience ...........................2651<br />
lps industries, llC .....................3068<br />
lre Medical, an esterline Company ....3143<br />
lumigen, inc. ..........................917<br />
luminex Corporation ..................1645<br />
lw scientific . . . . . . . . . . . . . . . . . . . . . . . . . .4309<br />
M&d, inc. .............................3565<br />
Magellan biosciences .................1921<br />
Magnabiosciences ....................1650<br />
MagneMotion ........................3605<br />
Magnisense ............................222<br />
Maine biotechnology services .........2467<br />
Maine standards Co. llC. ...............907<br />
Man & Machine, inc. ...................4210<br />
Market diagnostics international ........13<br />
Martel instruments ltd. ................347<br />
Matest systemtechnik gmbH .........3762<br />
Mayo Medical laboratories .............410<br />
McKesson . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1014<br />
Medialab, inc. ........................4207<br />
Medica 2011/ Messe duesseldorf ......2244<br />
Medica Corporation ...................1851<br />
Medicago ab .........................2869<br />
Medical automation systems ..........1223<br />
Medical device Consultants, inc. .......2757<br />
Medical device safety service gmbH ...2815<br />
Medical electronic systems, llC ........103<br />
Medical laboratory evaluation(Mle) ....316<br />
Medicon gmbH .......................1953<br />
Medix biochemica ....................3264<br />
Medtest dX, inc. . . . . . . . . . . . . . . . . . . . . . .2918<br />
MedtoX laboratories .................1507<br />
Medtronic inc. .........................323<br />
Meizhou Cornely Hi-tech Co. ltd. ......4311<br />
Meridian bioscience, inc. ..............3615<br />
Meridian life science, inc. .............2948<br />
Merion Matters/advance news Magazine 450<br />
Metertech inc. ........................3060<br />
MgM instruments, inc. ................2772<br />
Michigan diagnostics, llC .............3516<br />
MiCobioMed ...........................113<br />
Microbix biosystems inc. ..............3554<br />
microfluidic Chipshop gmbH ..........3165<br />
MiCrolit .............................3748<br />
Microliter analytical supplies, inc. ......243<br />
Micropoint bioscience, inc. .............216<br />
Microscan systems, inc. ................239<br />
Microvisk technologies ................3271<br />
Midland bioproducts Corp . . . . . . . . . . . . .2117<br />
Mindray ..............................3531<br />
Minifab (aust) pty ltd. .................446<br />
Minigrip ...............................206<br />
Minitubes .............................3911<br />
Mlo-Medical laboratory observer .....4107<br />
Mo bio laboratories, inc. ..............2766<br />
Moduline systems, inc. ................4402<br />
Monobind inc. ........................3550<br />
Moss, inc. .............................3749<br />
Motoman inc. .........................3517<br />
Mp biomedicals .......................3171<br />
mspeC group .........................4442<br />
Mt promedt Consulting gmbH . . . . . . . .3070<br />
Multisorb technologies ................3435<br />
mut-ag ...............................2451<br />
nanjing liming bio-products Co. ltd ....117<br />
nanjing perlove Medical<br />
equipment Co. ltd ..................4343<br />
nano-ditech Corporation ...............125<br />
nanoq ................................3423<br />
nanosphere, inc. ......................2208<br />
nantong egens biotechnology Co., ltd. 3668<br />
national academy of <strong>Clinical</strong><br />
biochemistry .......................2131<br />
national registry of Certified Chemists 2234<br />
neogen Corporation ..................1552<br />
netlims, llC ............................139<br />
neuroscience, inc. .....................205<br />
new england biolabs, inc. .............1308<br />
new england small tube ..............2656<br />
newscen Cost bio-pharmaceutical<br />
Co., ltd. ............................3465<br />
next Control systems .................3850<br />
nextslide imaging, llC ................4438<br />
niCHirei biosCienCes, inC. ...........3760<br />
nikon instruments inc. ................3654<br />
noeMalife ...........................4008<br />
nof america Corporation .............3360<br />
norgren/Kloehn .......................2902<br />
nor-lake scientific . . . . . . . . . . . . . . . . . . . . . 307<br />
nova biomedical ......................2923<br />
novatec immundiagnostica gmbH ....2566<br />
nuaire inc. ...........................2109<br />
oak ridge products ....................662<br />
oapi—Medical device division . .......4004<br />
omega diagnostics group plC ........3343<br />
omni print, inc. .......................4048<br />
operon ..............................1943<br />
opti Medical . . . . . . . . . . . . . . . . . . . . . . . . .4223<br />
orasure technologies, inc. ............3539<br />
orasure technologies, inc. ............2216<br />
orchard software Corp ................3623<br />
orphee s.a. ...........................2853<br />
ortho <strong>Clinical</strong> diagnostics .............1003<br />
owen Mum<strong>for</strong>d .......................3417<br />
oYC americas, inc. ....................1449<br />
oyster bay pump works, inc. ...........4323<br />
pacific die Cut industries/pdCi Medical ..335<br />
pall life sciences ......................3168<br />
panagene, inc. .......................3665<br />
pango Medical devices .................212<br />
parker precision fluidics division ......2778<br />
peaK-service usa .....................3347<br />
pel-freez biologicals ..................2671<br />
phadia us inc. ........................2523<br />
phenomenex ..........................303<br />
philosys, ltd. ..........................3905<br />
pHtHisis diagnostics .................4414<br />
plexus ................................4209<br />
pointe scientific .......................1640<br />
polar King international ................856<br />
polar leasing ..........................852<br />
polymed <strong>the</strong>rapeutics, inc. ............3907<br />
polymedco, inc. .......................2920<br />
polYMiCrospHeres ..................2669<br />
precision systems inc. .................2938<br />
premstar international, ltd. . . . . . . . . . . . .4313<br />
primeradx .............................143<br />
princeton bioMeditech Corp. ..........3248<br />
prior scientific, inc. .....................233<br />
proliant Health and biologicals ........1561<br />
pulssar technologies . . . . . . . . . . . . . . . . . . . 310<br />
puritan Medical products ..............4448<br />
pVt labsystems, llC ..................3011<br />
QbC diagnostics .......................424<br />
Qiagen inc. ..........................4302<br />
Qualtex laboratories ..................4005<br />
Quantimetrix Corporation .............2252<br />
Quasar instruments, llC ...............4408<br />
Quest diagnostics ....................3130<br />
Quest product development Corp. ....4112<br />
Quidel Corporation ....................2909<br />
Quimica Clinica aplicada, s.a. .........1945<br />
radim spa ............................3768<br />
radiometer america ...................722<br />
randox laboratories ..................1301<br />
rareCyte ..............................3650<br />
rayto life & analytical sciences Co, ltd. 4305<br />
r-biopharm ag .......................2850<br />
rd plastics .............................514<br />
recipe Chemicals & instruments .......3763<br />
research organics, inc. ................4217<br />
rheonix, inc. ..........................4434<br />
rnd group, inc., <strong>the</strong> ...................1535<br />
roche diagnostics ....................2205<br />
rockland immunochemicals, inc. ......2868<br />
roHM Co., ltd. .........................112<br />
rotek industries .......................4321<br />
runlab labware Manufacturing Co., ltd 3854<br />
ruro incorporated ....................241<br />
sa scientific ltd ......................2570<br />
saCaCe biotechnolgoies srl ...........4422<br />
safC .................................1841<br />
saKae Corporation ...................3957<br />
sanyo .................................2946<br />
sarstedt, inc. ..........................3218<br />
sartorius stedim biotech ..............3261<br />
scantibodies laboratory inc. ..........2123<br />
sCC soft Computer ....................4017<br />
sCeti K.K. ............................3571<br />
scienion ag . . . . . . . . . . . . . . . . . . . . . . . . . .2878<br />
scientific device laboratory ............340<br />
scimedx Corporation ...................406<br />
scipac ltd. ............................1531<br />
scripps laboratories ..................3857<br />
scytek laboratories, inc. ..............3162<br />
sd biosensor, inc. .....................1523<br />
sdiX ..................................3755<br />
sebia electrophoresis .................3111<br />
seegene, inc. .........................1653<br />
sekisui diagnostics . . . . . . . . . . . . . . . . . . . .2705<br />
sekisui Medical Co., ltd ................2607<br />
select laboratory partners .............213<br />
selective Micro technologies llC ......2670<br />
sensovation ..........................4206<br />
sentinel CH spa . . . . . . . . . . . . . . . . . . . . .4039<br />
separation technology, inc. (sti) .......2557<br />
sequenom, inc. .......................4308<br />
seraCare life sciences .................4014<br />
serion immundiagnostica gmbH ......2650<br />
shanghai Kehua bioengineering<br />
Co., ltd. ............................3568<br />
shanghai fosun Med tech<br />
development Co. ...................1514<br />
shanghai tellgen life science Co.,ltd. 4208<br />
shanghai ZJ bio-tech Co., ltd. ..........204<br />
shanghaibio Corp. ....................3166<br />
shenzhen emperor electronic<br />
technology ...........................306<br />
shenzhen genius electronics Co., ltd. ...108<br />
shenzhen landwind industry Co., ltd. 3045<br />
shenzhen procan electronics inc. ......4101<br />
shin Jin Medics inc. ...................3771<br />
sias ag ................................144<br />
siemens Healthcare diagnostics .......1605<br />
siemens water technologies ..........1614<br />
sifin gmbH. ...........................3664<br />
simport ...............................3943<br />
sinnowa Medical science &<br />
technology Co. ......................342<br />
skannex as ............................121<br />
slr research Corporation .............3069<br />
sMC Corporation of america ...........661<br />
snibe Co, ltd. .........................2855<br />
sony dadC ...........................2970<br />
source scientific, a bit Company .......2955<br />
sou<strong>the</strong>rn biotechnology associates, inc. 2567<br />
specialty glass products ...............4203<br />
spherotech, inc. ......................2966<br />
spinreact .............................2042<br />
stanbio laboratory ...................3313<br />
strateC biomedical systems ag ......2053<br />
stratos product development .........4007<br />
streck laboratories, inc. ...............1513<br />
sunquest in<strong>for</strong>mation systems ........3810<br />
surModics ............................1302<br />
swisslog ...............................130<br />
syntron bioresearch, inc. ..............2569<br />
sysmex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2611<br />
systelab technologies .................2239<br />
taidoc technology Corporation ........4312<br />
taigen bioscience Corporation .........246<br />
taiyuan Zhongke Henyer<br />
digital Co., ltd. .....................4204<br />
tcoag ..................................631<br />
tecan .................................1431<br />
technidata america Medical software . . . 402<br />
techno Medica Co. ltd. ................1630<br />
teco diagnostics ......................3451<br />
telCor ...............................4430<br />
tetracore, inc. .........................3752<br />
<strong>the</strong>rapak Corporation .................2043<br />
<strong>the</strong>ratest labs inc. .....................302<br />
<strong>the</strong>rmo fisher scientific ...............2672<br />
<strong>the</strong>rmo scientific .....................1720<br />
thinXXs Microtechnology ag ..........3065<br />
tianjin era biology engineering Co., ltd. .4303<br />
toKYo boeKi MaCHinerY ltd. ........208<br />
topCon ..............................4350<br />
tosoh bioscience .......................401<br />
toyobo Co. ltd. .......................4200<br />
trek diagnostics systems, inc. .........2020<br />
triContinent scientific, inc. .............231<br />
trilink biotechnologies, inc. ...........2866<br />
trina bioreaCtiVes ag ..............3923<br />
trinity biotech ........................2915<br />
turklab a.s. ...........................3769<br />
uCla Health system ..................3420<br />
ulti Med products gmbH ..............4113<br />
uniCo ................................3067<br />
urit Medical electronic Co., ltd. ........330<br />
utaK laboratories, inc. ................1761<br />
ValuMax international .................3656<br />
Vedalab .............................2771<br />
Veracity group, inc. ...................... 7<br />
Vermillion ..............................236<br />
Viralab inc. ...........................4216<br />
Vircell .................................1949<br />
Virostat, inc. ..........................1549<br />
Vital diagnostics . . . . . . . . . . . . . . . . . . . . . .3243<br />
Viva products, inc. ....................1661<br />
Vivacta ltd. ............................215<br />
Vonco products .......................4109<br />
wako diagnostics .....................2831<br />
warde Medical laboratory .............1660<br />
waters Corporation ...................3136<br />
weidmann plastics technology ag .....338<br />
weifang Kanghua biotech Co., ltd. ....2768<br />
werfen group .........................2338<br />
westgard QC, inc. . . . . . . . . . . . . . . . . . . . . .1634<br />
wheaton industries inc. ...............1322<br />
wHpM bioresearch &<br />
technology Co., ltd. ................3953<br />
wi - Medical device development .....3903<br />
wiener laboratorios saiC .............3670<br />
wiley .................................4103<br />
wisepac active packaging<br />
Components Co. ...................3956<br />
wondfo biotech Co., ltd. ..............1551<br />
worthington biochemical Corporation 3260<br />
wslH proficiency testing ..............4045<br />
XeMa .................................3863<br />
Xiril ag ...............................2751<br />
Yd diagnostics ........................3445<br />
Zebra technologies ....................137<br />
Zentech ..............................3524<br />
ZeptoMetrix Corporation ..............2873<br />
Zeta Corporation ......................3412<br />
Zhejiang gongdong<br />
Medical technology Co. .............4030<br />
Zymo research .......................2668<br />
As of June 7, 2011<br />
CliniCal laboratory news July 2011 21
special section<br />
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22 CliniCal laboratory news July 2011<br />
2 0 11 N E w P r o d U c T s r E v I E w<br />
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blood plasma samples are automatically<br />
inverted prior to analysis and a continuous<br />
access sample wheel allows <strong>for</strong> addition of<br />
samples at any time. True positive sample<br />
ID is achieved with full traceability. A<br />
complete test menu is available, including:<br />
protein electrophoresis, immunotyping,<br />
and CDT (chronic alcohol abuse marker).<br />
*Pending FDA clearance. Available <strong>for</strong> sale<br />
outside <strong>the</strong> U.S.<br />
Sebia Electrophoresis<br />
www.sebia-usa.com<br />
Booth No. 3111<br />
CAPILLARYS 2 FLEx Piercing:<br />
Whole-Blood Hb Testing*<br />
Whole-blood hemoglobinopathy testing by<br />
capillary electrophoresis (CE) with cappiercing<br />
capabilities is now available with<br />
<strong>the</strong> CAPILLARYS 2 FLEX Piercing system.<br />
Whole-blood plasma samples are automatically<br />
inverted be<strong>for</strong>e sampling to ensure<br />
thorough homogenization of <strong>the</strong> sample and<br />
accurate Hb results. A high-resolution Hb<br />
separation takes place concurrently in eight<br />
capillaries with a sample throughput of 37<br />
results per hour. CAPILLARYS 2 FLEX Piercing<br />
is a continuous-feed system that provides<br />
full traceability from bar-coded primary<br />
sample tube to final result. A complete test<br />
menu is available, including serum and urine<br />
protein electrophoresis; immunotyping; and<br />
CDT (chronic alcohol abuse marker). *Pending<br />
FDA clearance. Available <strong>for</strong> sale outside<br />
<strong>the</strong> U.S.<br />
Sebia Electrophoresis<br />
www.sebia-usa.com<br />
Booth No. 3111<br />
Tumor Marker Control*<br />
Fujirebio Diagnostics, Inc., <strong>the</strong> industry<br />
leader in biomarker assays, presents its solution<br />
<strong>for</strong> accurate precision monitoring of<br />
laboratory tumor marker assays. The Tumor<br />
Marker Control is intended <strong>for</strong> use as a<br />
quantitative, assayed serum control. This<br />
is <strong>the</strong> only multi-constituent control to<br />
contain <strong>the</strong> novel biomarker HE4 used to<br />
monitor progression and recurrence of<br />
epi<strong>the</strong>lial ovarian carcinoma. It contains<br />
clinically relevant proportions of free<br />
PSA and PSA-ACT. Analytes include AFP,<br />
CA 15-3, CA 19-9, CA 125, CEA, ferritin,<br />
HE4, total PSA, and free PSA. Reconstituted,<br />
open-vial stability is 14 days at 2–8ºC<br />
with <strong>the</strong> following exception: Free PSA is<br />
stable <strong>for</strong> 7 days. The control sustains nine<br />
freeze/thaw cycles at ≤–20ºC. *Available<br />
<strong>for</strong> sale outside <strong>the</strong> U.S.<br />
Fujirebio Diagnostics, Inc.<br />
www.fdimcc.com<br />
Booth No. 2221<br />
EncompassMDx*<br />
Rheonix® introduces an automated microfluidic<br />
plat<strong>for</strong>m <strong>for</strong> <strong>the</strong> evolving molecular<br />
diagnostics industry. Rheonix CARD®<br />
technology automatically processes samples<br />
through purification, multiplexed amplification,<br />
and endpoint detection, offering true<br />
sample-to-result functionality with minimal<br />
technician hands-on time. The versatile<br />
system can be rapidly customized <strong>for</strong> a broad<br />
spectrum of diagnostic applications and incorporates<br />
low-cost consumables to analyze<br />
raw clinical samples such as blood, saliva,<br />
buccal and vaginal swabs. Successful pilot<br />
programs have applied a range of functional<br />
assays to <strong>the</strong> EncompassMDx plat<strong>for</strong>m,<br />
including SNP detection, pathogen identification,<br />
immunoassays, cell-based assays, and<br />
o<strong>the</strong>r molecular diagnostic applications. *For<br />
research use only.<br />
Rheonix, Inc.<br />
www.rheonix.com<br />
Booth No. 4434<br />
Chemiluminescence Immunoassay <strong>for</strong> TB*<br />
The Anti-TB kit is a chemiluminescence immunoassay<br />
(CLIA) test <strong>for</strong> detecting specific<br />
antibodies to Mycobacterium tuberculosis<br />
(TB) in human serum or plasma. In conjunction<br />
with Chemclin®100, a semi-automated<br />
CLIA analyzer, and Chemclin®600, a<br />
fully automated CLIA instrument, this assay<br />
provides high throughput and reliable detection.<br />
This assay offers laboratories higher<br />
sensitivity and is more user-friendly than<br />
o<strong>the</strong>r ELISA and RIA-based anti-TB assays.<br />
*Available <strong>for</strong> sale outside <strong>the</strong> U.S.<br />
Beijing Chemclin Biotech Co., Ltd.<br />
www.chemclin.com<br />
Booth No. 3952<br />
ARCHITECT HIV Ag/Ab Combo Assay*<br />
ARCHITECT HIV Ag/Ab Combo assay is a<br />
chemiluminescent microparticle immunoassay<br />
<strong>for</strong> simultaneous qualitative detection<br />
of human immunodeficiency virus (HIV)<br />
p24 antigen and antibodies to HIV type 1
See us at <strong>the</strong> 2011 Clin Lab Expo, Booth No. 2611
special section<br />
Advertisement<br />
(HIV-1 group M and group O) and/or type<br />
2 (HIV-2) in human serum and plasma. It<br />
is intended <strong>for</strong> use as an aid in <strong>the</strong> diagnosis<br />
of HIV-1/HIV-2 infection in subjects age<br />
≥2 and pregnant women, including acute/<br />
primary HIV-1 infection. The test does not<br />
distinguish between HIV-1 p24 antigen,<br />
HIV-1 antibody, or HIV-2 antibody and is<br />
not intended <strong>for</strong> blood screening. Results<br />
should be interpreted with <strong>the</strong> patient’s<br />
presentation, history, and laboratory results.<br />
*For in vitro diagnostic use only in <strong>the</strong> U.S.;<br />
<strong>for</strong> sale by or on order of physician or to<br />
clinical laboratory only.<br />
Abbott Diagnostics<br />
www.abbottdiagnostics.com<br />
Booth No. 2531<br />
StrongStep® Candida albicans /Trichomonas<br />
vaginalis Antigen Combo Rapid Test*<br />
Vaginitis is one of <strong>the</strong> principal reasons<br />
women see an obstetrician or gynecologist.<br />
Candidiasis and trichomoniasis are<br />
responsible <strong>for</strong> most cases of infectious<br />
vaginitis, but <strong>the</strong>y need different treatment.<br />
StrongStep Candida albicans/Trichomonas<br />
vaginalis Antigen Combo Rapid Test is an<br />
immunochromatographic assay <strong>for</strong> qualitative<br />
presumptive detection of <strong>the</strong>se two<br />
pathogens from vaginal swabs. Samples can<br />
be self-collected by patients. In addition,<br />
compared with wet mount and culture,<br />
<strong>the</strong> results from this antigen test are less<br />
influenced by vaginal local drug treatment<br />
be<strong>for</strong>e <strong>the</strong> patient’s clinic visit. The test<br />
offers a simple testing procedure and fast<br />
results at <strong>the</strong> time of patients’ clinic visit.<br />
*Pending FDA clearance. Available <strong>for</strong> sale<br />
outside <strong>the</strong> U.S.<br />
Nanjing Liming Bio-products Co., Ltd.<br />
www.limingbio.com<br />
Booth No. 117<br />
StrongStep® N. gonorrhoeae/C. trachomatis<br />
Antigen Combo Rapid Test *<br />
N. gonorrhoeae and C. trachomatis are closely<br />
related, and patients are often co-infected<br />
with <strong>the</strong> two pathogens. Patients should<br />
<strong>the</strong>re<strong>for</strong>e be tested <strong>for</strong> gonorrhea and<br />
chlamydia simultaneously. StrongStep N.<br />
gonorrhoeae/C. trachomatis Antigen Combo<br />
Rapid Test is an immunochromatographic<br />
assay <strong>for</strong> qualitative presumptive detection<br />
of N. gonorrhoeae and C. trachomatis in<br />
female cervical-swab and male urethral-swab<br />
specimens. Unlike culture, <strong>the</strong> results from<br />
this antigen test are seldom influenced by patient’s<br />
self drug treatment be<strong>for</strong>e a clinic visit.<br />
The test offers convenience <strong>for</strong> clinicians<br />
and provides patients with rapid results at<br />
<strong>the</strong> time of <strong>the</strong>ir clinic visit, <strong>the</strong>reby allowing<br />
early treatment and preventing fur<strong>the</strong>r com-<br />
24 CliniCal laboratory news July 2011<br />
2 0 11 N E w P r o d U c T s r E v I E w<br />
plications. *Pending FDA clearance. Available<br />
<strong>for</strong> sale outside <strong>the</strong> U.S.<br />
Nanjing Liming Bio-products Co., Ltd.<br />
www.limingbio.com<br />
Booth No. 117<br />
StrongStep® HSV 1/2 Antigen Rapid Test*<br />
Diagnosing herpes by visual examination of<br />
a lesion does not give an accurate diagnosis<br />
because many o<strong>the</strong>r infections or irritations<br />
can look just like herpes. Testing <strong>for</strong> <strong>the</strong> virus<br />
directly from <strong>the</strong> skin is useful if genital<br />
symptoms are present during <strong>the</strong> patient’s<br />
clinic visit. StrongStep HSV 1/2 Antigen<br />
Rapid Test is an immunochromatographic<br />
assay <strong>for</strong> qualitative presumptive detection<br />
of HSV 1&2 antigens in mucocutaneous<br />
specimens. The test is intended <strong>for</strong> confirmation<br />
of HSV symptomatic infection but<br />
also differentiates o<strong>the</strong>r genital ulcer diseases<br />
with herpes easily and quickly. Because <strong>the</strong><br />
test detects antigen, it yields much higher<br />
sensitivity and specificity than antibody tests.<br />
Compared to PCR or culture, <strong>the</strong> test offers<br />
wider feasibility. *Pending FDA clearance.<br />
Available <strong>for</strong> sale outside <strong>the</strong> U.S.<br />
Nanjing Liming Bio-products Co., Ltd.<br />
www.limingbio.com<br />
Booth No. 117<br />
Aquaporin-4 Antibody ELISA Test kit*<br />
KRONUS, a leading provider of specialized<br />
autoimmune diagnostic test kits, is pleased to<br />
announce <strong>the</strong> availability of a new ELISA test<br />
kit <strong>for</strong> measuring antibodies to aquaporin-4<br />
(AQP-4Ab). Aquaporin-4 is <strong>the</strong> most abun-<br />
dant water channel protein in <strong>the</strong> central<br />
nervous system and is expressed extensively<br />
within <strong>the</strong> brain and spinal cord regions.<br />
This new ELISA allows <strong>for</strong> accurate and<br />
specific determination of autoantibodies to<br />
AQP-4. *For research use only.<br />
KRONUS, Inc.<br />
www.kronus.com<br />
Booth No. 1622<br />
Voltage-Gated Potassium<br />
Channel Antibody RIA Test kit*<br />
KRONUS, a leading provider of specialized<br />
autoimmune diagnostic test kits, is pleased to<br />
announce <strong>the</strong> availability of a new RIA test<br />
kit <strong>for</strong> measuring antibodies to <strong>the</strong> voltagegated<br />
potassium channel (VGKC–Kv1.1, 1.2<br />
and 1.6). This new RIA allows <strong>for</strong> accurate<br />
and specific determination of VGKCAb.<br />
Measurement of antibodies to voltage-gated<br />
potassium channels (VGKC) may be useful<br />
in select indications.*For research use only.<br />
KRONUS, Inc.<br />
www.kronus.com<br />
Booth No. 1622<br />
CLC 720 Chemistry Analyzer*<br />
Carolina Liquid Chemistries’ CLC 720 is a<br />
discrete, random-access, fully automated,<br />
floor-model chemistry analyzer. The CLC<br />
720 is capable of running up to 100 different<br />
tests from CMPs, DAUs, and lipids to<br />
specialty tests such as cystatin C and 1,5 AG<br />
(GlycoMark®). The CLC 720 can run 560<br />
tests/hour with ISE. It is an excellent fit <strong>for</strong><br />
hospital, start-up, and small reference laboratories,<br />
as well as satellite laboratories, large<br />
reference laboratories, or large physician<br />
clinics. *Pending FDA clearance.<br />
Carolina Liquid Chemistries Corp.<br />
www.carolinachemistries.com<br />
Booth No. 4121<br />
Four-Level Methotrexate Controls*<br />
UTAK’s Four-Level Methotrexate Controls<br />
are manufactured in 100% human serum<br />
with no added preservatives to eliminate matrix<br />
effects and improve precision. The four<br />
methotrexate concentrations are 0.05, 0.075,<br />
0.5, and 0.75 µmol/L. These lyophilized<br />
controls have a 30- month shelf life, 25 days<br />
of reconstituted stability, and are packaged<br />
in a 5 x 5-mL volume size.*Available <strong>for</strong> sale<br />
outside <strong>the</strong> U.S.<br />
UTAK Laboratories, Inc.<br />
www.utak.com<br />
Booth No. 1761<br />
Bi-Level Antifungal Controls *<br />
UTAK’s Bi-Level Antifungal Controls are<br />
manufactured in 100% human serum with<br />
no added preservatives to eliminate matrix<br />
effects and improve precision. The analyte<br />
panel of antifungals includes Fluconazole,<br />
5-Flucytosine, Itraconazole, Hydroxy-Itra-<br />
conazole, Posaconazole, and Voriconazole at<br />
clinically relevant concentration levels. These<br />
lyophilized controls have a 30-month shelf<br />
life, 25 days of reconstituted stability, and are<br />
packaged in a 5 x 5-mL volume size. *Available<br />
<strong>for</strong> sale outside <strong>the</strong> U.S.<br />
UTAK Laboratories, Inc.<br />
www.utak.com<br />
Booth No. 1761<br />
MALDI Biotyper*<br />
Bruker’s MALDI Biotyper identifies<br />
microorganisms using MALDI-TOF mass<br />
spectrometry by measuring <strong>the</strong> unique,<br />
characteristic molecular fingerprint of <strong>the</strong><br />
proteins that are found in all microorganisms.<br />
The resulting patterns of <strong>the</strong>se proteins<br />
are used to reliably and accurately identify a<br />
broad range of microorganism down to <strong>the</strong><br />
species level. The MALDI Biotyper is very<br />
accurate, highly reproducible, extremely costeffective,<br />
fast, and easy-to-use. It is especially<br />
designed to meet <strong>the</strong> demands of <strong>the</strong> microbiology<br />
laboratory. This new technology has<br />
changed and modernized <strong>the</strong> way microbial<br />
identification is done in clinical laboratories<br />
around <strong>the</strong> world. *For research use only.<br />
Pending FDA clearance. Available <strong>for</strong> sale<br />
outside <strong>the</strong> U.S.<br />
Bruker Daltonics<br />
www.bdal.com<br />
Booth No. 3853<br />
T Module System*<br />
The T Module System is a revolutionary<br />
multi-parameter instrument based on latex<br />
technology that simultaneously per<strong>for</strong>ms<br />
tests such as CRP, ASO, RF, and Hb1Ac in<br />
a few minutes. The modular configuration<br />
allows laboratories to run <strong>the</strong> instrument<br />
with a customized panel of tests according to<br />
<strong>the</strong> needs of each laboratory. The instrument<br />
analyzes <strong>the</strong> kinetic reaction and recognizes<br />
<strong>the</strong> prozona effect, recovering <strong>the</strong> sample<br />
with appropriate dilution. The calibration<br />
curves of each reagent kit are recorded into a<br />
volumetric card that enables <strong>the</strong> analysis. *In<br />
development.<br />
Alifax SpA<br />
www.alifax.com<br />
Booth No. 4031<br />
ACQuITY® Online SPE System*<br />
Waters introduces <strong>the</strong> ACQUITY Online<br />
SPE System <strong>for</strong> general laboratory use. The<br />
ACQUITY Online SPE System couples powerful<br />
and enabling UPLC® Technology with<br />
automated, online, solid-phase extraction to<br />
streamline workflows and improve analytical<br />
per<strong>for</strong>mance <strong>for</strong> LC-MS/MS-based assays.<br />
This fully integrated system solution is designed<br />
to improve <strong>the</strong> flexibility of LC-MS/<br />
MS testing by allowing multiple assays to
2 0 11 N E w P r o d U c T s r E v I E w special section<br />
Advertisement<br />
be per<strong>for</strong>med on a single plat<strong>for</strong>m. Singleuse<br />
cartridges are used to per<strong>for</strong>m each and<br />
every extraction on <strong>the</strong> system, reducing <strong>the</strong><br />
risks of analyte carryover and accumulation<br />
of matrix components that can compromise<br />
analytical per<strong>for</strong>mance. *For research use<br />
only.<br />
Waters Corporation<br />
www.waters.com/clinical<br />
Booth No. 3136<br />
The NGAL Test*<br />
The NGAL Test, a particle-enhanced<br />
turbidimetric assay <strong>for</strong> <strong>the</strong> quantitative<br />
determination of NGAL in human urine or<br />
plasma, is designed <strong>for</strong> routine diagnostic<br />
use on chemistry analyzers from numerous<br />
manufactures, such as Roche, Abbott,<br />
Siemens, and Beckman Coulter. NGAL is a<br />
novel biomarker <strong>for</strong> diagnosing acute kidney<br />
injury (AKI). The test effectively gives almost<br />
any laboratory immediate access to a fast and<br />
easy method to measure NGAL. This test is<br />
intended <strong>for</strong> in vitro diagnostic use in select<br />
countries only. Check <strong>for</strong> availability in your<br />
country on our website. *For research use<br />
only.<br />
BioPorto Diagnostics A/S<br />
www.bioporto.com<br />
Booth No. 2809<br />
hema-screen SPECIFIC*<br />
hema-screen SPECIFIC is an immunochemical,<br />
fecal, occult-blood test specific <strong>for</strong><br />
human hemoglobin. hema-screen SPECIF-<br />
IC’s distinguishing feature is our patented<br />
DEVEL-A-TAB collection slide, allowing<br />
two specimens to be tested at <strong>the</strong> same time.<br />
The new enhanced version of hema-screen<br />
SPECIFIC contains an additional 10 collection<br />
system/mailing envelopes. This feature<br />
allows doctors or labs to hand out additional<br />
collection system/mailing envelopes to compensate<br />
<strong>for</strong> non-compliance. Look <strong>for</strong> our<br />
new packaging. *In development.<br />
Immunostics Inc.<br />
www.immunostics.com<br />
Booth No. 1556<br />
ABO & RhD Blood Grouping kit*<br />
INTEC ABO & RhD Blood Grouping Kit<br />
uses unique visual testing technology to<br />
detect ABO and RhD blood groups based on<br />
<strong>the</strong> immune response principle of antigens<br />
and antibodies. The kit is suitable <strong>for</strong> on-site<br />
blood collection, medical laboratory testing,<br />
and urgent pre-transfusion testing. With<br />
rapid accurate results and good per<strong>for</strong>mance<br />
in specificity and stability, <strong>the</strong> kit can be stored<br />
at 2–30ºC <strong>for</strong> 2 years. The kit offers detection<br />
of ABO and RhD blood groups simultane-<br />
ously in one test without any additional<br />
equipment. This product has international<br />
patent: No.: PCT/CN2009/000322. *Pending<br />
FDA clearance.<br />
InTec PRODUCTS, Inc.<br />
www.intecasi.com<br />
Booth No. 741<br />
BS-800 Modular System*<br />
BS-800 Modular System, an innovative clinical<br />
chemistry diagnostic system manufactured<br />
by Mindray Corporation, incorporates<br />
Mindray’s suggested reagents, calibrators,<br />
and controls. It can be adapted to customers’<br />
needs by integrating one to four modular<br />
units with various throughputs, ranging<br />
from 1,200–4,800 tests/hour. The systems<br />
uses only 100 µL of reagent, takes up to 860<br />
The scientific proof of a technology breakthrough<br />
is not established by a single study. The technology<br />
must be evaluated and <strong>the</strong> study results duplicated<br />
in numerous settings to be considered scientifically<br />
valid. In <strong>the</strong> last two years, 50 published studies<br />
by leading diabetes hospitals throughout <strong>the</strong> world<br />
validate that Nova’s StatStrip glucose sensor<br />
technology dramatically improves accuracy by<br />
reducing hematocrit and o<strong>the</strong>r interferences. These<br />
studies have been conducted at some of <strong>the</strong> most<br />
prestigious diabetes centers in <strong>the</strong> world including<br />
<strong>the</strong> Mayo Clinic, John Hopkins University School<br />
of Medicine, University of Cali<strong>for</strong>nia Davis<br />
Center <strong>for</strong> Point of Care Technology, University<br />
of Toronto Sunnybrook Health Sciences Center,<br />
Addenbrooke’s Hospital Cambridge University<br />
Hospitals, UK, WEQAS and University Hospital,<br />
Cardiff, Wales, Isala Klinieken, Ne<strong>the</strong>rlands.<br />
Some conclusions:<br />
www.statstrip.com<br />
samples, has 2–8ºC reagent cooling, reagent<br />
bubble detection, and user-friendly operating<br />
software. The system allows labs to focus on<br />
cost-effectiveness, result accuracy, operator<br />
safety, and technology advancement. BS-800<br />
Modular System provides a brand new experience<br />
in laboratory practice and lets labs<br />
Scientific Papers Validate<br />
Nova’s Technology Breakthrough<br />
In Glucose Sensor Accuracy<br />
Nova Multi-Well <br />
Glucose StatStrip ® Technology<br />
Publications and Presentations<br />
Copies of this booklet are available by<br />
contacting Nova Biomedical Tel: 781-894-0800<br />
www.novabiomedical.com<br />
“Here we fur<strong>the</strong>r demonstrate <strong>for</strong> <strong>the</strong> first time that anemia is <strong>the</strong> primary<br />
cause of glucometer error in hemodynamically stable adult ICU patients<br />
and that eliminating hematocrit error decreases <strong>the</strong> frequency of hypoglycemia.”<br />
Pidcoke M et al. Crit Care Med 2010<br />
“The new generation StatStrip glucose meter, which has been designed to<br />
compensate <strong>for</strong> hematocrit and chemical interferences, reduces <strong>the</strong> likelihood<br />
of erroneous results arising from interference factors that influence current<br />
conventional glucose meters.”<br />
Bewley B et al. Point of Care 2009<br />
“The StatStrip system was not susceptible to hematocrit, ascorbate or maltose<br />
interferences, ei<strong>the</strong>r alone or in combination with one ano<strong>the</strong>r. The o<strong>the</strong>r<br />
strip meter systems tested were significantly influenced by <strong>the</strong>se interferences.”<br />
Lyon ME. AACC, Annual Meeting 2008<br />
“With <strong>the</strong> exception of <strong>the</strong> Nova StatStrip, all meters were affected by<br />
variable hematocrit.”<br />
Mohn B. NZJ Med Lab Sci 2010<br />
United States<br />
GLU<br />
Canada (Cont’d)<br />
Asia<br />
Europe<br />
Europe Cont’d<br />
The Nova StatStrip ® Blood Glucose Meter<br />
Evaluation: Hematocrit Dependency,<br />
Method Comparison, Interfering<br />
Substances and Neonatal Samples<br />
<strong>Clinical</strong> Evaluation of a Point of Care Device<br />
<strong>for</strong> Creatinine measurements in <strong>the</strong> Followup<br />
of Kidney Transplant Patients<br />
Validation of two Point-of-Care Testing<br />
devices <strong>for</strong> fetal lactate assessment<br />
during labour<br />
Evaluation of <strong>the</strong> Nova Biomedical<br />
StatStrip ® Glucose Meter<br />
Assessment of <strong>the</strong> Per<strong>for</strong>mance of Handheld<br />
POC Sensors <strong>for</strong> Measuring<br />
3-Hydroxybutyrate<br />
Four Step Validation Procedure <strong>for</strong><br />
Evaluating POCT Meters<br />
Comparison of Four Hospital Based<br />
Glucose Meter Technologies <strong>for</strong> Accuracy,<br />
Precision and Interferences Encountered<br />
in Hospitalized Patients<br />
An Evaluation of <strong>the</strong> Analytical<br />
Specificity and <strong>Clinical</strong> Application of a<br />
New Generation Hospital Based Glucose<br />
Meter in a Dialysis Setting<br />
Improved POC Meter Accuracy <strong>for</strong><br />
Monitoring and Managing Glucose Levels<br />
in Dialysis Patients<br />
Nova StatStrip ® Evaluation of a Point-Of-Care (POC) Glucose<br />
Meter Suitable <strong>for</strong> Use in Complex Tertiary<br />
Care Facilities<br />
Per<strong>for</strong>mance of a StatStrip<br />
: Could This Device be used<br />
to Effectively Implement Tight Glycemic<br />
Control and Triage Blood Glucose and<br />
Insulin Management in Critical Illness<br />
An Evaluation of <strong>the</strong> Analytical<br />
Per<strong>for</strong>mance of a New Generation<br />
Hospital Based Glucose Meter in a<br />
Neonatal Care Unit<br />
Reliability of Glucose Meters in Hospitals<br />
in Austria<br />
Per<strong>for</strong>mance of <strong>the</strong> Nova StatStrip<br />
Care Glucose Meter in a Neonatal Intensive<br />
Care Unit<br />
Multi-site Evaluation of Point of Care<br />
Glucose Meters in a Neonatal Intensive<br />
Care Unit<br />
A Multi-Site Analytical Assessment of a<br />
New Hospital POC Glucose Meter <strong>for</strong><br />
Accuracy, Precision, Correlation, and<br />
Interferences Encountered in<br />
Hospitalized Patients<br />
® Meter<br />
Comparison of Accuracy of a Glucometer<br />
and a Blood Gas Analyzer in an Adult ICU<br />
Comparison of Accuracy of Three<br />
POC Glucometers in an Adult ICU<br />
Per<strong>for</strong>mance Of The Statstrip Glucose Meter<br />
In Inpatient Management Of Diabetes Mellitus<br />
Testování Glukometrů a Jejich Porvnání<br />
Evaluation d’un Nouveau Lecteur de<br />
Glycémie Intégrant une Correction<br />
Automatique de l’Hématocrite<br />
Galatose Interference on POCT Glucose<br />
Analysis<br />
Interference of Hematocrit and Maltose<br />
Plasma Concentrations on <strong>the</strong> Accuracy of<br />
Different Blood Glucose Measuring Systems<br />
Das Blutzuckermessystem StatStrip ® ist nicht<br />
empfindlich für Interferenzen durch<br />
Hämatokrit oder andere bekannte<br />
Störsubstanzen<br />
Genauigkeit des Blutzuckermess-systems<br />
StatStrip ® Comparison Evaluation of Three<br />
Point-of-Care Glucose Meters with<br />
Neonatal Patient Samples Exhibiting<br />
Varied Hematocrit and Triglyceride<br />
Concentrations<br />
Comparative Testing <strong>for</strong> Better<br />
Glycemic Control<br />
Accuracy and Reliability of <strong>the</strong> Nova<br />
StatStrip® Glucose Meter <strong>for</strong> Real-Time<br />
Blood Glucose Determinations<br />
during Glucose Clamp Studies<br />
Evaluation of <strong>the</strong> Impact of<br />
Hematocrit and O<strong>the</strong>r<br />
Interference on <strong>the</strong> Accuracy of<br />
Hospital-Based Glucose Meters<br />
Use of Samples from Indwelling Venous<br />
Ca<strong>the</strong>ters <strong>for</strong> Glucose Meter Testing<br />
Comparison of Four Hospital Based<br />
Glucose Meter Technogies Accuracy,<br />
Precision, and Interference Encountered<br />
in Critically Ill Patient<br />
Evaluation of a New POCT Bedside<br />
Glucose Meter and Strip with Hematocrit<br />
and Interference Corrections<br />
Evaluations of Nova StatStrip<br />
im Vergleich zu anderen<br />
Messsystems und zu einer Standard- Labormethode<br />
Analytical Per<strong>for</strong>mance of an Interference-<br />
Resistant Glucose Meter<br />
Suitability Assessment of a New Bedside<br />
Interference Free Glucose System <strong>for</strong> Use<br />
in Critical Care<br />
® Blood<br />
Glucose Monitoring System in Neonates<br />
Evaluation and Implementation of <strong>the</strong><br />
Nova StatStrip® Bedside Glucose<br />
Monitor <strong>for</strong> Patients Undergoing Cardiopmonary<br />
Bu-pass Graft Surgery (CABG)<br />
Development and Use of a Methodology<br />
<strong>for</strong> <strong>the</strong> Evaluation and Implementation of<br />
POCT Devices<br />
RGH’s Method <strong>for</strong> Evaluation and Implementation<br />
of Data-managed Bedside<br />
Glucose (POCTG) Monitoring<br />
Evaluation of Point of Care Bedside<br />
Glucose Monitors <strong>for</strong> Use in a Specialty<br />
and Transplant Hospital<br />
Hematocrit Effect Outweighs O<strong>the</strong>r<br />
Sources of Glucometer Error in<br />
Critical Care<br />
Assessing <strong>the</strong> Per<strong>for</strong>mance of Handheld<br />
Glucose Testing <strong>for</strong> Critical Care<br />
Evaluation of a Glucose Meter with Negligible<br />
Hematocrit or Chemical Interference<br />
Predicted Discrepancies Between Direct<br />
Reading Whole Blood Biosensors and<br />
Central Lab Plasma Methods: Predicting<br />
and Avoiding Medical Error<br />
Estimates of Total Analytical Error in<br />
Consumer and Hospital Glucose Meters<br />
Contibuted by Hematocrit, Maltose and<br />
Ascorbate<br />
Interference Studies with Two<br />
Hospital-Grade and Two Home-Grade<br />
Glucose Meters<br />
see us at <strong>the</strong> 2011 clin lab expo, booth no. 2923<br />
Canada<br />
Multi-National Sites<br />
200 Prospect Street<br />
Waltham, MA 02454-9141 U.S.A.<br />
TEL: (781) 894-0800 (800) 458-5813<br />
www.novabiomedical.com<br />
® Point of<br />
No. 169 Rev. 1/20/11<br />
CliniCal laboratory news July 2011 25
special section<br />
Advertisement<br />
explore <strong>the</strong> cutting-edge instrumentation<br />
of modern technology. *Available <strong>for</strong> sale<br />
outside <strong>the</strong> U.S.<br />
Shenzhen Mindray Bio-Medical<br />
Electronics Co., Ltd.<br />
www.mindray.com<br />
Booth No. 3531<br />
CAPILLARYS 2 Flex Piercing HbA1c *<br />
This next-generation HbA1c assay, based<br />
on <strong>the</strong> principle of capillary electrophoresis,<br />
provides high-resolution, clear-cut, and<br />
precise separation of HbA1c and HbA0 fractions.<br />
Capillary electrophoresis eliminates<br />
direct interferences on <strong>the</strong> A1c fraction<br />
from carbamylated, acetylated, labile, and<br />
common Hb variants such as HbS, HbD,<br />
and HbE, as well as <strong>the</strong> analytical exclusion<br />
of HbA2 and HbF from <strong>the</strong> measurement.<br />
The method produces highly accurate results<br />
and extremely low CVs. CAPILLARYS 2 Flex<br />
Piercing HbA1c, with whole-blood, closed<br />
tube capacity, offers <strong>the</strong> best equilibrium in<br />
precision, robustness, and throughput along<br />
with <strong>the</strong> ability to run traditional electrophoresis<br />
testing. *Pending FDA clearance.<br />
Available <strong>for</strong> sale outside <strong>the</strong> U.S.<br />
Sebia Electrophoresis<br />
www.sebia-usa.com<br />
Booth No. 3111<br />
TwinPower Dual Solenoid Valve System<br />
The TwinPower patented, dual-solenoid coil<br />
system cannot be found anywhere else on<br />
<strong>the</strong> market. It offers <strong>the</strong> flexibility to increase<br />
flow, pressure, throughput, and safety,<br />
without increasing <strong>the</strong> size of <strong>the</strong> solenoid<br />
valve. The technology provides flexibility to<br />
decrease <strong>the</strong> size of <strong>the</strong> valve and instrument,<br />
saving space and time and cutting costs while<br />
maintaining per<strong>for</strong>mance of valves twice<br />
<strong>the</strong> size. Burkert’s high-quality and reliable<br />
rocker valves were re-engineered to increase<br />
<strong>the</strong> robust nature of <strong>the</strong> fluid separated<br />
diaphragm, decrease internal and dead<br />
volume, reduce <strong>the</strong> manifold footprint, and<br />
add power-saving electronics, LED, latching<br />
and o<strong>the</strong>r special features now available as a<br />
standard. Burkert’s Twin Power technology<br />
comes in three valve sizes: 10mm, 16mm,<br />
and 22mm.<br />
Burkert Fluid Control Systems<br />
www.burkert-usa.com<br />
Booth No. 841<br />
MICROLAB® 600 Diluter and Dispenser*<br />
Hamilton Company, <strong>the</strong> world leader in fluid<br />
measurement, introduces <strong>the</strong> MICROLAB<br />
600, <strong>the</strong> next-generation in its line of semiautomated<br />
laboratory diluters and dispensers<br />
<strong>for</strong> pre-analytical sample preparation. Based<br />
on Hamilton’s leading syringe technology<br />
and positive-displacement dispensing, <strong>the</strong><br />
26 CliniCal laboratory news July 2011<br />
2 0 11 N E w P r o d U c T s r E v I E w<br />
new instrument has been designed <strong>for</strong> easeof-use<br />
and offers flexibility <strong>for</strong> more routines<br />
and smaller sample volumes. The MICRO-<br />
LAB 600 is ideal <strong>for</strong> a range of applications,<br />
including blood alcohol and metals analyses.<br />
The new MICROLAB 600 features an internet-enabled<br />
controller with an icon-based,<br />
graphical touch screen <strong>for</strong> increased ease-ofuse.<br />
*Available <strong>for</strong> sale outside <strong>the</strong> U.S.<br />
Hamilton Company<br />
www.ML600.com<br />
Booth No. 1441<br />
Tellgenplex Tumor Marker<br />
Quantitative Assay*<br />
Tellgenplex Tumor Marker Quantitative<br />
Assay is intended <strong>for</strong> simultaneous quantitative<br />
determination of multiple tumor markers<br />
based on xMAP technology, including<br />
AFP, CEA, CA242, CA125, NSE, CYFRA21-1,<br />
free-β-hCG, total-PSA, free-PSA, CA19-9,<br />
CA15-3, CA50, and SCCA. Laboratories<br />
can detect <strong>the</strong>se tumor markers in single or<br />
multiplex <strong>for</strong>mats to meet <strong>the</strong>ir needs. All<br />
<strong>the</strong>se tumor markers have been cleared by<br />
State of Food and Drug Administration of<br />
China, and total-PSA/free-PSA has received<br />
CE certification. With a variety of tumor<br />
marker detection assays on <strong>the</strong> market, this<br />
in vitro diagnostic test can also be used as an<br />
aid in managing cancer patients *Available<br />
<strong>for</strong> sale outside <strong>the</strong> U.S.<br />
Shanghai Tellgen Life Science Co., Ltd.<br />
www.tellgen.com<br />
Booth No. 4208<br />
Cascade Abrazo System*<br />
The Cascade Abrazo system represents <strong>the</strong><br />
next-generation in point-of-care hemostasis<br />
testing. The Abrazo analyzer features a hand-<br />
held design with an intuitive touchscreen interface,<br />
wireless connectivity, and 2D barcode<br />
reader <strong>for</strong> capturing patient and reagent data.<br />
The administrative software and docking station<br />
allow remote management and quality<br />
control with customizable lockout features.<br />
The unique dry chemistry reagent plat<strong>for</strong>m<br />
is incorporated into barcoded assay cards <strong>the</strong><br />
size of a driver’s license. Analytes will include<br />
routine PT, aPTT, celite, ACT, plus low-range<br />
ACT, heparin management (heparin and<br />
protamine response), ENOX (enoxaparin),<br />
fibrinogen-LR, and direct thrombin manage-<br />
ment <strong>for</strong> monitoring bivalirudin, dabigatran,<br />
and DTIs. *For research use only.<br />
Helena Laboratories<br />
www.helena.com<br />
Booth No. 1006<br />
Protein-Free Assay Diluent*<br />
Introducing <strong>the</strong> newest member of Sur-<br />
Modics’ family of exceptional immunoassay<br />
products. This protein-free diluent is a<br />
proprietary buffer <strong>for</strong>mulation that reduces<br />
matrix interference in samples, including<br />
heterophillic antibodies such as HAMA (human<br />
anti-mouse antibody) and RF (rheumatoid<br />
factor). The protein-free <strong>for</strong>mulation removes<br />
any possible risk of BSA-related <strong>issue</strong>s<br />
in sample quantitation. You can improve <strong>the</strong><br />
true value of your sample results by simultaneously<br />
diluting false-positive samples and<br />
your standard curve with SurModics’ assay<br />
diluent. More accurate results mean better<br />
patient outcomes. This reagent per<strong>for</strong>ms as<br />
an excellent diluent <strong>for</strong> samples, standard<br />
curves, and/or antibodies. *Available <strong>for</strong> sale<br />
outside <strong>the</strong> U.S.<br />
SurModics<br />
www.surmodicsIVD.com<br />
Booth No. 1302<br />
AVE-76 Series urine-Formed<br />
Element Analyzer*<br />
AVE Science & Technology has taken <strong>the</strong> lead<br />
in implementing machine vision technology<br />
into microscopic morphology examination<br />
and has successfully developed <strong>the</strong> AVE-76<br />
Series Urine Formed Element Analyzer. The<br />
AVE-76 Series Analyzer is fully automated<br />
and fulfills <strong>the</strong> standardized quantitation<br />
and morphological analysis of all urine<strong>for</strong>med<br />
elements. With advanced target<br />
locating and tracking technology, threshold<br />
sample concentrations of 3–5 cells/µL can be<br />
detected without centrifuging or staining. As<br />
a result of <strong>the</strong> fast screening and recognition<br />
technology, <strong>the</strong> throughput is up to 200 tests/<br />
hour. Positive samples only need verification,<br />
and <strong>the</strong>re is no re-examination needed. The<br />
analyzer’s identification accuracy is more<br />
than 95%. *Available <strong>for</strong> sale outside <strong>the</strong> U.S.<br />
AVE SCIENCE & TECHNOLOGY<br />
INDUSTRY CO., LTD.<br />
www.c-ave.com<br />
Booth No. 311<br />
Phadia® 2500<br />
The world leader of in vitro diagnostics of<br />
allergy and autoimmune-related diseases<br />
introduces <strong>the</strong> Phadia 2500 instrument. This<br />
instrument is designed <strong>for</strong> cost-conscious,<br />
high-volume laboratories, and it offers<br />
efficiency and flexibility to meet a broad<br />
range of immunoassay testing needs. Phadia<br />
Laboratory Systems are optimized <strong>for</strong> <strong>the</strong><br />
ImmunoCAP® Specific IgE blood test and<br />
EliA® autoimmune assays. Contact us today<br />
at (800) 346-4364.<br />
Phadia US Inc.<br />
www.phadia.us<br />
Booth No. 2523<br />
Phadia® 5000<br />
The world leader of in vitro diagnostics of<br />
allergy and autoimmune-related diseases<br />
introduces <strong>the</strong> Phadia 5000 instrument. This<br />
instrument is designed <strong>for</strong> cost-conscious,<br />
high-volume laboratories, and it offers<br />
efficiency and flexibility to meet a broad<br />
range of immunoassay testing needs. Phadia<br />
Laboratory Systems are optimized <strong>for</strong> <strong>the</strong><br />
ImmunoCAP® Specific IgE blood test and<br />
EliA® autoimmune assays. Contact us today<br />
at (800) 346-4364.<br />
Phadia US Inc.<br />
www.phadia.us<br />
Booth No. 2523<br />
Alere PBP2a MRSA Test<br />
The Alere PBP2a is a rapid, lateral-flow assay<br />
that detects <strong>the</strong> PBP2a protein found in<br />
methicillin-resistant Staphylococcus aureus<br />
(MRSA) directly from isolates. It is a costeffective,<br />
targeted approach to identifying<br />
MRSA. The Alere PBP2a test provides results<br />
in 5 minutes, uses samples from cultures,<br />
including wounds, skin, and urine and has<br />
built-in quality controls on every test strip.<br />
Alere, Inc.<br />
www.alere.com<br />
Booth No. 1931<br />
Horizon Lab Analytics<br />
McKesson’s Horizon Lab Analytics solution<br />
provides essential management-decision support<br />
tools and scorecards to quickly measure<br />
a laboratory’s per<strong>for</strong>mance. This unique application<br />
integrates clinical and operational<br />
data into visual intuitive displays to monitor<br />
laboratory initiatives, optimize per<strong>for</strong>mance,<br />
and enhance regulatory compliance. This<br />
graphical tool produces meaningful in<strong>for</strong>mation,<br />
empowering <strong>the</strong> organization to measure,<br />
manage, and improve care. It monitors<br />
<strong>the</strong> per<strong>for</strong>mance of laboratory operations<br />
and provides alerts so managers can quickly<br />
address <strong>issue</strong>s. It also measures key safety<br />
and operational metrics with standard outof-<strong>the</strong>-box<br />
content. McKesson has been
2 0 11 N E w P r o d U c T s r E v I E w special section<br />
Advertisement<br />
providing laboratory in<strong>for</strong>mation systems<br />
<strong>for</strong> more than 30 years.<br />
McKesson Provider Technologies<br />
www.mckesson.com/laboratory<br />
Booth No. 1014<br />
NextSlide Review*<br />
NextSlide Imaging has created an integrated,<br />
digital-imaging toolset <strong>for</strong> laboratory microscopy.<br />
NSI Review is a digital workflow<br />
solution used to examine and review smear<br />
slides of blood, body fluids, and cultures. The<br />
system makes and uses full-resolution images<br />
of <strong>the</strong> <strong>entire</strong> reviewed portion of every<br />
slide. Applications in hematology include:<br />
WBC diff count; Kleihauer-Betke; LAP; and<br />
reticulocyte counts. Automation tailored <strong>for</strong><br />
each application includes cell location and<br />
classification. NSI Review reduces <strong>the</strong> cost<br />
of smear review, while delivering improved<br />
quality control and remote review capability.<br />
The system integrates a 100x slide scanner, a<br />
hosted data center, and a web-based review<br />
workflow. *Pending FDA clearance.<br />
NextSlide Imaging, LLC<br />
www.nextslideimaging.com<br />
Booth No. 4438<br />
ARk Methotrexate Assay*<br />
ARK Diagnostics, Inc., <strong>the</strong> leader in <strong>the</strong><br />
next-generation of TDM assays, introduces<br />
<strong>the</strong> new ARK Methotrexate Assay, a homogeneous,<br />
enzyme immunoassay to measure<br />
methotrexate in serum or plasma. Compatible<br />
with a variety of automated clinical<br />
chemistry analyzers, ARK’s liquid-stable,<br />
ready-to-use <strong>for</strong>mulation delivers an assay<br />
with a limit of detection below 0.05 µmol/L.<br />
Specificity in <strong>the</strong> presence of 7-hydroxymethotrexate<br />
is excellent. The calibration<br />
range extends from 0–1.20 µmol/L and high<br />
concentrations may be tested after dilution<br />
with a provided buffer. Calibration-range and<br />
high-range controls are available. Methotrexate<br />
is <strong>the</strong> latest member in ARK’s family of<br />
assays <strong>for</strong> <strong>the</strong>rapeutic drug management.<br />
*Pending FDA clearance.<br />
ARK Diagnostics, Inc.<br />
www.ark-tdm.com<br />
Booth No. 3753<br />
ARk AntiAED Assays<br />
ARK Diagnostics, Inc., <strong>the</strong> leader in nextgeneration<br />
TDM assays, is pleased to release<br />
a menu of assays <strong>for</strong> newer generation<br />
antiepileptic drugs (AEDs). ARK is <strong>the</strong> sole<br />
provider of FDA-cleared, homogeneous, enzyme<br />
immunoassays to measure levetiracetam<br />
(Keppra®) or gabapentin (Neurontin®)<br />
in serum or plasma. Assays <strong>for</strong> lamotrigine<br />
(Lamictal®), topiramate (Topamax®) and<br />
zonisamide (Zonegran®) are also available.<br />
ARK produces high-quality, liquid-stable,<br />
Technical modifications reserved<br />
ready-to-use assays that deliver precise results<br />
on a variety of automated clinical chemistry<br />
analyzers. With excellent specificity and<br />
reportable ranges, <strong>the</strong>se assays offer rapid<br />
turn-around times to meet <strong>the</strong> needs of<br />
patients and physicians.<br />
ARK Diagnostics, Inc.<br />
www.ark-tdm.com<br />
Booth No. 3753<br />
BioPlex® 2200 APLS IgG, IgM, and IgA kits*<br />
The BioPlex 2200 Antiphospholipid Syndrome<br />
(APLS) IgG, IgM, and IgA kits are<br />
<strong>the</strong> first and only fully-automated, randomaccess<br />
multiplex flow immunoassays <strong>for</strong> <strong>the</strong><br />
semi-quantitative detection of IgG, IgM,<br />
and IgA antibodies to cardiolipin (CL) and<br />
beta-2 glycoprotein I (β2GPI). Combined<br />
with clinical findings, <strong>the</strong>se kits aid in <strong>the</strong><br />
diagnosis of antiphospholipid syndrome<br />
(APS). These kits consolidate six traditional<br />
single-analyte tests into one disease-state<br />
panel. From a patient serum or plasma<br />
sample as small as 5 µL, workflow efficiency<br />
is enhanced with throughput up to 200<br />
tests/hour. These kits also offer results in<br />
45 minutes. The BioPlex 2200 APLS IgG,<br />
IgM, and IgA kits join an expanding menu<br />
Needleless or Vacuum?<br />
Your choice of urine collection systems<br />
V-Monovette Urine ®<br />
Urine Monovette ®<br />
The Urine Monovette ® uses <strong>the</strong> classical aspiration<br />
principle to collect from any cup. The suction tip is<br />
placed into a urine sample and <strong>the</strong> piston withdrawn<br />
and removed. Alternatively, a Luer-lock option can<br />
be attached to needleless sampling ports of<br />
drainage systems.<br />
• Needleless<br />
The V-Monovette ® Urine uses vacuum pressure<br />
<strong>for</strong> closed urine collection from corresponding<br />
cups and containers.<br />
• Enclosed system <strong>for</strong> enhanced hygiene<br />
• Convenient handling <strong>for</strong> patients and users<br />
• Options with boric acid stabilizer<br />
• Urine cup and container with integrated<br />
sampling port<br />
• A transfer device <strong>for</strong> urine sampling from<br />
open containers<br />
• Hygienic screw cap<br />
• Vessel <strong>for</strong> test strips<br />
see us at <strong>the</strong> 2011 clin lab expo, booth no. 3218<br />
• Centrifuge tube <strong>for</strong> sedimentation<br />
• Options with boric acid stabilizer<br />
800-257-5101 . sarstedt@bellsouth.net . www.sarstedt.com<br />
CliniCal laboratory news July 2011 27
special section<br />
Advertisement<br />
of autoimmune and infectious disease tests<br />
on <strong>the</strong> BioPlex 2200 system. *Pending FDA<br />
clearance. Available <strong>for</strong> sale outside <strong>the</strong> U.S.<br />
Bio-Rad Laboratories, Inc.<br />
www.bio-rad.com<br />
Booth No. 1631<br />
BioPlex® 2200 Anti-CCP Assay<br />
The BioPlex 2200 Anti-CCP assay is a multiplex,<br />
flow immunoassay intended <strong>for</strong> semiquantitative<br />
detection of IgG antibodies to<br />
cyclic citrullinated peptide (CCP) in human<br />
serum or plasma (EDTA and sodium heparin).<br />
Detection of CCP antibodies is used as<br />
an aid in diagnosis of rheumatoid arthritis<br />
and should be used in conjunction with<br />
o<strong>the</strong>r clinical findings and laboratory<br />
results.<br />
Bio-Rad Laboratories, Inc.<br />
www.bio-rad.com<br />
Booth No. 1631<br />
StatProfile® pHOx®—Critical Care Analyzer*<br />
Nova introduces a new family of pHOx<br />
blood gas/critical care analyzers featuring <strong>the</strong><br />
largest selection of critical care tests including<br />
pH, PCO2, PO2, Na, K, Cl, iCa, iMg,<br />
glucose, BUN, creatinine, lactate, hematocrit,<br />
hemoglobin, SO2%, and co-oximetry.<br />
StatProfile pHOx design features include:<br />
robust connectivity and on-board data<br />
management system; bright, color touchscreen<br />
user interface; simplified operation;<br />
snap-in reagent cartridges; auto-calibration;<br />
fully automated quality control; and test<br />
results in 45 seconds. The combination of <strong>the</strong><br />
pHOx long-life sensors and cartridge-based<br />
technology provides <strong>the</strong> most cost-effective<br />
way <strong>for</strong> hospitals to provide blood gas/critical<br />
care testing. *Pending FDA clearance.<br />
Available <strong>for</strong> sale outside <strong>the</strong> U.S.<br />
Nova Biomedical<br />
www.novabiomedical.com<br />
Booth No. 2923<br />
illumigene® Group B<br />
Streptococcus (GBS) Assay*<br />
Meridian Bioscience announces <strong>the</strong> illumigene<br />
Group B Streptococcus (GBS) assay.<br />
This is <strong>the</strong> latest offering from illumigene’s<br />
molecular portfolio. The assay uses <strong>the</strong><br />
power of LAMP (loop-mediated iso<strong>the</strong>rmal<br />
amplification) technology and runs on <strong>the</strong><br />
28 CliniCal laboratory news July 2011<br />
2 0 11 N E w P r o d U c T s r E v I E w<br />
compact illumipro-10 instrument, allowing<br />
flexible operation of 1–10 samples/<br />
run. Running from an enriched sample, in<br />
accordance with CDC guidelines, illumigene<br />
GBS provides highly accurate results in
2 0 11 N E w P r o d U c T s r E v I E w special section<br />
Advertisement<br />
Exchanges may also occur on <strong>the</strong> fly. The<br />
cobas c 702 module is a member of <strong>the</strong><br />
cobas 8000 modular analyzer series and may<br />
be combined with mid-volume chemistry<br />
(cobas c 502 module) and immunoassay<br />
(cobas e 602 module) modules to create an<br />
integrated plat<strong>for</strong>m with 24 unique system<br />
configurations that meets <strong>the</strong> individual<br />
needs of high-volume laboratories.<br />
Roche Diagnostics<br />
www.mylabonline.com<br />
Booth No. 2205<br />
cobas® e 602 Module<br />
The cobas e 602 module is an immunoassay<br />
module offering up to 170 tests/hour/module<br />
and an initial menu of more than 50<br />
assays. This module uses Roche’s patented<br />
electrochemiluminescence (ECL) technology,<br />
which offers broad measuring ranges and<br />
low-end sensitivity (HCG+β: 0.10– 10,000<br />
mIU/mL). The cobas e 602 module is a<br />
member of <strong>the</strong> cobas 8000 modular analyzer<br />
series and may be combined with two clinical<br />
chemistry modules to create an integrated<br />
plat<strong>for</strong>m with 24 unique system configurations<br />
to meet individual needs of high-volume<br />
laboratories. Combine <strong>the</strong> cobas 3 602<br />
module with mid-volume chemistry (cobas<br />
c 502 module) and immunoassay (cobas e<br />
602 module) modules to create an integrated<br />
plat<strong>for</strong>m with 24 unique system configurations<br />
that meets <strong>the</strong> individual needs of<br />
high-volume laboratories.<br />
Roche Diagnostics<br />
www.mylabonline.com<br />
Booth No. 2205<br />
9-Minute STAT Cardiac Assays<br />
9-Minute STAT assays <strong>for</strong> troponin T,<br />
troponin I, NT-proBNP, CK-MB, and<br />
myoglobin from Roche Diagnostics provide<br />
significant turnaround-time improvement<br />
on <strong>the</strong> cobas® 8000 modular analyzer series.<br />
On average, <strong>the</strong>se STAT assays can produce<br />
<strong>the</strong> same critical results in half <strong>the</strong> time with<br />
only one, simple blood draw obtained via <strong>the</strong><br />
sophisticated Roche OneTUBE® solution—a<br />
faster, more efficient way to deliver accurate<br />
results without sacrificing per<strong>for</strong>mance, precision,<br />
or sensitivity. Laboratories can run a<br />
comprehensive battery of cardiac STAT tests<br />
to provide accurate results faster than current<br />
testing methods.<br />
Roche Diagnostics<br />
www.mylabonline.com<br />
Booth No. 2205<br />
Elecsys Anti-HAV Total Assay<br />
The Roche Elecsys Anti-HAV Total Assay is<br />
an electrochemiluminescence (ECL) immunoassay<br />
<strong>for</strong> in vitro qualitative detection of<br />
total antibodies (IgM and IgG) to hepatitis A<br />
virus in human serum and plasma. The<br />
assay is intended as an aid in <strong>the</strong> laboratory<br />
diagnosis of past or acute/recent hepatitis A<br />
infection. The Roche Anti-HAV Total assay<br />
runs on <strong>the</strong> Elecsys 2010 system, MODU-<br />
LAR ANALYTICS E170 module, cobas e 601<br />
analyzer, cobas e 602 analyzer, and cobas e<br />
411 analyzer.<br />
Roche Diagnostics<br />
www.mylabonline.com<br />
Booth No. 2205<br />
Elecsys Thyroglobulin (Tg) Assay*<br />
The Roche Elecsys Tg Assay is an electrochemiluminescence<br />
(ECL) immunoassay <strong>for</strong><br />
quantitative determination of thyroglobulin<br />
in human serum and plasma. Tg levels aid<br />
in monitoring <strong>for</strong> <strong>the</strong> presence of local and<br />
metastatic thyroid t<strong>issue</strong> in patients who<br />
have had thyroid ablation, ei<strong>the</strong>r with or<br />
without ablative radioiodine <strong>the</strong>rapy. The<br />
Roche Tg assay runs on <strong>the</strong> Elecsys 2010<br />
system, MODULAR ANALYTICS E170<br />
module, cobas e 601 analyzer, cobas e 602<br />
analyzer, and cobas e 411 analyzer. *Pending<br />
FDA clearance. Available <strong>for</strong> sale outside <strong>the</strong><br />
U.S.<br />
Roche Diagnostics<br />
www.mylabonline.com<br />
Booth No. 2205<br />
Elecsys Human Growth Hormone (hGH) Assay<br />
The Roche Elecsys Human Growth Hormone<br />
Assay is an electrochemiluminescence<br />
(ECL) immunoassay <strong>for</strong> quantitative determination<br />
of <strong>the</strong> biologically active 20-kDa<br />
and 22-kDa iso<strong>for</strong>ms of human growth<br />
hormone in serum and plasma. The onestep,<br />
sandwich assay takes only 18 minutes<br />
and demonstrates excellent total precision of<br />
1.7–2.5 CV% <strong>for</strong> <strong>the</strong> MODULAR ANALYT-<br />
ICS E170 module, cobas e 601 analyzer, and<br />
cobas e 602 analyzer. The high precision and<br />
reliability of <strong>the</strong> assay provide a solid base <strong>for</strong><br />
a growth hormone assessment. The Roche<br />
Human Growth Hormone assay is available<br />
<strong>for</strong> all Roche immunoassay systems.<br />
Roche Diagnostics<br />
www.mylabonline.com<br />
Booth No. 2205<br />
Middleware Solutions—Moving Averages<br />
Roche Middleware Solutions offers Moving<br />
Averages, software that monitors <strong>the</strong> per<strong>for</strong>mance<br />
of assays and analyzers in between<br />
QC runs. The laboratory creates automated<br />
protocols within middleware to monitor <strong>the</strong><br />
average of patient results on an assay-byassay<br />
basis and between multiple analyzers. If<br />
<strong>the</strong> average of patient results drifts above or<br />
below pre-defined threshold levels, moving<br />
averages will automatically stop autoverification<br />
and hold test results. The lab will<br />
CliniCal laboratory news July 2011 29
special section<br />
Advertisement<br />
be notified via email or screen pop-up. It<br />
empowers labs to detect potential assay or<br />
instrument degradation in between QC runs<br />
and offers <strong>the</strong> ability to intervene be<strong>for</strong>e<br />
experiencing QC failure.<br />
Roche Diagnostics<br />
www.mylabonline.com<br />
Booth No. 2205<br />
RIDASCREEN® Calprotectin Test<br />
The RIDASCREEN Calprotectin test is a new<br />
ELISA <strong>for</strong> quantitative measurement of fecal<br />
calprotectin with a one-point calibration<br />
<strong>for</strong> evaluation. RIDASCREEN Calprotectin<br />
shows highly distinctive and reliable quantification<br />
of calprotectin in stool samples within<br />
<strong>the</strong> <strong>entire</strong> measuring range. By using onepoint<br />
calibration, RIDASCREEN Calprotectin<br />
significantly increases <strong>the</strong> throughput of<br />
samples/microtiter plate. Measuring of fecal<br />
calprotectin provides reliable differentiation<br />
between chronic inflammatory bowel<br />
disease and irritable bowel syndrome.<br />
Fur<strong>the</strong>rmore, it is used <strong>for</strong> early detection of<br />
relapses and monitoring response to treatment<br />
of irritable bowel syndrome.<br />
R-Biopharm<br />
www.r-biopharm.com<br />
Booth No. 2850<br />
Histamine Release Assay*<br />
The Histamine Release Assay is an in vitro<br />
cellular allergy diagnostic test that detects<br />
allergen-induced histamine release from basophil<br />
leukocytes using a glass-fiber method.<br />
The released histamine is bound selectively<br />
and permanently to <strong>the</strong> glass-fiber matrix<br />
in a microwell plate and can be measured<br />
within weeks. The Histamine Release assay<br />
primarily detects type I allergies against<br />
foods, drugs, and insect venoms. It can also<br />
be used <strong>for</strong> occupational, environmental,<br />
and inhalant allergens. About 90 allergens are<br />
available. Measurement requires a dedicated<br />
fluorescence reader, <strong>the</strong> Histareader 501.<br />
*Available <strong>for</strong> sale outside <strong>the</strong> U.S.<br />
R-Biopharm<br />
www.r-biopharm.com<br />
Booth No. 2850<br />
The RIDASCREEN Norovirus<br />
3 rd Generation Test<br />
The RIDASCREEN® Norovirus 3 rd Generation<br />
enzyme immunoassay (EIA) is <strong>the</strong> first<br />
30 CliniCal laboratory news July 2011<br />
2 0 11 N E w P r o d U c T s r E v I E w<br />
FDA-cleared test <strong>for</strong> in vitro diagnosis of<br />
norovirus infections. The RIDASCREEN<br />
Norovirus 3 rd Generation EIA test is a qualitative<br />
EIA intended <strong>for</strong> detecting selected<br />
genogroup I and genogroup II norovirus<br />
strains in human feces as an aid in investigating<br />
<strong>the</strong> cause of acute gastroenteritis outbreaks.<br />
The assay is a solid phase sandwichtype<br />
EIA that uses a mixture of genogroup<br />
I and genogroup II norovirus-specific<br />
monoclonal antibodies. The RIDASCREEN<br />
Norovirus 3 rd Generation EIA facilitates <strong>the</strong><br />
possible diagnosis of norovirus outbreaks<br />
in less than 2 hours, <strong>the</strong>reby enabling faster<br />
implementation of outbreak control<br />
procedures.<br />
R-Biopharm<br />
www.r-biopharm.com<br />
Booth No. 2850<br />
Hypoxic/Hyperbaric QC:<br />
pO2 AMR Validation Controls<br />
Hypoxic QC is <strong>the</strong> first pre-tonometered<br />
product of its kind to validate extra-low<br />
(15 mm Hg) pO2 values on any blood gas<br />
analyzer in <strong>the</strong> lab or at <strong>the</strong> point-of-care.<br />
Hyperbaric QC is designed to validate <strong>the</strong><br />
high pO2 range (710 mm Hg). Toge<strong>the</strong>r, <strong>the</strong>se<br />
two products validate <strong>the</strong> full pO2 analytical<br />
measurement range of blood gas analyzers.<br />
Hypoxic QC features active hemoglobin buffering<br />
with 10-minute, open-ampule stability,<br />
making it well-suited <strong>for</strong> method comparisons.<br />
Hyperbaric QC is an aqueous <strong>for</strong>mulation<br />
that validates ultra-high recovered values,<br />
making it ideal <strong>for</strong> cardiac ca<strong>the</strong>terization labs<br />
or operating room suites.<br />
Eurotrol, Inc.<br />
www.eurotrol.com<br />
Booth No. 2835<br />
GlucoTrol-WB Real Blood Glucose Control<br />
GlucoTrol-WB real blood glucose control is<br />
a new product packaged with ACU-CAP, a<br />
device that enables separation of red blood<br />
cells from <strong>the</strong> plasma fraction containing<br />
glucose, <strong>the</strong>reby eliminating glycolysis.<br />
GlucoTrol-WB is highly commutable and<br />
compatible with all point-of-care glucose<br />
devices with minimal matrix effects. All levels<br />
of GlucoTrol-WB per<strong>for</strong>mance yield very<br />
low imprecision and are very comparable<br />
with <strong>the</strong> imprecision of human whole blood.<br />
ACU-CAP also eliminates <strong>the</strong> need <strong>for</strong> pipetting.<br />
GlucoTrol-WB can be used as a QC <strong>for</strong><br />
method comparisons or validations and <strong>for</strong><br />
proficiency testing.<br />
Eurotrol, Inc.<br />
www.eurotrol.com<br />
Booth No. 2835<br />
Reagent Line <strong>for</strong><br />
Olympus 400/640 Analyzers*<br />
Escalon <strong>Clinical</strong> Diagnostics and JAS<br />
Diagnostics are pleased to offer laborato-<br />
ries a reagent line of general and specialty<br />
reagents designed <strong>for</strong> <strong>the</strong> Olympus AU400<br />
and AU640 series chemistry analyzers.<br />
Thisreagent line is supplied in barcoded<br />
Olympus reagent containers <strong>for</strong> easy<br />
customer use. Additionally, <strong>the</strong>se reagents<br />
provide quality per<strong>for</strong>mance in terms of<br />
results and stabilities, along with significant<br />
cost savings <strong>for</strong> <strong>the</strong> laboratory. Dedicated<br />
technical and customer service is available,<br />
including on-site conversion and validation<br />
programs. *Pending FDA clearance. Available<br />
<strong>for</strong> sale outside <strong>the</strong> U.S.<br />
Escalon <strong>Clinical</strong> Diagnostics/<br />
JAS Diagnostics<br />
www.escalonclinical.com<br />
Booth No. 753<br />
DS360 HbA1c Analyzer*<br />
Escalon <strong>Clinical</strong> Diagnostics and Drew<br />
Scientific Inc. introduce <strong>the</strong> latest in a long<br />
legacy of hemoglobin analysis systems offered<br />
by Drew Scientific: <strong>the</strong> DS360 HbA1c<br />
Analyzer. The DS360 HbA1c Analyzer uses<br />
ion-exchange HPLC to accurately determine<br />
HbA1c in minutes and is NGSP-certified<br />
and traceable to <strong>the</strong> IFCC reference method.<br />
The system provides automated testing with<br />
on-board patient demographic database,<br />
sample run management, and complete QC<br />
capabilities. The DS360 HbA1c Analyzer is<br />
fully compatible with laboratory in<strong>for</strong>mation<br />
systems and provides a touch-screen interface<br />
with multiple language capabilities. The<br />
DS360 HbA1c Analyzer has been introduced<br />
recently in Europe. *Pending FDA clearance.<br />
Available <strong>for</strong> sale outside <strong>the</strong> U.S.<br />
Escalon <strong>Clinical</strong> Diagnostics/<br />
Drew Scientific Inc.<br />
www.escalonclinical.com<br />
Booth No. 753<br />
Acetylcholine Receptor<br />
Blocking Antibody kit*<br />
The Acetylcholine Receptor Blocking<br />
Antibody Kit is a radioimmunoassay <strong>for</strong> in<br />
vitro determination of acetylcholine receptor<br />
blocking antibody levels in serum. We offer<br />
30- and 120-test kits at prices competitive<br />
with 25- and 100-test kits. The assay procedure<br />
involves allowing blocking antibodies<br />
from samples to complex with acetylcholine<br />
receptors. Then <strong>the</strong> antibody-receptor<br />
complexes are allowed to complex with<br />
125 I-labeled bungarotoxin. The complexes<br />
are <strong>the</strong>n precipitated, washed, counted, and<br />
determined. There are two 1-hour and one<br />
2-hour incubations <strong>for</strong> <strong>the</strong> procedure. *For<br />
research use only. Available <strong>for</strong> sale outside<br />
<strong>the</strong> U.S.<br />
IVD Technologies<br />
www.ivdtechnologies.com<br />
Booth No. 201<br />
Acetylcholine Receptor<br />
Binding Antibody kit*<br />
The Acetylcholine Receptor Binding Antibody<br />
Kit is a radioimmunoassay <strong>for</strong> in vitro<br />
diagnostic determination of acetylcholine receptor<br />
binding antibody levels in serum. We<br />
offer 30- and 120-test kits at prices competitive<br />
with 25- and 100-test kits. The assay<br />
procedure involves allowing acetylcholine<br />
receptor binding antibodies from samples<br />
to complex with 125 I-labeled acetylcholine<br />
receptors. Then <strong>the</strong> complexes are precipitated,<br />
washed, counted, and determined.<br />
The procedure involves 30- and 120-minute<br />
incubation times. The kit features an assay<br />
range of 0.2–7.5 nmol/L, a detection limit of<br />
0.058 nmol/L, a cutoff of 0.25 nmol/L, clinical<br />
sensitivity of 100%, and clinical specificity<br />
of 97%. *Available <strong>for</strong> sale outside <strong>the</strong> U.S.<br />
IVD Technologies<br />
www.ivdtechnologies.com<br />
Booth No. 201<br />
Direct Free T4 Coated Beads<br />
Equilibrium Dialysis kit*<br />
The Direct Free T4 Coated Beads Equilibrium<br />
Dialysis Kit is a highly sensitive and<br />
specific radioimmunoassay <strong>for</strong> <strong>the</strong> in vitro<br />
direct measurement of free T4 in serum. The<br />
assay procedure involves dialyzing samples<br />
overnight and running a radioimmunoassay<br />
<strong>for</strong> free T4 using coated beads on <strong>the</strong><br />
dialysates. The 100-test kit comes with 80<br />
disposable cells (QD-CellTM) <strong>for</strong> dialysis,<br />
making dialysis of samples easier and more<br />
convenient. The radioimmunoassay uses<br />
coated beads that make measurement of free<br />
T4 by equilibrium dialysis easier and less<br />
labor-demanding. *For research use only.<br />
Available <strong>for</strong> sale outside <strong>the</strong> U.S.<br />
IVD Technologies<br />
www.ivdtechnologies.com<br />
Booth No. 201<br />
Cell-Chex Control<br />
Cell-Chex is a spinal and body fluid control<br />
with distinct white (WBC) and red blood cell<br />
(RBC) populations <strong>for</strong> manual counts. When<br />
stained in <strong>the</strong> same manner as a patient<br />
sample, <strong>the</strong> WBCx can be differentiated. The<br />
two-level control is assayed <strong>for</strong> total RBC and<br />
WBC counts, a five-part WBC differential,
2 0 11 N E w P r o d U c T s r E v I E w special section<br />
Advertisement<br />
as well as a two-part polymorph nuclear<br />
and mononuclear differential. Level 1 now<br />
contains crystals to help assess lab technicians’<br />
skills in identifying accurate crystals in<br />
synovial fluid samples.<br />
Streck, Inc.<br />
www.streck.com<br />
Booth No. 1517<br />
uA-Cellular® <strong>for</strong> IQ Control<br />
UA-Cellular <strong>for</strong> IQ is Streck’s micro urinalysis<br />
control designed specifically <strong>for</strong> <strong>the</strong> Iris<br />
Diagnostics iQ® automated urine analyzers.<br />
UA-Cellular <strong>for</strong> IQ contains components<br />
at two clinically significant levels, providing<br />
thorough evaluation of <strong>the</strong> iQ instrument’s<br />
ability to both identify and quantify white<br />
blood cells, red blood cells, non-squamous<br />
epi<strong>the</strong>lial cells, and crystals. The product is<br />
contained in convenient 120-mL squeeze<br />
bottles with a flip-top cap dispenser that accurately<br />
allots <strong>the</strong> amount of control needed<br />
into sample tubes without waste. UA-Cellular<br />
<strong>for</strong> IQ has an open-vial stability of 30 days<br />
and a closed-vial stability of 105 days.<br />
Streck, Inc.<br />
www.streck.com<br />
Booth No. 1517<br />
uA-Cellular® <strong>for</strong> uF Control<br />
UA-Cellular <strong>for</strong> UF is Streck’s micro urinalysis<br />
control designed specifically <strong>for</strong> <strong>the</strong><br />
Sysmex® UF urine analyzers. UA-Cellular<br />
<strong>for</strong> UF contains cellular components at two<br />
clinically significant levels, providing thorough<br />
evaluation of <strong>the</strong> Sysmex UF analyzers’<br />
ability to qualify and quantify white blood<br />
cells, red blood cells, epi<strong>the</strong>lial cells, crystals,<br />
casts, and bacteria. The product is contained<br />
in convenient 60-mL squeeze bottles with<br />
a flip-top dispenser that accurately allots<br />
control material into sample tubes without<br />
waste. UA-Cellular <strong>for</strong> UF has an open-vial<br />
stability of 30 days and a closed-vial stability<br />
of 105 days.<br />
Streck, Inc.<br />
www.streck.com<br />
Booth No. 1517<br />
Cell-Free DNA BCT Control*<br />
Cell-Free DNA BCT is Streck’s 10-mL blood<br />
collection tube <strong>for</strong> preserving and stabilizing<br />
cell-free plasma DNA. The patented preservative<br />
in Cell-Free DNA BCT stabilizes white<br />
blood cells, preventing <strong>the</strong> release of genomic<br />
DNA during sample processing and storage<br />
and reducing post-sampling DNA background.<br />
Samples collected in Cell-Free DNA<br />
BCT are stable <strong>for</strong> up to 14 days at room<br />
temperature, allowing convenient sample<br />
HO<br />
D 2<br />
Controls<br />
H<br />
CH3<br />
CH3<br />
H<br />
CH2<br />
collection, transport, and storage. Processing<br />
patient samples <strong>for</strong> detection and analysis of<br />
circulating cell-free DNA requires minimal<br />
sample manipulation. Sample handling is<br />
less labor-intensive and time-consuming<br />
than traditional methods of plasma sample<br />
preparation. *For research use only.<br />
Streck, Inc.<br />
www.streck.com<br />
Booth No. 1517<br />
Philisa® Thermal Cycler<br />
The Philisa Thermal Cycler by Streck is an<br />
innovative, high-speed polymerase chain reaction<br />
(PCR) instrument with <strong>the</strong> potential<br />
to improve laboratory efficiency and flexibility.<br />
Industry-leading ramp rates, excellent<br />
<strong>the</strong>rmal control, and thin-walled plastic PCR<br />
CH3<br />
CH3<br />
CH3<br />
ergocalciferol<br />
tubes enable users to per<strong>for</strong>m reliable PCR<br />
in less than 15 minutes. The small footprint,<br />
intuitive Windows-based software, and<br />
access to Streck’s team of technical experts<br />
make <strong>the</strong> Philisa Thermal Cycler an excellent<br />
choice <strong>for</strong> any lab.<br />
Streck, Inc.<br />
www.streck.com<br />
Booth No. 1517<br />
Why UTAK is <strong>the</strong> “Real” Market Leader in Vitamin D Controls<br />
Because we manufacture our Vitamin D controls in 100% REAL human serum<br />
<strong>for</strong> testing 100% REAL humans.<br />
cholecalciferol<br />
UTAK Laboratories, Inc. 25020 Avenue Tibbitts Valencia, CA 91355 Tel: (800) 235-3442 Fax: (661) 294-9272<br />
www.UTAK.com inquiries@UTAK.com<br />
HO<br />
D 3<br />
Controls<br />
CH3<br />
CH3<br />
H<br />
H<br />
100%REAL<br />
Visit VitaminDcontrols.com <strong>for</strong> <strong>the</strong> 100% REAL story.<br />
see us at <strong>the</strong> 2011 clin lab expo, booth no. 1761<br />
H<br />
CH2<br />
CH3<br />
CH3<br />
CliniCal laboratory news July 2011 31
special section<br />
Advertisement<br />
CD-Chex® Plus BC Control<br />
CD-Chex Plus BC is a whole blood assayed<br />
control <strong>for</strong> immunophenotyping on Beckman<br />
Coulter® flow cytometry systems.<br />
CD-Chex Plus BC determines <strong>the</strong> accuracy<br />
and reproducibility of all <strong>the</strong> steps involved<br />
in <strong>the</strong> process of immunophenotyping,<br />
including red blood cell lysis. CD-Chex Plus<br />
BC provides <strong>the</strong> most assayed CD markers<br />
in <strong>the</strong> industry, including T lymphocytes, B<br />
lymphocytes, granulocytes, monocytes, and<br />
NK cells. CD-Chex Plus BC CD4 Low offers<br />
a depressed CD4 absolute number often<br />
indicated in patients with immunodeficiency<br />
diseases. Each level has 30-day open-vial<br />
stability and 90-day closed-vial stability.<br />
CD-Chex Plus BC and CD-Chex Plus BC<br />
CD4 Low are available in plastic vials with<br />
pierceable caps containing 3 mL.<br />
Streck, Inc.<br />
www.streck.com<br />
Booth No. 1517<br />
CD-Chex® Plus Control<br />
CD-Chex Plus is a whole blood assayed control<br />
<strong>for</strong> monitoring immunophenotyping by<br />
flow cytometry. CD-Chex Plus determines<br />
<strong>the</strong> accuracy and reproducibility of all <strong>the</strong><br />
steps involved in <strong>the</strong> process of immunophenotyping,<br />
including red blood cell lysis.<br />
CD-Chex Plus provides <strong>the</strong> most assayed<br />
CD markers in <strong>the</strong> industry, including T<br />
lymphocytes, B lymphocytes, granulocytes,<br />
monocytes, and NK cells. CD-Chex Plus<br />
is assayed <strong>for</strong> normal levels of CD34+ cells<br />
found in peripheral blood. CD-Chex Plus<br />
CD4 Low offers a depressed CD4 absolute<br />
number often indicated in patients with immunodeficiency<br />
diseases. Compatible with<br />
most popular flow cytometry systems, CD-<br />
Chex Plus and CD-Chex CD4 Low are available<br />
in <strong>the</strong> 2.5-mL and 3-mL cap-pierceable<br />
fill volumes. Both levels have an open-vial<br />
stability of 30 days and a closed-vial stability<br />
of 90 days.<br />
Streck, Inc.<br />
www.streck.com<br />
Booth No. 1517<br />
Cell-Free RNA BCT*<br />
Cell-Free RNA BCT is Streck’s 10-mL blood<br />
collection tube <strong>for</strong> preserving and stabilizing<br />
cell-free RNA in plasma <strong>for</strong> up to 3 days at<br />
32 CliniCal laboratory news July 2011<br />
2 0 11 N E w P r o d U c T s r E v I E w<br />
ambient temperature. The patented preservative<br />
in Cell-Free RNA BCT preserves cellfree<br />
RNA in plasma and prevents <strong>the</strong> release<br />
of cellular RNA during sample processing<br />
and storage, reducing background RNA<br />
level. With Cell-Free RNA BCT, processing<br />
patient samples <strong>for</strong> detection and analysis of<br />
circulating cell-free RNA requires minimal<br />
sample manipulation. Sample handling is<br />
less labor-intensive and time-consuming<br />
than traditional methods of plasma sample<br />
preparation. *For research use only.<br />
Streck, Inc.<br />
www.streck.com<br />
Booth No. 1517<br />
Streck Product Selection Guide<br />
Streck, Inc., introduces a new feature on its<br />
redesigned website, www.streck.com. The<br />
Product Selection Guide is a quick reference<br />
to help customers determine which Streck<br />
products work best with <strong>the</strong>ir instruments.<br />
Customers may search by instrument or<br />
instrument manufacturer to find <strong>the</strong> right<br />
controls and calibrators. The website also<br />
provides access to technical support from an<br />
experienced team of medical technologists<br />
and access to STATS, Streck’s inter-laboratory<br />
quality control program that gives participating<br />
labs monthly computerized reports comparing<br />
<strong>the</strong>ir values with a peer group using<br />
<strong>the</strong> same instrument type and control lot.<br />
Streck, Inc.<br />
www.streck.com<br />
Booth No. 1517<br />
Minivette® POCT Device<br />
The new Minivette POCT device from<br />
Sarstedt is designed <strong>for</strong> precise and hygienic<br />
collection, transfer, and subsequent<br />
dispensing of small capillary blood samples<br />
<strong>for</strong> point-of-care tests. Blood is easily collected<br />
via capillary action into <strong>the</strong> end of <strong>the</strong><br />
Minivette POCT device. The sample is held<br />
securely in <strong>the</strong> capillary without spills during<br />
transfer and <strong>the</strong>n dispensed onto <strong>the</strong> test<br />
field with a slight push of <strong>the</strong> opposing<br />
integral piston. The Minivette POCT device<br />
is available <strong>for</strong> blood volumes of 20 µL and<br />
50 µL, and <strong>the</strong> collection capillary is offered<br />
plain or prepared with EDTA or heparin.<br />
Sarstedt, Inc.<br />
www.sarstedt.com<br />
Booth No. 3218<br />
13 x 75-mm Tubes <strong>for</strong><br />
Automation and Analysis<br />
The new 13 x 75-mm screw cap aliquot tubes<br />
with round bases from Sarstedt are designed<br />
<strong>for</strong> compatibility with common laboratory<br />
automation and analysis plat<strong>for</strong>ms. A full volume<br />
13 x 75-mm tube accommodates 5 mL<br />
of sample, features printed writing block and<br />
graduations, and is available in clear or amber<br />
<strong>for</strong> light sensitive analytes. A 2.5-mL falsebottom<br />
version with an elevated conical base<br />
raises small sample volumes to an optimal<br />
height <strong>for</strong> analysis. The corresponding tall<br />
screw cap <strong>for</strong> improved gripping provides<br />
a leak-resistant closure that meets IATA<br />
requirements <strong>for</strong> transport. Alternatively, a<br />
flanged anti-evaporation push cap may be<br />
used to cover samples or to archive samples.<br />
Sarstedt, Inc.<br />
www.sarstedt.com<br />
Booth No. 3218<br />
PVS 1625 with Screw-Cap Recapper<br />
The Sarstedt PVS 1625 is a comprehensive,<br />
modular, laboratory automation system<br />
<strong>for</strong> pre- and post-analytical processing.<br />
Independent from an analytical plat<strong>for</strong>m, <strong>the</strong><br />
PVS 1625 can be customized according to a<br />
laboratory’s needs with available modules <strong>for</strong><br />
loading, identification, decapping, sorting,<br />
aliquoting, and recapping. A new screw-cap<br />
recapper module is available that places a<br />
screw cap onto Sarstedt aliquot tubes. Aliquots<br />
can be made directly into compatible<br />
screw-cap tubes and immediately recapped<br />
<strong>for</strong> send-outs or capped post-analysis <strong>for</strong><br />
archiving. The PVS 1625 is compatible with<br />
most analyzer racks and common tube types<br />
and dimensions.<br />
Sarstedt, Inc.<br />
www.sarstedt.com<br />
Booth No. 3218<br />
Electrolyte Analyzer with<br />
Ion Selective Electrode<br />
The EX-D is a fully automated electrolyte<br />
analyzer with ion-selective electrode <strong>for</strong><br />
measuring sodium, potassium, and chloride<br />
in whole blood, serum, and diluted urine.<br />
It also offers a solution <strong>for</strong> hemodialysis<br />
applications, allowing acid concentrates and<br />
sodium bicarbonate to be balanced. Twenty<br />
samples can be processed in one run and<br />
results are available within 36 seconds. The<br />
newly developed high-sensitivity electrodes<br />
allow calibration to be per<strong>for</strong>med only once<br />
a day. The electrode produces very accurate<br />
results with a CV of
2 0 11 N E w P r o d U c T s r E v I E w special section<br />
Advertisement<br />
new interactive rules building and testing<br />
tool streamlines rules configuration. A clear<br />
drill down structure gives immediate access<br />
to all essential parameters such as TAT, test<br />
status, and alarms. Thanks to its autoverification<br />
and monitor functionalities, HALIA<br />
allows lab managers to improve per<strong>for</strong>mance<br />
and efficiency, addressing <strong>the</strong> challenging lab<br />
automation environment. *Available <strong>for</strong> sale<br />
outside <strong>the</strong> U.S.<br />
NoemaLife SpA<br />
www.noemalife.com<br />
Booth No. 4008<br />
HemoCue® Glucose 201 RT Analyzer*<br />
HemoCue Glucose 201 RT is <strong>the</strong> newest<br />
addition to <strong>the</strong> HemoCue line of point-ofcare<br />
glucose analyzers. If refrigerated cuvettes<br />
have kept you from using HemoCue® to<br />
measure glucose at <strong>the</strong> point-of-care, <strong>the</strong> new<br />
HemoCue Glucose 201 RT system is <strong>for</strong> you.<br />
HemoCue Glucose 201 RT retains our easy<br />
testing method and <strong>the</strong> lab quality results so<br />
vital in patient care, but it uses room-temperature<br />
cuvettes. *Pending FDA clearance.<br />
Available <strong>for</strong> sale outside <strong>the</strong> U.S.<br />
HemoCue, Inc.<br />
www.hemocue.com<br />
Booth No. 3339<br />
A2o Advanced Automated osmometer<br />
The A2O from Advanced Instruments is a<br />
fully automated, multi-sample osmometer<br />
that incorporates more than 50 years of<br />
applied technology experience in <strong>the</strong> field<br />
of freezing-point osmometry. The A2O<br />
combines a functional design, exceptional<br />
analytical per<strong>for</strong>mance, and an intuitive software<br />
control package that is both powerful<br />
and elegantly simple to operate. Every aspect<br />
of <strong>the</strong> A2O has been intelligently engineered<br />
to fully automate osmolality testing with ease<br />
and simplicity. It is ideally suited <strong>for</strong> today’s<br />
busy laboratories that are being asked to<br />
achieve more results faster but with fewer<br />
resources.<br />
Advanced Instruments, Inc.<br />
www.aicompanies.com/A2O<br />
Booth No. 3422<br />
Dropper A1c - Diabetes Control*<br />
We crafted <strong>the</strong> Dropper A1c Control to make<br />
your laboratory and point-of-care hemoglobin<br />
A1c quality control simple. Six months of<br />
refrigerated, open-vial stability reduces waste,<br />
and our dropper bottles make dispensing<br />
outrageously simple. The liquid, human<br />
blood-based matrix and 21 days of open-vial,<br />
room-temperature stability eliminates storage<br />
problems and provides maximum portability—perfect<br />
<strong>for</strong> sites without refrigeration.<br />
The Dropper A1c Control is designed <strong>for</strong> use<br />
with most major immunoassay and boronate<br />
affinity laboratory and POCT analyzers, including<br />
Siemens DCA 2000/2000+/Vantage<br />
and Dimension, Beckman Coulter Synchron,<br />
Roche Cobas Integra and Hitachi, Ortho-<br />
<strong>Clinical</strong> Vitros, and Primus PDQ/ultra2. The<br />
Dropper A1c Control offers longer stability<br />
and is super convenient. *Pending FDA<br />
clearance. Available <strong>for</strong> sale outside <strong>the</strong> U.S.<br />
Quantimetrix<br />
www.4qc.com<br />
Booth No. 2252<br />
Pluggo RH Decapper System<br />
The Pluggo RH Decapping System <strong>for</strong><br />
ADVIA® Centaur racks is an automated,<br />
bench-top decapper designed to use<br />
instrument-specific, sample-tube racks <strong>for</strong><br />
<strong>the</strong> ADVIA Centaur or ADVIA Centaur XP<br />
System. The small footprint Pluggo RH System<br />
(22” w x 24” d x 14” h) automatically<br />
decaps all standard vacuum collection tubes<br />
at speeds up to 35 tubes/ minute. The Pluggo<br />
RH is designed to protect lab workers from<br />
repetitive motion injuries and from exposure<br />
to biohazardous material. The system<br />
provides walk-away operations with input<br />
capacity of up to 15 racks and output of up<br />
to 15 racks of uncapped tubes.<br />
m-u-t America, Inc.<br />
www.mut-group.com<br />
Booth No. 2451<br />
ReQuest Immunoassay kits*<br />
ReQuest Immunoassay Kits are manufactured<br />
in <strong>the</strong> U.S. and provide outstanding<br />
sensitivity, specificity, accuracy, and precision,<br />
<strong>the</strong>reby meeting <strong>the</strong> productivity needs of a<br />
wide range of laboratories. In today’s highly<br />
competitive environment, ReQuest Immunoassay<br />
Kits assures reliable, user-friendly,<br />
and cost-effective diagnostic test methods<br />
<strong>for</strong> TORCH, autoimmune panels, infectious<br />
disease markers, and more. *Available <strong>for</strong> sale<br />
outside <strong>the</strong> U.S.<br />
Awareness Technology, Inc.<br />
www.awaretech.com<br />
Booth No. 1203<br />
<strong>Clinical</strong> Chemistry Analyzer Global 4500DR*<br />
BPC BioSed srl is very proud to in<strong>for</strong>m all<br />
customers and end-users of <strong>the</strong> new Analyzer<br />
Global 4500DR launch. The main features<br />
meet <strong>the</strong> needs of <strong>the</strong> market, including two<br />
arms and o<strong>the</strong>rs main features on <strong>the</strong> right<br />
side <strong>for</strong> medium-to-high-volume hospital<br />
labs. The new analyzer is <strong>the</strong> latest development<br />
from our company and is based on<br />
recent customer requests. BPC BioSed is<br />
an Italian company founded in 1986 that<br />
produces markets and services automatic<br />
and semi-automatic chemistry analyzers<br />
<strong>for</strong> <strong>the</strong> human, veterinary, water analysis,<br />
oenology, and drugs analysis markets. *In<br />
development.<br />
BPC BioSed srl<br />
www.bpcbiosed.it<br />
Booth No. 3767<br />
FLAIR Microarray Scanner*<br />
FLAIR, Sensovation’s fluorescence array<br />
imaging reader, is a compact and af<strong>for</strong>dable<br />
microarray reader designed <strong>for</strong> routine<br />
applications. It is used <strong>for</strong> multiplexed<br />
diagnostics in clinical research and routine<br />
analyses. FLAIR allows fast measurement of<br />
planar fluorescent microarrays with up to<br />
three colors. Originally designed <strong>for</strong> array-in<br />
well applications, FLAIR accommodates 96well<br />
plates or four conventional slides on <strong>the</strong><br />
four-slide holder. FLAIR is an easy-to-use,<br />
standalone instrument with integrated<br />
processor, including array analysis software<br />
and touchscreen. FLAIR offers <strong>the</strong> full<br />
per<strong>for</strong>mance of a microarray scanner <strong>for</strong><br />
multiplexed diagnostics on an exceptionally<br />
small footprint. *For research use only. Pending<br />
FDA clearance. Available <strong>for</strong> sale outside<br />
<strong>the</strong> U.S.<br />
Sensovation<br />
www.sensovation.com<br />
Booth No. 4206<br />
Vision MINI ultra-Compact Smart Camera*<br />
Microscan’s new Vision MINI ultra-compact,<br />
smart camera is designed <strong>for</strong> reliable vision<br />
CliniCal laboratory news July 2011 33
special section<br />
Advertisement<br />
per<strong>for</strong>mance in embedded identification and<br />
inspection applications. As <strong>the</strong> world’s smallest<br />
fully integrated vision system, <strong>the</strong> Vision<br />
MINI’s small size, autofocus lens, and wide-<br />
angle optics provide <strong>the</strong> best per<strong>for</strong>mance<br />
available <strong>for</strong> vision tasks, such as cap presence/absence,<br />
cap type, and cap color. The<br />
Vision MINI delivers both excellent results<br />
and reliability, along with Microscan System’s<br />
assurance of long-term availability and support.<br />
This is essential <strong>for</strong> OEMs that require<br />
uninterrupted availability throughout <strong>the</strong><br />
life-cycle of <strong>the</strong>ir products, and it enables<br />
<strong>the</strong>m to focus on new development instead<br />
of obsolescence <strong>issue</strong>s. *Available <strong>for</strong> sale<br />
outside <strong>the</strong> U.S.<br />
Microscan Systems Inc.<br />
www.microscan.com<br />
Booth No. 239<br />
DENV Detect IgM Capture ELISA<br />
InBios is pleased to announce <strong>the</strong> first FDAcleared<br />
test manufactured in <strong>the</strong> U.S. <strong>for</strong><br />
diagnosis of dengue infection. The DENV<br />
Detect IgM Capture ELISA is a qualitative<br />
enzyme immunoassay that detects IgM<br />
antibodies to dengue virus in human serum.<br />
This easy-to-use kit contains all <strong>the</strong> readyto-use<br />
reagents and controls. Storage is at<br />
2–8ºC. The sensitivity and specificity was<br />
thoroughly evaluated with clinically confirmed<br />
cases of dengue 1-4 serotypes with<br />
excellent results. This product is CE Marked<br />
and represents <strong>the</strong> latest product offering by<br />
InBios <strong>for</strong> <strong>the</strong> detection of flaviviruses.<br />
InBios International, Inc.<br />
www.inbios.com<br />
Booth No. 4010<br />
ASiManager Digital Agglutination Analyzer<br />
The ASiManager AT is an integrated digital<br />
particle analyzer that objectively interprets<br />
slide agglutination tests manufactured by<br />
Arlington Scientific Inc. Laboratory managers<br />
per<strong>for</strong>m qualitative and semi-quantitative<br />
tests using <strong>the</strong> ASiManager AT to provide<br />
standardized test interpretation using criteria<br />
that define positive- and negative-agglutination<br />
reactions. The ASiManager AT also<br />
delivers an initial predictive titer analysis <strong>for</strong><br />
<strong>the</strong> ASI-RPR Card Test <strong>for</strong> syphilis. It also<br />
provides tools that enable creation, storage,<br />
retrieval, and transmittal of <strong>the</strong> test results.<br />
34 CliniCal laboratory news July 2011<br />
2 0 11 N E w P r o d U c T s r E v I E w<br />
This innovative technology provides a lowcost,<br />
state-of-<strong>the</strong>-art, digitally enhanced,<br />
integrated system <strong>for</strong> objective interpretation<br />
of proven particle agglutination immunoassay<br />
tests.<br />
Arlington Scientific, Inc.<br />
www.arlingtonscientific.com<br />
Booth No. 352<br />
Automated Laboratory Assistant*<br />
The Iris Automated Laboratory Assistant<br />
automates a variety of protocols <strong>for</strong> FISH,<br />
WISH, Western Blot, as well as many o<strong>the</strong>r<br />
slide-based applications that are labor-intensive,<br />
time- consuming, and require multiple<br />
washes and incubation times. The new unit<br />
is a small, highly flexible plat<strong>for</strong>m consisting<br />
of a fluid-exchange system that delivers<br />
reagents sequentially with temperature agitation<br />
and control. It frees lab personnel from<br />
time-consuming, repetitive procedures and<br />
improves data reliability. A flexible user interface<br />
allows labs to store and save multiple<br />
protocols and modifying <strong>the</strong>m as needed. *In<br />
development.<br />
Iris Sample Processing<br />
www.proiris.com<br />
Booth No. 419<br />
Liquichek Specialty Immunoassay Control<br />
Liquichek Specialty Immunoassay Control<br />
is <strong>the</strong> first and only liquid, human serum-<br />
based control with a comprehensive menu<br />
that includes 25-OH vitamin D, iPTH, anti-<br />
TPO, and anti-Tg. The 25-OH vitamin D<br />
insert listing has been expanded to include<br />
all major automated methods, as well as<br />
LC-MS/MS values <strong>for</strong> vitamins D2 and D3.<br />
The control’s long, open-vial stability and<br />
multi-analytes provide convenience and<br />
cost savings to laboratories. When using<br />
Liquichek Specialty Immunoassay Control<br />
with our powerful Unity software, you join<br />
more than 17,000 laboratories worldwide<br />
that already benefit from Unity’s superior<br />
analytical capabilities and <strong>the</strong> most comprehensive<br />
inter-laboratory comparison.<br />
Bio-Rad Laboratories<br />
www.bio-rad.com<br />
Booth No. 1631<br />
unity Alert QC Software*<br />
Unity Alert is a new add-on module <strong>for</strong><br />
Unity Real Time®, an expert QC data<br />
management solution from Bio-Rad. The<br />
software module continuously monitors QC<br />
status and alerts laboratories if QC data is<br />
missing or rejected against statistical process<br />
control rules such as <strong>the</strong> Westgard rules. Alert<br />
notifications can be provided by email or<br />
visually through taskbar icons. Unity Alert<br />
runs in <strong>the</strong> background as a service and operates<br />
even when Unity Real Time is closed.<br />
*Available <strong>for</strong> sale outside <strong>the</strong> U.S.<br />
Bio-Rad Laboratories<br />
www.bio-rad.com<br />
Booth No. 1631<br />
Hicera Series<br />
Iwaki’s new precision dosing pumps are<br />
designed to accurately dispense critical fluids.<br />
The Hicera Series provides 0.1% repeatable<br />
per<strong>for</strong>mance <strong>for</strong> volumes as low as microliters/<br />
sample. Much smaller than traditional<br />
syringe pump designs, Iwaki piston metering<br />
pumps eliminate <strong>the</strong> need <strong>for</strong> re-calibration<br />
while providing more than 40,000 hours<br />
of no-touch, maintenance-free service life.<br />
The APN Series is built to handle <strong>the</strong> most<br />
aggressive fluid handling requirements on<br />
analyzers. APN’s molded diaphragm maintains<br />
<strong>the</strong> pump’s accuracy whe<strong>the</strong>r handling<br />
fluids or gas. The solids-handling diaphragm<br />
ensures dependable per<strong>for</strong>mance under adverse<br />
operating conditions. Custom designs<br />
and prototype quantities are available.<br />
Iwaki America Inc.<br />
www.iwakicustompumps.com<br />
Booth No. 2660<br />
mLabs® D-Dimer Test*<br />
Micropoint’s mLabs D-Dimer test is<br />
designed <strong>for</strong> point-of-care applications.<br />
The mLabs D-Dimer test is a quantitative<br />
microfluidic immunoassay that provides<br />
rapid test results <strong>for</strong> evaluation of pulmonary<br />
embolism or deep vein thrombosis. Patented<br />
mLabs microfluidic control technology<br />
enables high precision and highly reliable<br />
D-Dimer testing, featuring wide measureable<br />
range, fool-proof operations, and excellent<br />
correlations with central lab equipment, such<br />
as <strong>the</strong> mini-VIDAS. The test uses 250 µL of<br />
citrated whole blood or plasma. Testing time<br />
is
2 0 11 N E w P r o d U c T s r E v I E w special section<br />
Advertisement<br />
one protocol <strong>for</strong> both routine and intraoperative<br />
testing with results available in 18<br />
minutes. The VITROS iPTH Assay runs in a<br />
fully automated, random-access <strong>for</strong>mat on<br />
<strong>the</strong> VITROS ECi/ECiQ and 3600 Immunodiagnostic<br />
Systems and can also run on <strong>the</strong><br />
VITROS 5600 Integrated System. Equivalent<br />
analytical results are generated across all<br />
three systems.<br />
Ortho <strong>Clinical</strong> Diagnostics<br />
www.orthoclinical.com<br />
Booth No. 1003<br />
VITROS® Anti HBe and HBeAg Assays*<br />
Ortho <strong>Clinical</strong> Diagnostic announces <strong>the</strong><br />
pending FDA approval of <strong>the</strong> VITROS<br />
Anti-HBe and HBeAg assays <strong>for</strong> use on <strong>the</strong><br />
VITROS ECi/ECiQ Immunodiagnostic<br />
Systems. These fully automated, randomaccess<br />
assays will complete <strong>the</strong> full hepatitis<br />
panel and compliment HIV and rubella<br />
infectious disease assays, as well as 29 routine<br />
immunoassays. HBeAg in serum is a strong<br />
indicator of high infectivity of HBV. Presence<br />
of Anti-HBe indicates <strong>the</strong> convalescent stage<br />
of HBV infection and is found in carriers<br />
of HBV who are able to clear HBeAg from<br />
<strong>the</strong> circulation. HBeAg/anti HBe assays are<br />
important to define <strong>the</strong> specific HBV disease<br />
state. *Pending FDA clearance.<br />
Ortho <strong>Clinical</strong> Diagnostics<br />
www.orthoclinical.com<br />
Booth No. 1003<br />
Centrisart® Concentrator <strong>for</strong><br />
Antigens and Antibodies<br />
The Sartorius Centrisart centrifugal ultrafiltration<br />
device can be used <strong>for</strong> concentrating<br />
fungal antibodies in serum prior to<br />
complement fixation or immunodiffusion.<br />
The sensitivity of <strong>the</strong>se tests <strong>for</strong> Coccidioides<br />
antibodies has been improved greatly by this<br />
method. The Centrisart may also be used<br />
<strong>for</strong> concentrating bacterial antigens in urine,<br />
serum, or cerebrospinal fluid. Antigens associated<br />
with H. influenzae and S. pneumoniae<br />
can be concentrated and tested with latex<br />
particle agglutination or o<strong>the</strong>r methods. This<br />
has been useful in <strong>the</strong> diagnosis of sepsis in<br />
newborns. The Centrisart features a unique<br />
design in which <strong>the</strong> ultrafiltration takes place<br />
in <strong>the</strong> opposite direction to <strong>the</strong> centrifugal<br />
<strong>for</strong>ce. This is effective in greatly reducing<br />
blockage of <strong>the</strong> filter and improving flow.<br />
Vivaproducts<br />
www.vivaproducts.com<br />
Booth No. 1661<br />
AWEL Centrifuges<br />
The new AWEL range of centrifuges has<br />
been launched, including <strong>the</strong> multifunction<br />
<strong>for</strong>mat. Bringing practical innovation to<br />
our customers, each model in <strong>the</strong> MF series<br />
offers a large sample capacity <strong>for</strong> its class and<br />
accepts a variety of swing-out, microplate,<br />
and angle rotors. New features include <strong>the</strong><br />
AWELight system that displays blue lid<br />
lights at <strong>the</strong> end of <strong>the</strong> run, indicating <strong>the</strong><br />
samples are ready to be removed. This not<br />
only increases operator efficiency, but it also<br />
improves process results. The AWELock<br />
system permits rotors to be exchanged and<br />
safely locked in position without using tools.<br />
A low profile adds to <strong>the</strong> convenience. *Available<br />
<strong>for</strong> sale outside <strong>the</strong> U.S.<br />
NuAire, Inc.<br />
www.nuaire.com<br />
Booth No. 2109<br />
Vitamin D Total Assay*<br />
on ADVIA Centaur® System<br />
Laboratories can now meet <strong>the</strong> increased demand<br />
<strong>for</strong> vitamin D total testing with precise<br />
consistent results in as little as 18 minutes.<br />
The ADVIA Centaur Vitamin D Total Assay<br />
is an equimolar, fully automated vitamin D<br />
total assay that is traceable to LC-MS/MS,<br />
considered <strong>the</strong> gold standard in vitamin D<br />
Accurate and precise<br />
• Sensitivity: < 1pg/ml<br />
• Intra-assay CVs: < 5%<br />
• Inter-assay CVs:
special section<br />
Advertisement<br />
VersaCell Connectivity to<br />
Dimension® ExL Systems<br />
The VersaCell system’s newest connectivity<br />
options include <strong>the</strong> Dimension EXL with<br />
LM, Dimension EXL 200, and RxL Max<br />
Systems. These Dimension plat<strong>for</strong>ms join<br />
<strong>the</strong> ADVIA® 1800 Chemistry, IMMULITE®,<br />
and ADVIA Centaur® Immunoassay Systems<br />
as VersaCell connectivity options. The<br />
Dimension EXL with LM systems combine<br />
<strong>the</strong> power of a uni<strong>for</strong>m reagent system, 182<br />
concurrent onboard assays, QuikLYTE®<br />
electrolytes, and LOCI® immunoassay<br />
technology. VersaCell provides unique pre-<br />
and post-analytical sample management and<br />
workload balancing. The new connectivity<br />
options create specific, needs-based workstations,<br />
combining two Dimension EXL<br />
systems or a Dimension EXL system with an<br />
immunoassay plat<strong>for</strong>m.<br />
Siemens Healthcare Diagnostics<br />
www.siemens.com/diagnostics<br />
Booth No. 1605<br />
RAPIDPoint® 500* Blood Gas System*<br />
RAPIDPoint 500 Blood Gas Analyzers<br />
provide <strong>the</strong> accuracy and reliability you have<br />
come to trust in an easy-to-use, maintenance-free<br />
solution. Designed to satisfy <strong>the</strong><br />
unique demands of point-of-care testing, <strong>the</strong><br />
cartridge-based system delivers a complete<br />
critical-care test menu from a single, wholeblood<br />
sample: pH and blood gases, electrolytes,<br />
glucose, total neonatal bilirubin, and<br />
full CO-oximetry. Engineered to maximize<br />
uptime, you can count on <strong>the</strong> RAPIDPoint<br />
500 system to be ready to use without slowing<br />
down your staff with complex operating<br />
procedures and maintenance tasks. Longlasting<br />
cartridges, integrated automatic QC,<br />
and proven technologies free clinicians to<br />
focus on patient care as your workload and<br />
testing needs continue to grow. *In development.<br />
Siemens Healthcare Diagnostics<br />
www.siemens.com/diagnostics<br />
Booth No. 1605<br />
Personalized Education Plan<br />
The Personalized Education Plan (PEP) is<br />
a patent-pending, competency-based approach<br />
to customized laboratory education.<br />
36 CliniCal laboratory news July 2011<br />
2 0 11 N E w P r o d U c T s r E v I E w<br />
Managed online, PEP blends <strong>the</strong> unique<br />
attributes of <strong>for</strong>mal instruction, interactive<br />
training, state-of-<strong>the</strong>-art technology, and<br />
expert insight that help advance staff development<br />
and improve productivity. With<br />
a core system-based curriculum, PEP also<br />
provides ongoing guidance and educational<br />
support <strong>for</strong> a wide variety of professional<br />
and disease-management topics. In addition,<br />
PEP can be personalized to accommodate<br />
different needs, preferences, and learning<br />
styles through a multitude of convenient<br />
delivery vehicles.<br />
Siemens Healthcare Diagnostics<br />
www.siemens.com/diagnostics<br />
Booth No. 1605<br />
LOCI® CA Assays on Dimension Vista® System<br />
LOCI CA 125II, CA 15-3, and CA 19-9 assays<br />
<strong>for</strong> Dimension Vista systems are homogenous,<br />
sandwich, chemiluminescent immunoassays<br />
<strong>for</strong> <strong>the</strong> quantitative measurement of<br />
CA 125II, CA 15-3, and CA 19-9. LOCI CA<br />
assays integrate oncology testing into routine<br />
workflows on a consolidated plat<strong>for</strong>m and<br />
are <strong>the</strong> only CA assays to employ LOCI<br />
technology. When used in conjunction with<br />
o<strong>the</strong>r clinical and diagnostic procedures,<br />
serial testing with LOCI CA markers may<br />
be useful as an aid in managing previously<br />
treated cancers, <strong>for</strong> monitoring response to<br />
<strong>the</strong>rapy, or <strong>for</strong> monitoring disease progress,<br />
recurrence, or residual disease.<br />
Siemens Healthcare Diagnostics<br />
www.siemens.com/diagnostics<br />
Booth No. 1605<br />
INNOVANCE® D-Dimer Assay<br />
The INNOVANCE D-Dimer Assay has been<br />
used by labs to aid in diagnosis of life-threatening<br />
venous thromboembolic events like<br />
deep vein thrombosis (DVT) and pulmonary<br />
embolism (PE). It is now available <strong>for</strong> use in<br />
conjunction with a non-high clinical pretest<br />
probability assessment model to exclude<br />
<strong>the</strong> presence of DVT and PE. Speed and<br />
per<strong>for</strong>mance make INNOVANCE D-Dimer<br />
a robust, cost-effective assay <strong>for</strong> both routine<br />
and emergency (STAT) use, capable of<br />
streamlining your laboratory workflow. The<br />
fully automated blood test runs on multiple<br />
coagulation systems offered by Siemens,<br />
including <strong>the</strong> BCS®, BCS® XP, and Sysmex®<br />
Coagulation Systems.<br />
Siemens Healthcare Diagnostics<br />
www.siemens.com/diagnostics<br />
Booth No. 1605<br />
IMMuLITE® 2000 xPi Immunoassay System*<br />
The IMMULITE 2000 XPi Immunoassay<br />
System is a continuous, random-access<br />
analyzer that includes enhanced hardware<br />
and software features designed to handle<br />
many of today’s immunoassay-testing chal-<br />
lenges. Enhancements include Auto Rack<br />
Load <strong>for</strong> no-pause sampling and AutoStart<br />
<strong>for</strong> automation of routine maintenance,<br />
and QC. Additionally, <strong>the</strong> IMMULITE 2000<br />
XPi system features an extensive automated<br />
routine, allergy, and specialty immunoassay<br />
menu and processes up to 200 tests/hour.<br />
*Not available <strong>for</strong> sale in <strong>the</strong> U.S. Pending<br />
FDA clearance. Available <strong>for</strong> sale outside <strong>the</strong><br />
U.S.<br />
Siemens Healthcare Diagnostics<br />
www.siemens.com/diagnostics<br />
Booth No. 1605<br />
Dimension® ExL 200<br />
Integrated Chemistry System<br />
The Dimension EXL 200 Integrated<br />
Chemistry System is <strong>the</strong> latest addition to<br />
<strong>the</strong> Dimension family of analyzers. This<br />
new system features LOCI® advanced chemiluminescence<br />
technology, providing lowervolume<br />
laboratories with access to fast,<br />
sensitive immunoassay testing on a trusted,<br />
proven, and integrated plat<strong>for</strong>m. The test<br />
menu includes more than 90% of <strong>the</strong> critical<br />
methods ordered by physicians and features<br />
a cardiac STAT menu that delivers highsensitivity<br />
troponin I results in 10 minutes.<br />
Additionally, <strong>the</strong> Dimension EXL 200 system<br />
features technology new to <strong>the</strong> Dimension<br />
EXL line that helps increase productivity<br />
in <strong>the</strong> laboratory, such as a sample transfer<br />
module, sample clot check, and <strong>the</strong> capability<br />
to sample from pediatric tubes.<br />
Siemens Healthcare Diagnostics<br />
www.siemens.com/diagnostics<br />
Booth No. 1605<br />
syngo® Lab Data Manager*<br />
syngo Lab Data Manager is a new datamanagement<br />
system that links analyzers and<br />
StreamLAB® Automation Solutions to <strong>the</strong><br />
laboratory in<strong>for</strong>mation system (LIS) and<br />
Siemens remote services. This system provides<br />
a consolidated view of patient results<br />
and offers autoverification through which<br />
laboratories can automate release of test<br />
results, reduce errors, and increase consistency.<br />
The integrated quality control module<br />
ensures high quality result reporting through<br />
automated Westgard rules, custom rules, and<br />
real-time analysis of patient median statistics.<br />
syngo Lab Data Manager is future-ready, with<br />
a built-in growth path to process management<br />
<strong>the</strong> next generation of diagnostics IT.<br />
*Available <strong>for</strong> sale outside <strong>the</strong> U.S.<br />
Siemens Healthcare Diagnostics<br />
www.siemens.com/diagnostics<br />
Booth No. 1605<br />
CEDIA® Oral Fluids Immunoassays<br />
These new Thermo Scientific CEDIA Oral<br />
Fluid assays use <strong>the</strong> same well-respected<br />
CEDIA technology as <strong>the</strong> urine drug monitoring<br />
products. The assay <strong>for</strong>mat makes administering<br />
sample collection easier during<br />
field visits or check-ins. Observing oral fluid<br />
collection also is noninvasive, reducing <strong>the</strong><br />
risk of sample adulteration. Different size kits<br />
are available <strong>for</strong> a range of lab testing needs,<br />
and calibrators and controls are supplied as<br />
ready-to-use liquids. The CEDIA Oral Fluid<br />
Control Set is packaged at more than 50%<br />
of cutoff and can be used with any lot of<br />
reagent. Oral-fluid screening is now faster<br />
and more cost-effective with applications<br />
<strong>for</strong> a variety of clinical chemistry analyzers.<br />
Contact us at (800) 232-3342 or email us at<br />
sales.diagnostics.fmt@<strong>the</strong>rmofisher.com.<br />
Thermo Fisher Scientific<br />
www.<strong>the</strong>rmoscientific.com<br />
Booth No. 1720<br />
QMS® Teicoplanin Immunoassay*<br />
The Thermo Scientific QMS Teicoplanin<br />
Immunoassay is intended <strong>for</strong> quantitative<br />
determination of teicoplanin in human<br />
serum or plasma as an aid in managing patients<br />
receiving teicoplanin <strong>the</strong>rapy. The assay<br />
uses <strong>the</strong> Quantitative Microparticle Systems<br />
technology that is based on a competitive<br />
inhibition principle. Teicoplanin is used to<br />
treat moderate-to-serious infections caused<br />
by bacteria. QMS liquid-stable, ready-to-use<br />
reagents offer superior per<strong>for</strong>mance and<br />
are widely applicable to a variety of general<br />
chemistry analyzers. The assay offers excellent<br />
curve stability and low interference with<br />
endogenous substances. Contact us at (800)<br />
232-3342 or email us at sales.diagnostics.<br />
fmt@<strong>the</strong>rmofisher.com. *Available <strong>for</strong> sale<br />
outside <strong>the</strong> US.<br />
Thermo Fisher Scientific<br />
www.<strong>the</strong>rmoscientific.com<br />
Booth No. 1720<br />
QMS® Everolimus Immunoassay<br />
The Thermo Scientific QMS Everolimus<br />
Immunoassay is <strong>the</strong> newest addition to a full<br />
menu of immunosuppressant drug monitoring<br />
immunoassays. There are applications <strong>for</strong><br />
a variety of clinical chemistry analyzers. The<br />
QMS Everolimus assay was developed using<br />
<strong>the</strong> Quantitative Microsphere Systems technology,<br />
incorporating microparticle beads.
2 0 11 N E w P r o d U c T s r E v I E w special section<br />
Advertisement<br />
The test is based on a competitive inhibition<br />
principle. This assay recently received FDA<br />
clearance <strong>for</strong> management of kidney transplant<br />
patients receiving everolimus <strong>the</strong>rapy.<br />
Training and service is available by our highly<br />
trained field technical service team, and our<br />
24/7 hotline provides on-going support <strong>for</strong><br />
your lab. Contact us at (800) 232-3342 or<br />
email us at sales.diagnostics.fmt@<strong>the</strong>rmofisher.com.<br />
Thermo Fisher Scientific<br />
www.<strong>the</strong>rmoscientific.com<br />
Booth No. 1720<br />
Indiko <strong>Clinical</strong> Chemistry Analyzer*<br />
Introducing <strong>the</strong> new Thermo Scientific<br />
Indiko, a superior benchtop photometric<br />
analyzer. Indiko’s compact design occupies<br />
a small footprint, is easy-to-install, and does<br />
not require external water or drainage connections.<br />
An easy-to-use graphic interface,<br />
combined with <strong>the</strong> unique low-volume<br />
cuvette design, reduces reagent usage and<br />
operating cost. A flexible loading system with<br />
combined sample and reagent disks allows<br />
<strong>for</strong> continuous access to samples, reagents,<br />
and cuvettes without interrupting <strong>the</strong> testing<br />
process. Once loaded, <strong>the</strong> analyzer automates<br />
all necessary steps, providing a walk-away<br />
time of up to 2 hours. Contact us at (800)<br />
232-3342 or email us at sales.diagnostics.<br />
fmt@<strong>the</strong>rmofisher.com. *Pending FDA<br />
clearance.<br />
Thermo Fisher Scientific<br />
www.<strong>the</strong>rmoscientific.com<br />
Booth No. 1720<br />
MAS® Omni•IMMUNE Control*<br />
Thermo Scientific MAS Omni•IMMUNE<br />
and MAS Omni•IMMUNE PRO consolidates<br />
immunochemistry QC testing. Com-<br />
bining <strong>the</strong> analytes <strong>for</strong> routine immunoassays,<br />
cancer markers, and newer specialty<br />
tests into a single, three-level QC material<br />
streamlines lab QC testing process by<br />
rolling three historically distinct products<br />
into a single vial. MAS Omni•IMMUNE<br />
PRO provides anti-Tg, anti-TPO, and<br />
SHBG in addition to assays provided in <strong>the</strong><br />
standard Omni-IMMUNE. Value assignment<br />
is provided <strong>for</strong> <strong>the</strong> newer generation<br />
of consolidated instrument systems that<br />
use multiple technologies. The new MAS<br />
Omni products help align lab QC requirements<br />
with <strong>the</strong>se new instrument options.<br />
Contact us at (800) 232-3342 or email us at<br />
sales.diagnostics.fmt@<strong>the</strong>rmofisher.com.<br />
*Pending FDA clearance.<br />
Thermo Fisher Scientific<br />
www.<strong>the</strong>rmoscientific.com<br />
Booth No. 1720<br />
MAS® Omni•CORE Control*<br />
Thermo Scientific MAS Omni•CORE<br />
provides <strong>the</strong> highly requested consolidation<br />
of general chemistry and immunology QC<br />
products. Combining CRP, Rheumatoid<br />
Factor, and key serum protein tests with a<br />
general chemistry panel into a single, threelevel<br />
QC material streamlines lab QC testing,<br />
rolling two historically distinct products into<br />
a single vial. MAS Omni•CORE provides<br />
class-leading QC stability while maintaining<br />
distinct level separation. Value assignment<br />
is provided <strong>for</strong> <strong>the</strong> newer generation of<br />
consolidated instrument systems that use<br />
multiple technologies. The new MAS Omni<br />
products help align lab QC requirements<br />
with <strong>the</strong>se new instrument options. Contact<br />
us at (800) 232-3342 or email us at sales.diagnostics.fmt@<strong>the</strong>rmofisher.com.<br />
*Pending<br />
FDA clearance.<br />
Thermo Fisher Scientific<br />
www.<strong>the</strong>rmoscientific.com<br />
Booth No. 1720<br />
MAS® DOA Total Control<br />
The new Thermo Scientific MAS DOA<br />
TOTAL Control is a multi-constituent urine<br />
toxicology control offering 19 analytes with<br />
four distinct levels at drug concentrations<br />
25% above and below commonly used<br />
screening and SAMHSA cutoffs. A drug-free<br />
level and high-positive level are also available<br />
(six levels total). The MAS DOA TOTAL<br />
Control is a liquid, ready-to-use product<br />
available <strong>for</strong> use on a variety of instrument<br />
plat<strong>for</strong>ms. Each level of control is individually<br />
packed, which gives you <strong>the</strong> flexibility to<br />
choose your levels according to your drug-<br />
screen panel cutoffs while keeping <strong>the</strong> number<br />
of control vials to a minimum. Contact<br />
us at (800) 232-3342 or email us at sales.<br />
diagnostics.fmt@<strong>the</strong>rmofisher.com.<br />
Thermo Fisher Scientific<br />
www.<strong>the</strong>rmoscientific.com<br />
Booth No. 1720<br />
Fluoro-Max Fluorescent Particles*<br />
Fluoro-Max Fluorescent Particles are internally<br />
dyed with europium chelate and come<br />
in carboxylate-modified and streptavidincoated<br />
versions. The particles produce a very<br />
broad Stokes shift so that any non-specific<br />
fluorescent interference can be avoided. This<br />
characteristic makes <strong>the</strong>se particles ideal <strong>for</strong><br />
lateral flow, diagnostic assay, nucleic acid hybridization,<br />
immuno/histological, research,<br />
point-of-care, membrane, and o<strong>the</strong>r timeresolved<br />
microfluorescent applications. Available<br />
in 0.1-, 0.2-, and 0.3- µ diameters, <strong>the</strong>se<br />
particles excite at 333 nm and emit at 613<br />
nm, and <strong>the</strong>y do so <strong>for</strong> an extended lifetime<br />
of approximately 0.5 milliseconds. *Available<br />
<strong>for</strong> sale outside <strong>the</strong> U.S.<br />
Thermo Fisher Scientific<br />
www.<strong>the</strong>rmoscientific.com/<br />
particletechnology<br />
Booth No. 1720<br />
Sera-Mag® SpeedBeads<br />
Magnetic Protein A/G Particles*<br />
Sera-Mag SpeedBeads Magnetic Protein A/G<br />
Particles provide a fast and convenient method<br />
<strong>for</strong> both manual and automated magnetic<br />
isolation of proteins using affinity binding.<br />
These nominal 1-µm diameter, uni<strong>for</strong>m, colloidally<br />
stable, monodispersed, non-porous<br />
super paramagnetic particles can be used <strong>for</strong><br />
isolating antibodies from serum, cell culture<br />
supernatant, or ascites, as well as <strong>for</strong> immunoprecipitation<br />
and co-immunoprecipitation<br />
of antigens from cell or t<strong>issue</strong> extracts.<br />
The particles are supplied at 1% solids (10<br />
mg/mL) in 0.05% sodium azide and are<br />
available in 1-, 15-, and 100- mL bottles.<br />
Manufactured under strict quality and GMP<br />
controls in our medical device-registered,<br />
ISO 13485-certified facility. *In development.<br />
Available <strong>for</strong> sale outside <strong>the</strong> U.S.<br />
Thermo Fisher Scientific<br />
www.<strong>the</strong>rmoscientific.com<br />
Booth No. 1720<br />
Labmaster® ABC-CB200R<br />
The Labmaster Automatic Balancing Compact<br />
Benchtop Centrifuge with refrigeration<br />
features a built-in, auto-balancing mechanism<br />
that measures imbalance and corrects<br />
it automatically. It has a maximum RCF of<br />
19,839 x g and a maximum speed of 13,000<br />
rpm. The centrifuge is very stable and operates<br />
silently. You can choose from four differ-<br />
CliniCal laboratory news July 2011 37
special section<br />
Advertisement<br />
ent rotors. Redesign your lab with Labmaster<br />
Auto Balancing Centrifuge and save yourself<br />
time and money.<br />
Hanlab Corporation<br />
www.hanlab.co.kr<br />
Booth No. 3446<br />
Qualiris by Stago Hemostasis QA Program<br />
Qualiris by Stago is <strong>the</strong> new hemostasis<br />
quality assessment program. The program<br />
offers <strong>the</strong> broadest range of routine and<br />
specialty parameters <strong>for</strong> proficiency testing<br />
with <strong>the</strong> flexibility to meet <strong>the</strong> needs<br />
of your laboratory. The Qualiris program<br />
is an easy-to-use, web-based system, with<br />
thousands of participants worldwide, ensuring<br />
<strong>the</strong> maximum statistical comparison of<br />
your results. With Qualiris, Stago is pleased<br />
to provide real-time, peer-group reports,<br />
advanced technical support, and diagnostic<br />
challenges—an additional level of confidence<br />
<strong>for</strong> your hemostasis lab.<br />
Diagnostica Stago, Inc.<br />
www.stago-us.com<br />
Booth No. 731<br />
STA®-Staclot® dRVV Screen and Confirm<br />
The FDA-cleared STA-Staclot dRVV Screen<br />
and Confirm are fully automated assays<br />
<strong>for</strong> detecting lupus anticoagulants (LA) in<br />
patient plasma by <strong>the</strong> diluted Russell viper<br />
venom method. Each reagent is barcoded <strong>for</strong><br />
ease-of-use on <strong>the</strong> STA line of analyzers. The<br />
STA Staclot dRVV Screen uses a reagent with<br />
a low phospholipid concentration, enhancing<br />
its sensitivity and prolonging <strong>the</strong> clotting<br />
time. The STA Staclot dRVV Confirm uses a<br />
reagent with a high phospholipid concentration<br />
that neutralizes <strong>the</strong> LA present in <strong>the</strong><br />
plasma, shortening <strong>the</strong> clotting time. The<br />
tests are not affected by contact factor deficiencies,<br />
factor VIII, and IX deficiencies, or<br />
o<strong>the</strong>r specific inhibitors, as well as by samples<br />
containing <strong>the</strong>rapeutic levels of heparin. STA<br />
Staclot dRVV Screen and Confirm in conjunction<br />
with Staclot LA are complimentary<br />
in fulfilling <strong>the</strong> recommendations established<br />
by ISTH.<br />
Diagnostica Stago, Inc.<br />
www.stago-us.com<br />
Booth No. 731<br />
38 CliniCal laboratory news July 2011<br />
2 0 11 N E w P r o d U c T s r E v I E w<br />
CY-Quant VASP/P2712*<br />
CY-Quant VASP/P2Y12 by Stago is a<br />
ELISA-based assay <strong>for</strong> measuring patient<br />
responsiveness to thienopyridines or o<strong>the</strong>r<br />
drugs that target <strong>the</strong> platelet P2Y12 receptor.<br />
Responsiveness by patients to <strong>the</strong>se drugs<br />
exhibits bell-shaped curve behavior, with low<br />
responders at risk of ischemic injury due to<br />
clot <strong>for</strong>mation. Due to this fact, research into<br />
how patients respond to and factors that<br />
affect this response will serve extremely useful<br />
<strong>for</strong> future ef<strong>for</strong>ts to treat patients using<br />
this class of drugs. *For research use only.<br />
Diagnostica Stago, Inc.<br />
www.stago-us.com<br />
Booth No. 731<br />
Ecarin Chromogenic Assay*<br />
The Ecarin Chromogenic Assay (ECA) is an<br />
enhancement of <strong>the</strong> Ecarin Clotting Time<br />
(ECT), <strong>the</strong> reference method <strong>for</strong> determining<br />
direct thrombin inhibitors (DTIs) such as<br />
argatroban (Argatra®). Although general<br />
monitoring of <strong>the</strong>se drugs is not recommended,<br />
many high-risk patients require an<br />
adapted dosage to minimize dangerous side<br />
effects. *For research use only.<br />
Diagnostica Stago, Inc.<br />
www.stago-us.com<br />
Booth No. 731<br />
STA Coag Connexion<br />
STA Coag ConneXion is an easy-to-use,<br />
Windows® 7-based user interface that offers<br />
comprehensive QC management, remote<br />
QC capability, and standardized result<br />
reporting with <strong>the</strong> use of expert rules <strong>for</strong><br />
autovalidation. Automatic re-runs reflex<br />
test capability, and delta checks also are<br />
included in <strong>the</strong> Coag ConneXion system.<br />
Coag ConneXion gives you <strong>the</strong> flexibility<br />
of a completely paperless solution with <strong>the</strong><br />
ability to record all of your patient samples,<br />
quality control samples, service calls, reagent<br />
logs, and maintenance logs. Future features,<br />
such as automated lot conversion templates,<br />
will fur<strong>the</strong>r enhance your lab’s ability to<br />
automate and simplify time-consuming<br />
processes. STA Coag ConneXion is <strong>the</strong><br />
perfect compliment to any Diagnostica Stago<br />
analyzer and provides <strong>the</strong> highest level of<br />
data automation in <strong>the</strong> industry.<br />
Diagnostica Stago, Inc.<br />
www.stago-us.com<br />
Booth No. 731<br />
AlfaLYZER Saliva Parent<br />
THC Low-Cutoff System<br />
Alfa Scientific Design announces our new<br />
breakthrough in parent THC detection <strong>for</strong><br />
our rapid drugs-of-abuse tests. Stop by our<br />
booth to hear about this exciting, new breakthrough<br />
in THC testing that is a quantum<br />
leap ahead of <strong>the</strong> competition. It didn’t take<br />
a genius to realize that up until now, rapid<br />
drug testing products that were on <strong>the</strong> market<br />
were really not detecting parent THC.<br />
This year we will be showing a new product<br />
at our booth that will make it relatively easy<br />
to detect parent THC at levels that previously<br />
were not achievable.<br />
Alfa Scientific Designs, Inc.<br />
www.alfascientific.com<br />
Booth No. 315<br />
iRICELL® 1500 Automated urinalysis System<br />
The iRICELL 1500 consists of <strong>the</strong> iQ<br />
200SELECT Automated Urine Microscopy<br />
Analyzer connected to <strong>the</strong> iCHEM® VELOC-<br />
ITY Automated Urine Chemistry analyzer.<br />
Iris Diagnostics,<br />
a Division of IRIS International<br />
www.irisdiagnostics.com<br />
Booth No. 419<br />
OVA1 Test<br />
OVA1 is <strong>the</strong> first FDA-cleared test <strong>for</strong> aiding<br />
in pre-surgical evaluation of an ovarian mass<br />
<strong>for</strong> cancer, and also is <strong>the</strong> first protein-based<br />
in vitro diagnostic multi-variate index assay,<br />
a new class of state-of-<strong>the</strong> art, software-based<br />
diagnostics. The test uses five biomarkers—<br />
transthyretin, apolipoprotein A-1, beta2microglobulin,<br />
transferrin (Tfr), and CA 125<br />
II—and a proprietary software to determine<br />
<strong>the</strong> likelihood of malignancy in women<br />
with an ovarian mass <strong>for</strong> whom surgery is<br />
planned. OVA1 is indicated <strong>for</strong> women who<br />
meet <strong>the</strong> following criteria: >18 years; ovarian<br />
adnexal mass present <strong>for</strong> which surgery is<br />
planned; and not yet referred to an oncologist.<br />
Additional product in<strong>for</strong>mation can be<br />
found at www.ova-1.com/.<br />
Vermillion, Inc.<br />
www.vermillion.com<br />
Booth No. 236<br />
Assayed VIROTROL® I Controls<br />
Assayed VIROTROL I Controls are liquid,<br />
human serum-based controls, providing<br />
laboratories with <strong>the</strong> ability to monitor assay<br />
precision. With a long shelf-life and openvial<br />
stability, <strong>the</strong>se products are packaged in<br />
a convenient dropper bottle. These products<br />
include anti-CMV, anti-HBc, anti-HCV, anti-<br />
HIV-1, anti-HTLV-1, and HBsAg analytes<br />
with expected values provided <strong>for</strong> major<br />
instrument plat<strong>for</strong>ms.<br />
Bio-Rad Laboratories<br />
www.bio-rad.com<br />
Booth No. 1631<br />
VIROCLEAR® Control<br />
VIROCLEAR Control is a liquid, human<br />
serum-based control designed as a negative<br />
control <strong>for</strong> 18 commonly tested analytes <strong>for</strong><br />
hepatitis, retrovirus, syphilis, and antibodies<br />
to CMV. With a long shelf-life and open-vial<br />
stability, <strong>the</strong>se products are packaged in two<br />
convenient dropper bottle sizes and primary<br />
tube.<br />
Bio-Rad Laboratories<br />
www.bio-rad.com<br />
Booth No. 1631<br />
MAGO® 4S Analyzer<br />
The MAGO® 4S is <strong>the</strong> only analyzer capable<br />
of providing laboratories infinite possibilities<br />
in ELISA and IFA testing. By allowing ELISA<br />
and IFA samples to be processed simultaneously,<br />
<strong>the</strong> MAGO 4S offers multiple solutions<br />
to increase laboratory productivity. Additionally,<br />
with an expanded menu, <strong>the</strong> MAGO<br />
4S introduces a level of automation that is in<br />
a class by itself. This analyzer also per<strong>for</strong>ms<br />
serial, two-fold dilutions, self-cleans and<br />
calibrates daily, and per<strong>for</strong>ms pre-assay plate/<br />
reagent volume checks. Windows®- based<br />
software adds inverse curve capability and a<br />
full-color screen simplifies setup. Diamedix<br />
provides a one-stop solution that increases<br />
productivity, efficiency, and economy.<br />
IVAX Diagnostics, Inc.<br />
www.ivaxdiagnostics.com<br />
Booth No. 3805<br />
Interlab G26 Agarose Gel<br />
Electrophoresis Analyzer<br />
The INTERLAB G26 is a compact, benchtop,<br />
fully automated agarose gel electrophoresis<br />
analyzer that delivers precise walk-away<br />
electrophoresis with simplified robotics,<br />
primary tube sampling, positive sample ID,
2 0 11 N E w P r o d U c T s r E v I E w special section<br />
Advertisement<br />
simultaneous assay processing, and automated<br />
sample dilutions. The robotic arm,<br />
with its electromagnetic head, controls all<br />
<strong>the</strong> automated steps. Simply load barcodelabeled<br />
sample tubes <strong>for</strong> positive sample<br />
identification from tube to completed result.<br />
Neat samples, and those requiring dilutions,<br />
are prepared with ease using <strong>the</strong> on-board<br />
sampler. The migration chamber peltier uses<br />
vacuum-controlled gel adhesion with disposable<br />
electrode sponges <strong>for</strong> precise band focalization<br />
and easy set-up and maintenance.<br />
Grifols USA<br />
www.grifols.com<br />
Booth No. 3719<br />
Enzymatic Creatinine Reagent Set<br />
Pointe Scientific has introduced a new enzymatic<br />
creatinine assay <strong>for</strong> automated chemistry<br />
analyzers. This two-part, liquid-stable<br />
reagent eliminates endogenous creatine and<br />
ascorbic acid and offers 18-month shelf-life<br />
and up to 30-day, on-board stability. Hemoglobin<br />
to 500 mg/dL, conjugated bilirubin to<br />
32 mg/dL, and unconjugated bilirubin to 40<br />
mg/dL has been shown not to interfere with<br />
<strong>the</strong> assay. The assay shows excellent correlation<br />
to o<strong>the</strong>r creatinine assays. Precision studies<br />
conducted according to CLSI: EP 5 protocol<br />
yielded excellent precision with CVs below 2%.<br />
Pointe Scientific, Inc.<br />
www.pointescientific.com<br />
Booth No. 1640<br />
DYNEx Agility System<br />
Magellan Biosciences has redefined ELISA<br />
processing with <strong>the</strong> new DYNEX Agility—an<br />
ingenious, state-of-<strong>the</strong>-art system featuring<br />
<strong>the</strong> most advanced walkaway automation in<br />
<strong>the</strong> category. Agility allows up to 12 microplates<br />
to be loaded on-board as <strong>the</strong>y are<br />
prepared and can process 16 assays simultaneously.<br />
Agility also minimizes hands-on<br />
time thanks to revolutionary reagent loading<br />
technology, eliminating nearly all liquid transfer<br />
steps with Agility SmartKits. SmartKits<br />
contain all <strong>the</strong> reagents needed <strong>for</strong> each assay<br />
in a durable kit that is loaded directly onto <strong>the</strong><br />
instrument in one step—no manual reagent<br />
pipetting is required! Achieve optimal turnaround<br />
and productivity with Agility.<br />
Dynex Technologies, Inc.<br />
www.dynextechnologies.com<br />
Booth No. 1924<br />
EasyRA <strong>Clinical</strong> Chemistry Analyzer<br />
The EasyRA is a fully automated, clinical<br />
chemistry analyzer <strong>for</strong> use in low-to-<br />
moderate volume hospital and physician<br />
office laboratories. New software capabilities<br />
allow <strong>for</strong> both standard chemistry testing<br />
and now urine drugs-of-abuse testing, as well<br />
as turbidimetric and enzymatic immunoassay<br />
tests. The EasyRA sets a new standard in<br />
its class with a combination of unprecedented<br />
ease-of-use, intuitive user interface, and<br />
limited maintenance.<br />
Medica Corporation<br />
www.medicacorp.com<br />
Booth No. 1851<br />
ST AIA-PACk ACTH and ST AIA-PACk DHEA-S*<br />
Tosoh introduces two new assays to add to<br />
its AIA test menu: ST AIA-PACK ACTH<br />
and ST AIA-PACK DHEA-S. ST AIA-PACK<br />
ACTH is designed <strong>for</strong> in vitro diagnostic use<br />
only <strong>for</strong> quantitative measurement of ACTH<br />
in human EDTA plasma on Tosoh AIA System<br />
Analyzers. ST AIA-PACK DHEA-S<br />
is designed <strong>for</strong> in vitro diagnostic use only<br />
<strong>for</strong> quantitative measurement of dehydroepiandrosterone<br />
sulfate (DHEA-S) in<br />
human serum, heparinized or EDTA plasma,<br />
on TOSOH AIA System Analyzers. Both<br />
ACTH and DHEA-S use Tosoh’s unit-dose<br />
test cup technology, and <strong>the</strong> assay time is<br />
approximately 20 minutes. Both assays offer<br />
a calibration stability of 90 days. *Pending<br />
FDA clearance.<br />
Tosoh Bioscience<br />
www.tosohbioscience.us<br />
Booth No. 401<br />
AIA-900 Automated Immunoassay Analyzer*<br />
Tosoh introduces <strong>the</strong> highly anticipated AIA-<br />
900 Automated Immunoassay Analyzer. This<br />
flexible new addition to Tosoh’s respected<br />
family of AIA analyzers has a throughput<br />
of 90 tests/hour and is available in three<br />
different options: <strong>the</strong> AIA-900, <strong>the</strong> AIA-900<br />
with <strong>the</strong> nine-tray sorter, and <strong>the</strong> AIA-900<br />
with <strong>the</strong> 19-tray sorter. The three models<br />
present customers with a unique opportunity<br />
to grow with <strong>the</strong>ir testing volumes.<br />
For example, a laboratory that purchases<br />
<strong>the</strong> AIA-900 can add <strong>the</strong> nine-tray sorter to<br />
increase testing capacity without changing<br />
<strong>the</strong>ir instrument. The AIA-900 uses <strong>the</strong> same<br />
Unit-Dose Test Cup reagent technology as<br />
all Tosoh AIA immunoassay analyzers. The<br />
AIA-900 is being launched with <strong>the</strong> full AIAtest<br />
menu*. *Pending FDA clearance <strong>for</strong> ST<br />
AIA-PACK PA.<br />
Tosoh Bioscience<br />
www.tosohbioscience.us<br />
Booth No. 401<br />
Rx suzuka <strong>Clinical</strong> Analyzer*<br />
The RX suzuka is a fully automated,<br />
random-access clinical analyzer capable of<br />
per<strong>for</strong>ming up to 1200 tests/hour includ-<br />
ing ISEs, providing laboratories with increased<br />
efficiency and productivity. The RX<br />
suzuka offers: unparalleled productivity via<br />
economic reagent handling; guaranteed flexibility<br />
with our comprehensive and diverse<br />
test menu, allowing <strong>for</strong> complete consolidation<br />
of routine and specialized tests on one<br />
plat<strong>for</strong>m; and unique system reliability,<br />
resulting in greater accuracy and efficiency.<br />
Unrivaled versatility and flexibility make <strong>the</strong><br />
RX suzuka suitable <strong>for</strong> a variety of settings,<br />
including clinical chemistry, research, veterinary,<br />
toxicology, and food and wine testing<br />
*Pending FDA clearance. Available <strong>for</strong> sale<br />
outside <strong>the</strong> U.S.<br />
Randox Laboratories<br />
www.randox.com<br />
Booth No. 1301<br />
Aution Max Ax-4030<br />
urine Chemistry Analyzer<br />
The Aution Max AX-4030 is <strong>the</strong> latest<br />
advancement from U.S. ARKRAY, Inc. The<br />
Aution Max AX-4030 is a high-capacity, fully<br />
automated, urine chemistry analyzer with<br />
true walk-away capabilities. The Aution Max<br />
AX-4030 can hold up to 100 samples and<br />
400 test strips, meeting your workflow<br />
demands. The Aution Max AX-4030 allows<br />
<strong>for</strong> batch, continuous loading, and STAT<br />
capabilities and provides a throughput of 225<br />
samples/hour. Key technological features include:<br />
a refractometer <strong>for</strong> specific gravity and<br />
CliniCal laboratory news July 2011 39
special section<br />
Advertisement<br />
a test strip feeding mechanism with a sensor<br />
that ensures a single strip is dispensed and in<br />
<strong>the</strong> correct position, eliminating waste.<br />
Arkray, Inc.<br />
www.arkrayusa.com<br />
Booth No. 3251<br />
HE4 Antigen*<br />
Human epididymis protein 4 (HE4) is a secreted<br />
glycoprotein that is expressed by ovarian<br />
carcinomas. HE4 is an FDA-approved<br />
biomarker <strong>for</strong> monitoring <strong>the</strong> recurrence or<br />
progression of ovarian cancer. Bioprocessing,<br />
Inc. has been providing <strong>the</strong> diagnostic market<br />
with high-quality tumor marker antigens<br />
<strong>for</strong> clinically approved and novel immunoassays<br />
<strong>for</strong> 20 years. We now offer HE4 Antigen<br />
from cell culture sources to add to your control,<br />
calibrator, or standard. Available as ei<strong>the</strong>r<br />
a highly purified or a partially pure product<br />
with low cross-reactivity, Bioprocessing, Inc.’s<br />
HE4 products will be a valued addition to your<br />
multi-analyte control. *For research use only.<br />
BioProcessing, Inc.<br />
www.bioprocessinginc.com<br />
Booth No. 39<br />
Thunderbolt TM ELISA Plat<strong>for</strong>m<br />
The GSD ThunderBolt is a powerful, compact,<br />
multi-language, fully automated, completely<br />
open, user-friendly, ELISA plat<strong>for</strong>m.<br />
The features of <strong>the</strong> instrument include: three<br />
microtiter plates; intelligent sample racks <strong>for</strong><br />
positive patient identification; LED reader;<br />
built-in barcode scanner; bi-directional<br />
interface; orbital shaker; incubator; and onboard<br />
optics <strong>for</strong> remote troubleshooting. Up<br />
to 192 results can be generated in one run on<br />
a combination of up to eight different assays.<br />
The innovative design provides customers<br />
with a flexible, cost-effective, highly efficient,<br />
automated laboratory solution.<br />
Gold Standard Diagnostics, Inc.<br />
www.gsdx.us<br />
Booth No. 1310<br />
ProbeTec Herpes Simplex<br />
Viruses 1 & 2 Qx Assays<br />
The new BD ProbeTec Herpes Simplex<br />
Viruses (HSV 1 & 2) Qx Amplified DNA<br />
Assays (HSV Qx Assays) run on <strong>the</strong> BD<br />
Viper System with XTR Technology<br />
that uses strand-displacement amplification<br />
technology to qualitatively detect and differentiate<br />
HSV1 and HSV2 DNA. The new<br />
BD ProbeTec HSV Qx Assays offer<br />
40 CliniCal laboratory news July 2011<br />
2 0 11 N E w P r o d U c T s r E v I E w<br />
excellent sensitivity and specificity and a<br />
significant improvement in <strong>the</strong> time-toresults<br />
over culture methods that often take<br />
2–10 days. BD’s new automated HSV assays<br />
also provide laboratories with <strong>the</strong> capability<br />
to read up to 96 positive or negative results in<br />
about 2.5 hours. Using <strong>the</strong> BD Viper System<br />
with XTR Technology, laboratories also will<br />
be able to test o<strong>the</strong>r samples <strong>for</strong> chlamydia<br />
and gonorrhea on <strong>the</strong> same automated run<br />
used <strong>for</strong> <strong>the</strong> BD ProbeTec HSV1 and HSV2<br />
Qx Assays.<br />
BD Diagnostics<br />
www.bd.com/ds<br />
Booth No. 820<br />
CleanAmp PCR kits<br />
CleanAmp PCR Kits are powered by<br />
TriLink’s innovative, heat-activated dNTP<br />
chemistry. Activation of <strong>the</strong> CleanAmp<br />
chemistry occurs during <strong>the</strong> initial heat cycle<br />
of hot start PCR and each subsequent denaturation<br />
step, releasing just enough reagents<br />
to allow efficient amplification. CleanAmp<br />
PCR Kits benefit basic applications, as well<br />
as more advanced variants, such as real-time,<br />
multiplex, and reverse-transcription PCR.<br />
Customers can eliminate or reduce off-target<br />
amplification, significantly increase amplicon<br />
yield and specificity, and commercialize <strong>for</strong><br />
less with reasonable licensing options.<br />
TriLink Biotechnologies, Inc.<br />
www.trilinkbiotech.com<br />
Booth No. 2886<br />
ultra-Sensitive Gold Sol<br />
BioAssay Works has developed unique<br />
colloidal-gold nanoparticle manufacturing<br />
technology, producing 15- to 100-OD concentrated<br />
gold particles in sizes ranging from<br />
10–120 nm. These higher concentrations<br />
confer demonstrable per<strong>for</strong>mance advantages,<br />
especially increased test sensitivity, when<br />
applied to immunoassays. BAW’s nanoparticles<br />
are used to develop ultra-sensitive,<br />
point-of-care rapid tests, molecular circuitry,<br />
evanescent wave backscatter technologies,<br />
and <strong>for</strong>ward, light-scattering, flow cytometric<br />
immunoassays. BAW nanoparticles’ high<br />
concentration allows <strong>the</strong> user to rapidly coat<br />
<strong>the</strong> surface of <strong>the</strong> particles with biomolecules<br />
and use <strong>the</strong> coated particles in various testing<br />
<strong>for</strong>mats without fur<strong>the</strong>r concentration or<br />
purification.<br />
BioAssay Works<br />
www.bioassayworks.com<br />
Booth No. 4020<br />
LIAISON® Measles and Mumps IgG Assays<br />
The LIAISON Measles and Mumps IgG<br />
Assays use chemiluminescent immunoassay<br />
technology on <strong>the</strong> LIAISON Analyzer<br />
<strong>for</strong> detecting IgG antibodies to measles and<br />
mumps viruses in human serum to aid in<br />
determining serological status to measles and<br />
mumps virus. With first result in 35 minutes<br />
and throughput of 90 results/hour, <strong>the</strong>se chemiluminescent<br />
immunoassays <strong>for</strong> measles<br />
and mumps IgG complete <strong>the</strong> MMRV IgG<br />
assay panel. DiaSorin is a worldwide specialty<br />
immunoassay leader in vitamin D and<br />
infectious disease testing with a history of<br />
expertise that spans more than 25 years.<br />
DiaSorin, Inc.<br />
www.diasorin.com<br />
Booth No. 1319<br />
syngo® Lab Process Manager*<br />
syngo Lab Process Manager integrates data<br />
management with process control to deliver<br />
next-generation diagnostics IT. This breakthrough<br />
IT solution provides a consolidated<br />
view of <strong>the</strong> lab’s testing processes and equipment<br />
so <strong>the</strong> operator can quickly identify<br />
and resolve problems be<strong>for</strong>e <strong>the</strong>y impact<br />
quality and turnaround times. *Available <strong>for</strong><br />
sale outside <strong>the</strong> U.S.<br />
Siemens Healthcare Diagnostics<br />
www.siemens.com/diagnostics<br />
Booth No. 1605<br />
EHIV Assay on ADVIA Centaur® CP Sys<br />
The ADVIA Centaur HIV 1/O/2 Enhanced<br />
(EHIV) Assay is an immunoassay <strong>for</strong> qualitative<br />
determination of antibodies to human<br />
immunodeficiency virus (HIV) type 1,<br />
including Group O, and/or HIV type 2, in<br />
serum or plasma. Addition of <strong>the</strong> highper<strong>for</strong>mance<br />
EHIV assay on <strong>the</strong> ADVIA<br />
Centaur CP extends <strong>the</strong> total available menu<br />
to 64 assays. The EHIV assay is developed,<br />
manufactured, and sold by Siemens Healthcare<br />
Diagnostics, Inc. <strong>for</strong> Ortho-<strong>Clinical</strong><br />
Diagnostics, Inc.<br />
Siemens Healthcare Diagnostics<br />
www.siemens.com/diagnostics<br />
Booth No. 1605<br />
LOCI® TPSA and FPSA Assays<br />
on <strong>the</strong> Dimension Vista®*<br />
LOCI TPSA and FPSA <strong>for</strong> <strong>the</strong> Dimension<br />
Vista 1500 system consolidate PSA testing on<br />
a single plat<strong>for</strong>m and are <strong>the</strong> only PSA assays<br />
on <strong>the</strong> market to employ LOCI technology, a<br />
homogenous, sandwich, chemiluminescent<br />
immunoassay <strong>for</strong> quantitatively measuring<br />
total prostate-specific antigen (TPSA) and<br />
free prostate-specific antigen (FPSA).<br />
Measurements of TPSA and/or FPSA aid<br />
in detecting prostate cancer when used in<br />
conjunction with digital rectal exam in men<br />
≥50 years, in management of prostate cancer,<br />
and with calculations of percent FPSA in<br />
distinguishing cancer from benign prostate<br />
conditions. *Pending FDA clearance.<br />
Siemens Healthcare Diagnostics<br />
www.siemens.com/diagnostics<br />
Booth No. 1605<br />
LOCI® Free T3 Assay on <strong>the</strong><br />
Dimension® ExL System<br />
The Dimension EXL Free T3 Assay is a<br />
homogenous, chemiluminescent immunoassay<br />
based on LOCI technology. The LOCI free<br />
T3 methodology provides rapid turnaround,<br />
high analytical sensitivity, and excellent precision<br />
to assist physicians in diagnosing and<br />
treating thyroid patients. The free T3 assay<br />
completes <strong>the</strong> common panel of thyroidfunction<br />
assays on <strong>the</strong> Dimension EXL with<br />
LM system. This panel includes ultrasensitive,<br />
third-generation TSH, total T4,<br />
FT4, and FT3. Consolidation of <strong>the</strong>se assays<br />
on a single, integrated plat<strong>for</strong>m enhances<br />
<strong>the</strong> laboratory’s workflow efficiency without<br />
compromising on results.<br />
Siemens Healthcare Diagnostics<br />
www.siemens.com/diagnostics<br />
Booth No. 1605<br />
BRAHMS PCT Assay* on ADVIA Centaur®<br />
The ADVIA Centaur BRAHMS PCT<br />
(procalcitonin) Assay is a one-step, sandwich,<br />
chemiluminescent immunoassay used <strong>for</strong><br />
determining PCT in human serum and plasma<br />
on <strong>the</strong> ADVIA Centaur Immunoassay<br />
System. This PCT assay provides additional,<br />
specific in<strong>for</strong>mation that may be helpful<br />
in increasing <strong>the</strong> accuracy of sepsis<br />
diagnosis at an early stage to aid in risk<br />
assessment of critically ill patients. Sepsis<br />
is a serious medical condition caused by<br />
<strong>the</strong> body’s response to an infection. Early<br />
detection and targeted clinical intervention<br />
have been demonstrated to be crucial<br />
<strong>for</strong> improved outcomes in septic patients.<br />
*Not available <strong>for</strong> sale in <strong>the</strong> US. Pending<br />
FDA clearance.<br />
Siemens Healthcare Diagnostics<br />
www.siemens.com/diagnostics<br />
Booth No. 1605
2 0 11 N E w P r o d U c T s r E v I E w special section<br />
Advertisement<br />
25-OH Vitamin D Assay<br />
Diazyme’s 25-Hydroxy Vitamin D assay is an<br />
innovative homogenous assay that measures<br />
<strong>the</strong> true total 25-hydroxy vitamin D, <strong>the</strong> sum<br />
of both D3 + D2. The new assay introduces a<br />
number of enhancements, including a wide<br />
dynamic range with improved precision,<br />
while eliminating time-consuming washing<br />
steps found in conventional EIA methods.<br />
The assay is both fast and flexible with<br />
reduced testing time and cost compared to<br />
some competitive products that recommend<br />
running patient samples in duplicate. The<br />
test is user-friendly and can be run manually<br />
or easily adapted <strong>for</strong> use on a wide range<br />
of fully automated microtiter plate readers,<br />
making it suitable <strong>for</strong> use in laboratories of<br />
all sizes and testing needs.<br />
Diazyme Laboratories<br />
www.diazyme.com<br />
Booth No. 4023<br />
Enzymatic Glycated Albumin Assay kit<br />
Diazyme’s Glycated Albumin Assay Kit is a<br />
two-part, liquid-stable reagent that can be<br />
used with most automated clinical chemistry<br />
analyzers and is more specific and accurate<br />
than <strong>the</strong> current non-enzymatic NBT-based<br />
fructosamine test. Serum GSP concentrations<br />
in conjunction with HbA1c can be used<br />
to determine <strong>the</strong> “glycation gap” that offers<br />
improved diagnostic value by more reliably<br />
predicting complications of diabetes, including<br />
coronary artery and kidney disease. In<br />
addition, <strong>the</strong> glycated albumin test serves as<br />
an intermediate-term indicator of average<br />
blood glucose <strong>for</strong> <strong>the</strong> past 2–3 weeks, which<br />
closes <strong>the</strong> existing in<strong>for</strong>mation gap between<br />
daily blood glucose testing and <strong>the</strong> 2-3<br />
month snapshot provided by HbA1c testing.<br />
Diazyme Laboratories<br />
www.diazyme.com<br />
Booth No. 4023<br />
MAx Open System*<br />
Announcing <strong>the</strong> BD MAX Open System<br />
<strong>for</strong> molecular testing—<strong>the</strong> first and only<br />
system capable of per<strong>for</strong>ming user-defined<br />
protocols, IVD assays, and life science<br />
research with full automation. The BD MAX<br />
offers laboratories <strong>the</strong> possibilities of walkaway<br />
automation, standardized workflow,<br />
and consolidation of a broad range of molecular<br />
tests on a single plat<strong>for</strong>m in order to<br />
build programs that meet both current and<br />
future molecular testing needs. BD MAX—<br />
offering The Power of Choice. *Available <strong>for</strong><br />
sale outside <strong>the</strong> U.S.<br />
BD Diagnostics<br />
www.bd.com/GeneOhm<br />
Booth No. 820<br />
VITROS® 4600 Chemistry System<br />
The VITROS 4600 Chemistry System is<br />
Ortho <strong>Clinical</strong> Diagnostics’ most recent<br />
addition to <strong>the</strong> VITROS Family of analyzers.<br />
Like its siblings <strong>the</strong> VITROS 5600 Integrated<br />
System and <strong>the</strong> VITROS 3600 Immunodiagnostic<br />
System, our newest analyzer offers<br />
standardized, high-quality test results using<br />
common technologies across <strong>the</strong> continuum<br />
of integrated and stand-alone systems. The<br />
VITROS 4600 System leverages our patented<br />
enabling technologies. These maximize quality<br />
of patient results as <strong>the</strong>y continuously promote<br />
ease-of-use and productivity. The VITROS<br />
4600 System answers <strong>the</strong> essential healthcare<br />
challenges you face everyday: improve patient<br />
care while balancing staffing, compliance, and<br />
total operating cost containment.<br />
Ortho <strong>Clinical</strong> Diagnostics<br />
www.orthoclinical.com<br />
Booth No. 1003<br />
APTIMA® Trichomonas vaginalis Assay<br />
The Gen-Probe APTIMA Trichomonas<br />
vaginalis Assay is <strong>the</strong> first NAAT to be FDAcleared<br />
<strong>for</strong> <strong>the</strong> detection of Trichomonas<br />
vaginalis, a sexually transmitted parasite that<br />
is more prevalent than Neisseria gonorrhoeae<br />
and Chlamydia trachomatis. Untreated infections<br />
can negatively impact reproductive<br />
health and increase risk <strong>for</strong> HIV acquisition<br />
and transmission. Published data demonstrate<br />
NAATs offer improved sensitivity <strong>for</strong> detection<br />
of Trichomonas compared with current<br />
testing methods, including wet mount and<br />
culture. The APTIMA Trichomonas vaginalis<br />
Assay is cleared <strong>for</strong> use with <strong>the</strong> TIGRIS DTS<br />
System to test clinician-collected endocervical<br />
or vaginal swabs, urine, and PreservCyt<br />
solution specimens from symptomatic or<br />
asymptomatic women.<br />
Gen-Probe Incorporated<br />
www.gen-probe.com<br />
Booth No. 1021<br />
i-STAT 1 Wireless<br />
On February 14, 2011, Abbott Point-of-Care<br />
received FDA clearance in <strong>the</strong> U.S. to market<br />
its i-STAT 1 Wireless. The i-STAT 1 Wireless<br />
is a new wireless version of <strong>the</strong> i-STAT pointof-care<br />
testing system that is widely used in<br />
hospitals, emergency rooms, and physicians’<br />
offices. The new system allows <strong>for</strong> <strong>the</strong> real-time<br />
transmission of diagnostics test results wirelessly<br />
from <strong>the</strong> patient’s bedside via 802.11<br />
technology. The wireless, handheld device can<br />
potentially save precious time by allowing caregivers<br />
to per<strong>for</strong>m critical tests at <strong>the</strong> bedside<br />
and <strong>the</strong>n transmit test results immediately.<br />
Abbott Point-of-Care<br />
www.abbottpointofcare.com<br />
Booth No. 2531<br />
AliFax Test 1 and Roller 20 Analyzers<br />
Excalibur Lab Specialists, Inc. announces <strong>the</strong><br />
U.S. introduction of <strong>the</strong> Test 1 and Roller 20<br />
lab analyzers from Alifax® Italy. These new<br />
analyzers offer a unique new approach to<br />
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> Wide Range of glass and plastic vials<br />
> Broad Selection of sizes and capabilities<br />
> Conical Well Design provides maximum sample retrieval<br />
> Custom Design available to meet your specifi c requirements<br />
> Plastic Options:<br />
– Resin and colorants chosen to assure no reactivity with<br />
biological samples<br />
– 7 closure colors <strong>for</strong> easy sample or product identifi cation<br />
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measuring erythrocyte sedimentation rate<br />
(ESR). Both <strong>the</strong> Test 1 and Roller 20 provide<br />
results in as little as 20 seconds. This is made<br />
possible by a novel approach that uses <strong>the</strong><br />
kinetics of red-cell aggregation. The test’s<br />
fast turnaround time and <strong>the</strong> system’s ability<br />
to use only a 150-µL sample from standard,<br />
primary blood-collection tubes enables<br />
improved batch processing that establishes a<br />
new benchmark <strong>for</strong> ESR automation.<br />
Alifax SpA<br />
www.excaliburlabspecialists.com<br />
Booth No. 4031<br />
Vitamin D Control*<br />
The Fujirebio Diagnostics, Inc. Vitamin D<br />
Control is an assayed, tri-level vitamin D<br />
control containing both 25(OH) vitamin<br />
D2 and 25(OH) vitamin D3. The control<br />
contains clinically relevant concentrations<br />
of 25(OH) vitamin D, as well as excellent<br />
reconstitution stability. Manufactured to <strong>the</strong><br />
highest quality standards and value assigned<br />
across plat<strong>for</strong>ms, <strong>the</strong> Vitamin D Control<br />
ensures accurate precision monitoring of in<br />
vitro diagnostics laboratory testing procedures<br />
and techniques. Reconstituted, openvial<br />
stability is 14 days at 2–8ºC. All analytes<br />
are stable <strong>for</strong> 60 days when stored at ≤–10ºC.<br />
The control sustains nine freeze/thaw cycles.<br />
*Available <strong>for</strong> sale outside <strong>the</strong> U.S.<br />
Fujirebio Diagnostics, Inc.<br />
www.fdimcc.com<br />
Booth No. 2221<br />
For more in<strong>for</strong>mation, call us at 856.776.4254 | email Kate Gove at kate.gove@wheaton.com | www.wheatonpkg.com<br />
8867<br />
CliniCal laboratory news July 2011 41
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hhs announces Proposed<br />
changes to hiPaa Privacy rule<br />
under a rule proposed by <strong>the</strong> U.S. Department<br />
of Health and Human Services<br />
Office <strong>for</strong> Civil Rights, individuals<br />
would be given <strong>the</strong> right to get a report on<br />
who has electronically accessed <strong>the</strong>ir protected<br />
health in<strong>for</strong>mation. The proposed<br />
rule is a change to <strong>the</strong> Privacy Rule under<br />
<strong>the</strong> Health Insurance Portability and Accountability<br />
Act (HIPAA).<br />
With this change, people could obtain<br />
this in<strong>for</strong>mation by requesting an electronic<br />
access report that would document<br />
<strong>the</strong> particular persons who electronically<br />
accessed and viewed <strong>the</strong>ir protected health<br />
in<strong>for</strong>mation. Although covered entities, including<br />
physicians, hospitals, labs, health<br />
plans, and o<strong>the</strong>r healthcare organizations,<br />
are currently required by <strong>the</strong> HIPAA Security<br />
Rule to track access to electronic<br />
reguLatory<br />
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44 CliniCal laboratory news July 2011<br />
p r o f i L e s<br />
p r o f i L e s<br />
protected health in<strong>for</strong>mation, <strong>the</strong>y are not<br />
required to share this in<strong>for</strong>mation. The<br />
proposed rule also requires an accounting<br />
of more detailed in<strong>for</strong>mation <strong>for</strong> certain<br />
disclosures that are most likely to affect a<br />
person’s rights or interests.<br />
To effect <strong>the</strong> change, all healthcare organizations<br />
will be required to update <strong>the</strong>ir<br />
privacy notices under HIPAA to educate<br />
patients about requesting access reports.<br />
The new rule will take effect January 1,<br />
2013, if adopted.<br />
Comments on <strong>the</strong> proposed rule will be<br />
accepted through August 1, 2011. To read<br />
<strong>the</strong> proposed rule or submit a comment, go<br />
to www.regulations.gov.<br />
re<strong>for</strong>m to net $120 billion<br />
in savings <strong>for</strong> medicare<br />
an analysis <strong>issue</strong>d by <strong>the</strong> Centers <strong>for</strong><br />
Medicare and Medicaid Services (CMS)<br />
www.optima-usa.com<br />
More in<strong>for</strong>mation / sign in: www.immucoat.com<br />
Meet us at AACC, Atlanta, July 26–28, 2011<br />
booth no. 1953<br />
outlines $120 billion in 5-year projected<br />
savings resulting from improvements to <strong>the</strong><br />
Medicare program, including implementation<br />
of many provisions in <strong>the</strong> Af<strong>for</strong>dable<br />
Care Act. The report summed up projected<br />
savings from several sources, including new<br />
tools to combat fraud, waste, and abuse<br />
in <strong>the</strong> Medicare system, as well as delivery<br />
system re<strong>for</strong>ms, such as those that deter<br />
hospital readmissions.<br />
The report looked at five general areas<br />
of projected savings: re<strong>for</strong>ming provider<br />
payments to reward quality of care, $55<br />
billion; lowering hospital readmission and<br />
hospital-acquired infections, $10 billion;<br />
fraud and abuse prevention, $1.8 billion;<br />
improvements in durable medical equipment<br />
purchasing, $2.9 billion; reducing<br />
payments to insurance companies, $50 billion.<br />
The full report is available from <strong>the</strong><br />
CMS website, www.cms.gov/apps/files/<br />
medicare-savings-report.pdf.<br />
sured. Most uninsured people have virtually<br />
no savings, and <strong>the</strong> median per-family<br />
financial assets <strong>for</strong> uninsured families are<br />
just $20. Even among higher-income families,<br />
assets are low: half of families with income<br />
at 400% of <strong>the</strong> Federal Poverty Level,<br />
or $89,400 a year <strong>for</strong> a family of four in<br />
2011, have financial assets below $4,100.<br />
The report is available from <strong>the</strong> HHS<br />
website, https://aspe.hhs.gov/health/reports<br />
/2011/ValueofInsurance/rb.shtml.<br />
hhs begins broad<br />
battle over Payment<br />
advisory board continues<br />
The Af<strong>for</strong>dable Care Act established a<br />
15-member Independent Payment Advisory<br />
Board (IPAB) charged with making<br />
cuts to Medicare in years that spending exceeds<br />
a target growth rate. Under <strong>the</strong> Act,<br />
IPAB recommendations will automatically<br />
become law unless blocked by both Congress<br />
and <strong>the</strong> President. The Congressional<br />
Budget Office (CBO) recently estimated<br />
that repealing IPAB would inevitably mean<br />
stronger spending growth, adding up to<br />
regulatory review<br />
$2.4 billion between 2018 and 2021.<br />
The U.S. Department of Health and Hu- The CBO report is bad news <strong>for</strong> House<br />
man Services (HHS) released its pre- Republicans who have targeted IPAB in<br />
liminary plan <strong>for</strong> retrospective review of <strong>the</strong>ir ef<strong>for</strong>t to defund or repeal healthcare<br />
existing rules based on a comprehensive re<strong>for</strong>m provisions. This year Representative<br />
inventory of each of its agencies’ existing Phil Roe (R-Tenn.) introduced legislation,<br />
regulations. The plan highlights regulations H.R.452, <strong>the</strong> “Medicare Decisions Account-<br />
already being modified or streamlined and ability Act,” to abolish IPAB. The projected<br />
identifies additional candidates <strong>for</strong> fur<strong>the</strong>r costs of doing away with IPAB means that<br />
review.<br />
<strong>the</strong> bill would also need to offset <strong>the</strong>se costs<br />
Earlier this year, President Obama out- somewhere else in <strong>the</strong> budget.<br />
lined his plan <strong>for</strong> ongoing review of regula- Beginning April 2013, <strong>the</strong> Af<strong>for</strong>dable<br />
tions in <strong>the</strong> federal government with <strong>the</strong> in- Care Act requires <strong>the</strong> chief actuary of <strong>the</strong><br />
tention of culling rules that are out-of-date, Centers <strong>for</strong> Medicare and Medicaid Servic-<br />
unnecessary, excessively burdensome, or in es to project whe<strong>the</strong>r Medicare per capita<br />
conflict with o<strong>the</strong>r rules.<br />
spending exceeds <strong>the</strong> average Consumer<br />
The HHS plan outlined several areas Price Index, based on a 5-year period. If<br />
<strong>for</strong> improvement, including conflicting so, beginning January 15, 2014, IPAB must<br />
requirements between Medicaid and Medi- submit recommendations to cut Medicare<br />
care; reviewing <strong>the</strong> criteria used to define spending. The board must also submit rec-<br />
health professional shortages and mediommendations every o<strong>the</strong>r year to slow <strong>the</strong><br />
cally underserved areas; and using more growth in national private health expendi-<br />
cost-effective technologies like electronic tures while preserving quality of care. The<br />
signatures and document storage.<br />
threshold target will <strong>the</strong>n change begin-<br />
The full regulatory review plan <strong>for</strong> <strong>the</strong> ning in 2018, when it becomes Medicare<br />
agency is available on www.whitehouse. per capita spending that exceeds gross do-<br />
gov.<br />
mestic product per capita plus 1%. The law<br />
specifically prohibits IPAB from submitting<br />
proposals that would ration care, increase<br />
report: most uninsured<br />
revenues, or change benefits, eligibility, or<br />
can’t Pay bills<br />
Medicare beneficiary cost sharing.<br />
new report released by <strong>the</strong> U.S. De- More in<strong>for</strong>mation is available from <strong>the</strong><br />
a partment of Health and Human Ser- CBO website, www.cbo.gov.<br />
vices (HHS) shows that few families without<br />
health insurance have <strong>the</strong> financial<br />
assets to pay potential hospital bills. On<br />
average, uninsured families can only af<strong>for</strong>d<br />
to pay in full <strong>for</strong> approximately 12% next in CLN<br />
of hospital stays <strong>the</strong>y may experience, and<br />
even higher-income uninsured families are<br />
unable to pay <strong>for</strong> most potential hospitalizations,<br />
<strong>the</strong> report found.<br />
Hospital stays <strong>for</strong> which <strong>the</strong> uninsured<br />
cannot pay in full account <strong>for</strong> 95% of <strong>the</strong><br />
total amount hospitals bill <strong>the</strong> uninsured.<br />
Platelet<br />
function<br />
Testing<br />
The idea that people without heath insurance<br />
can get care with little or no problem<br />
is an enduring myth, said HHS Secretary<br />
Kathleen Sebelius.<br />
According to <strong>the</strong> new report, approximately<br />
50 million <strong>American</strong>s are unin-<br />
30 years of<br />
hiv Testing
iNdustry<br />
p r o f i L e s<br />
p r o f i L e s<br />
Quest completes<br />
in pre-clinical development <strong>for</strong> advanced<br />
non-small cell lung cancer (NSCLC) pa-<br />
acquisition of celera<br />
tients, will run on Roche’s Cobas 4800 sys-<br />
Quest Diagnostics has successfully tem and is intended <strong>for</strong> <strong>the</strong> identification<br />
completed acquisition of Celera Cor- of mutations, including <strong>the</strong> EGFR T790M<br />
poration <strong>for</strong> approximately $671 million. mutation, in patients with NSCLC. “Our<br />
According to Quest, <strong>the</strong> deal was com- agreement with Clovis Oncology strengthpleted<br />
through a short-<strong>for</strong>m merger, after ens our position as <strong>the</strong> partner of choice <strong>for</strong><br />
its tender offer expired. Quest announced <strong>the</strong> development of companion diagnos-<br />
plans to purchase Celera in March in an eftics. Roche hopes that through this collabo<strong>for</strong>t<br />
to streng<strong>the</strong>n its molecular diagnostics ration we will be able to advance oncology<br />
portfolio.<br />
diagnostic testing and drug <strong>the</strong>rapy <strong>for</strong> <strong>the</strong><br />
benefit of many patients worldwide,” said<br />
Paul Brown, head of Roche Molecular Di-<br />
danaher extends offer<br />
agnostics.<br />
<strong>for</strong> beckman coulter<br />
danaher has extended <strong>for</strong> a third time<br />
its cash tender offer to acquire all of Thermo fisher signs deal to<br />
<strong>the</strong> outstanding shares of Beckman Coulter,<br />
Inc. <strong>for</strong> $83.50 per share in cash. All<br />
o<strong>the</strong>r terms and conditions of <strong>the</strong> offer<br />
expand specialty dx Portfolio<br />
Thermo Fisher Scientific has inked a<br />
definitive deal to acquire Phadia, an al-<br />
remain unchanged. Danaher continues to lergy and autoimmunity diagnostics firm.<br />
anticipate completing <strong>the</strong> acquisition in The deal is designed to significantly expand<br />
2011. The deal is valued at approximately Thermo Fisher’s specialty diagnostics port-<br />
$6.8 billion.<br />
folio. Currently, Thermo Fisher’s diagnostics<br />
business focuses on t<strong>issue</strong>-based cancer<br />
diagnostics, microbiology technologies <strong>for</strong><br />
myriad Genetics licenses cancer detecting pathogens in food and infectious<br />
diagnostic Technology from chronix diseases, and specialty assays, such as drugs-<br />
myriad Genetics has licensed <strong>the</strong> of-abuse testing and its biomarker business.<br />
rights to technology <strong>for</strong> early detec- “Phadia is a strong fit strategically with our<br />
tion of cancer from Chronix Biomedical. existing specialty diagnostic plat<strong>for</strong>m, sig-<br />
Under <strong>the</strong> terms of <strong>the</strong> deal, Myriad has nificantly increasing our penetration of a<br />
<strong>the</strong> rights to commercialize tests derived high-growth market,” said Thermo Fisher<br />
from <strong>the</strong> technology <strong>for</strong> <strong>the</strong> early detection<br />
of breast, colon, and prostate cancers<br />
in North America, South America,<br />
president and CEO, Marc Casper.<br />
and Europe. Myriad Genetics will pay nestle health science acquires<br />
upfront fees, milestone payments, and<br />
royalty payments in exchange <strong>for</strong> access<br />
to Chronix Biomedical’s technology.<br />
Prome<strong>the</strong>us laboratories<br />
nestle Health Science has finalized an<br />
agreement to buy Prome<strong>the</strong>us Labo-<br />
“The technology we have licensed from ratories <strong>for</strong> an undisclosed amount. The<br />
Chronix Biomedical has <strong>the</strong> potential to deal is aimed at moving <strong>the</strong> company into<br />
revolutionize <strong>the</strong> early detection of cancer <strong>the</strong> gastrointestinal diagnostics sector. Nes-<br />
through <strong>the</strong> analysis of unique DNA setle Health Science is a wholly owned subsidquences<br />
in blood samples,” said Mark Caiary of Nestle and is focused on developing<br />
pone, president of Myriad Genetics. science-based nutritional solutions <strong>for</strong> personalized<br />
medicine. Joseph Limber, president<br />
and CEO of Prome<strong>the</strong>us, said that as<br />
metabolon moves into <strong>the</strong><br />
a result of <strong>the</strong> acquisition, his company will<br />
diagnostics business<br />
“accelerate <strong>the</strong> development of our innova-<br />
metabolon will expand its offerings by tive diagnostics plat<strong>for</strong>ms <strong>for</strong> gastroenterol-<br />
moving into <strong>the</strong> diagnostics market. ogy and oncology and potentially into ad-<br />
The metabolomics firm anticipates <strong>the</strong><br />
launch of its first test <strong>for</strong> insulin resistance,<br />
called Quantose. The company will focus<br />
ditional important <strong>the</strong>rapeutic areas.”<br />
its attention on developing metabolomics- labcorp Purchases clearstone<br />
based diagnostics. Two tests <strong>for</strong> prostate<br />
cancer are also planned, as well as tests <strong>for</strong><br />
determining <strong>the</strong> aggressiveness of cancers<br />
central laboratories<br />
laboratory Corporation of America has<br />
signed a definitive deal to buy central<br />
and <strong>for</strong> assessing tolerance to chemo<strong>the</strong>ra- laboratory service provider Clearstone<br />
pies, directed at bladder and kidney cancers. Central Laboratories in an ef<strong>for</strong>t to bolster<br />
<strong>the</strong> company’s companion diagnostics<br />
business. According to LabCorp, <strong>the</strong> deal<br />
roche and clovis collaborate on will provide it with a global network of cen-<br />
companion dx <strong>for</strong> eGfr mutations tral laboratories and access to Clearstone’s<br />
roche and Clovis Oncology have part- clinical trials management system, Apollo<br />
nered to develop an in vitro PCR- CLPM, which offers real-time access to<br />
based companion diagnostic test. The as- global data. The deal is expected to close<br />
say <strong>for</strong> CO-1686, a compound currently this summer.<br />
myriad Genetics finalizes<br />
rules-based medicine Purchase<br />
myriad Genetics has completed its<br />
purchase of Rules-Based Medicine<br />
<strong>for</strong> $80 million. According to Myriad, Rules-<br />
Based Medicine will continue its collaborations<br />
with pharmaceutical partners in companion<br />
diagnostics discovery. The deal is<br />
expected to fur<strong>the</strong>r develop Myriad’s companion<br />
diagnostics franchise. In addition,<br />
<strong>the</strong> acquisition will help expand <strong>the</strong> company’s<br />
product portfolio into new disease areas<br />
including psychiatric disorders, infectious<br />
diseases, and inflammatory conditions.<br />
siemens signs agreements to<br />
streng<strong>the</strong>n microbiology Portfolio<br />
siemens Healthcare Diagnostics has<br />
signed a strategic partnership with<br />
Copan and a co-marketing agreement<br />
with Bruker Corporation in an ef<strong>for</strong>t to<br />
streng<strong>the</strong>n <strong>the</strong> analytical workflow and<br />
molecular identification functionality of<br />
its microbiology portfolio. The new agreements<br />
grant laboratories access to enhanced<br />
analytical workflow efficiency and<br />
advanced mass spectrometric identification,<br />
designed to support <strong>the</strong>ir microbiology<br />
testing needs.<br />
neoGenomics laboratories<br />
inks distribution deal with<br />
signal Genetics<br />
Laboratories has signed<br />
neoGenomics a deal to distribute Signal Genetics’s<br />
new gene expression profile test <strong>for</strong> multiple<br />
myeloma to pathologists and hospital-based<br />
hematologists and oncologists<br />
nationwide. Under <strong>the</strong> terms of <strong>the</strong> deal,<br />
Signal Genetics’s Myeloma Prognostic Risk<br />
Signature test (MyPRS) will be per<strong>for</strong>med<br />
at its CLIA-certified laboratory in Little<br />
Rock, Ark. The MyPRS test analyzes a defined<br />
number of relevant genes to determine<br />
<strong>the</strong> gene expression profile associated<br />
with a patient’s condition, giving physicians<br />
a predictive view of <strong>the</strong> patient’s progress<br />
and enabling personalized treatment decisions.<br />
NeoGenomics has also obtained<br />
<strong>the</strong> right of first negotiation to market any<br />
genomic and transcriptomic-based diagnostic<br />
test developed and/or launched by<br />
Signal Genetics in <strong>the</strong> future.<br />
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CliniCal laboratory news July 2011 45
hba1c alone not a reliable<br />
diagnostic Tool in obese<br />
adolescents<br />
new research by Yale University investigators<br />
indicates that a hemoglobin<br />
A1c (HbA1c) level of 6.5% underestimates<br />
<strong>the</strong> prevalence of prediabetes and diabetes<br />
in obese adolescents (Diabetes Care<br />
2011;34:1306–11). The results suggest that<br />
HbA1c alone is a poor diagnostic tool in<br />
this population, according to <strong>the</strong> authors.<br />
The researchers investigated <strong>the</strong> utility<br />
of HbA1c in obese adolescents because<br />
clinical guidelines recently endorsed HbA1c<br />
to diagnose diabetes and identify patients at<br />
risk <strong>for</strong> developing diabetes did not include<br />
studies involving adolescent populations.<br />
Studies evaluated to make those recommendations<br />
all involved adults, and little is<br />
known about <strong>the</strong> use of HbA1c in children<br />
and adolescents.<br />
The study involved 1,156 obese adolescents<br />
with a mean age of 13.3 years who<br />
were not taking medications that might affect<br />
glucose metabolism and who were not<br />
already known to have type 2 diabetes. All<br />
subjects had baseline oral glucose tolerance<br />
tests (OGTT) and HbA1c testing, and a<br />
subgroup of 218 subjects had repeated testing<br />
after a mean of 1.68 years.<br />
At baseline, 77% of subjects had normal<br />
glucose tolerance with HbA1c levels<br />
6.5%.<br />
However, 27% of subjects considered to<br />
have normal glucose tolerance based on<br />
HbA1c results were classified as being prediabetic<br />
based on OGTT. Among subjects<br />
diagNostiC<br />
46 CliniCal laboratory news July 2011<br />
p r o f i L e s<br />
p r o f i L e s<br />
placed in <strong>the</strong> at-risk group by HbA1c results,<br />
53% were considered to have normal<br />
glucose tolerance and 47% prediabetes or<br />
diabetes based on OGTT. Finally, 12.5% of<br />
subjects considered to have diabetes based<br />
on HbA1c results were designated as having<br />
normal glucose tolerance and 24% to<br />
have prediabetes by OGTT.<br />
Based on <strong>the</strong>se findings, <strong>the</strong> researchers<br />
called <strong>for</strong> fur<strong>the</strong>r investigation about <strong>the</strong><br />
role of HbA1c levels in diagnosing prediabetes<br />
and diabetes in adolescents and children.<br />
ovarian cancer screening does not<br />
reduce cancer-related mortality<br />
findings from <strong>the</strong> landmark Prostate,<br />
Lung, Colorectal and Ovarian (PLCO)<br />
Cancer Screening Trial indicate that <strong>for</strong><br />
women in a general population, annual<br />
screening with CA-125 biomarker testing<br />
and transvaginal ultrasound compared<br />
with usual care did not reduce ovarian cancer<br />
mortality (JAMA 2011;305:2295–2303).<br />
At <strong>the</strong> same time, this testing algorithm increased<br />
invasive medical procedures and<br />
associated harms.<br />
The ovarian cancer arm of PLCO involved<br />
78,216 women age 55–74 years at<br />
enrollment, 39,105 of whom underwent<br />
annual screening, and 39,111 of whom<br />
received usual care. Those in <strong>the</strong> intervention<br />
arm had CA-125 testing <strong>for</strong> 6 years and<br />
transvaginal ultrasound <strong>for</strong> 4 years, with a<br />
median follow-up of 12.4 years.<br />
The investigators found 212 and 176<br />
ovarian cancer cases in <strong>the</strong> intervention<br />
arm and usual care arms, respectively.<br />
There were 118 ovarian cancer-related<br />
StatisPro software makes method<br />
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■ Faithful implementation of <strong>the</strong> latest CLSI<br />
method evaluation guidelines<br />
StatisPro promotes best laboratory practices<br />
by following CLSI documents referenced<br />
by The Joint Commission and College of<br />
<strong>American</strong> Pathologists (CAP).<br />
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deaths in <strong>the</strong> intervention arm, compared<br />
with 100 in <strong>the</strong> usual care group or<br />
3.1/10,000 person-years versus 2.6/10,000<br />
person-years, respectively. The difference<br />
in survival between <strong>the</strong> intervention and<br />
usual care groups was not statistically significant,<br />
and no stage shift was observed,<br />
meaning that over <strong>the</strong> course of <strong>the</strong> study<br />
among intervention arm subjects in comparison<br />
to normal care subjects, <strong>the</strong>re was<br />
not a decline in cases first diagnosed in later<br />
stages of <strong>the</strong> disease.<br />
In addition, <strong>the</strong>re was an approximate<br />
5% false-positive rate <strong>for</strong> each screening<br />
round. Although this rate is comparable to<br />
or even lower than false-positive rates <strong>for</strong><br />
mammography screening, <strong>the</strong> researchers<br />
noted that “<strong>the</strong> nature of <strong>the</strong> diagnostic<br />
follow-up, which often included invasive<br />
procedures, was a serious concern.” They<br />
concluded that “even an optimized program<br />
of annual screening may be insufficient<br />
to detect cancers early enough to reduce<br />
mortality.”<br />
different centrifugation<br />
conditions Produce similar results<br />
an analysis of centrifugation conditions<br />
on clinical chemistry and immunology<br />
results found that three different conditions<br />
delivered identical test results (BMC<br />
<strong>Clinical</strong> Pathology 2011 doi:10.1186/1472–<br />
6890-11-6). The results are significant because<br />
<strong>the</strong>y suggest that laboratories may<br />
be able to reduce centrifugation times<br />
and consequently lower <strong>the</strong>ir overall turnaround<br />
times.<br />
The researchers conducted <strong>the</strong> investigation<br />
because although pre-analytical<br />
centrifugation occurs countless times every<br />
day in laboratories around <strong>the</strong> world,<br />
<strong>the</strong> influence of <strong>the</strong> process on lab results<br />
has only rarely and recently been investigated.<br />
World Health Organization (WHO)<br />
guidelines <strong>issue</strong>d in 2002 recommended a<br />
centrifugation time of at least 10 minutes<br />
The Gold Standard in implementing CLSI standards<br />
Verify precision, linearity, bias<br />
Per<strong>for</strong>m method comparisons<br />
Verify or transfer reference intervals<br />
Establish LOD/LOQ<br />
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<strong>for</strong> serum and 15 minutes <strong>for</strong> plasma with<br />
a relative centrifugation <strong>for</strong>ce (RCF) of<br />
2,000–3,000g.<br />
The study involved 74 tests on six samples<br />
from 44 consecutively admitted patients,<br />
<strong>for</strong> a total of 444 results per patient.<br />
The investigators compared three centrifugation<br />
conditions, including 15 minutes at<br />
2,180g RCF, 10 minutes at 2,180g RCF, and<br />
7 minutes at 1,870 g RCF, all at 15°C and<br />
with a deceleration time of 32 seconds. Two<br />
different plasma separators were used <strong>for</strong><br />
each centrifugation condition.<br />
The researchers found “identical” results<br />
in all parameters. They conducted Deming<br />
fit, alpha error, and beta error analyses,<br />
and found that only 3.6% of statistical test<br />
results fell outside <strong>the</strong> p
news from <strong>the</strong> fda<br />
Pcr-based hepatitis c Test Gets nod<br />
abbott has received FDA approval to<br />
market its RealTime PCR (polymerase<br />
chain reaction) test <strong>for</strong> measuring hepatitis<br />
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Test to monitor lung cancer cleared<br />
fujirebio Diagnostics has received FDA<br />
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<strong>the</strong> course of disease and treatment of lung<br />
cancer patients.<br />
Q fever mdx Test cleared<br />
fDA has cleared <strong>the</strong> first nucleic acid<br />
amplification test <strong>for</strong> <strong>the</strong> diagnosis of<br />
Q fever infection in military personnel<br />
serving overseas. The test was developed<br />
by Idaho Technology and funded by <strong>the</strong><br />
SamPLE PrEParaTiON daTabaSE<br />
Chemical Biological Medical System Joint<br />
Project Management Office within <strong>the</strong> U.S.<br />
Department of Defense. The test identifies<br />
and detects <strong>the</strong> bacteria that cause Q fever,<br />
Coxiella burnetii, within 4 hours.<br />
clearance <strong>for</strong> biomérieux’s<br />
mrsa Test<br />
bioMérieux has received FDA clearance<br />
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The NucliSens EasyQ MRSA test detects<br />
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siemens Gets clearance <strong>for</strong><br />
heroin use screening Test<br />
siemens Healthcare Diagnostics has<br />
received FDA clearance <strong>for</strong> its newest<br />
drugs-of-abuse test, <strong>the</strong> Emit® II Plus<br />
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Emit II Plus 6-Acetylmorphine assay differentiates<br />
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cross-reactivity to structurally related substances<br />
and is part of Siemens’ Syva® Emit<br />
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index To adverTisers<br />
Please visit <strong>the</strong>se websites to learn more about <strong>the</strong> products in this <strong>issue</strong>.<br />
arK diagnostics ............................................. 6<br />
www.ark-tdm.com<br />
bio-rad laboratories ........................................ 7<br />
www.bio-rad.com/diagnostics<br />
biotage ...................................................... 47<br />
www.biotage.com<br />
clinical and laboratory standards institute .................. 46<br />
www.statispro.org<br />
diazyme ..................................................... 48<br />
www.diazyme.com<br />
Greiner bio-one vacuette na ................................ 13<br />
http://us.gbo.com<br />
ids ltd. ...................................................... 9<br />
www.idsplc.com/en-us/home/<br />
Kamiya biomedical company .......................... 6, 12, 45<br />
www.kamiyabiomedical.com<br />
Kronus ....................................................... 29<br />
www.kronus.com<br />
medicon Gmbh .............................................. 44<br />
www.optima-packaging-group.de<br />
nova biomedical ............................................. 25<br />
www.statstrip.com<br />
Phadia us inc. ............................................... 19<br />
www.phadia.us<br />
randox laboratories ........................................ 5<br />
www.randox.com<br />
roche diagnostics corp. ..................................... 2<br />
www.roche.com<br />
sarstedt inc. ................................................. 27<br />
www.sarstedt.com<br />
sysmex corporation ......................................... 23<br />
www.sysmex.com/us<br />
Wako diagnostics ......................................... 8, 33<br />
www.wakodiagnostics.com<br />
oem<br />
biosPacific ................................................... 39<br />
www.biospacific.com<br />
cis-bio us ................................................... 35<br />
www.cisbio.com<br />
fluid metering inc. ........................................... 37<br />
www.fmipump.com<br />
utak laboratories ........................................... 31<br />
www.utaK.com<br />
Wheaton industries .......................................... 41<br />
www.wheaton.com<br />
CliniCal laboratory news July 2011 47
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