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news brief 

Forecast: 

robust Market For 

Molecular Diagnostics 

A new report released by Kalorama 

Information predicts the world market 

for molecular diagnostic tests will grow 

11% annually, reaching $8.085 billion 

U.S. dollars in 2015. Back in 1995, the 

market for these nascent tests was estimated 

to comprise just 2% of the total 

in vitro diagnostic (IVD) market or 

$360 billion. Today that number stands 

at $4.765 billion. 

The report, “The World Market for 

Molecular Diagnostics,” highlights the 

primary growth drivers for molecular 

diagnostics, and describes challenges 

facing the IVD industry in the future. 

The authors call the track record for 

molecular diagnostic testing a testament 

to innovation. 

The report attributes the continued 

growth in the market to the introduction 

of numerous assays over the past 5 

years, as well as publication of the Human 

Genome Project and advances in 

functional genomics, bioinformatics, 

miniaturization, and microelectronics. 

At the same time, demand for testing 

snaPshoT 

2010 Molecular Diagnostics Market 

Siemens 

6% 

BD, 4% 

Qiagen/Digene 

5% 

has been fueled by an increase in 

cancer patients, proliferation of infectious 

diseases and growing interest in 

parental gene carrier analysis. 

Especially notable is the fact that 

many of these complex tests have 

been commercialized as proprietary 

lab-developed tests offered by reference 

labs and company-sponsored lab 

services. 

But major challenges obstruct use of 

molecular diagnostic assays, including 

getting stakeholders, payers, physicians, 

researchers, and regulators to 

work together to close the gap between 

research and clinical applicability. 

Physician education is also lacking, 

and reimbursement problems threaten 

further implementation of these tests. 

The report also provides a snapshot 

of today’s market share. While some 350 

companies are actively involved in molecular 

diagnostics, most hold tiny fractions 

of the market. The major players 

are Roche Diagnostics with an estimated 

15% market share, followed by Abbott 

and Gen-Probe with 8% each. 

The full report is available for 

purchase at www.kaloramainformation.com. 

nonprofit org. 

u.s. postage 

Paid 

greenfield, oH 

permit no. 436 

Qiagen IVDs, 6% 

Other 

48% 

Gen-Probe 

8% 

Source: Kalorama Information. 

Used with permission. 

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 

Roche 

Diagnostics 

15% 

Abbott 

8% 

Clinical 

Laboratory 

News 

A Decade of Lab Tests Online 

What Are Millions of Users Searching For? 

By Bill Malone 

This year hospitals and physicians begin marching into 

the age of electronic health records under a new paradigm 

of information sharing and patient access, chasing 

government financial incentives now coming into 

effect. However, it looks like patients are already one 

step ahead. An estimated 80% of Web users now search online for 

health information, or about 59% of all adults in the U.S. Already 

one in four Internet users have tracked some aspect of their health 

online and 16% report looking online for information about medical 

test results, according to a new report from the Pew Internet 

& American Life Project, “The Social Life of Health Information, 

2011.” 

When it comes to patient-oriented information about lab testing, 

Lab Tests Online, AACC’s public resource on clinical lab testing, 

has represented the lab community for 10 years, evolving to 

meet the needs of 2 million visitors a month (www.labtestsonline. 

org). The Pew report underscores just how important sites like Lab 

Tests Online can be at a time when patients increasingly receive 

direct electronic access to their lab results. With more online access to personal records like lab tests, health 

information sites will act as intermediaries that help patients cope with all this new data, said Susannah Fox, an 

associate director at the Pew Internet & American Life Project and author of the recent report. 

“There is a critical role for the Internet to fill in the gap of understanding that we all know exists between the 

moment that a health professional gives information to someone and how that person deals with that informa- 

See lab Tests online, continued on page 3 

Low-Risk Chest Pain Patients 

Can a Two-Hour Assessment Protocol 

Send Them Home Safely? 

By Genna Rollins 

emergency department overcrowding has confounded hospital administrators and clinicians for 

years, with no simple solution in sight. In fact, emergency visits increased at twice the rate of growth 

of the U.S. population between 1997 and 2007, and a recent Government Accountability Office report 

found that it took more than double the recommended time to see patients with immediate 

care needs. Given these strains on the healthcare system, the idea of being able to quickly assess and 

safely discharge even a modest segment of the emergency population is quite appealing. 

That’s why a provocative protocol put forth by a consortium of Pacific Rim researchers has generated discussion 

internationally. The protocol, which involves a 2-hour accelerated diagnostic protocol using a point-of-care 

(POC) biomarker panel, a risk score, and electrocardiography (ECG) to identify and safely discharge patients 

with symptoms suggestive of acute coronary syndrome (ACS), one day could lead to much shorter assessment 

times for a substantial and resource-intensive segment of the emergency population, low-risk chest pain patients 

(Lancet 2011;377:1077–84). This approach has piqued interest in both 

the cardiology and emergency medicine fields because each year, patients 

presenting with symptoms suggestive of ACS account for as 

many as 10% of hospital emergency cases and up to one-quarter of 

admissions. Most undergo hours-long assessments, although 75–85% 

turn out not to have ACS, according to lead investigator Martin Than, 

MBBS. 

“We have to take people who present with chest pain very seriously, 

because the consequences of getting it wrong are significant. 

Clinical Laboratory News 

The American Association 

for Clinical Chemistry, Inc. 

1850 K Street, NW, Suite 625 

Washington, DC 20006 

Concern about the possibility of sending someone home to harm is 

a key driver of clinician behavior, which is essentially to investigate 

See chest Pain Protocol, continued on page 6 

The auThoriTaTive 

source for The 

clinical laboraTorian 

july 2011 

volume 37, number 7 

www.aacc.org 

in This issue 

Lab 2011 

10 Thyroglobulin— 

Analytical Pitfalls 

14 

Patient Safety Focus 

Designing Processes 

for Patient Safety 

15 Overcoming 

Disruptive Behavior 

16 

17 

18 

Confronting Conflict 

in the Lab 

Ensuring a Safety Culture 

Expert Access— 

The Delta Check in Action 

2011 AACC Annual Meeting 

20 

22 

44 

47 

List of Exhibitors 

2011 New Products 

Review 

Regulatory, Industry, 

& Diagnostic Profiles 

News from the FDA

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Most Adults Check Online for Health Info 

lab Tests online, continued from page 1 

tion,” she said. “As healthcare providers rush 

to implement electronic health records and 

patients get greater access, this is going to be 

an important opportunity for better patient 

education and communication.” 

The New Health Information Seekers 

Even though health professionals remain 

the primary source of information when 

people need an accurate medical diagnosis 

or have other serious health concerns, Pew 

survey data from the past decade consistently 

show that people use online sources as a 

significant supplement to their interactions 

with healthcare professionals. Young college 

graduates with higher-than-average household 

income still search online the most, 

but significant numbers of other groups are 

emerging as active users as well (See Health 

Information Seekers Box, right). 

The Internet has fundamentally changed 

Americans’ relationships to information, 

Fox said. “One of the first changes that we 

saw really broadly was with the advent of 

high speed Internet access. We found that 

broadband users are more likely to turn to 

the Internet first when they have a question, 

whether it’s a question about the weather, 

what movie is playing, or a new medical 

diagnosis—an important qualitative difference,” 

she said. “There is something about 

the always-on access that makes people 

think of the Internet as a first-line information 

resource far more often than before.” 

Mobile access, along with social media, 

is the third wave in this trend, especially 

among younger demographic groups. In 

user comments demonstrate a 

broad spectrum of site visitors 

Lab Tests Online invites user comments. 

Here is a sampling. 

My wife and I are RN’s. Your site is, excuse the pun, “bloody good.” 

Thanks so much. 

This site is excellent. It explained my laboratory blood work results. 

Once you understand what the medical terms—like B-U-N, W-B-C, 

and NEUTROPHILS—are, mentally it clears up worries as to what 

the test results mean and eliminates unnecessary stress. Thank 

you so much for this site. 

Excellent site! Information is clear, concise and helps you research 

further if needed. I work in healthcare as a phlebotomist and I 

have found this site to help me and my patients more than anything 

else. Thank you. 

My doctor ordered many tests and I did not know what they were 

all for. Reading your descriptions made me feel secure and gave 

me a clue about what the doctor was looking for or trying to rule 

out. Now he seems pretty smart! 

Thank you for providing such comprehensive and excellent information 

in lay terms. It has helped me better understand my—and 

my elderly parents’—health conditions as well as all our lab tests 

results. 

This site has been a wonderful help to me in understanding my 

health status and my doctor’s thinking. It has helped me to be a 

more responsible and active partner in the maintenance of my 

health and treatment. Thanks. 

It is Friday afternoon and I received test results that I did not 

understand. I won’t see my doctor until Monday afternoon. The information 

on this site helped ease my anxieties about the results. 

It was easy to understand and relevant to my needs. 

I am very glad to have stumbled upon this site. It is so much more 

easily searchable for clinical lab tests than others. It is also more 

helpful getting to the succinct facts about your test, your results 

versus normal, and potential things that can affect the results. I 

appreciate the public service mission of this site. 

Quite a useful reference when I need a reminder about the differences 

and uses of specific lab tests. Thanks. 

I am a lab director and I LOVE this site. 

This site was VERY helpful. My husband has cancer and the doctor 

gave us a print-out of all his blood tests and a graph showing low, 

high and where his results were. I found the tests on your site and 

was able to understand what the doctor was testing for. 

Fox’s report, about a third of those age 

18–29 reported using a cell phone to look 

for health information, compared to 15% 

overall. “With mobile, now it’s the alwayson, 

always-with-you access, and that is 

changing us as Internet users,” Fox said. 

“We have been able to see in many sectors, 

including health, what we call the mobile 

difference. That means that people are 

not only more likely to look for information 

online if they have a mobile device, 

but they are more likely to share it.” In the 

Pew survey, 34% of Internet users said they 

had read someone else’s commentary or 

experience about health or medical issues 

See lab Tests online, continued on page 4 

health information seekers 

according to the pew internet & american life project’s recent report, 

“the social life of Health information, 2011,” 80% of internet users have 

gone online for health information. that is almost 60% of all adults in 

the u.s. 

looking online for health information: demographics 

Percentage 

who go online 

Percentage who 

look online for 

health information 

all adults in the u.s. 74 59 

Gender 

Male 73 53 

female 75 65 

race 

white 77 63 

african american 66 47 

latino 62 45 

age 

18–29 92 71 

30–49 79 66 

50–64 71 58 

65+ 40 29 

education 

some high school 38 24 

High school graduate 64 45 

some college 84 70 

College graduate 91 

household income 

81 

< $30,000 57 41 

$30,000–49,999 80 66 

$50,000–74,999 86 71 

$75,000+ 95 83 

overall, 16% of all internet users in the telephone survey say they’ve 

searched online for information about medical test results. while much 

of the demographics are similar to those searching for other types of 

health information, certain groups are more likely than others to search 

for test information. 

27% currently caring for a loved one with a health problem 

23% experienced a medical crisis within the past year, 

self or someone close 

22% experienced a personal health change in the past year 

21% have at least one chronic condition, 

such as high blood pressure or diabetes 

0 10% 20% 30% 

7% less than high 

school education 

11% high school education 

16% some college 

23% college graduates 

0 10% 20% 30% 

Source: Fox, Susannah. The Social Life of Health Information, 2011. Pew Internet and 

American Life Project, May 12, 2011, www.pewinternet.org/Reports/2011/Social-Life-of- 

Health-Info.aspx. 

CliniCal laboratory news July 2011 3


Laboratory 

News 

ediTorial sTaff 

editor—Nancy Sasavage, PhD 

senior editor—Genna Rollins 

associate editor—Bill Malone 

editorial assistant—Laura Kachin 

contributor—Carole Spencer, MT, PhD, FACB 

board of ediTors 

chair—Elia Mears, MS, MT (ASCP), SM 

Independent Laboratory Consultant 

Houma, La. 

members—Nikola Baumann, PhD 

Mayo Clinic, Rochester, Minn. 

Andrew Don-Wauchope, MD 

McMaster University Medical Center 

Hamilton, Ontario 

Steven Goss, PhD 

Siemens Healthcare Diagnostics, Newark, Del. 

Mary Kimberly, PhD 

CDC, Atlanta, Ga. 

Amy Saenger, PhD 

Mayo Clinic, Rochester, Minn. 

aacc officers 

President— Ann Gronowski, PhD 

President-elect— W. Greg Miller, PhD, 

DABCC, FACB 

Treasurer—D. Robert Dufour, MD 

secretary—Elizabeth L. Frank, PhD, DABCC, 

FACB 

Past-President—Catherine Hammett-Stabler, 

PhD 

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Nancy Sasavage, PhD, Editor 

Clinical Laboratory News 



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Contents copyright © 2011 by the American 

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Clinical laboratory news (issn 0161-9640) 

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4 CliniCal laboratory news July 2011 

Few Sites Meet Quality Criteria 

lab Tests online, continued from page 3 

on an online news group, website, or blog, 

and 18% seek out others online who share 

similar health concerns. 

Compared to other types of websites, 

social networking sites like Facebook and 

MySpace are still not yet widely used for 

health information searches. But with 

the notably higher use of mobile searches 

among the young, health information seeking 

on social networking sites is likely to increase. 

“Now that they have these devices 

with them that are like Swiss army knives 

of participation, what’s really neat is that in 

healthcare, we are tapping into an ancient 

instinct to share,” Fox commented. “People 

have always gotten together to talk about 

their health, to talk with loved ones about 

what they’re facing, or to share with people 

who might have a similar diagnosis. But 

now we can widen our networks and speed 

up those conversations, and that’s the difference 

that the Internet makes.” 

Another notable trend revealed in the 

Pew survey is that many people searching 

for health information are caregivers. Almost 

half of Internet users seeking health 

information report that their most recent 

search was for another person, and overall, 

70% of all adults in the U.S. caring for 

a loved one have looked online for health 

information. This is a significant number, 

considering that one in four adults provides 

unpaid care for a friend or family 

member. 

Specifically for medical test information, 

the Pew survey found that those who 

are caregivers, have recently experienced a 

medical crisis, or have a chronic condition, 

are more likely to search for lab-related information 

online (See Health Information 

Seekers Box, p. 3). 

The Quality Conundrum 

Even a decade ago, when most Internet 

users still depended on slow, dial-up connections 

and blogging and social networks 

were in their infancy, people already had 

strong doubts about the quality of health 

information that was finding its way onto 

the Web. This is one of the reasons that 

AACC and other collaborating lab organizations 

felt so strongly about creating a 

site like Lab Tests Online. Pew found in a 

2006 survey that only one in four Internet 

users always look for the source and date 

of health information online. However, 

the vast majority of websites do not display 

such information, Fox noted. “I think you 

can forgive consumers for giving up searching 

for a needle in a haystack,” she said. “If 

they’re expected to look for the source and 

date of health information, then it’s up to 

the websites to display that.” 

The largest ever study on the quality of 

health information online comes from the 

U.S. Department of Health and Human 

Services’ Office of Disease Prevention and 

Health Promotion. The 2006 study selected 

a sample of 102 health-oriented websites 

out of 3,608 identified at the time and reviewed 

them for six criteria established 

by the agency as hallmarks of quality and 

completeness: information on the identity 

of the website sponsor; the purpose of the 

site; the source; the site’s privacy policy; 

how the site is evaluated; and how often 

content is updated. 

The results paint a bleak picture. Not 

one of the 102 sites in the sample, which 

did not include Lab Tests Online, met all six 

of the criteria. And though 90% complied 

with at least one, only 3% complied with 

more than three. More concerning, 10% 

complied with none. The report also noted 

that there was a lack of consistency in how 

or where websites disclosed information. 

While concerns about the quality of 

health information online seem to be 

justified, Fox suggested a more nuanced 

perspective. For instance, even the most 

highly respected sites that meet criteria like 

disclosing a source and date, such as those 

from the government, are not often the first 

choice of the average Internet user. In fact, 

only 6% of adults were even aware of the 

Hospital Compare Tool created by the Centers 

for Medicare and Medicaid Services. 

There are several reasons for this, according 

to Fox. “For better or for worse, 

Internet users by and large are not going to 

sites like PubMed [the National Library of 

Medicine’s online citation database of biomedical 

literature],” she said. “People have 

questions that are about all the aspects of 

health that surround the diagnosis—like 

what to expect and how they fit into the 

universe of people going through the same 

illness. So it’s not a rejection of going to see 

the doctor: it’s actually that they continue 

to embrace that, but they want to augment 

what they’re learning from health professionals.” 

The Lab’s Voice in Cyberspace 

Since it’s inception in 2001, AACC and 

other stakeholders intended Lab Tests Online 

to fill the apparent information gap 

online for the public and garner visibility 

and esteem for the practice of lab medicine 

at the same time. The site’s rapid climb in 

lab Tests online 

celebrates 10 years 

in the past 5 years alone, the number of visitors to lab tests online has 

tripled, a testament to the quality of the site and the high demand for 

online health information. the u.s. site was launched in July 2001, and 

had had 1 million visitors by the next year. Visitors to the site soared to 

25 million in 2006, and hit another milestone, 100 million, in february, 

2011. 

this month, the site launches an app for mobile devices in the itunes 

store and android market. once downloaded, the app will not require 

an internet connection to be used. an internet connection will only be 

needed to obtain content updates. 

Growth of the u.s. site 

annual Traffic 

increasing Global visibility 

lab tests online is now available in 17 countries and 14 languages. 

the first non-u.s. site was launched in the uK in 2004. Just 3 years later, 

spain, germany, poland, australia, Hungary, and italy launched localized 

sites. Currently, greece, Czech republic, China, france, portugal, brazil, 

and turkey also have sites up and running, with two more—Korea and 

romania—expected to launch soon. 

Total non-u.s. site visitors

visitors and the hundreds of thousands 

of questions answered by lab volunteers 

demonstrate the real public demand for 

high-quality lab-related information. The 

site has also maintained its original commitment 

to rigorous peer review, usability, 

and a non-commercial viewpoint, even as 

17 other countries have developed localized 

versions in 14 languages (See Lab Tests 

Online Box, left). Lab Tests Online has 

earned numerous awards for content and 

reliability, as well as praise from national 

news media such as the Washington Post, 

U.S. News and World Report, and Prevention 

magazine. 

Because of the hurried and fragmented 

care they often receive, patients need a site 

like Lab Tests Online, emphasized Elisa 

Passiment, CLS, executive vice president of 

American Society for Clinical Laboratory 

Science (ASCLS) and a member of the site’s 

editorial board. “There are so many benefits 

to us as laboratorians offering this kind of 

information to our patient-customers,” 

she said. “It is always interesting to me how 

concerned people are about their health 

status, yet how little they seem to understand 

about that status, even though they’re 

under a physician’s care. It’s not because 

the physician is not doing his or her job, 

it’s because there is just not enough time to 

explain everything in the depth that people 

need. So Lab Tests Online is the next round 

of education and understanding for people, 

and we as laboratorians can tell them much 

more about what lab tests mean than anyone 

else that they encounter.” 

The Internet has not only changed our 

relationship to information, but also the 

patient-physician relationship, noted Murilo 

Melo, MD, PhD, editor of the Brazilian Lab 

Tests Online site that was launched in 2010. 

“Patients are taking more control of their 

health and it is now customary to perform 

an Internet search before and after a medical 

visit. Physicians are still trying to adapt to 

this new reality,” he said. “What is disturbing 

to most physicians is that since patients 

often get most of their information on sites 

that have poor quality content, they must 

spend extra time educating them. Lab Tests 

Online-Brazil aims to help both patients and 

physicians by providing reliable content that 

empowers patients while directing them to 

the most important aspects of each lab test.” 

Melo is associate professor of molecular 

medicine at Santa Casa Medical School in 

São Paulo and vice-scientific director of the 

Brazilian Society for Clinical Pathology and 

Laboratory Medicine (SBPC/ML). 

The need for a trustworthy source of lab 

test information can also be seen in how 

Lab Tests Online has evolved over the past 

decade, Passiment commented. “When we 

first started out, we thought that it was going 

to be pretty basic information, written 

only for the consumer, just to give people 

an appreciation of what laboratory testing 

was all about,” she said. “We have now realized 

that there are many kinds of patients 

and caregivers that are using the site. So we 

are way past just the routine tests. We always 

keep in mind that we’re helping a broad 

spectrum of caregivers and healthcare professionals, 

so we’re incredibly careful that 

everything is totally clear and accurate.” 

The balancing act between technically 

complete content and the clarity patients 

need takes the most time and effort, said 

another long-time editorial board member, 

Patrick St. Louis, PhD, laboratory director 

at Clearstone Central Laboratorie in Mississauga, 

Ontario. “In terms of content, it 

comes back to our target audience,” he said. 

“It’s a mixture of ordinary patients and professionals 

as well as people like ourselves. So 

we need something understandable to the 

guy next door who may be a laborer, an engineer, 

or a lawyer, or then someone who is 

a physician or a lab professional. The content 

must be sufficiently technical but also 

readable.” 

Now that Lab Tests Online has developed 

so many international sites, with 

more on the way, its staff and editors face 

new challenges that highlight the variety 

of ways lab testing is utilized around the 

world. “Initially, we looked at this primarily 

as an effort to translate the site, but in fact 

what we’re discovering is that international 

sites must be adapted in other ways,” said 

D. Robert Dufour, MD, executive editor of 

Lab Tests Online. “Once you develop content, 

it can’t just be left static. You have to 

constantly review it and bring it up-to-date, 

whether it’s new guidelines, new evidence, 

or new ways of using the test. We spend in 

the U.S. about 80 percent of our time, not 

creating new content, but reviewing the existing 

content. So this we see as the challenge 

for our international colleagues, where they 

generally do not have as large an editorial 

team.” Dufour is emeritus professor of pathology 

at George Washington University 

Medical Center, and a consultant in pathology 

and hepatology at the Veterans Affairs 

Medical Center in Washington, D.C. 

As the site continues to expand and refine 

content to keep up with new methods, 

guidelines, and patient needs, there will be 

opportunities for more volunteers to con- 

H-FABP - A Global Biomarker of 

Myocardial Ischemia across the 

full ACS spectrum 

Heart-type fatty acid binding protein (H-FABP) is a sensitive & specific 

biomarker of Myocardial Ischemia 

• Early rise acute cardiac biomarker following the onset of ischemic episode 

• Shows prognostic value across ACS spectrum (unstable angina, NSTEMI & 

STEMI patients1 ) 

• Significantly additive diagnostic & prognostic value to Troponin, even in the 

era of highly sensitive assays1,2,3 1, 2 

• Predicts long-term mortality & reinfarction in Troponin negative patients 

1.Viswanathan K, Kilcullen N, Morrell C, Thistlethwaite SJ, Sivananthan MU, Hassan TB, Barth JH. Hall AS. 

‘Heart-type fatty-acid binding-protein (H-FABP) predicts long-term mortality and re-infarction in consecutive 

patients with suspected acute coronary syndrome who are troponin negative.’ 

J. Am.Coll. Cardiol. 2010;55(23): 2590-8 

2. McCann CJ, Glover BM, Menown IB, Moore MJ, McEneny J, Owens CG, Smith B, Sharpe PC, Young IS, Adgey JA. 

‘Novel biomarkers in early diagnosis of acute myocardial infarction compared with cardiac troponin’ 

T. Eur. Heart J. 2008;29(23):2843-50. 

3. Kilcullen N, Viswanathan K, Das R, Morrell C, Farrin A, Barth JH, Hall AS. EMMACE-2 Investigators. 

‘Heart-type fatty acid-binding protein predicts long-term mortality after acute coronary syndrome and identifies 

high-risk patients across the range of troponin values.’ 

J. Am. Coll. Cardiol. 2007;50(21):2061-7. 

tribute, Dufour emphasized. Lab experts 

are needed to answer the questions that 

visitors to the site submit, a responsibility 

that ASCLS until recently has managed, but 

now includes AACC members as well. “It’s 

important to note that this is a huge effort. 

We have hundreds of people all over the 

world who are participating in this, both in 

developing and adapting content, answering 

the questions, and this is something 

that could not have happened without 

the efforts of all of these volunteers, many 

of whom have devoted years and years to 

working on this project,” Dufour said. “It 

also could not have happened without the 

support of the professional societies who 

recruit those volunteers, or without the 

support of the companies who give financial 

support, or AACC that continues to 

produce the site.” CLN 

Visit Randox in Atlanta, Booth 1301 for more 

information on our new automated assay for 

H-FABP, enabling rapid assessment on a wide range 

of immunoturbidimetric analysers and attend the 

Randox sponsored workshop; 

‘H-FABP in the evaluation of chest pain patients’ 

Dr Tanja Zeller, University of Mainz, Germany 

Tuesday July 26th. 6.00pm - 7.30pm 

Hyatt Regency, Atlanta 

Randox Laboratories US Limited 

515 Industrial Boulevard, Bardane Industrial Park, 

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CLN JUN11.indd 1 10/06/2011 14:54 


More Data Needed for Protocol Change 

chest Pain Protocol, continued from page 1 

chest pain patients to get the risk as low 

as possible,” Than explained. “Given that 

only 20 to 25 percent have acute myocardial 

infarction, that’s a lot of people being 

investigated. That, paired with the fact that 

hospitals have an immense problem with 

overcrowding, is one of the challenges of 

the healthcare system for the next decade, 

if not longer.” He is director of emergency 

medicine research at Christchurch Hospital 

in Christchurch, New Zealand. 

The Details of ASPECT 

Than and his colleagues at 14 emergency 

departments in nine countries in the Asia- 

Pacific region launched the Asia-Pacific 

Evaluation of Chest Pain Trial (ASPECT) 

to assess whether a pre-defined protocol 

could identify patients presenting to 

the emergency department with chest 

pain who would be at low risk of harm if 

they were discharged early. The protocol’s 

POC panel consisted of cardiac troponin I 

(cTn), creatine kinase MB (CK-MB), and 

myoglobin. Researchers combined biomarker 

results with the Thrombolysis in 

Myocardial Infarction (TIMI) risk score 

and electrocardiograph (ECG) to establish 

patient risk. 

ASPECT involved 3,582 consecutive 

adult patients who reported at least 5 minutes 

of chest pain suggestive of ACS. Patients 

received normal care, and attending physicians 

had access to central lab cTn results 

but were blinded to TIMI score and results 

from the POC panel, samples for which were 

drawn at admission and after 2-hours. The 

researchers combined the ASPECT protocol 

with medical records and telephone followup 

to determine the study’s primary endpoint, 

major adverse cardiac events within 

30 days after initial presentation. 

The POC panel results were considered 

positive when cTn was ≥0.05µg/L, CK MB 

was ≥4.3 µg/L or had an increase ≥1.6 µg/L 

within 2 hours, or myoglobin was ≥108 

µg/L or increased ≥25% within 2 hours. 

Patients were deemed low risk if they had a 

TIMI score of 0, no new ischemic changes 

on ECG, and normal results from the POC 

biomarker panel, at both admission and 

2-hours. The researchers found that 9.8% 

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of patients were at low risk and would have 

been eligible for early discharge. Following 

release from the hospital, a major cardiac 

event occurred in three (0.9%) low-risk 

patients, giving the protocol a sensitivity 

of 99.3%, specificity of 11%, and negative 

predictive value of 99.1%. 

Practice Changes Desired but Difficult 

Observers agreed that a system which 

would lead to as many as 10% of suspected 

ACS patients being discharged quickly 

and safely would have considerable merit. 

“There’s overcrowding in emergency departments 

in the U.S. and world wide, so 

even a nine or 10 percent discharge rate 

that wasn’t there before would make a big 

difference in work flow,” said Alan Wu, 

PhD, director of clinical chemistry and 

toxicology at the University of California- 

San Francisco. 

However, Wu was not alone in cautioning 

that as intriguing as the ASPECT results 

may be, a 2-hour assessment protocol is 

unlikely to be adopted in practice anytime 

soon. “It’s not a simple thing to change protocols. 

No single study would be the driving 

force to elicit such a change, but this will 

contribute to it,” he said. “Every institution 

would have to look at its own resources, 

needs, and turnaround times, and determine 

if it would be comfortable with a twohour 

rule-out. A lot of hospitals in the U.S. 

will not be ready to adopt this today, especially 

where the medicolegal aspects are so 

different and we don’t have the luxury of 

missing an MI.” 

Hospitals worldwide adhere to guidelines 

on the universal definition of MI issued 

in 2007 by the European Society of 

Cardiology, American College of Cardiology 

Foundation, American Heart Association, 

and World Heart Foundation. These 

guidelines call for a cTn measurement 

exceeding the 99th percentile of a normal 

reference population with a coefficient of 

variation ≤10% as an element of diagnosing 

MI, along with at least one additional criterion: 

symptoms or ECG changes indicative 

of ischemia; development of pathological Q 

waves in the ECG; or imaging evidence of 

new loss of viable myocardium or regional 

wall motion abnormality. The guidelines 

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also note the importance of rising and/or 

falling cTn values in discerning MI. Measurements 

should be taken at the time of 

first assessment and 6–9 hours later to detect 

any pattern. CK-MB by mass assay is an 

acceptable alternative when cTn values are 

not available, according to the guidelines. 

Cutting Down Assessment Times 

Healthcare systems have adopted various 

strategies to adhere to the universal definition 

of MI while not keeping chest pain patients 

in emergency department beds per se. 

For example, many have chest pain or observation 

units where they transfer suspected 

ACS patients for continued work up. 

However, depending on how the units are 

staffed and where they’re located, they may 

still demand attention and resources from 

the emergency department for 6–8 hours, 

and in some instances, up to 12 hours. 

Widespread adoption of the universal 

definition of MI and use of strategies like 

observation units reflect how far the fields 

of emergency medicine and cardiology 

have come over the past three decades in 

discerning MI from other sources of chest 

pain and moving towards shorter, more efficient 

assessment processes, according to 

Ezra Amsterdam, MD, associate chief of 

cardiovascular medicine at UC Davis Medical 

Center in Sacramento, Calif. “There’s 

been an evolution over the past 30 years. 

K-ASSAY ® 

We’ve gone from admitting every adult 

patient with chest pain, and putting them 

through these rule-out procedures with serial 

cardiac enzymes and ECGs over several 

days until you finally decided it was OK 

to discharge the patient. That’s accelerated 

into protocols where a majority of patients 

are not admitted, and it’s done safely,” he 

explained. “So the ASPECT protocol is not 

new per se. What’s new is their systematic 

approach to a two-hour assessment.” 

An Objective Method 

Such a systematic approach to identifying 

patients at low risk has been a missing ingredient 

in emergency medicine, according 

to W. Frank Peacock, MD, vice chair 

of emergency medicine at the Cleveland 

Clinic Foundation. “Chest pain is the emergency 

department’s first or second most 

common presentation. The likelihood of 

an emergency doctor having a bad outcome 

in patients with chest pain occurs in 

the first five years of practice, so that tells 

you it’s really subjective,” he said. “What 

Martin did was to validate an accelerated 

diagnostic protocol with completely objective 

measures. There’s nothing subjective 

about it, and that’s the advantage.” Peacock 

helped analyze data and write the ASPECT 

report, but no Cleveland Clinic patients 

were part of the study. 

See chest Pain Protocol, continued on page 8 

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hs-cTn Assays: A Game Changer? 

chest Pain Protocol, continued from page 6 

Than added that demonstrating the 

value of a structured risk assessment was 

a key objective of ASPECT. “A lot of literature 

shows that assessments of pre-test 

probabilities are done extremely poorly 

by clinicians,” he observed. “In general, we 

tend to overestimate the risks because we’re 

concerned about the possibility of getting 

it wrong. We also tend not to agree with 

each other in assessing risk. That’s why we 

thought some sort of structured risk assessment 

was important.” 

The Role of High-Sensitivity cTn Assays 

While experts agreed that the ASPECT protocol 

broke ground by laying out objective 

assessment criteria for ACS, several observers 

questioned the relevancy of a POC panel 

employing CK-MB, myoglobin, and a 

contemporary—but not high-sensitivity— 

cTnI assay, given that both high-sensitivity 

cTnT and cTnI assays with limits of detection 

10 times lower than conventional assays 

are about to hit the U.S. market (CLN 

Feb 2011). In addition, the cTnI assay used 

in ASPECT, the Alere Triage CardioProfiler, 

is not approved for use in the U.S. 

“There’s no question that ASPECT adds 

to the argument that myoglobin and CK- 


MB are no longer necessary,” said Wu. “In 

my opinion that conclusion was reached 

years ago, even before the advent of the 

current generation of troponin assays, but 

this reaffirms even more so that labs should 

move away from the former two.” 

Than explained that in his own clinical 

practice, he has not used myoglobin or 

CK-MB for at least a decade, but that the 

ASPECT investigators specifically wanted 

to evaluate a POC biomarker panel. “We 

were interested in the point-of-care concept, 

but we also felt that by using a slightly 

inferior troponin assay, one can say you 

can do this with any troponin assay you 

like—either point-of-care or central lab— 

because even a less-sensitive assay works 

just fine,” he explained. “The main message 

of the paper was that the combination 

of this risk/pre-test probability tool, with 

ECG and troponin or combinations of 

biomarkers can be used for safe, early discharge 

of some patients. 

Whether the new high-sensitivity cTn 

assays will hinder or harm efforts to speed 

emergency department assessment of chest 

pain patients remains unclear. Some observers, 

like Michael Kontos, MD, argued 

that the assays will help quickly identify the 

lowest of low-risk patients but contribute 

Guidelines for 

managing acute coronary 

syndrome Patients 

Key professional organizations have published guidelines on 

the use and interpretation of cardiac biomarkers in aCs. 

acc/aha 2007 Guidelines for the management of Patients 

with unstable angina/non-sT-elevation myocardial 

infarction, J am Coll Cardiol 2007;50:e1–157. 

clinical Policy: critical issues in the evaluation and 

management of adult Patients with non-sT-segment 

elevation acute coronary syndromes, 

annals of emergency Medicine 2006;48:270–301. 

nacb laboratory medicine Practice Guidelines for 

utilization of biochemical markers in acute coronary 

syndromes and heart failure, Clin Chem 2007;53:2086–2096. 

Testing of low-risk Patients Presenting to the emergency 

department with chest Pain: a scientific statement from 

the american heart association, Circulation 2010;122;1756–76. 

universal definition of myocardial infarction, 

J am Coll Cardiol 2007;50:2173–2195. 

in other ways to slower emergency department 

processing times. “You’ll have the really 

low-risk cohort where the troponin will 

be so sensitive that once you do the test and 

clinical assessment, you’ll essentially be able 

to exclude an acute coronary syndrome,” 

he said. “But then you’ll have a more intermediate 

risk group that will have detectible 

troponin levels—not necessarily with serial 

changes or highly suggestive of acute 

coronary syndrome—but they clearly need 

some sort of further evaluation.” Kontos is 

associate professor of internal medicine at 

Virginia Commonwealth University’s Pauley 

Heart Center in Richmond. 

While high-sensitivity cTnI and cTnT 

assays might pose challenges in understanding 

just what very low levels of circulating 

cTn mean, Than suggested that 

when used with other components of the 

ASPECT protocol, the tests still would 

bring clarity and speed to emergency department-based 

chest pain evaluations. 

“There are far more patients who need to 

be ruled-out than ruled-in, and the way 

I see the high-sensitivity troponin assays 

working is that you’ll be able to set a slightly 

higher pretest probability to your risk score 

because the assay will be more sensitive,” he 

said. “This will enable you to incorporate 

a broader group of patients in a potential 

early rule-out group. There needs to be a 

greater awareness of rule-out and the benefits 

it can have on the healthcare system.” 

A Glimpse of the Future 

Most experts agreed that the high-sensitivity 

cTnT and cTnI assays eventually would 

lead the way towards shorter chest pain assessment 

protocols. “Conceptually, this a 

great model to consider, and it’s a good first 

step in thinking about whether assays will 

be able to differentiate chest pain patients 

this early in the process. The high-sensitivity 

troponin assays will narrow the window,” 

predicted Fred Apple, PhD, professor 

of laboratory medicine and pathology 

at the University of Minnesota School of 

Medicine, and medical director of clinical 

laboratories at Hennepin County Medical 

Center in Minneapolis. 

However, Apple cautioned that considerably 

more research would be needed 

before 2-hour chest pain work-ups become 

standard-of-care. “We’ll need a wealth of 

more information before we start changing 

practice patterns. The high-sensitivity troponin 

assays will need to be looked at for 

baseline and two hours for every person 

who walks in the emergency department 

with suspected acute coronary syndrome, 

and determine whether an absolute value 

or delta change percent is best for patient 

triage. This is not ready for primetime just 

yet.” 

Research efforts that might transform 

chest pain assessment standards already are 

underway. For example, a team of British 

researchers recently reported that patients 

with suspected MI who were tested at presentation 

and after 90 minutes with a POC 

biomarker panel consisting of cTn, CK- 

MB, and myoglobin had shorter median, 

but not mean, lengths of stay in the emergency 

department and were discharged 

more frequently without inpatient admission 

(Heart 2011;97:190–196). 

In addition, Amsterdam and his colleagues 

at UC Davis are preparing to 

publish results from an accelerated assessment 

process for very low risk patients. 

“We’ve been investigating a protocol 

that involves a clinical assessment, 

biomarkers, and ECG with a two-to-four 

hour period,” he said. “It’s a minority 

of our population, but we’ve found 

the patients we’re doing this with to be 

very safe with no events at 30-days.” 

Than also has initiated a randomized 

controlled trial using the ASPECT protocol 

but with a central lab-based cTn assay. 

“I wouldn’t expect anyone to change their 

practice necessarily based on the ASPECT 

study, but I might expect them to take more 

interest when results from this second study 

become available,” he said. “We expect that 

we’ll demonstrate that you can send 15 

to 20 percent of patients home early and 

safely, with an economic benefit in terms of 

bed days saved.” CLN

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Thyroglobulin 

Solutions to Analytical Pitfalls in 

Differentiated Thyroid Cancer Monitoring 

By CaRole spenCeR, Mt, phD, FaCB 

differentiated thyroid cancer (dtC), the most common endocrine malignancy, is a highly curable 

disease with 5-year survival rates in excess of 95%. treatment for dtC typically involves thyroidectomy 

followed by, in certain cases, radioactive iodine ablation, as well as thyroid-stimulating 

hormone (tsH) suppression. serum thyroglobulin (tg) measurement is a cornerstone of postoperative 

monitoring and long-term surveillance of dtC patients. 

a radioimmunoassay (ria) for measuring serum tg measurement was first developed in the 1970s, but since 

then, several different immunometric assay (iMa) methods have been introduced and gained in popularity over 

time. in concert with these changes, clinicians now use serum tg primarily for dtC monitoring, whereas in the past 

they also relied on it to investigate non-neoplastic pathologies such as hyperthyroidism, thyroiditis, and goiter. 

Despite the fact that serum Tg measurement 

is a well-accepted test that has been in 

common use for 4 decades, it still is subject 

to a variety of analytical challenges, including 

insensitivity, wide between-method 

variability, and Tg autoantibody (TgAb) 

interference, among others. This review 

will contrast the clinical utility of Tg testing 

in DTC with the technical limitations related 

to the test and provide laboratorians 

with suggested remedies for these analytical 

challenges. 

The Role of Tg in DTC 

Following thyroidectomy, DTC patients 

need life-long surveillance to monitor for 

tumor recurrence. An estimated 10% experience 

recurrence during the first decade after 

surgery, and an additional 5% have late 

recurrences that may develop decades after 

the initial treatment. Serum Tg measurement 

and periodic cervical ultrasound are 

the main tools for long-term surveillance 

(1). 

The reason serum Tg measurement 

has such value as a tumor-marker for 

DTC is that Tg protein is synthesized 

uniquely in thyroid follicular cells. Even 

though the pre-operative Tg concentra- 

tion is not informative as a biomarker for 

DTC, preoperative values can provide a 

gauge of the tumor’s efficiency for Tg secretion 

and validate the utility of postoperative 

Tg monitoring. Postoperative Tg 

measurement is likely to be most sensitive 

when small tumors are associated with a 

high preoperative Tg concentration, as 

compared to large tumors being associated 

with low preoperative serum Tg values. 

The latter suggests the tumor is not 

capable of secreting appreciable amounts 

of Tg. 

Staging and risk-stratification are critical 

for determining both the frequency of 

Tg monitoring and the need for additional 

imaging modalities (CT, MRI, PET) or 

radioiodine treatment. Most Tg testing is 

done with serum. However, in recent years 

it has become common to measure Tg in 

saline wash-outs of the needles used to biopsy 

suspicious lymph nodes (2). 

Because Tg is thyroid- but not tumorspecific, 

patient-related factors influence 

the interpretation of serum Tg concentrations. 

Examples include the mass of remaining 

thyroid tissue after thyroidectomy, 

recent injury, and the TSH status of the 

patient. 

Tg Assay Limitations 

The technical pitfalls of Tg measurement 

include between-method variability, inappropriate 

reference ranges, suboptimal 

functional sensitivity (FS), hook effects, and 

human anti-mouse antibody (HAMA), as 

well as TgAb interferences. Table 1 summarizes 

the characteristics of nine current Tg 

assays, which include several different IMA 

methods, an enzyme-linked immunosorbent 

assay, and an RIA. First-generation 

IMA methods have two particularly serious 

limitations, including insensitivity and 

TgAb interference. Second-generation IMA 

methods have a ten-fold higher FS that facilitates 

monitoring of basal Tg levels and 

may eliminate the need for expensive and 

inconvenient recombinant human TSH 

(rhTSH) stimulation. However, secondgeneration 

IMAs are still prone to TgAb 

and HAMA interferences. 

Method and Biological Variability 

Although a Tg reference preparation 

(CRM-457) has been available for at least 

15 years, method-related variabilities in Tg 

measurement persist (3). Some disparities 

reflect TgAb interference, which will be 

discussed more fully later in this review. 

However, even in the absence of interfering 

TgAb, the between-method coefficient of 

variation is about 30%, more than twice the 

within-person biologic variability (3–5). 

Complicating matters, serum Tg obtained 

from DTC patients is very heterogeneous, 

and different from the glandular Tg preparations 

used as standards. Abnormalities 

in the post-translational maturation of Tg 

protein involving glycosylation, phosphorylation, 

sulfation, and iodination cause this 

heterogeneity. Indeed, some tumors secrete 

immature, poorly iodinated, and/or conformationally 

abnormal Tg molecules that 

are detected with different specificities by 

different assays depending on the monoclonal 

antibody reagents they use (3). 

Between-method variability—whether 

caused by TgAb interferences or patientrelated 

Tg heterogeneity compounded by 

differences in assay sensitivity and specificity—require 

serial Tg monitoring for 

each patient using the same method over 

time. This is a challenge because DTC patients 

need lifelong Tg monitoring and may 

move, change physicians, and/or insurance 

plans that result in a change in contract 

laboratory. When a change in Tg method is 

necessary, it is critical to re-baseline the patient’s 

Tg level to prevent disrupting patient

care. Unfortunately, most laboratories are 

not able to do this because archived unused 

specimens usually are not available. 

Setting the Reference Range 

Biochemical test results are typically reported 

relative to a reference range established 

from measurements made on individuals 

without conditions likely to affect 

the test. Any Tg assay reference range established 

using normal euthyroid subjects will 

be influenced by the rigor used to exclude 

individuals with thyroid pathologies such 

as goiter and thyroiditis. Regardless of these 

factors, Tg reference ranges established for 

normal euthyroid subjects have little relevance 

when interpreting serum Tg concentrations 

in thyroidectomized DTC patients. 

In these patients, it is better to interpret 

serum Tg levels relative to the degree of 

surgery (lobectomy versus near-total thyroidectomy), 

the TSH status of the patient, 

and the technical benchmarks of the assay 

used (Figure 1). 

Another factor in interpreting postoperative 

Tg values is that Tg is thyroid- but 

not tumor-specific, so the serum Tg concentration 

represents the contribution from 

normal and any residual tumor tissue. For 

example, the typical 1–2 g normal thyroid 

remnant left after thyroidectomy contributes 

1–2 µg/L Tg to the serum concentration 

in the absence of TSH stimulation. 

Additionally, some tumors are not efficient 

Tg secretors. In extreme cases, tumors may 

not secrete a detectable Tg concentration 

or may secrete abnormal Tg isoforms that 

are not detected by the monoclonal antibodies 

employed as IMA reagents. Lastly, 

there typically is a 10 to 20-fold difference 

between Tg measured in the absence versus 

the presence of TSH stimulation with either 

rhTSH or the high endogenous TSH associated 

with thyroid hormone withdrawal. 

The Benefits of Functional Sensitivity 

A realistic determination of Tg assay sensitivity 

is critical for the effective management 

of DTC patients following thyroidectomy, 

when very little Tg-producing tissue is left. 

Current guidelines recommend using FS as 

a means of determining Tg assay sensitivity 

(6). FS is a clinically relevant parameter 

based on low-end, between-run precision. 

The guidelines define it as the Tg concentra- 

figure 1 

factors that influence Tg reference intervals 

schematic diagram of how the tg reference range is influenced by the degree of surgery: lobectomy 

(center panel) or near-total thyroidectomy (right panel), tsH status (on abscissa), and assay functional 

sensitivity (first- versus second-generation). 

Adapted from reference 6. 

tion that can be measured with 20% coefficient 

of variation determined from multiple 

measurements of a human serum pool containing 

a low Tg level made across a clinically-relevant 

time-span (6–12 months) and 

employing at least two calibrator lots and 

two reagent lots. The guidelines committee 

developed this definition to realistically represent 

the sensitivity of the test used in clinical 

practice, and to replace descriptive terms 

like “ultrasensitive” and “supersensitive” 

that manufacturers favor for marketing. 

First- Versus Second-Generation FS 

RIA methodology is only capable of firstgeneration 

FS ranging from 0.5–1.0 µg/L 

(3). Laboratorians hoped that replacing 

RIA with IMA methodology would improve 

FS by an order of magnitude, as was 

the case in the 1980s for TSH. Unfortunately, 

most current Tg IMA methods still only 

have first-generation FS, with a detection 

limit only marginally below the lower reference 

limit for control subjects with intact 

thyroid glands (Figure 1 and Table 1). 

First-generation assays are too insensitive 

clinically to use for basal Tg monitoring 

without TSH stimulation. As a result, 

it is customary to measure serum Tg after 

rhTSH stimulation, a maneuver analogous 

to the use of thyrotropin-releasing hormone 

stimulation to overcome the insensitivity 

of the TSH assays used before the 

1990s (7). By consensus, a 72-hour rhTSHstimulated 

Tg above 2.0 µg/L is considered 

a risk factor for disease (7). In reality, this 

fixed rhTSH-Tg cutoff has a low positive 

predictive value for disease of about 50%. 

Furthermore, depending on the method 

used, a Tg value of 2.0 µg/L could be reported 

as being anywhere between 1.5 and 

3.2 µg/L using different methods (8). 

More recently, second-generation IMAs 

have become available with FS ranging 

table 1 

characteristics of current Tg assays 

from 0.05–0.1 µg/L (9). These more sensitive 

assays show that there is a strong 10fold 

difference between basal and rhTSHstimulated 

Tg values, thereby obviating 

the need for expensive and inconvenient 

rhTSH-stimulated Tg testing for most patients 

(Figure 3) (8). Second generation 

IMAs also facilitate the monitoring of basal 

Tg trends that improve positive and negative 

predictive values for assessing risk for 

disease, as compared with the rhTSH-Tg 

cutoff value of 2.0 µg/L (1,10,11). 

Notably, when TgAb is present, rhTSH 

stimulation offers no diagnostic benefit. This 

is because rhTSH-Tg responses are paradoxically 

blunted or absent in the presence 

of TgAb, possibly because of increased metabolic 

clearance of Tg-TgAb complexes (9). 

The Hook Effect 

A high-dose hook effect can occur when 

using IMA to measure exceedingly high Tg 

Assay # 1 2 3 4 5 6 7 8 9 

Assay Name Access Tg Tg-Plus TgIRMA Immulite 2000 Tg TgRIA Elecsys Tg Tg Wallac Delfia Tg 

Manufacturer 

Beckman Coulter, 

US 

BRAHMS 

diagnostica, 

Germany 

CISbio-Schering, 

Germany 

Siemens, US 

Genesis 

Diagnostics, UK 

University 

Southern 

California, US 

Roche, 

Germany 

Sanofi Pasteur, 

France 

Perkin-Elmer, 

Finland 

Assay Type 

non-competitive 

ICMA 

competitive 

IRMA 

competitive 

IRMA 

competitive 

ICMA 

non-competitive 

ELISA 

competitive 

RIA 

competitive 

IECMA 

competitive 

IRMA 

competitive 

IFMA 

Capture Antibody 4xMab pab (rabbit) 4xMab Mab pab (rabbit) pab (rabbit) Mab 4xMab Mab 

Tracer ap-Mab 125-iMab 125-iMab (sheep) ap-pab (rabbit) 125-itg Mab 125-iMab eu-Mab 

Sample Size µL 40 100 100 50 50 200 20 100 50 

1:1 CRM-457 

Standardization 

Functional 

yes 

no 

(factor of 2) 

yes yes no yes yes no no 

Sensitivity ng/mL 

(µg/L)*# 

Reference 

0.1 [5,1] 0.4* 0.7 0.9 na 0.5 1.0 na na 

Range ng/mL 

(µg/L)* 

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 

*expressed relative to 1:1 CrM-457 standardization; # defined by naCb guidelines (6); [ ] literature citation, no manufacturer data 


concentrations characteristic of patients 

with metastatic disease. These high Tg levels 

overwhelm the assay’s reagent binding 

capacities, which yields inappropriately low 

values. Although adoption of a two-step 

assay design has reduced this problem, a 

hook effect still can occur when measuring 

saline wash-outs of the needles used to biopsy 

metastatic lymph nodes. In such cases, 

Tg levels often exceed 10,000 µg/L. Because 

of these challenges, laboratories need to use 

linearity studies to check the high range for 

hooking and the potential for carry-over 

contamination of specimens. 

Countering Interferences 

Unfortunately, the Tg IMA methodology 

favored by most laboratories is more prone 

to interferences from both human antimouse 

antibody (HAMA) and TgAb than 

is Tg RIA methodology (3,12,13). HAMA 

interference usually results in a falsely high 

serum Tg that may prompt unnecessary 

imaging or radioiodine treatment for presumed 

disease. In contrast, TgAb interference 

causes falsely low or undetectable 

serum Tg that can have more serious consequences 

because it can mask the presence 

of disease. Whereas contemporary IMA 

methods routinely include blocker reagents 

to minimize HAMA interference to around 

0.5%, currently there are no effective measures 

to overcome TgAb interference encountered 

with Tg IMA methodology (8). 


HAMA in the specimen can interact 

with one of the monoclonal antibody reagents 

to create a false signal that simulates 

the presence of a high antigen (Tg) concentration 

(12). Rarely, HAMA can block the 

participation of the antibody reagents and 

cause a falsely low Tg value (13). Physicians 

should suspect HAMA when the serum Tg 

level appears inappropriate in the context 

of the patient’s clinical status, or fails to 

respond appropriately to changes in TSH. 

An example would be when Tg levels rise 

Apo AII 

> Apo CII 

> Apo CIII 

> Apo E 


Lipoprotein CLN 09-2010.indd 1 8/2/2010 1:11:04 PM 

so for the approximately 20% of DTC patients 

with detectable TgAb, the TgAb concentration 

can be used to monitor changes 

in tumor mass in preference to measuring 

Tg by IMA (14). Specifically, when the antigenic 

stimulus is removed by thyroidectomy, 

TgAb concentrations typically decline 

by approximately 50% within the first year 

and eventually disappear within a median 

of 3 years when patients are rendered disease-free 

(14). Conversely, TgAb concentrations 

rise in response to increased antigen 

concentrations following second surgeries, 

fine needle biopsy, or radioiodine therapy 

as well as with recurrence. Serial monitoring 

of TgAb concentrations can overcome 

the problem of unreliable Tg IMA measurements. 

TgAb Interference in IMA 

TgAb interference with Tg IMA measurements 

can cause Tg underestimation and 

the reporting of falsely low or undetectable 

values that can mask the presence of 

disease (3,6). Although RIA methods tend 

to be more resistant to TgAb interference, 

they too can produce falsely low or high 

values, depending on the characteristics 

of the assay reagents and the endogenous 

TgAb in the specimen. Therefore, reliable 

TgAb detection is critical for authenticating 

all Tg measurements. Although the 

propensity for interference is related to the 

TgAb concentration, high TgAb levels do 

not necessarily produce interference, and in 

some cases, low TgAb concentrations may 

profoundly interfere (3). 

Manufacturer-recommended assay cutoffs 

for detecting TgAb are typically set in 

the detectable range and relate to the diagnosis 

of autoimmune thyroid disease, not 

the detection of interfering TgAb. Inappropriate 

cutoffs, together with differences in 

assay sensitivity and specificity, cause some 

specimens to be classified as TgAb-positive 

by one method and TgAb-negative by another 

(5). Laboratorians should be aware 

that any TgAb detected above the analytic 

sensitivity limit has the potential to interfere 

with Tg measurement. Notably, these 

between-method disparities exist despite 

the methods’ purported standardization 

with the same international reference 

preparation (WHO 1st IRP 65/93). TgAb 

method-related disparities are difficult to 

eliminate because they reflect patient-related 

TgAb heterogeneity compounded by 

differences in assay sensitivity and specificity 

(5). 

Labs on the Front Lines 

Given the importance of life-long postoperative 

monitoring of DTC patients, labs 

have a vital responsibility to ensure that Tg 

measurements are as accurate as possible, 

and that they keep abreast of and address 

the analytical limitations of their Tg assay 

methods. Ongoing dialogue with endocrinologists 

and oncologists likewise is essential, 

so these clinicians can be well-informed 

of any method changes and confer readily 

with laboratorians about any discrepant 

results. CLN 

REFERENCES 

1. Cooper DS, Doherty GM, Haugen BR, 

Kloos RT, et al. Revised American Thyroid 

Association management guidelines for patients 

with thyroid nodules and differentiated 

thyroid cancer. Thyroid 2009;19:1–48. 

2. Snozek CL, Chambers EP, Reading CC, 

Sebo TJ, et al. Serum thyroglobulin, highresolution 

ultrasound, and lymph node 

thyroglobulin in diagnosis of differentiated 

thyroid carcinoma nodal metastases. J Clin 

Endocrinol Metab 2007;1992:4278–4281. 

3. Spencer CA, Bergoglio LM, Kazarosyan 

M, Fatemi S, et al. Clinical impact of thyroglobulin 

(Tg) and Tg autoantibody method 

differences on the management of patients 

with differentiated thyroid carcinomas. 

J Clin Endocrinol Metab 2005;1990:5566– 

5575. 

4. Jensen E, Petersen PH, Blaabjerg O, Hegedüs 

L. Biological variation of thyroid autoantibodies 

and thyroglobulin. Clin Chem 

Lab Med 2007;45:1058–1064. 

5. Spencer C, Petrovic I, Fatemi S. Current 

thyroglobulin autoantibody (TgAb) 

assays often fail to detect interfering TgAb 

that can result in the reporting of falsely 

low/undetectable serum Tg IMA values for 

patients with differentiated thyroid cancer. 

J Clin Endocrinol Metab 96:1283–91, 2011. 

6. Baloch Z, Carayon P, Conte-Devolx B, 

Demers LM, et al. Laboratory medicine 

practice guidelines: laboratory support for 

the diagnosis and monitoring of thyroid 

disease. Thyroid 2003;13:3–126. 

7. Mazzaferri EL, Robbins RJ, Spencer 

CA, Braverman LE, et al. A consensus report 

of the role of serum thyroglobulin as 

a monitoring method for low-risk patients 

with papillary thyroid carcinoma. J Clin 

Endocrinol Metab 2003;88:1433–1441. 

8. Spencer CA, Fatemi S, Singer P, Nicoloff 

JT, et al. Serum basal thyroglobulin measured 

by a 2nd generation assay correlates 

with the recombinant human tsh-stimulated 

thyroglobulin response in patients 

treated for differentiated thyroid cancer. 

Thyroid 2010;20:587–95. 

9. Spencer CA, Lopresti JS. Measuring 

thyroglobulin and thyroglobulin autoantibody 

in patients with differentiated thyroid 

cancer. Nat Clin Pract Endocrinol Metab 

2008;4:223–233. 

10. Tuttle RM, Leboeuf R. Follow up approaches 

in thyroid cancer: a risk adapted 

paradigm. Endocrinol Metab Clin North 

Am 2008;37:419–435. 

11. Giovanella L, Ceriani L, Suriano S, 

Ghelfo A, et al. Thyroglobulin measurement 

before rhTSH-aided (131)I ablation 

in detecting metastases from differentiated 

thyroid carcinoma. Clin Endocrinol (Oxf) 

2008;69:659–663. 

12. Preissner CM, O’Kane DJ, Singh RJ, 

Morris JC, et al. Phantoms in the assay 

tube: heterophile antibody interferences in 

serum thyroglobulin assays. J Clin Endocrinol 

Metab 2003; 88:3069–3074. 

13. Giovanella L, Ghelfo A. Undetectable 

serum thyroglobulin due to negative 

interference of heterophile antibodies in 

relapsing thyroid carcinoma. Clin Chem 

2007;53:1871–1872. 

14. Chiovato L, Latrofa F, Braverman LE, 

Pacini F, et al. Disappearance of humoral 

thyroid autoimmunity after complete removal 

of thyroid antigens. Ann Intern Med 

2003;139:346–351. 

Carole Spencer, MT, PhD, 

FACB, is a professor of 

medicine in the Department 

of Medicine at the University 

of Southern California. 

Email: cspencer@usc.edu

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What are the three most important 

elements of safe process design? 

The first is accounting for human factors. 

It is important to recognize that processes 

which rely on perfect human performance 

are incapable of high reliability. The second 

is standardization with limited discretionary 

variability (See “Examples,” below). 

Furthermore, reasons for appropriate variation 

should be captured and fed into the 

process design. The third is organizational 

culture. It is essential to have a positive reporting 

culture that exposes misses and 

near misses, because no process or procedure 

is failure-proof. Successful reporting 

cultures also identify key vulnerabilities. 

How do attitudes about safety in the 

laboratory affect process design? 

All processes that rely on vigilance and hard 

work are incapable of performing at a high 

level of reliability. If leadership and/or the 

front line worker do not understand the 

limitations of human performance, then 

high levels of reliability will not be possible. 

Also, a positive reporting culture is essential. 

Punishment for human error will impede 

process improvement and make the 

organization less safe and less reliable. 


PATIENT SAFETY FOCUS 

TAkING AIM AT REDuCING LAB ERRORS 

Designing Processes for Patient Safety 

The Key is Finding the Vulnerabilities and Fixing Them 

richard gitomer, Md, Mba, is chief quality 

officer for emory university Hospital 

Midtown and is a general internist by 

training. He has led numerous improvement 

projects related to access, efficiency, 

and innovation in the ambulatory setting 

and care of patients with chronic conditions. 

dr. gitomer is a recognized leader 

in process improvement through his collaborations 

with the institute for Healthcare 

improvement and the association of 

american Medical Colleges. 

this inteRview was ConDuCteD By CoRinne Fantz, phD. 

Clinical laboratories routinely monitor 

key processes. Is it not enough to know 

what errors occur and why they occur? 

Measurement alone does not result in improvement, 

but it is essential for identifying 

areas that need improvement and for monitoring 

improvement. There is a saying, “You 

don’t fatten the chicken by weighing it.” (See 

Figure, above). 

What opportunities and challenges do 

new technology bring to old processes? 

New technologies increase the capability of 

systems. For example, autoverification in 

the lab is faster and more reproducible than 

manual verification of results. But technology 

comes with some inherent risks. For 

those technologies that still require human 

intervention, the interface between humans 

and the technology remains the most 

vulnerable point. These vulnerabilities 

include incorrect human operation, due 

either to human error or errors that result 

from interacting with the new technology. 

All systems will fail at some point. With 

older technology, we know those failure 

modes and have designed processes to limit 

their impact. We do not have the same understanding 

of new technologies. So, until 

lab examples of standardization 

with limited variability 

® standardized procedures across all sites 

® standardized phlebotomy trays 

® one type of point- of-care glucometer in the health system 

® automation that limits the care providers choice of tube types 

® selection of a primary referral laboratory 

® use of templates for interpretative reports 

Prothrombin Time 

90% Turn around Time 

measurement is important to quality improvement, but by itself 

will not significantly improve quality. 

those vulnerabilities are fully understood, 

there will be safety and reliability shortfalls. 

Communication errors are a major 

contributor of preventable harm to 

patients. How can laboratory staff make 

change-of-shift hand-offs safer? 

Handoffs, like all processes, benefit from 

standardization, which increases the likelihood 

that key information will not be 

missed. Standardization also creates an 

opportunity to measure and improve the 

process. The standard process should include 

a template, or checklist (See “Checklist,” 

opposite), which highlights key information 

that should be exchanged. 

While every laboratory has a process 

for communicating critical values, 

could you elaborate on a few design 

elements that make one process safer 

than another? 

Communicating critical lab values is a process 

that is heavily reliant on humans with 

all their inherent vulnerabilities. In addition, 

creating a first-level communication 

process that includes all the eventualities 

and exceptions necessary to respond to 

every situation would result in a process 

so complex that the staff would be unable 

to execute it in a reliable fashion. Using a 

reliable approach to design as described by 

Roger Resar, performance levels in the high 

90 percentages can be achieved with a series 

of simple processes (See “Designing a 

Process,” opposite). 

The first step is to create a standardized 

process that effectively communicates at 

least 80% of the critical lab values on the 

first attempt. For all the failures, there is a 

second process that ensures appropriate 

communication. This second process usually 

is more resource-intensive, but it is able 

to handle the complexities not addressed in 

the first process. The benefit of this strategy 

is more effective use of resources. The risk is 

that failure of the initial standard process to 

function at an 80% level of reliability or better 

can overwhelm the redundant process. 

By design, the redundant process is more 

resource-intensive but has limited capacity. 

As a physician consumer of laboratory 

services, could you provide an example 

of a laboratory process that directly 

impacts the safety of your patients? 

I am a general internist who sees ambulatory 

patients. Reliable communication of critical 

lab results directly impacts the safety of 

my patients. By definition, these patients are 

mostly healthy, so the incidence of critical 

lab values is very low. Being an infrequent 

event makes the likelihood that any process 

designed to remedy the notification barriers 

has a greater likelihood of failing. Therefore, 

in my case, because receiving prompt and 

accurate notification of critical lab results is 

a rare event, it has a higher failure rate than 

a process that occurs regularly. 

Positive patient identification is essential 

to ensuring patient safety. Do errors 

in patient identification always mean 

the process is bad? 

Process failure is expected for all processes. 

Since identifying patients is a process carried 

out by humans, it will fail at some 

measurable rate. Based on the specifications 

of the clinical team, these error rates 

could be well below the needs of the users

checklist for structured 

handoffs at shift change 

o Current staffing __________________________________ 

_______________________________________________ 

o problem cases still pending ________________________ 

_______________________________________________ 

o instrument/method issues _________________________ 

_______________________________________________ 

o inventory/supplies _______________________________ 

_______________________________________________ 

o Computer issues _________________________________ 

_______________________________________________ 

o other issues _____________________________________ 

_______________________________________________ 

structured communication will reduce the likelihood of missing key elements. 

of the information and therefore considered 

a good process. But if the error rate is 

such that it significantly impedes the care 

of the patient, the process does not meet 

specifications and must be improved. 

Would you provide examples of a few 

good questions to ask when assessing 

how well a process is working? 

The first question to ask is: does the process 

meet the needs of the customer of the 

process? If it is not meeting the specifications 

of the customer, then there are three 

possibilities to assess. First, if there is no 

standard process to do the task, then the 

standard process must be developed. The 

second possibility is that there is a standard 

process, but it is not being followed. 

designing a Process for 

handling critical values 

step 1 

® standardize critical value list throughout the system 

® employ templates for communication and documentation 

step 2 

If critical value communication is unsuccessful after the first attempt: 

® pass calls from busy technologist to call center with access to many 

other data feeds that help overcome problems, such as a patient 

being registered to wrong the physician. 

® use a clear escalation plan, such as licensed practitioner, ordering 

provider, on-call physician, chief-of-service. 

® Call patient at home if an outpatient. 

By design, the redundant process is more resource-intensive but has limited 

capacity. 

In this case, it is important to understand 

why the process is not being followed and 

redesign the process if necessary. Monitors 

have to be put in place to detect the decline 

in performance and allow for the appropriate 

response. Last, if the standard process is 

being followed, and customer need is not 

met, then the standard process must be improved. 

How can laboratories design processes 

that integrate clinical teams and 

patients? 

Laboratories are frequently accused of optimizing 

their processes at the expense of 

the patient and the clinical team. Part of 

the problem is that we tend to measure and 

Disruptive Behavior 

How Labs Can Recognize and Overcome Its Negative Effects 

By MiChael astion, MD, phD 

In the laboratory, producing accurate and 

timely patient test results depends on teamwork, 

communication, and a collaborative 

work environment. However, laboratory 

staff who display intimidating and disruptive 

behaviors can quickly destabilize this 

cooperative environment and negatively 

impact patient safety. The Joint Commis- 

examples of disruptive behavior 

Disruptive Behavior Potential Effect on Patient Safety 

physical and verbal intimidation of 

a coworker, leading to decreased 

communication. 

refusal to communicate with 

coworkers regarding a problem 

testing situation in the lab, such as 

an intermittent problem with lab 

reagents or instruments. 

refusal to perform a laboratory 

task, such as processing a specimen 

or performing a laboratory test. 

refusal to make an outgoing 

phone call or answer an incoming 

phone call related to patient care. 

refusal to come to work despite 

being on-call. 

perpetrator makes a harmful lab 

error because victim, who suspects 

the error, refuses to speak up. 

problem goes unresolved, leading 

to erroneous results, delays, and 

patient harm. 

delay in testing that harms patient. 

Critical/urgent test results not 

communicated to care provider in 

timely fashion leading to patient 

harm. 

lab understaffing leads to delays in 

testing. 

verbal abuse negatively impacts patient safety. 

sion advises health care organizations to 

confront behavior problems in order to 

promote a culture of safety and efficient 

team performance (1). 

To overcome the negative effects of 

disruptive employee behaviors, labs first 

need to recognize inappropriate conduct. 

The Joint Commission developed 

assess each section independently rather 

than the entire care process that results in 

healing the patient. There may be times, 

however, when efficiency in the lab may 

need to be subordinate to the efficiency of 

the entire process of care. 

SuGGESTED READING 

Grimm E. Shift-to-Shift communication: 

what can labs learn from NASA and other 

highly reliable organizations? Clinical 

Laboratory News 2011 (January). 

Resar RK. Making non-catastrophic health 

care processes more reliable: learning to 

walk before running in creating highreliability 

organizations. Health Serv Res 

2006; 41:1677–1689. 

a list of workplace behaviors considered 

both disruptive and threatening to patient 

safety (1), including verbal abuse, physical 

threats, and intimidation, all of which can 

compromise laboratories’ ability to operate 

efficiently and effectively. Passive, uncooperative 

behavior, such as refusing to perform 

assigned tasks and not communicat- 


ing with coworkers, also negatively affect 

laboratories’ day-to-day operations. 

These disruptive behaviors are relatively 

common and have a significant impact on 

medical errors, according to oncology nurse 

and author, Theresa Brown. In a recent New 

York Times article, she explained how such 

inappropriate workplace conduct adversely 

affects patient safety (2). For example, out 

of fear, a nurse being bullied by a doctor 

would be less likely to question the doctor’s 

orders, despite suspecting an error. Brown 

contended that a healthcare worker being 

abused or intimated by a co-worker often 

avoids communicating with the perpetrator, 

thereby increasing the probability of a medical 

error. In addition, she observed that any 

type of disruptive behavior negatively affects 

patient safety because it distracts and upsets 

the people involved. When staff members 

are not able to concentrate on their assigned 

Confronting Conflict in the Lab 

How Lab Managers Can Curb the Effects of Disruptive Behavior 

By JaMes s. heRnanDez, MD, Ms 

We all probably have known one: the lab 

staff member whose disruptive behavior 

affects not only her own performance, but 

also keeps her co-workers from doing their 

best. 

Disruptive behavior can include verbal 

abuse, sexual harassment, yelling, profanity, 

vulgarity, and threatening words or actions, 

according to Gerald B. Hickson, MD, 

director of the Center for Patient and Professional 

Advocacy at Vanderbilt University 

Medical Center in Nashville, Tenn. He says 

disruptive behavior can negatively affect 

both lab operations and the level of respect 

and camaraderie among lab staff (1). 

Why is it so important to stop disruptive 

behavior? Because such conduct not 

only can lead to medical errors, but failure 

to curb it also can cause team members to 

adopt the disruptive person’s negative behavior, 

which in turn can reduce the level 

of trust and respect among co-workers, 

says Hickson. Inappropriate attitudes and 

actions also reduce productivity in the lab 

sources of 

conflict in the 

Workplace 

® goals and/or values conflict 

® ambiguous jurisdictions; 

role ambiguity 

® Competitively fueled reward 

systems yielding divisiveness 

® weak communication 

capabilities 

® perceived power imbalances 

® personality style differences 

® difficult behavior patterns 



tasks, they are more likely to commit noncognitive 

errors, meaning they make mistakes 

in a process that is normally automatic. 

Bad Behavior Leads to Lab Errors 

How serious is the disruptive behavior 

problem in healthcare systems today? 

Rosenstein and O’Daniel recently described 

the scope of the problem based on 

a survey involving more than 100 Veteran’s 

Health Administration Hospitals (3). In 

their study, approximately 4,500 physicians, 

nurses, and other healthcare workers 

responded to questions about the frequency 

of disruptive behavior and its effect on 

patient safety. More than three-quarters of 

participants reported witnessing disruptive 

behavior by physicians, while two-thirds 

had observed disruptive behavior by nurses. 

Furthermore, 71% said they believed 

there is a link between disruptive behaviors 

because staff are distracted by the perpetrator’s 

behavior. As this environment affects 

how efficiently a lab operates and has negative 

repercussions for all involved, lab managers 

should continuously monitor the offender’s 

disruptive behavior (2). 

Multiple sources of conflict in the workplace 

exist, according to management expert 

Louellen Essex, president of Louellen 

Essex & Associates (See “Sources of Conflict,” 

below). Essex has worked extensively 

with healthcare organizations, including 

laboratories. 

When Conflict is Good 

Not all conflict is dysfunctional, according 

to management guru Charles Dwyer, PhD, 

academic director for the Aresty Institute’s 

Leading and Managing People Program at 

the University of Pennsylvania Wharton 

School of Business. Although some people 

actually enjoy conflict, the lab director’s 

goal should be to manage, rather than 

squelch, conflict. (4). In fact, getting to the 

Tips for 

confronting 

disruptive 

behavior 

® prepare by writing down and 

practicing what you are going 

to say. 

® Make sure you are in the right 

mindset. 

® document and stay calm at all 

times. 

® be objective, not judgmental. 

® get help when you need it. 


and medical errors, and 18% indicated that 

they were aware of specific adverse events 

related to disruptive behavior. 

Policies and Procedures 

Given the possible dire consequences of 

medical errors, clinical laboratories should 

not hesitate to take action against employees 

who display disruptive behaviors (See 

Table, p. 15). The first step is to develop and 

enforce policies and procedures based on 

a professional code of conduct (4). These 

policies and procedures must include a protocol 

for reporting and managing disruptive 

behavior without fear of retaliation. A successful 

workplace environment depends on 

encouraging lab workers to confront these 

behaviors at all levels of the organization. 

Removing intimidators and disruptors from 

the laboratory not only boosts productivity 

but also helps ensure patient safety. 

disruptive behaviors, such as sexual harassment, create tension in the 

laboratory and threaten its safe operation. 

root of the conflict has several benefits for 

laboratories, including raising important 

and unresolved issues, resolving deep-seated 

problems, and helping the lab to evolve 

better group cohesion. Overall, such resolution 

can lead to productive changes in lab 

culture and output. 

Managing Conflict 

As unsettling as disruptive behavior can be, 

some individuals thrive on conflict. Today, 

it seems that conflict among co-workers is 

rooted in American culture, which often 

times rewards and encourages bad behavior. 

In fact, some co-workers may even instigate 

or encourage conflict. It takes courage, discipline, 

and practice for lab managers to learn 

how to de-escalate conflict in a healthy way. 

What should lab managers do when 

they observe conflict in the laboratory? 

Barbara Linney, vice president of career 

development at the American College of 

Physician Executives in Tampa, Fla., offers 

a few pointers (5). First, avoid teasing 

REFERENCES 

1. Behaviors that undermine a culture 

of safety. The Joint Commission Sentinel 

Event Alert. Issue 40. July 9, 2008. Available 

at: www.jointcommission.org/assets/1/18/ 

SEA_40.PDF, accessed May 26, 2011. 

2. Brown T. Physician, Heel Thyself. New 

York Times. May 7, 2011. Available at: 

www.nytimes.com/2011/05/08/, accessed 

May 26, 2011. 

3. Rosenstein AH, O’Daniel M. A survey 

of the impact of disruptive behaviors and 

communication defects on patient safety. 

Jt Comm J Qual Patient Saf 2008:34;464– 

71. 

4. Saxton RS, Hines T, Enriquez M. The 

negative impact of nurse-physician disruptive 

behavior on patient safety: A 

review of the literature. J Patient Saf 

2009;5:180–183. 

subordinates about the behavior. This only 

makes the lab manager an equal with the 

disruptive staff member. Second, avoid 

big shows of emotions, such as angry outbursts 

or crying. This merely escalates the 

problem. Linney also advises lab professionals 

to be mindful of their body language, 

since 55% of what we communicate 

is through body language, 38% is from the 

tone of our voice, and only 7% is due to 

the words we are speaking (6) (See “Tips,” 

left). 

Listening skills are essential to resolving 

conflict, according to Essex (3). Lab 

managers should listen and avoid being 

defensive when managing conflict. It helps 

to paraphrase the concerns of the other 

person or team members and to ask questions 

to clarify your understanding. If you 

are at fault, don’t be afraid to admit it, and 

if you’re not at fault, explain your point of 

view to clear up the misunderstanding. Finally, 

thank the person or team for bringing 

the matter to your attention.

Being Prepared 

Hickson urges laboratories to have an 

infrastructure in place for addressing 

unprofessional behavior (7). Key components 

of such a system include commitment 

from the organization’s leadership, 

supportive institutional policies, surveillance 

tools to capture complaints, a model 

to guide graduated interventions, and 

a process for reviewing allegations. It also 

may help to institute a training program 

for employees and develop resources to 

aid both those being disruptive and the 

The Slippery Slope of Errors 

Steps Labs Can Take to Avoid the Normalization of Deviance 

By KaRen appolD anD MiChael astion, MD, phD 

People who prefer to sleep in are often 

in the habit of rushing to get to work on 

time. In their rush, they may multitask to 

make up for the lack of time by combing 

their hair and using their mobile devices 

while driving. Obviously, these behaviors 

increase the chances of a serious accident. 

But late sleepers who have never been in a 

wreck gradually adopt these risky actions 

as part of their normal routine to compensate 

for sleeping in. They may even 

rationalize that more sleep improves their 

work performance. Despite that little voice 

telling them they should go to bed earlier 

instead of risking an accident, their unsafe 

morning routine has become acceptable to 

them. This is an example of the normalization 

of deviance. 

In the workplace, the normalization of 

deviance refers to the gradual acceptance 

of incidents or activities that were initially 

defined as deviant and unacceptable. Typically 

this occurs because organizations fail 

to deploy their mission, vision, and goals at 

the ground level with employees. Factors 

that favor the normalization of deviance 

include inadequate or incompetent supervision, 

time pressure, and resource scarcity. 

Lessons Learned from The Challenger 

Diane Vaughan, PhD, coined the term 

“normalization of deviance” in her book, 

“The Challenger Launch Decision: Risky 

Technology, Culture, and Deviance at 

NASA.” Vaughan is a professor in the Departments 

of International and Public Affairs 

and Sociology at Columbia University 

in New York. 

She concluded that the Space Shuttle 

Challenger disaster on January 28, 1986, 

which killed all seven crew members, occurred 

due to normalization of deviance, 

rather than misconduct. The events leading 

up to this tragic accident are a good exam- 

looking for The joint 

commission standards? 

the Joint Commission standards 

are available in print and electronic 

formats and can be purchased 

from Joint Commission resources. 

www.jointcommission.org/ 

standards_information/standards. 

aspx 

staff members affected by the behavior. 

Even with limited resources, by taking 

tips from other areas in healthcare to guide 

policies and procedures, laboratorians can 

confront and combat disruptive behavior. 

In the end, experts agree that the ultimate 

goal is to eliminate poor behavior in the 

clinical laboratory in order to ensure patient 

safety. 

REFERENCES 

1. Hickson G. Dealing with Disruptive Behavior 

among Health Care Professionals, 

ple of how normalization of deviance transpires. 

Organizations typically accept an 

initial deviant occurrence or two because 

it was unintended and little or no harm 

occurred. However, the initial incidents establish 

a precedent for accepting more and 

more deviance. 

In the case of the Challenger, when the 

first deviation from the expected performance 

happened involving O-ring pressure 

seals during flight, the problem was 

fixed. Overtime, more damage took place 

on subsequent flights. Eventually, more serious 

damage became acceptable to NASA. 

“Because failure did not occur and the 

causes of the problem continued to change, 

the pattern continued,” Vaughan explained. 

“It became normal to fly with the flawed 

design.” Eventually though, problems with 

the O-rings caused the Challenger disaster. 

The normalization of deviance often 

results from patterns of information that 

disguise the seriousness of the problem. 

For example, as NASA moved forward 

with launches, each decision seemed rational. 

“Technical deviations indicating something 

was wrong were interspersed with information 

that all was well,” Vaughan said. 

“What in retrospect seemed like strong 

warning signals of danger prior to the accident 

did not have the same meaning to 

insiders at the time events were occurring. 

Signals were mixed, weak, and routine.” 

Don’t Let Deviance Become the Norm 

In the laboratory, normalization of deviance 

tends to occur when employees become 

less sensitive to slight changes or 

take small shortcuts to improve work performance, 

according to Mark R. Chassin, 

MD, president of The Joint Commission 

in Oak Brook Terrace, Ill. The problem is 

that laboratory professionals don’t realize 

this behavior can cause unsafe situations 

that eventually can harm patients. Chassin 

believes they fall into this behavior when 

strong safety systems aren’t in place and the 

lab doesn’t have a clear commitment to follow 

safety protocols without fail. 

As a former commissioner of the New 

York State Department of Health, Chassin 

oversaw medical institutions’ quality programs 

and had the opportunity to observe 

normalization of deviance events in clinical 

laboratories. He recalled one instance in 

which patient and specimen identification 

CLMA audioconference, Gerald B. Hickson, 

MD, director, Center for Patient and 

Professional Advocacy, Vanderbilt University 

Medical Center. 

2. Felps W, et al. How, when, and why bad 

apples spoil the barrel: negative group 

members and dysfunctional groups. Res 

Organ Behav 2006;27:175–222. 

3. Louellen Essex and Associates, www. 

louellenessex.com/contact.html, accessed 

May 12, 2011. 

4. Dwyer C. The Shifting Source of Power 

and Influence, ACPE Publication, 1991 

labels were slightly cut off as they were dispensed 

from the label maker. As the problem 

worsened, some letters and numbers 

were omitted. “That small abnormality 

went unreported until it caused several patient 

misidentifications,” Chassin said. “If 

people would have been more attentive to 

that slight change earlier and called it to the 

attention of the right individuals sooner, 

then it wouldn’t have led to the misidentifications 

of patients and specimens.” 

Another example involved reporting of 

highly abnormal test results. A technologist 

had difficulty reaching clinicians when 

reporting critical lab values. He became 

satisfied with leaving the information with 

a clerk or non-clinician, even though the 

protocol called for leaving it with a nurse 

or doctor. Since nothing bad resulted from 

the technologist’s actions, this deviation 

continued. He eventually developed a habit 

of being less careful about adhering to the 

critical value policy, even though this increased 

the likelihood of an adverse event. 

Taking Action 

The Joint Commission has put in place 

several standards to help labs combat the 

normalization of deviance, and it has es- 

Patient safety focus editorial board 

chair 

michael astion, md, Phd 

seattle Children’s Hospital 

seattle, wash. 

members 

Peggy a. ahlin, bs, mT(ascP) 

Consultant 

salf lake City, utah 

5. Linney, Barbara, Conflict and Cooperation, 

American College of Physician Executive 

course, 2008. 

6. Malandro, LA, Barker, LL, Barker, DA 

Nonverbal Communication, 2nd Edition, 

New York, Random House (1989). 

7. Hickson GB, Pichert JW, Webb LE, 

Gabbe SG. A Complementary Approach 

to Promoting Professionalism: Identifying, 

Measuring and Addressing Unprofessional 

Behaviors. Acad Med. 2007; 82: 

1040–48. 

lab examples of the 

normalization of deviance 

® repeating quality control until it is in range 

® allowing relabeling of mislabeled specimens that are replaceable 

® allowing physicians to opt out of a critical value policy 

® accepting outdated specimens 

® labeling specimens in batch at the nurses’ station 

® accepting a culture of rudeness on the phone 

® ordering a CbC, tsH, and basic metabolic panel on all ambulatory 

patients 

tablished safety guidelines, which identify 

situations that increase the likelihood of 

patient harm. 

“If there is a problem, no one should feel 

intimidated about identifying it, regardless 

of how junior an individual may be,” Chassin 

said. “For example, a lab technologist 

asks a doctor, ‘Are you sure you want to order 

this test?’ The doctor replies, ‘That’s a 

really stupid question; it is on the ordering 

sheet.’ This kind of intimidating behavior, 

although subtle, is likely to result in the 

technologist not questioning the doctor 

again, even if he or she feels that the doctor 

is creating an unsafe situation for patients. 

Behavior that diminishes communication 

needs to be eliminated when building a 

safety culture. Otherwise, such behavior 

promotes the normalization of deviance.” 

SuGGESTED READING 

Vaughan, D. The Challenger Launch Decision: 

Risky Technology, Culture, and Deviance 

at NASA. Chicago, Ill: University of 

Chicago Press 1996. 

Karen Appold is an editorial consultant 

for the clinical laboratory industry. 

Email: karenappold@comcast.net 

corrine fantz, Phd 

emory university 

atlanta, ga. 

james s. hernandez, md, ms 

Mayo Clinic arizona 

scottsdale and phoenix, ariz. 

brian r. jackson, md, ms 

arup laboratories 

salt lake City, utah 


AACC’S ExPERT ACCESS 

The Delta Check in Action 

Causes and Consequences of Discrepant Laboratory Results 

Each month, AACC’s Expert Access Live Online Program features a 

different topic of importance to clinical laboratory practice. 

Visit AACC’s website, www.aacc.org/events/expert_access, for more 

information and an archive of past presentations. 

the following is an excerpt from the March 2011 

presentation by Joely straseski, phd, Mt(asCp), 

dabCC, medical director of endocrinology at arup 

laboratories in salt lake City, utah, and assistant 

professor of pathology at the university of utah 

school of Medicine. 

Should results identified by delta 

checking be flagged in the laboratory 

information system? What comments 

do you recommend? 

When first identified, delta check flags 

should indicate to the technologist that this 

result exceeds the established delta limits 

for this analyte and should be investigated, 

for example, by repeating the test or calling 

the clinician. This keeps the result from 

being autoverified. Beyond that, if an investigation 

reveals a sample integrity error, 

results should be cancelled with a comment 

describing the error, such as IV dilution 

or EDTA contamination. It may be 

helpful to document these types of issues, 

since trends in sampling errors may be revealed 

this way. If an investigation reveals 

a misidentified specimen, results should be 

cancelled with a comment describing that 

issue as well. If a provider is contacted during 

an investigation to confirm whether 

the discrepant results are expected, and the 

results fit with the clinical picture of the 

patient, you might add a comment stating 

that the clinician was contacted and results 

were discussed. Then, upon review of the 

patient chart, explanations for any large 

fluctuations would be documented. A simple 

comment such as “results repeated and 

verified” is commonly added to repeated 


specimens and may be used for delta check 

failures as well. If a result is “questionable,” 

an investigation should be conducted to 

clarify any issues before reporting. 

Do delta checks alert only medically 

significant discrepancies? 

While labs traditionally use delta checks to 

highlight medically important analyte concentrations, 

they can be tailored to whatever 

your needs may be. You can set up alert 

limits specifically for your patient population 

to highlight only likely misidentified 

specimens, typically a large delta value, or 

to highlight medically relevant changes in 

analyte concentrations. 

What is your perspective on delta checks 

as it relates to autoverification? 

Delta checks can certainly become part of 

autoverification procedures. They are simply 

another step in the autoverification process, 

one that provides yet another layer of 

confidence in your results before you send 

them to the provider. The delta limits, once 

determined, become additional rules that a 

sample must follow in order to be autoverified. 

For example, a rule involving sodium 

levels would state: Is the sodium for this 

patient less than 13 mEq/L different from 

their sodium results over the past 3 days? 

STAT Facts 

atlanta, Georgia 

Site of the 2011 AACC Annual Meeting 

and Clinical Lab Expo 

® population: 486,411 

® City-owned parks: 277 

® Churches: 1,500 

® fortune 500 Companies: 13 

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Sources: U.S. Census Bureau and Atlanta.net 

If so, and if all other autoverification rules 

have passed, autoverify the results. If not, 

flag for further review or repeated analysis. 

Do you recommend delta checks for 

enzymes or other disease markers like 

carcinoembryonic antigen (CEA)? 

Yes, several institutions follow tumor 

markers such as CEA. Delta checks for 

these markers can be helpful, but you may 

see fluctuations as patients go through 

treatment, remission, etc. Although these 

deltas will trigger a discrepant results investigation, 

tumor markers are a valuable 

analyte for delta checks. Alerting a clinician 

to a large change in a tumor marker value 

may be extremely important in the care 

and management of that particular patient. 

With the reliability of automated instruments, 

is it truly necessary to repeat a 

delta check? 

This will vary depending on the analyte 

and the methodologies and/or analyzers in 

question. Review of quality control values 

and a historical review of repeated values 

within your institution may give you a better 

indication of the analytical performance 

of each specific analyte. This will help you 

determine whether repeating delta check 

failures is necessary. 

I need help with percent difference 

for delta checks between hematology 

parameters. 

Hematology was one of the first areas to 

use delta checks, so there are several parameters 

that may be helpful for you. Most notably, 

the mean corpuscular value (MCV) 

is a commonly used delta check, as this is 

a value that should not change appreciably 

within an individual. An examples of delta 

check limits for MCV include: 4 fL over 2 

days; 5 fL over any period of time; and 10 fL 

over one day. Mean corpuscular hemoglobin 

concentration (MCHC) is another 

parameter with little biological variation 

in the short term. Calculating the Index 

of Individuality (II) for hematology tests 

will help you identify good delta check 

candidates. Beyond MCV and MCHC, 

other hematology tests with low II include 

hemoglobin, hematocrit, and platelet volume. 

However, care should be used when 

setting up delta checks on these measures, 

since they can vary depending on the patient 

population, for instance, in acute care 

patients with hemorrhage. 

How do you handle results that look 

as though the sample might have been 

contaminated with IV fluid? 

The biological ramifications of reporting 

results that have been diluted cannot be 

stressed strongly enough. Each institution 

may have their own procedure for dealing 

with these types of specimens, and each 

case is different. Although only one analyte 

may be in question, such as absurdly elevated 

glucose level possibly coming from the 

IV, the chance that other analytes have been 

similarly diluted is high. The safest course 

of action is to redraw the patient; however, 

that isn’t always possible. In the case where 

only one analyte appears to be diluted, but 

others were also ordered from the same 

specimen, do a careful investigation of the 

other analytes if there are recent results for 

comparison. If any analytes are reported, a 

comment regarding the possible dilution 

with IV fluid should accompany the results. 

Clinicians also should be alerted to interpret 

results with caution. Generally speaking, 

institutions’ policies vary as to the best 

way to handle these types of situations. 

How many days back should we include 

in our delta checks? 

Every analyte will be different. As you can 

imagine, a difference in sodium may be 

checked over a period of a few days, while 

an ABO blood type could be stable over a 

lifetime. An exaggerated example, but you 

see the difference. Shorter timeframes are 

usually more specific; as time goes on, differences 

in an analyte may be attributed to 

normal changes and not an acute process 

or sampling issue. 

Sampson and colleagues used time intervals 

to optimize error detection with 

delta checks (Sampson et al. Journal of 

Clinical Ligand Assay 30:44–54, 2007). 

They looked at 20 different analytes and 

found that the optimal delta time interval 

was generally between 2 and 5 days. Again, 

this is extremely analyte-specific, and this 

time interval is simply a general guide. Using 

rate changes is another way to evaluate 

delta values over time. However, the most 

common way to determine the number of 

days to use for delta check limits is experience 

over time. Adjusting time limits will 

allow you to balance lab staff investigations 

and error detection. CLN 

Disclaimer—The opinions and information 

are the sole responsibility of the presenter. 

AACC reviews the presentation for overall 

appropriateness, but this should not be construed 

as an endorsement by the association 

or its employees of the opinions and information 

offered here. 

visit aacc.org 

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registrations, 

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Chemtron biotech, inc. ................2961 

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Citizen systems america ...............4205 

Clearbridge bioloc. .....................217 

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Clinical and laboratory standards inst. 2139 

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Kingmed diagnostics ..................3511 

KMC systems, inc. .....................3351 

Knf neuberger inc. . . . . . . . . . . . . . . . . . . .4331 

Kpl, inc. ..............................3262 

Kronus, inc. ..........................1622 

lab Medica ...........................2356 

lab safety supply .....................4149 

labCorp - esoterix .....................3431 

labitec gmbH ........................2845 

labnovation technologies, inc. ........4215 

laboratory data systems, inc. .........3321 

labotix automation, inc. ..............2351 

labproducts, inc. . . . . . . . . . . . . . . . . . . . . . . . 147 

labs are Vital ..........................2431 

labtest ...............................3560 

lampire biological laboratories, inc. ...2212 

lasX industries, inc. ...................4316 

lathrop engineering inc. ..............2908 

lead Care .............................1920 

lee Company, the .....................2954 

life technologies .......................919 

lifesign llC ...........................3149 

linear Chemicals, s.l. .................2046 

liposcience ...........................2651 

lps industries, llC .....................3068 

lre Medical, an esterline Company ....3143 

lumigen, inc. ..........................917 

luminex Corporation ..................1645 

lw scientific . . . . . . . . . . . . . . . . . . . . . . . . . .4309 

M&d, inc. .............................3565 

Magellan biosciences .................1921 

Magnabiosciences ....................1650 

MagneMotion ........................3605 

Magnisense ............................222 

Maine biotechnology services .........2467 

Maine standards Co. llC. ...............907 

Man & Machine, inc. ...................4210 

Market diagnostics international ........13 

Martel instruments ltd. ................347 

Matest systemtechnik gmbH .........3762 

Mayo Medical laboratories .............410 

McKesson . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1014 

Medialab, inc. ........................4207 

Medica 2011/ Messe duesseldorf ......2244 

Medica Corporation ...................1851 

Medicago ab .........................2869 

Medical automation systems ..........1223 

Medical device Consultants, inc. .......2757 

Medical device safety service gmbH ...2815 

Medical electronic systems, llC ........103 

Medical laboratory evaluation(Mle) ....316 

Medicon gmbH .......................1953 

Medix biochemica ....................3264 

Medtest dX, inc. . . . . . . . . . . . . . . . . . . . . . .2918 

MedtoX laboratories .................1507 

Medtronic inc. .........................323 

Meizhou Cornely Hi-tech Co. ltd. ......4311 

Meridian bioscience, inc. ..............3615 

Meridian life science, inc. .............2948 

Merion Matters/advance news Magazine 450 

Metertech inc. ........................3060 

MgM instruments, inc. ................2772 

Michigan diagnostics, llC .............3516 

MiCobioMed ...........................113 

Microbix biosystems inc. ..............3554 

microfluidic Chipshop gmbH ..........3165 

MiCrolit .............................3748 

Microliter analytical supplies, inc. ......243 

Micropoint bioscience, inc. .............216 

Microscan systems, inc. ................239 

Microvisk technologies ................3271 

Midland bioproducts Corp . . . . . . . . . . . . .2117 

Mindray ..............................3531 

Minifab (aust) pty ltd. .................446 

Minigrip ...............................206 

Minitubes .............................3911 

Mlo-Medical laboratory observer .....4107 

Mo bio laboratories, inc. ..............2766 

Moduline systems, inc. ................4402 

Monobind inc. ........................3550 

Moss, inc. .............................3749 

Motoman inc. .........................3517 

Mp biomedicals .......................3171 

mspeC group .........................4442 

Mt promedt Consulting gmbH . . . . . . . .3070 

Multisorb technologies ................3435 

mut-ag ...............................2451 

nanjing liming bio-products Co. ltd ....117 

nanjing perlove Medical 

equipment Co. ltd ..................4343 

nano-ditech Corporation ...............125 

nanoq ................................3423 

nanosphere, inc. ......................2208 

nantong egens biotechnology Co., ltd. 3668 

national academy of Clinical 

biochemistry .......................2131 

national registry of Certified Chemists 2234 

neogen Corporation ..................1552 

netlims, llC ............................139 

neuroscience, inc. .....................205 

new england biolabs, inc. .............1308 

new england small tube ..............2656 

newscen Cost bio-pharmaceutical 

Co., ltd. ............................3465 

next Control systems .................3850 

nextslide imaging, llC ................4438 

niCHirei biosCienCes, inC. ...........3760 

nikon instruments inc. ................3654 

noeMalife ...........................4008 

nof america Corporation .............3360 

norgren/Kloehn .......................2902 

nor-lake scientific . . . . . . . . . . . . . . . . . . . . . 307 

nova biomedical ......................2923 

novatec immundiagnostica gmbH ....2566 

nuaire inc. ...........................2109 

oak ridge products ....................662 

oapi—Medical device division . .......4004 

omega diagnostics group plC ........3343 

omni print, inc. .......................4048 

operon ..............................1943 

opti Medical . . . . . . . . . . . . . . . . . . . . . . . . .4223 

orasure technologies, inc. ............3539 

orasure technologies, inc. ............2216 

orchard software Corp ................3623 

orphee s.a. ...........................2853 

ortho Clinical diagnostics .............1003 

owen Mumford .......................3417 

oYC americas, inc. ....................1449 

oyster bay pump works, inc. ...........4323 

pacific die Cut industries/pdCi Medical ..335 

pall life sciences ......................3168 

panagene, inc. .......................3665 

pango Medical devices .................212 

parker precision fluidics division ......2778 

peaK-service usa .....................3347 

pel-freez biologicals ..................2671 

phadia us inc. ........................2523 

phenomenex ..........................303 

philosys, ltd. ..........................3905 

pHtHisis diagnostics .................4414 

plexus ................................4209 

pointe scientific .......................1640 

polar King international ................856 

polar leasing ..........................852 

polymed therapeutics, inc. ............3907 

polymedco, inc. .......................2920 

polYMiCrospHeres ..................2669 

precision systems inc. .................2938 

premstar international, ltd. . . . . . . . . . . . .4313 

primeradx .............................143 

princeton bioMeditech Corp. ..........3248 

prior scientific, inc. .....................233 

proliant Health and biologicals ........1561 

pulssar technologies . . . . . . . . . . . . . . . . . . . 310 

puritan Medical products ..............4448 

pVt labsystems, llC ..................3011 

QbC diagnostics .......................424 

Qiagen inc. ..........................4302 

Qualtex laboratories ..................4005 

Quantimetrix Corporation .............2252 

Quasar instruments, llC ...............4408 

Quest diagnostics ....................3130 

Quest product development Corp. ....4112 

Quidel Corporation ....................2909 

Quimica Clinica aplicada, s.a. .........1945 

radim spa ............................3768 

radiometer america ...................722 

randox laboratories ..................1301 

rareCyte ..............................3650 

rayto life & analytical sciences Co, ltd. 4305 

r-biopharm ag .......................2850 

rd plastics .............................514 

recipe Chemicals & instruments .......3763 

research organics, inc. ................4217 

rheonix, inc. ..........................4434 

rnd group, inc., the ...................1535 

roche diagnostics ....................2205 

rockland immunochemicals, inc. ......2868 

roHM Co., ltd. .........................112 

rotek industries .......................4321 

runlab labware Manufacturing Co., ltd 3854 

ruro incorporated ....................241 

sa scientific ltd ......................2570 

saCaCe biotechnolgoies srl ...........4422 

safC .................................1841 

saKae Corporation ...................3957 

sanyo .................................2946 

sarstedt, inc. ..........................3218 

sartorius stedim biotech ..............3261 

scantibodies laboratory inc. ..........2123 

sCC soft Computer ....................4017 

sCeti K.K. ............................3571 

scienion ag . . . . . . . . . . . . . . . . . . . . . . . . . .2878 

scientific device laboratory ............340 

scimedx Corporation ...................406 

scipac ltd. ............................1531 

scripps laboratories ..................3857 

scytek laboratories, inc. ..............3162 

sd biosensor, inc. .....................1523 

sdiX ..................................3755 

sebia electrophoresis .................3111 

seegene, inc. .........................1653 

sekisui diagnostics . . . . . . . . . . . . . . . . . . . .2705 

sekisui Medical Co., ltd ................2607 

select laboratory partners .............213 

selective Micro technologies llC ......2670 

sensovation ..........................4206 

sentinel CH spa . . . . . . . . . . . . . . . . . . . . .4039 

separation technology, inc. (sti) .......2557 

sequenom, inc. .......................4308 

seraCare life sciences .................4014 

serion immundiagnostica gmbH ......2650 

shanghai Kehua bioengineering 

Co., ltd. ............................3568 

shanghai fosun Med tech 

development Co. ...................1514 

shanghai tellgen life science Co.,ltd. 4208 

shanghai ZJ bio-tech Co., ltd. ..........204 

shanghaibio Corp. ....................3166 

shenzhen emperor electronic 

technology ...........................306 

shenzhen genius electronics Co., ltd. ...108 

shenzhen landwind industry Co., ltd. 3045 

shenzhen procan electronics inc. ......4101 

shin Jin Medics inc. ...................3771 

sias ag ................................144 

siemens Healthcare diagnostics .......1605 

siemens water technologies ..........1614 

sifin gmbH. ...........................3664 

simport ...............................3943 

sinnowa Medical science & 

technology Co. ......................342 

skannex as ............................121 

slr research Corporation .............3069 

sMC Corporation of america ...........661 

snibe Co, ltd. .........................2855 

sony dadC ...........................2970 

source scientific, a bit Company .......2955 

southern biotechnology associates, inc. 2567 

specialty glass products ...............4203 

spherotech, inc. ......................2966 

spinreact .............................2042 

stanbio laboratory ...................3313 

strateC biomedical systems ag ......2053 

stratos product development .........4007 

streck laboratories, inc. ...............1513 

sunquest information systems ........3810 

surModics ............................1302 

swisslog ...............................130 

syntron bioresearch, inc. ..............2569 

sysmex . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2611 

systelab technologies .................2239 

taidoc technology Corporation ........4312 

taigen bioscience Corporation .........246 

taiyuan Zhongke Henyer 

digital Co., ltd. .....................4204 

tcoag ..................................631 

tecan .................................1431 

technidata america Medical software . . . 402 

techno Medica Co. ltd. ................1630 

teco diagnostics ......................3451 

telCor ...............................4430 

tetracore, inc. .........................3752 

therapak Corporation .................2043 

theratest labs inc. .....................302 

thermo fisher scientific ...............2672 

thermo scientific .....................1720 

thinXXs Microtechnology ag ..........3065 

tianjin era biology engineering Co., ltd. .4303 

toKYo boeKi MaCHinerY ltd. ........208 

topCon ..............................4350 

tosoh bioscience .......................401 

toyobo Co. ltd. .......................4200 

trek diagnostics systems, inc. .........2020 

triContinent scientific, inc. .............231 

trilink biotechnologies, inc. ...........2866 

trina bioreaCtiVes ag ..............3923 

trinity biotech ........................2915 

turklab a.s. ...........................3769 

uCla Health system ..................3420 

ulti Med products gmbH ..............4113 

uniCo ................................3067 

urit Medical electronic Co., ltd. ........330 

utaK laboratories, inc. ................1761 

ValuMax international .................3656 

Vedalab .............................2771 

Veracity group, inc. ...................... 7 

Vermillion ..............................236 

Viralab inc. ...........................4216 

Vircell .................................1949 

Virostat, inc. ..........................1549 

Vital diagnostics . . . . . . . . . . . . . . . . . . . . . .3243 

Viva products, inc. ....................1661 

Vivacta ltd. ............................215 

Vonco products .......................4109 

wako diagnostics .....................2831 

warde Medical laboratory .............1660 

waters Corporation ...................3136 

weidmann plastics technology ag .....338 

weifang Kanghua biotech Co., ltd. ....2768 

werfen group .........................2338 

westgard QC, inc. . . . . . . . . . . . . . . . . . . . . .1634 

wheaton industries inc. ...............1322 

wHpM bioresearch & 

technology Co., ltd. ................3953 

wi - Medical device development .....3903 

wiener laboratorios saiC .............3670 

wiley .................................4103 

wisepac active packaging 

Components Co. ...................3956 

wondfo biotech Co., ltd. ..............1551 

worthington biochemical Corporation 3260 

wslH proficiency testing ..............4045 

XeMa .................................3863 

Xiril ag ...............................2751 

Yd diagnostics ........................3445 

Zebra technologies ....................137 

Zentech ..............................3524 

ZeptoMetrix Corporation ..............2873 

Zeta Corporation ......................3412 

Zhejiang gongdong 

Medical technology Co. .............4030 

Zymo research .......................2668 

As of June 7, 2011 


special section 

Advertisement 

OSOM® C. difficile Toxin A/B Test* 

OSOM C. difficile Toxin A/B is a rapid test to 

aid in the diagnosis of C. difficile infection. 

The assay requires just four simple steps, and 

results are available in 20 minutes or less. No 

incubation is required, and labs can run the 

test in batch or STAT. An accurate, easy-toread, 

two-color dipstick provides clear objective 

results. Each kit contains all the materials 

necessary to run the test, plus two additional 

test sticks for external QC. Online training 

is available anytime at www.osomtraining. 

com. *Made in the U.S. 

Sekisui Diagnostics, LLC 

www.sekisuidiagnostics.com 

Booth No. 2705 

Clostridium difficile 

Immunochromatographic Test* 

A-B diff is a rapid immunochromatographic 

test for Clostridium difficile detection. Its 

main innovations compared to other tests 

in the market are detection of toxin A and 

toxin B in independent bands. This fact is 

important for making treatment decisions 

and isolating infected patients. It’s extremely 

quick, 10 minutes for sample preparation 

plus 15 minutes for reading results. It’s a 

very easy procedure, and it does not require 

special equipment, merely dissolve the stool 

sample in a buffer and add a quantity of the 

supernatant to the strip. HYPER diff is a 

rapid immunochromatographic test that can 

detect suspected hypervirulent strains of C. 

difficile as the ribotypes O27 or O17. *Available 

for sale outside the U.S. 

OPERON, S.A. 

www.operon.es 


Chagas Disease Detection kits* 

Wiener Labs has a complete line of kits for 

detection of Chagas disease, a parasitic infection 

produced by Trypanosoma cruzi. Commonly, 

the disease evolves towards a chronic 

phase. During the acute phase, the diagnosis 

is performed by detection of parasites in 

blood. During the chronic phase, serologic 

methods are used as screening tests. Today, 

blood donations in all endemic Latin American 

countries undergo Chagas screening, and 


2 0 11 N E w P r o d U c T s r E v I E w 

testing is expanding to other countries like 

the U.S. The line is composed of: Chagatest 

ELISA recombinante v.4.0®, Chagatest ELISA 

recombinante v.3.0®, Chagatest ELISA lisado®, 

WL Check Chagas®, Chagatest HAI®, 

Chagatest HAI A-V®. *For research use only. 

Wiener Laboratories SAIC 

www.wiener-lab.com.ar 


iRICELL®pro Automated urinalysis System 

The iRICELL pro consists of the iQ®200 

Series Automated Urine Microscopy analyzer 

and the iCHEM®VELOCITY Automated 

Urine Chemistry analyzer with iWARE® 

Integrated Urinalysis Software. 

Iris Diagnostics, 

a division of IRIS International, Inc. 

www.irisdiagnostics.com 

Booth No. 419 

BioCode-HP Analyzer* 

Barcoded Magnetic Beads (BMBs), a digital 

multiplex platform, are encoded with a high- 

contrast pattern that simplifies multiplexed 

diagnostic and molecular diagnostic assays 

while offering high throughput, high accuracy, 

and cost savings. Each bead contains 

one of 4,096 digital barcodes. Up to 4,096 

immunoassay or nucleic acid analytes/ 

sample can be tested simultaneously in a 

96-microwell plate. Biocode-HP Analyzer 

rapidly scans the BMBs, decodes the barcode, 

detects label fluorescence, and displays the 

results. The system provides a wide variety 

of applications, including infectious diseases, 

cancer diagnostics, HLA, autoimmune, companion 

diagnostics, gene expression analysis, 

micro RNA, genetic testing, and biomarker 

validation. *For research use only. 

Applied BioCode, Inc. 

www.ApBioCode.com 


MINICAP FLEx Piercing: 

Whole-Blood Hb Testing* 

Whole-blood hemoglobinopathy testing by 

capillary electrophoresis (CE) with cappiercing 

capabilities is now available with the 

MINICAP FLEX Piercing instrument. The 

MINICAP FLEX Piercing system with its 

small footprint is designed to optimize and 

completely automate electrophoresis testing 

in low- to medium-volume laboratories. 

Simply place a barcoded primary tube 

on the system and walk away; the whole 

blood plasma samples are automatically 

inverted prior to analysis and a continuous 

access sample wheel allows for addition of 

samples at any time. True positive sample 

ID is achieved with full traceability. A 

complete test menu is available, including: 

protein electrophoresis, immunotyping, 

and CDT (chronic alcohol abuse marker). 

*Pending FDA clearance. Available for sale 

outside the U.S. 

Sebia Electrophoresis 

www.sebia-usa.com 


CAPILLARYS 2 FLEx Piercing: 

Whole-Blood Hb Testing* 

Whole-blood hemoglobinopathy testing by 

capillary electrophoresis (CE) with cappiercing 

capabilities is now available with 

the CAPILLARYS 2 FLEX Piercing system. 

Whole-blood plasma samples are automatically 

inverted before sampling to ensure 

thorough homogenization of the sample and 

accurate Hb results. A high-resolution Hb 

separation takes place concurrently in eight 

capillaries with a sample throughput of 37 

results per hour. CAPILLARYS 2 FLEX Piercing 

is a continuous-feed system that provides 

full traceability from bar-coded primary 

sample tube to final result. A complete test 

menu is available, including serum and urine 

protein electrophoresis; immunotyping; and 

CDT (chronic alcohol abuse marker). *Pending 

FDA clearance. Available for sale outside 

the U.S. 




Tumor Marker Control* 

Fujirebio Diagnostics, Inc., the industry 

leader in biomarker assays, presents its solution 

for accurate precision monitoring of 

laboratory tumor marker assays. The Tumor 

Marker Control is intended for use as a 

quantitative, assayed serum control. This 

is the only multi-constituent control to 

contain the novel biomarker HE4 used to 

monitor progression and recurrence of 

epithelial ovarian carcinoma. It contains 

clinically relevant proportions of free 

PSA and PSA-ACT. Analytes include AFP, 

CA 15-3, CA 19-9, CA 125, CEA, ferritin, 

HE4, total PSA, and free PSA. Reconstituted, 

open-vial stability is 14 days at 2–8ºC 

with the following exception: Free PSA is 

stable for 7 days. The control sustains nine 

freeze/thaw cycles at ≤–20ºC. *Available 


Fujirebio Diagnostics, Inc. 

www.fdimcc.com 


EncompassMDx* 

Rheonix® introduces an automated microfluidic 

platform for the evolving molecular 

diagnostics industry. Rheonix CARD® 

technology automatically processes samples 

through purification, multiplexed amplification, 

and endpoint detection, offering true 

sample-to-result functionality with minimal 

technician hands-on time. The versatile 

system can be rapidly customized for a broad 

spectrum of diagnostic applications and incorporates 

low-cost consumables to analyze 

raw clinical samples such as blood, saliva, 

buccal and vaginal swabs. Successful pilot 

programs have applied a range of functional 

assays to the EncompassMDx platform, 

including SNP detection, pathogen identification, 

immunoassays, cell-based assays, and 

other molecular diagnostic applications. *For 

research use only. 

Rheonix, Inc. 

www.rheonix.com 


Chemiluminescence Immunoassay for TB* 

The Anti-TB kit is a chemiluminescence immunoassay 

(CLIA) test for detecting specific 

antibodies to Mycobacterium tuberculosis 

(TB) in human serum or plasma. In conjunction 

with Chemclin®100, a semi-automated 

CLIA analyzer, and Chemclin®600, a 

fully automated CLIA instrument, this assay 

provides high throughput and reliable detection. 

This assay offers laboratories higher 

sensitivity and is more user-friendly than 

other ELISA and RIA-based anti-TB assays. 

*Available for sale outside the U.S. 

Beijing Chemclin Biotech Co., Ltd. 

www.chemclin.com 


ARCHITECT HIV Ag/Ab Combo Assay* 

ARCHITECT HIV Ag/Ab Combo assay is a 

chemiluminescent microparticle immunoassay 

for simultaneous qualitative detection 

of human immunodeficiency virus (HIV) 

p24 antigen and antibodies to HIV type 1

See us at the 2011 Clin Lab Expo, Booth No. 2611


Advertisement 

(HIV-1 group M and group O) and/or type 

2 (HIV-2) in human serum and plasma. It 

is intended for use as an aid in the diagnosis 

of HIV-1/HIV-2 infection in subjects age 

≥2 and pregnant women, including acute/ 

primary HIV-1 infection. The test does not 

distinguish between HIV-1 p24 antigen, 

HIV-1 antibody, or HIV-2 antibody and is 

not intended for blood screening. Results 

should be interpreted with the patient’s 

presentation, history, and laboratory results. 

*For in vitro diagnostic use only in the U.S.; 

for sale by or on order of physician or to 

clinical laboratory only. 

Abbott Diagnostics 

www.abbottdiagnostics.com 


StrongStep® Candida albicans /Trichomonas 

vaginalis Antigen Combo Rapid Test* 

Vaginitis is one of the principal reasons 

women see an obstetrician or gynecologist. 

Candidiasis and trichomoniasis are 

responsible for most cases of infectious 

vaginitis, but they need different treatment. 

StrongStep Candida albicans/Trichomonas 

vaginalis Antigen Combo Rapid Test is an 

immunochromatographic assay for qualitative 

presumptive detection of these two 

pathogens from vaginal swabs. Samples can 

be self-collected by patients. In addition, 

compared with wet mount and culture, 

the results from this antigen test are less 

influenced by vaginal local drug treatment 

before the patient’s clinic visit. The test 

offers a simple testing procedure and fast 

results at the time of patients’ clinic visit. 



Nanjing Liming Bio-products Co., Ltd. 

www.limingbio.com 

Booth No. 117 

StrongStep® N. gonorrhoeae/C. trachomatis 

Antigen Combo Rapid Test * 

N. gonorrhoeae and C. trachomatis are closely 

related, and patients are often co-infected 

with the two pathogens. Patients should 

therefore be tested for gonorrhea and 

chlamydia simultaneously. StrongStep N. 

gonorrhoeae/C. trachomatis Antigen Combo 

Rapid Test is an immunochromatographic 

assay for qualitative presumptive detection 

of N. gonorrhoeae and C. trachomatis in 

female cervical-swab and male urethral-swab 

specimens. Unlike culture, the results from 

this antigen test are seldom influenced by patient’s 

self drug treatment before a clinic visit. 

The test offers convenience for clinicians 

and provides patients with rapid results at 

the time of their clinic visit, thereby allowing 

early treatment and preventing further com- 



plications. *Pending FDA clearance. Available 




Booth No. 117 

StrongStep® HSV 1/2 Antigen Rapid Test* 

Diagnosing herpes by visual examination of 

a lesion does not give an accurate diagnosis 

because many other infections or irritations 

can look just like herpes. Testing for the virus 

directly from the skin is useful if genital 

symptoms are present during the patient’s 

clinic visit. StrongStep HSV 1/2 Antigen 

Rapid Test is an immunochromatographic 

assay for qualitative presumptive detection 

of HSV 1&2 antigens in mucocutaneous 

specimens. The test is intended for confirmation 

of HSV symptomatic infection but 

also differentiates other genital ulcer diseases 

with herpes easily and quickly. Because the 

test detects antigen, it yields much higher 

sensitivity and specificity than antibody tests. 

Compared to PCR or culture, the test offers 

wider feasibility. *Pending FDA clearance. 

Available for sale outside the U.S. 



Booth No. 117 

Aquaporin-4 Antibody ELISA Test kit* 

KRONUS, a leading provider of specialized 

autoimmune diagnostic test kits, is pleased to 

announce the availability of a new ELISA test 

kit for measuring antibodies to aquaporin-4 

(AQP-4Ab). Aquaporin-4 is the most abun- 

dant water channel protein in the central 

nervous system and is expressed extensively 

within the brain and spinal cord regions. 

This new ELISA allows for accurate and 

specific determination of autoantibodies to 

AQP-4. *For research use only. 

KRONUS, Inc. 

www.kronus.com 


Voltage-Gated Potassium 

Channel Antibody RIA Test kit* 

KRONUS, a leading provider of specialized 

autoimmune diagnostic test kits, is pleased to 

announce the availability of a new RIA test 

kit for measuring antibodies to the voltagegated 

potassium channel (VGKC–Kv1.1, 1.2 

and 1.6). This new RIA allows for accurate 

and specific determination of VGKCAb. 

Measurement of antibodies to voltage-gated 

potassium channels (VGKC) may be useful 

in select indications.*For research use only. 

KRONUS, Inc. 



CLC 720 Chemistry Analyzer* 

Carolina Liquid Chemistries’ CLC 720 is a 

discrete, random-access, fully automated, 

floor-model chemistry analyzer. The CLC 

720 is capable of running up to 100 different 

tests from CMPs, DAUs, and lipids to 

specialty tests such as cystatin C and 1,5 AG 

(GlycoMark®). The CLC 720 can run 560 

tests/hour with ISE. It is an excellent fit for 

hospital, start-up, and small reference laboratories, 

as well as satellite laboratories, large 

reference laboratories, or large physician 

clinics. *Pending FDA clearance. 

Carolina Liquid Chemistries Corp. 

www.carolinachemistries.com 


Four-Level Methotrexate Controls* 

UTAK’s Four-Level Methotrexate Controls 

are manufactured in 100% human serum 

with no added preservatives to eliminate matrix 

effects and improve precision. The four 

methotrexate concentrations are 0.05, 0.075, 

0.5, and 0.75 µmol/L. These lyophilized 

controls have a 30- month shelf life, 25 days 

of reconstituted stability, and are packaged 

in a 5 x 5-mL volume size.*Available for sale 


UTAK Laboratories, Inc. 

www.utak.com 


Bi-Level Antifungal Controls * 

UTAK’s Bi-Level Antifungal Controls are 

manufactured in 100% human serum with 

no added preservatives to eliminate matrix 

effects and improve precision. The analyte 

panel of antifungals includes Fluconazole, 

5-Flucytosine, Itraconazole, Hydroxy-Itra- 

conazole, Posaconazole, and Voriconazole at 

clinically relevant concentration levels. These 

lyophilized controls have a 30-month shelf 

life, 25 days of reconstituted stability, and are 

packaged in a 5 x 5-mL volume size. *Available 


UTAK Laboratories, Inc. 

www.utak.com 


MALDI Biotyper* 

Bruker’s MALDI Biotyper identifies 

microorganisms using MALDI-TOF mass 

spectrometry by measuring the unique, 

characteristic molecular fingerprint of the 

proteins that are found in all microorganisms. 

The resulting patterns of these proteins 

are used to reliably and accurately identify a 

broad range of microorganism down to the 

species level. The MALDI Biotyper is very 

accurate, highly reproducible, extremely costeffective, 

fast, and easy-to-use. It is especially 

designed to meet the demands of the microbiology 

laboratory. This new technology has 

changed and modernized the way microbial 

identification is done in clinical laboratories 

around the world. *For research use only. 

Pending FDA clearance. Available for sale 


Bruker Daltonics 

www.bdal.com 


T Module System* 

The T Module System is a revolutionary 

multi-parameter instrument based on latex 

technology that simultaneously performs 

tests such as CRP, ASO, RF, and Hb1Ac in 

a few minutes. The modular configuration 

allows laboratories to run the instrument 

with a customized panel of tests according to 

the needs of each laboratory. The instrument 

analyzes the kinetic reaction and recognizes 

the prozona effect, recovering the sample 

with appropriate dilution. The calibration 

curves of each reagent kit are recorded into a 

volumetric card that enables the analysis. *In 

development. 

Alifax SpA 

www.alifax.com 


ACQuITY® Online SPE System* 

Waters introduces the ACQUITY Online 

SPE System for general laboratory use. The 

ACQUITY Online SPE System couples powerful 

and enabling UPLC® Technology with 

automated, online, solid-phase extraction to 

streamline workflows and improve analytical 

performance for LC-MS/MS-based assays. 

This fully integrated system solution is designed 

to improve the flexibility of LC-MS/ 

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 

Advertisement 

be performed on a single platform. Singleuse 

cartridges are used to perform each and 

every extraction on the system, reducing the 

risks of analyte carryover and accumulation 

of matrix components that can compromise 

analytical performance. *For research use 

only. 

Waters Corporation 

www.waters.com/clinical 


The NGAL Test* 

The NGAL Test, a particle-enhanced 

turbidimetric assay for the quantitative 

determination of NGAL in human urine or 

plasma, is designed for routine diagnostic 

use on chemistry analyzers from numerous 

manufactures, such as Roche, Abbott, 

Siemens, and Beckman Coulter. NGAL is a 

novel biomarker for diagnosing acute kidney 

injury (AKI). The test effectively gives almost 

any laboratory immediate access to a fast and 

easy method to measure NGAL. This test is 

intended for in vitro diagnostic use in select 

countries only. Check for availability in your 

country on our website. *For research use 

only. 

BioPorto Diagnostics A/S 

www.bioporto.com 


hema-screen SPECIFIC* 

hema-screen SPECIFIC is an immunochemical, 

fecal, occult-blood test specific for 

human hemoglobin. hema-screen SPECIF- 

IC’s distinguishing feature is our patented 

DEVEL-A-TAB collection slide, allowing 

two specimens to be tested at the same time. 

The new enhanced version of hema-screen 

SPECIFIC contains an additional 10 collection 

system/mailing envelopes. This feature 

allows doctors or labs to hand out additional 

collection system/mailing envelopes to compensate 

for non-compliance. Look for our 

new packaging. *In development. 

Immunostics Inc. 

www.immunostics.com 


ABO & RhD Blood Grouping kit* 

INTEC ABO & RhD Blood Grouping Kit 

uses unique visual testing technology to 

detect ABO and RhD blood groups based on 

the immune response principle of antigens 

and antibodies. The kit is suitable for on-site 

blood collection, medical laboratory testing, 

and urgent pre-transfusion testing. With 

rapid accurate results and good performance 

in specificity and stability, the kit can be stored 

at 2–30ºC for 2 years. The kit offers detection 

of ABO and RhD blood groups simultane- 

ously in one test without any additional 

equipment. This product has international 

patent: No.: PCT/CN2009/000322. *Pending 

FDA clearance. 

InTec PRODUCTS, Inc. 

www.intecasi.com 

Booth No. 741 

BS-800 Modular System* 

BS-800 Modular System, an innovative clinical 

chemistry diagnostic system manufactured 

by Mindray Corporation, incorporates 

Mindray’s suggested reagents, calibrators, 

and controls. It can be adapted to customers’ 

needs by integrating one to four modular 

units with various throughputs, ranging 

from 1,200–4,800 tests/hour. The systems 

uses only 100 µL of reagent, takes up to 860 

The scientific proof of a technology breakthrough 

is not established by a single study. The technology 

must be evaluated and the study results duplicated 

in numerous settings to be considered scientifically 

valid. In the last two years, 50 published studies 

by leading diabetes hospitals throughout the world 

validate that Nova’s StatStrip glucose sensor 

technology dramatically improves accuracy by 

reducing hematocrit and other interferences. These 

studies have been conducted at some of the most 

prestigious diabetes centers in the world including 

the Mayo Clinic, John Hopkins University School 

of Medicine, University of California Davis 

Center for Point of Care Technology, University 

of Toronto Sunnybrook Health Sciences Center, 

Addenbrooke’s Hospital Cambridge University 

Hospitals, UK, WEQAS and University Hospital, 

Cardiff, Wales, Isala Klinieken, Netherlands. 

Some conclusions: 

www.statstrip.com 

samples, has 2–8ºC reagent cooling, reagent 

bubble detection, and user-friendly operating 

software. The system allows labs to focus on 

cost-effectiveness, result accuracy, operator 

safety, and technology advancement. BS-800 

Modular System provides a brand new experience 

in laboratory practice and lets labs 

Scientific Papers Validate 

Nova’s Technology Breakthrough 

In Glucose Sensor Accuracy 

Nova Multi-Well 

Glucose StatStrip ® Technology 

Publications and Presentations 

Copies of this booklet are available by 

contacting Nova Biomedical Tel: 781-894-0800 

www.novabiomedical.com 

“Here we further demonstrate for the first time that anemia is the primary 

cause of glucometer error in hemodynamically stable adult ICU patients 

and that eliminating hematocrit error decreases the frequency of hypoglycemia.” 

Pidcoke M et al. Crit Care Med 2010 

“The new generation StatStrip glucose meter, which has been designed to 

compensate for hematocrit and chemical interferences, reduces the likelihood 

of erroneous results arising from interference factors that influence current 

conventional glucose meters.” 

Bewley B et al. Point of Care 2009 

“The StatStrip system was not susceptible to hematocrit, ascorbate or maltose 

interferences, either alone or in combination with one another. The other 

strip meter systems tested were significantly influenced by these interferences.” 

Lyon ME. AACC, Annual Meeting 2008 

“With the exception of the Nova StatStrip, all meters were affected by 

variable hematocrit.” 

Mohn B. NZJ Med Lab Sci 2010 

United States 

GLU 

Canada (Cont’d) 

Asia 

Europe 

Europe Cont’d 

The Nova StatStrip ® Blood Glucose Meter 

Evaluation: Hematocrit Dependency, 

Method Comparison, Interfering 

Substances and Neonatal Samples 

Clinical Evaluation of a Point of Care Device 

for Creatinine measurements in the Followup 

of Kidney Transplant Patients 

Validation of two Point-of-Care Testing 

devices for fetal lactate assessment 

during labour 

Evaluation of the Nova Biomedical 

StatStrip ® Glucose Meter 

Assessment of the Performance of Handheld 

POC Sensors for Measuring 

3-Hydroxybutyrate 

Four Step Validation Procedure for 

Evaluating POCT Meters 

Comparison of Four Hospital Based 

Glucose Meter Technologies for Accuracy, 

Precision and Interferences Encountered 

in Hospitalized Patients 

An Evaluation of the Analytical 

Specificity and Clinical Application of a 

New Generation Hospital Based Glucose 

Meter in a Dialysis Setting 

Improved POC Meter Accuracy for 

Monitoring and Managing Glucose Levels 

in Dialysis Patients 

Nova StatStrip ® Evaluation of a Point-Of-Care (POC) Glucose 

Meter Suitable for Use in Complex Tertiary 

Care Facilities 

Performance of a StatStrip 

: Could This Device be used 

to Effectively Implement Tight Glycemic 

Control and Triage Blood Glucose and 

Insulin Management in Critical Illness 

An Evaluation of the Analytical 

Performance of a New Generation 

Hospital Based Glucose Meter in a 

Neonatal Care Unit 

Reliability of Glucose Meters in Hospitals 

in Austria 

Performance of the Nova StatStrip 

Care Glucose Meter in a Neonatal Intensive 

Care Unit 

Multi-site Evaluation of Point of Care 

Glucose Meters in a Neonatal Intensive 

Care Unit 

A Multi-Site Analytical Assessment of a 

New Hospital POC Glucose Meter for 

Accuracy, Precision, Correlation, and 

Interferences Encountered in 

Hospitalized Patients 

® Meter 

Comparison of Accuracy of a Glucometer 

and a Blood Gas Analyzer in an Adult ICU 

Comparison of Accuracy of Three 

POC Glucometers in an Adult ICU 

Performance Of The Statstrip Glucose Meter 

In Inpatient Management Of Diabetes Mellitus 

Testování Glukometrů a Jejich Porvnání 

Evaluation d’un Nouveau Lecteur de 

Glycémie Intégrant une Correction 

Automatique de l’Hématocrite 

Galatose Interference on POCT Glucose 

Analysis 

Interference of Hematocrit and Maltose 

Plasma Concentrations on the Accuracy of 

Different Blood Glucose Measuring Systems 

Das Blutzuckermessystem StatStrip ® ist nicht 

empfindlich für Interferenzen durch 

Hämatokrit oder andere bekannte 

Störsubstanzen 

Genauigkeit des Blutzuckermess-systems 

StatStrip ® Comparison Evaluation of Three 

Point-of-Care Glucose Meters with 

Neonatal Patient Samples Exhibiting 

Varied Hematocrit and Triglyceride 

Concentrations 

Comparative Testing for Better 

Glycemic Control 

Accuracy and Reliability of the Nova 

StatStrip® Glucose Meter for Real-Time 

Blood Glucose Determinations 

during Glucose Clamp Studies 

Evaluation of the Impact of 

Hematocrit and Other 

Interference on the Accuracy of 

Hospital-Based Glucose Meters 

Use of Samples from Indwelling Venous 

Catheters for Glucose Meter Testing 

Comparison of Four Hospital Based 

Glucose Meter Technogies Accuracy, 

Precision, and Interference Encountered 

in Critically Ill Patient 

Evaluation of a New POCT Bedside 

Glucose Meter and Strip with Hematocrit 

and Interference Corrections 

Evaluations of Nova StatStrip 

im Vergleich zu anderen 

Messsystems und zu einer Standard- Labormethode 

Analytical Performance of an Interference- 

Resistant Glucose Meter 

Suitability Assessment of a New Bedside 

Interference Free Glucose System for Use 

in Critical Care 

® Blood 

Glucose Monitoring System in Neonates 

Evaluation and Implementation of the 

Nova StatStrip® Bedside Glucose 

Monitor for Patients Undergoing Cardiopmonary 

Bu-pass Graft Surgery (CABG) 

Development and Use of a Methodology 

for the Evaluation and Implementation of 

POCT Devices 

RGH’s Method for Evaluation and Implementation 

of Data-managed Bedside 

Glucose (POCTG) Monitoring 

Evaluation of Point of Care Bedside 

Glucose Monitors for Use in a Specialty 

and Transplant Hospital 

Hematocrit Effect Outweighs Other 

Sources of Glucometer Error in 

Critical Care 

Assessing the Performance of Handheld 

Glucose Testing for Critical Care 

Evaluation of a Glucose Meter with Negligible 

Hematocrit or Chemical Interference 

Predicted Discrepancies Between Direct 

Reading Whole Blood Biosensors and 

Central Lab Plasma Methods: Predicting 

and Avoiding Medical Error 

Estimates of Total Analytical Error in 

Consumer and Hospital Glucose Meters 

Contibuted by Hematocrit, Maltose and 

Ascorbate 

Interference Studies with Two 

Hospital-Grade and Two Home-Grade 

Glucose Meters 


Canada 

Multi-National Sites 

200 Prospect Street 

Waltham, MA 02454-9141 U.S.A. 

TEL: (781) 894-0800 (800) 458-5813 


® Point of 

No. 169 Rev. 1/20/11 



Advertisement 

explore the cutting-edge instrumentation 

of modern technology. *Available for sale 


Shenzhen Mindray Bio-Medical 

Electronics Co., Ltd. 

www.mindray.com 


CAPILLARYS 2 Flex Piercing HbA1c * 

This next-generation HbA1c assay, based 

on the principle of capillary electrophoresis, 

provides high-resolution, clear-cut, and 

precise separation of HbA1c and HbA0 fractions. 

Capillary electrophoresis eliminates 

direct interferences on the A1c fraction 

from carbamylated, acetylated, labile, and 

common Hb variants such as HbS, HbD, 

and HbE, as well as the analytical exclusion 

of HbA2 and HbF from the measurement. 

The method produces highly accurate results 

and extremely low CVs. CAPILLARYS 2 Flex 

Piercing HbA1c, with whole-blood, closed 

tube capacity, offers the best equilibrium in 

precision, robustness, and throughput along 

with the ability to run traditional electrophoresis 

testing. *Pending FDA clearance. 





TwinPower Dual Solenoid Valve System 

The TwinPower patented, dual-solenoid coil 

system cannot be found anywhere else on 

the market. It offers the flexibility to increase 

flow, pressure, throughput, and safety, 

without increasing the size of the solenoid 

valve. The technology provides flexibility to 

decrease the size of the valve and instrument, 

saving space and time and cutting costs while 

maintaining performance of valves twice 

the size. Burkert’s high-quality and reliable 

rocker valves were re-engineered to increase 

the robust nature of the fluid separated 

diaphragm, decrease internal and dead 

volume, reduce the manifold footprint, and 

add power-saving electronics, LED, latching 

and other special features now available as a 

standard. Burkert’s Twin Power technology 

comes in three valve sizes: 10mm, 16mm, 

and 22mm. 

Burkert Fluid Control Systems 

www.burkert-usa.com 

Booth No. 841 

MICROLAB® 600 Diluter and Dispenser* 

Hamilton Company, the world leader in fluid 

measurement, introduces the MICROLAB 

600, the next-generation in its line of semiautomated 

laboratory diluters and dispensers 

for pre-analytical sample preparation. Based 

on Hamilton’s leading syringe technology 

and positive-displacement dispensing, the 



new instrument has been designed for easeof-use 

and offers flexibility for more routines 

and smaller sample volumes. The MICRO- 

LAB 600 is ideal for a range of applications, 

including blood alcohol and metals analyses. 

The new MICROLAB 600 features an internet-enabled 

controller with an icon-based, 

graphical touch screen for increased ease-ofuse. 


Hamilton Company 

www.ML600.com 


Tellgenplex Tumor Marker 

Quantitative Assay* 

Tellgenplex Tumor Marker Quantitative 

Assay is intended for simultaneous quantitative 

determination of multiple tumor markers 

based on xMAP technology, including 

AFP, CEA, CA242, CA125, NSE, CYFRA21-1, 

free-β-hCG, total-PSA, free-PSA, CA19-9, 

CA15-3, CA50, and SCCA. Laboratories 

can detect these tumor markers in single or 

multiplex formats to meet their needs. All 

these tumor markers have been cleared by 

State of Food and Drug Administration of 

China, and total-PSA/free-PSA has received 

CE certification. With a variety of tumor 

marker detection assays on the market, this 

in vitro diagnostic test can also be used as an 

aid in managing cancer patients *Available 


Shanghai Tellgen Life Science Co., Ltd. 

www.tellgen.com 


Cascade Abrazo System* 

The Cascade Abrazo system represents the 

next-generation in point-of-care hemostasis 

testing. The Abrazo analyzer features a hand- 

held design with an intuitive touchscreen interface, 

wireless connectivity, and 2D barcode 

reader for capturing patient and reagent data. 

The administrative software and docking station 

allow remote management and quality 

control with customizable lockout features. 

The unique dry chemistry reagent platform 

is incorporated into barcoded assay cards the 

size of a driver’s license. Analytes will include 

routine PT, aPTT, celite, ACT, plus low-range 

ACT, heparin management (heparin and 

protamine response), ENOX (enoxaparin), 

fibrinogen-LR, and direct thrombin manage- 

ment for monitoring bivalirudin, dabigatran, 

and DTIs. *For research use only. 

Helena Laboratories 

www.helena.com 


Protein-Free Assay Diluent* 

Introducing the newest member of Sur- 

Modics’ family of exceptional immunoassay 

products. This protein-free diluent is a 

proprietary buffer formulation that reduces 

matrix interference in samples, including 

heterophillic antibodies such as HAMA (human 

anti-mouse antibody) and RF (rheumatoid 

factor). The protein-free formulation removes 

any possible risk of BSA-related issues 

in sample quantitation. You can improve the 

true value of your sample results by simultaneously 

diluting false-positive samples and 

your standard curve with SurModics’ assay 

diluent. More accurate results mean better 

patient outcomes. This reagent performs as 

an excellent diluent for samples, standard 

curves, and/or antibodies. *Available for sale 


SurModics 

www.surmodicsIVD.com 


AVE-76 Series urine-Formed 

Element Analyzer* 

AVE Science & Technology has taken the lead 

in implementing machine vision technology 

into microscopic morphology examination 

and has successfully developed the AVE-76 

Series Urine Formed Element Analyzer. The 

AVE-76 Series Analyzer is fully automated 

and fulfills the standardized quantitation 

and morphological analysis of all urineformed 

elements. With advanced target 

locating and tracking technology, threshold 

sample concentrations of 3–5 cells/µL can be 

detected without centrifuging or staining. As 

a result of the fast screening and recognition 

technology, the throughput is up to 200 tests/ 

hour. Positive samples only need verification, 

and there is no re-examination needed. The 

analyzer’s identification accuracy is more 

than 95%. *Available for sale outside the U.S. 

AVE SCIENCE & TECHNOLOGY 

INDUSTRY CO., LTD. 

www.c-ave.com 

Booth No. 311 

Phadia® 2500 

The world leader of in vitro diagnostics of 

allergy and autoimmune-related diseases 

introduces the Phadia 2500 instrument. This 

instrument is designed for cost-conscious, 

high-volume laboratories, and it offers 

efficiency and flexibility to meet a broad 

range of immunoassay testing needs. Phadia 

Laboratory Systems are optimized for the 

ImmunoCAP® Specific IgE blood test and 

EliA® autoimmune assays. Contact us today 

at (800) 346-4364. 

Phadia US Inc. 

www.phadia.us 


Phadia® 5000 

The world leader of in vitro diagnostics of 

allergy and autoimmune-related diseases 

introduces the Phadia 5000 instrument. This 

instrument is designed for cost-conscious, 

high-volume laboratories, and it offers 

efficiency and flexibility to meet a broad 

range of immunoassay testing needs. Phadia 

Laboratory Systems are optimized for the 

ImmunoCAP® Specific IgE blood test and 

EliA® autoimmune assays. Contact us today 

at (800) 346-4364. 

Phadia US Inc. 

www.phadia.us 


Alere PBP2a MRSA Test 

The Alere PBP2a is a rapid, lateral-flow assay 

that detects the PBP2a protein found in 

methicillin-resistant Staphylococcus aureus 

(MRSA) directly from isolates. It is a costeffective, 

targeted approach to identifying 

MRSA. The Alere PBP2a test provides results 

in 5 minutes, uses samples from cultures, 

including wounds, skin, and urine and has 

built-in quality controls on every test strip. 

Alere, Inc. 

www.alere.com 


Horizon Lab Analytics 

McKesson’s Horizon Lab Analytics solution 

provides essential management-decision support 

tools and scorecards to quickly measure 

a laboratory’s performance. This unique application 

integrates clinical and operational 

data into visual intuitive displays to monitor 

laboratory initiatives, optimize performance, 

and enhance regulatory compliance. This 

graphical tool produces meaningful information, 

empowering the organization to measure, 

manage, and improve care. It monitors 

the performance of laboratory operations 

and provides alerts so managers can quickly 

address issues. It also measures key safety 

and operational metrics with standard outof-the-box 

content. McKesson has been


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providing laboratory information systems 

for more than 30 years. 

McKesson Provider Technologies 

www.mckesson.com/laboratory 


NextSlide Review* 

NextSlide Imaging has created an integrated, 

digital-imaging toolset for laboratory microscopy. 

NSI Review is a digital workflow 

solution used to examine and review smear 

slides of blood, body fluids, and cultures. The 

system makes and uses full-resolution images 

of the entire reviewed portion of every 

slide. Applications in hematology include: 

WBC diff count; Kleihauer-Betke; LAP; and 

reticulocyte counts. Automation tailored for 

each application includes cell location and 

classification. NSI Review reduces the cost 

of smear review, while delivering improved 

quality control and remote review capability. 

The system integrates a 100x slide scanner, a 

hosted data center, and a web-based review 

workflow. *Pending FDA clearance. 

NextSlide Imaging, LLC 

www.nextslideimaging.com 


ARk Methotrexate Assay* 

ARK Diagnostics, Inc., the leader in the 

next-generation of TDM assays, introduces 

the new ARK Methotrexate Assay, a homogeneous, 

enzyme immunoassay to measure 

methotrexate in serum or plasma. Compatible 

with a variety of automated clinical 

chemistry analyzers, ARK’s liquid-stable, 

ready-to-use formulation delivers an assay 

with a limit of detection below 0.05 µmol/L. 

Specificity in the presence of 7-hydroxymethotrexate 

is excellent. The calibration 

range extends from 0–1.20 µmol/L and high 

concentrations may be tested after dilution 

with a provided buffer. Calibration-range and 

high-range controls are available. Methotrexate 

is the latest member in ARK’s family of 

assays for therapeutic drug management. 

*Pending FDA clearance. 

ARK Diagnostics, Inc. 



ARk AntiAED Assays 

ARK Diagnostics, Inc., the leader in nextgeneration 

TDM assays, is pleased to release 

a menu of assays for newer generation 

antiepileptic drugs (AEDs). ARK is the sole 

provider of FDA-cleared, homogeneous, enzyme 

immunoassays to measure levetiracetam 

(Keppra®) or gabapentin (Neurontin®) 

in serum or plasma. Assays for lamotrigine 

(Lamictal®), topiramate (Topamax®) and 

zonisamide (Zonegran®) are also available. 

ARK produces high-quality, liquid-stable, 

Technical modifications reserved 

ready-to-use assays that deliver precise results 

on a variety of automated clinical chemistry 

analyzers. With excellent specificity and 

reportable ranges, these assays offer rapid 

turn-around times to meet the needs of 

patients and physicians. 

ARK Diagnostics, Inc. 



BioPlex® 2200 APLS IgG, IgM, and IgA kits* 

The BioPlex 2200 Antiphospholipid Syndrome 

(APLS) IgG, IgM, and IgA kits are 

the first and only fully-automated, randomaccess 

multiplex flow immunoassays for the 

semi-quantitative detection of IgG, IgM, 

and IgA antibodies to cardiolipin (CL) and 

beta-2 glycoprotein I (β2GPI). Combined 

with clinical findings, these kits aid in the 

diagnosis of antiphospholipid syndrome 

(APS). These kits consolidate six traditional 

single-analyte tests into one disease-state 

panel. From a patient serum or plasma 

sample as small as 5 µL, workflow efficiency 

is enhanced with throughput up to 200 

tests/hour. These kits also offer results in 

45 minutes. The BioPlex 2200 APLS IgG, 

IgM, and IgA kits join an expanding menu 

Needleless or Vacuum? 

Your choice of urine collection systems 

V-Monovette Urine ® 

Urine Monovette ® 

The Urine Monovette ® uses the classical aspiration 

principle to collect from any cup. The suction tip is 

placed into a urine sample and the piston withdrawn 

and removed. Alternatively, a Luer-lock option can 

be attached to needleless sampling ports of 

drainage systems. 

• Needleless 

The V-Monovette ® Urine uses vacuum pressure 

for closed urine collection from corresponding 

cups and containers. 

• Enclosed system for enhanced hygiene 

• Convenient handling for patients and users 

• Options with boric acid stabilizer 

• Urine cup and container with integrated 

sampling port 

• A transfer device for urine sampling from 

open containers 

• Hygienic screw cap 

• Vessel for test strips 


• Centrifuge tube for sedimentation 

• Options with boric acid stabilizer 

800-257-5101 . sarstedt@bellsouth.net . www.sarstedt.com 



Advertisement 

of autoimmune and infectious disease tests 

on the BioPlex 2200 system. *Pending FDA 

clearance. Available for sale outside the U.S. 

Bio-Rad Laboratories, Inc. 

www.bio-rad.com 


BioPlex® 2200 Anti-CCP Assay 

The BioPlex 2200 Anti-CCP assay is a multiplex, 

flow immunoassay intended for semiquantitative 

detection of IgG antibodies to 

cyclic citrullinated peptide (CCP) in human 

serum or plasma (EDTA and sodium heparin). 

Detection of CCP antibodies is used as 

an aid in diagnosis of rheumatoid arthritis 

and should be used in conjunction with 

other clinical findings and laboratory 

results. 

Bio-Rad Laboratories, Inc. 



StatProfile® pHOx®—Critical Care Analyzer* 

Nova introduces a new family of pHOx 

blood gas/critical care analyzers featuring the 

largest selection of critical care tests including 

pH, PCO2, PO2, Na, K, Cl, iCa, iMg, 

glucose, BUN, creatinine, lactate, hematocrit, 

hemoglobin, SO2%, and co-oximetry. 

StatProfile pHOx design features include: 

robust connectivity and on-board data 

management system; bright, color touchscreen 

user interface; simplified operation; 

snap-in reagent cartridges; auto-calibration; 

fully automated quality control; and test 

results in 45 seconds. The combination of the 

pHOx long-life sensors and cartridge-based 

technology provides the most cost-effective 

way for hospitals to provide blood gas/critical 

care testing. *Pending FDA clearance. 


Nova Biomedical 



illumigene® Group B 

Streptococcus (GBS) Assay* 

Meridian Bioscience announces the illumigene 

Group B Streptococcus (GBS) assay. 

This is the latest offering from illumigene’s 

molecular portfolio. The assay uses the 

power of LAMP (loop-mediated isothermal 

amplification) technology and runs on the 



compact illumipro-10 instrument, allowing 

flexible operation of 1–10 samples/ 

run. Running from an enriched sample, in 

accordance with CDC guidelines, illumigene 

GBS provides highly accurate results in


Advertisement 

Exchanges may also occur on the fly. The 

cobas c 702 module is a member of the 

cobas 8000 modular analyzer series and may 

be combined with mid-volume chemistry 

(cobas c 502 module) and immunoassay 

(cobas e 602 module) modules to create an 

integrated platform with 24 unique system 

configurations that meets the individual 

needs of high-volume laboratories. 

Roche Diagnostics 

www.mylabonline.com 


cobas® e 602 Module 

The cobas e 602 module is an immunoassay 

module offering up to 170 tests/hour/module 

and an initial menu of more than 50 

assays. This module uses Roche’s patented 

electrochemiluminescence (ECL) technology, 

which offers broad measuring ranges and 

low-end sensitivity (HCG+β: 0.10– 10,000 

mIU/mL). The cobas e 602 module is a 

member of the cobas 8000 modular analyzer 

series and may be combined with two clinical 

chemistry modules to create an integrated 

platform with 24 unique system configurations 

to meet individual needs of high-volume 

laboratories. Combine the cobas 3 602 

module with mid-volume chemistry (cobas 

c 502 module) and immunoassay (cobas e 

602 module) modules to create an integrated 

platform with 24 unique system configurations 

that meets the individual needs of 

high-volume laboratories. 




9-Minute STAT Cardiac Assays 

9-Minute STAT assays for troponin T, 

troponin I, NT-proBNP, CK-MB, and 

myoglobin from Roche Diagnostics provide 

significant turnaround-time improvement 

on the cobas® 8000 modular analyzer series. 

On average, these STAT assays can produce 

the same critical results in half the time with 

only one, simple blood draw obtained via the 

sophisticated Roche OneTUBE® solution—a 

faster, more efficient way to deliver accurate 

results without sacrificing performance, precision, 

or sensitivity. Laboratories can run a 

comprehensive battery of cardiac STAT tests 

to provide accurate results faster than current 

testing methods. 




Elecsys Anti-HAV Total Assay 

The Roche Elecsys Anti-HAV Total Assay is 

an electrochemiluminescence (ECL) immunoassay 

for in vitro qualitative detection of 

total antibodies (IgM and IgG) to hepatitis A 

virus in human serum and plasma. The 

assay is intended as an aid in the laboratory 

diagnosis of past or acute/recent hepatitis A 

infection. The Roche Anti-HAV Total assay 

runs on the Elecsys 2010 system, MODU- 

LAR ANALYTICS E170 module, cobas e 601 

analyzer, cobas e 602 analyzer, and cobas e 

411 analyzer. 




Elecsys Thyroglobulin (Tg) Assay* 

The Roche Elecsys Tg Assay is an electrochemiluminescence 

(ECL) immunoassay for 

quantitative determination of thyroglobulin 

in human serum and plasma. Tg levels aid 

in monitoring for the presence of local and 

metastatic thyroid tissue in patients who 

have had thyroid ablation, either with or 

without ablative radioiodine therapy. The 

Roche Tg assay runs on the Elecsys 2010 

system, MODULAR ANALYTICS E170 

module, cobas e 601 analyzer, cobas e 602 

analyzer, and cobas e 411 analyzer. *Pending 

FDA clearance. Available for sale outside the 

U.S. 




Elecsys Human Growth Hormone (hGH) Assay 

The Roche Elecsys Human Growth Hormone 

Assay is an electrochemiluminescence 

(ECL) immunoassay for quantitative determination 

of the biologically active 20-kDa 

and 22-kDa isoforms of human growth 

hormone in serum and plasma. The onestep, 

sandwich assay takes only 18 minutes 

and demonstrates excellent total precision of 

1.7–2.5 CV% for the MODULAR ANALYT- 

ICS E170 module, cobas e 601 analyzer, and 

cobas e 602 analyzer. The high precision and 

reliability of the assay provide a solid base for 

a growth hormone assessment. The Roche 

Human Growth Hormone assay is available 

for all Roche immunoassay systems. 




Middleware Solutions—Moving Averages 

Roche Middleware Solutions offers Moving 

Averages, software that monitors the performance 

of assays and analyzers in between 

QC runs. The laboratory creates automated 

protocols within middleware to monitor the 

average of patient results on an assay-byassay 

basis and between multiple analyzers. If 

the average of patient results drifts above or 

below pre-defined threshold levels, moving 

averages will automatically stop autoverification 

and hold test results. The lab will 



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be notified via email or screen pop-up. It 

empowers labs to detect potential assay or 

instrument degradation in between QC runs 

and offers the ability to intervene before 

experiencing QC failure. 




RIDASCREEN® Calprotectin Test 

The RIDASCREEN Calprotectin test is a new 

ELISA for quantitative measurement of fecal 

calprotectin with a one-point calibration 

for evaluation. RIDASCREEN Calprotectin 

shows highly distinctive and reliable quantification 

of calprotectin in stool samples within 

the entire measuring range. By using onepoint 

calibration, RIDASCREEN Calprotectin 

significantly increases the throughput of 

samples/microtiter plate. Measuring of fecal 

calprotectin provides reliable differentiation 

between chronic inflammatory bowel 

disease and irritable bowel syndrome. 

Furthermore, it is used for early detection of 

relapses and monitoring response to treatment 

of irritable bowel syndrome. 

R-Biopharm 

www.r-biopharm.com 


Histamine Release Assay* 

The Histamine Release Assay is an in vitro 

cellular allergy diagnostic test that detects 

allergen-induced histamine release from basophil 

leukocytes using a glass-fiber method. 

The released histamine is bound selectively 

and permanently to the glass-fiber matrix 

in a microwell plate and can be measured 

within weeks. The Histamine Release assay 

primarily detects type I allergies against 

foods, drugs, and insect venoms. It can also 

be used for occupational, environmental, 

and inhalant allergens. About 90 allergens are 

available. Measurement requires a dedicated 

fluorescence reader, the Histareader 501. 


R-Biopharm 



The RIDASCREEN Norovirus 

3 rd Generation Test 

The RIDASCREEN® Norovirus 3 rd Generation 

enzyme immunoassay (EIA) is the first 



FDA-cleared test for in vitro diagnosis of 

norovirus infections. The RIDASCREEN 

Norovirus 3 rd Generation EIA test is a qualitative 

EIA intended for detecting selected 

genogroup I and genogroup II norovirus 

strains in human feces as an aid in investigating 

the cause of acute gastroenteritis outbreaks. 

The assay is a solid phase sandwichtype 

EIA that uses a mixture of genogroup 

I and genogroup II norovirus-specific 

monoclonal antibodies. The RIDASCREEN 

Norovirus 3 rd Generation EIA facilitates the 

possible diagnosis of norovirus outbreaks 

in less than 2 hours, thereby enabling faster 

implementation of outbreak control 

procedures. 

R-Biopharm 



Hypoxic/Hyperbaric QC: 

pO2 AMR Validation Controls 

Hypoxic QC is the first pre-tonometered 

product of its kind to validate extra-low 

(15 mm Hg) pO2 values on any blood gas 

analyzer in the lab or at the point-of-care. 

Hyperbaric QC is designed to validate the 

high pO2 range (710 mm Hg). Together, these 

two products validate the full pO2 analytical 

measurement range of blood gas analyzers. 

Hypoxic QC features active hemoglobin buffering 

with 10-minute, open-ampule stability, 

making it well-suited for method comparisons. 

Hyperbaric QC is an aqueous formulation 

that validates ultra-high recovered values, 

making it ideal for cardiac catheterization labs 

or operating room suites. 

Eurotrol, Inc. 

www.eurotrol.com 


GlucoTrol-WB Real Blood Glucose Control 

GlucoTrol-WB real blood glucose control is 

a new product packaged with ACU-CAP, a 

device that enables separation of red blood 

cells from the plasma fraction containing 

glucose, thereby eliminating glycolysis. 

GlucoTrol-WB is highly commutable and 

compatible with all point-of-care glucose 

devices with minimal matrix effects. All levels 

of GlucoTrol-WB performance yield very 

low imprecision and are very comparable 

with the imprecision of human whole blood. 

ACU-CAP also eliminates the need for pipetting. 

GlucoTrol-WB can be used as a QC for 

method comparisons or validations and for 

proficiency testing. 

Eurotrol, Inc. 

www.eurotrol.com 


Reagent Line for 

Olympus 400/640 Analyzers* 

Escalon Clinical Diagnostics and JAS 

Diagnostics are pleased to offer laborato- 

ries a reagent line of general and specialty 

reagents designed for the Olympus AU400 

and AU640 series chemistry analyzers. 

Thisreagent line is supplied in barcoded 

Olympus reagent containers for easy 

customer use. Additionally, these reagents 

provide quality performance in terms of 

results and stabilities, along with significant 

cost savings for the laboratory. Dedicated 

technical and customer service is available, 

including on-site conversion and validation 

programs. *Pending FDA clearance. Available 


Escalon Clinical Diagnostics/ 

JAS Diagnostics 

www.escalonclinical.com 

Booth No. 753 

DS360 HbA1c Analyzer* 

Escalon Clinical Diagnostics and Drew 

Scientific Inc. introduce the latest in a long 

legacy of hemoglobin analysis systems offered 

by Drew Scientific: the DS360 HbA1c 

Analyzer. The DS360 HbA1c Analyzer uses 

ion-exchange HPLC to accurately determine 

HbA1c in minutes and is NGSP-certified 

and traceable to the IFCC reference method. 

The system provides automated testing with 

on-board patient demographic database, 

sample run management, and complete QC 

capabilities. The DS360 HbA1c Analyzer is 

fully compatible with laboratory information 

systems and provides a touch-screen interface 

with multiple language capabilities. The 

DS360 HbA1c Analyzer has been introduced 

recently in Europe. *Pending FDA clearance. 


Escalon Clinical Diagnostics/ 

Drew Scientific Inc. 

www.escalonclinical.com 

Booth No. 753 

Acetylcholine Receptor 

Blocking Antibody kit* 

The Acetylcholine Receptor Blocking 

Antibody Kit is a radioimmunoassay for in 

vitro determination of acetylcholine receptor 

blocking antibody levels in serum. We offer 

30- and 120-test kits at prices competitive 

with 25- and 100-test kits. The assay procedure 

involves allowing blocking antibodies 

from samples to complex with acetylcholine 

receptors. Then the antibody-receptor 

complexes are allowed to complex with 

125 I-labeled bungarotoxin. The complexes 

are then precipitated, washed, counted, and 

determined. There are two 1-hour and one 

2-hour incubations for the procedure. *For 

research use only. Available for sale outside 


IVD Technologies 

www.ivdtechnologies.com 

Booth No. 201 

Acetylcholine Receptor 

Binding Antibody kit* 

The Acetylcholine Receptor Binding Antibody 

Kit is a radioimmunoassay for in vitro 

diagnostic determination of acetylcholine receptor 

binding antibody levels in serum. We 

offer 30- and 120-test kits at prices competitive 

with 25- and 100-test kits. The assay 

procedure involves allowing acetylcholine 

receptor binding antibodies from samples 

to complex with 125 I-labeled acetylcholine 

receptors. Then the complexes are precipitated, 

washed, counted, and determined. 

The procedure involves 30- and 120-minute 

incubation times. The kit features an assay 

range of 0.2–7.5 nmol/L, a detection limit of 

0.058 nmol/L, a cutoff of 0.25 nmol/L, clinical 

sensitivity of 100%, and clinical specificity 

of 97%. *Available for sale outside the U.S. 



Booth No. 201 

Direct Free T4 Coated Beads 

Equilibrium Dialysis kit* 

The Direct Free T4 Coated Beads Equilibrium 

Dialysis Kit is a highly sensitive and 

specific radioimmunoassay for the in vitro 

direct measurement of free T4 in serum. The 

assay procedure involves dialyzing samples 

overnight and running a radioimmunoassay 

for free T4 using coated beads on the 

dialysates. The 100-test kit comes with 80 

disposable cells (QD-CellTM) for dialysis, 

making dialysis of samples easier and more 

convenient. The radioimmunoassay uses 

coated beads that make measurement of free 

T4 by equilibrium dialysis easier and less 

labor-demanding. *For research use only. 




Booth No. 201 

Cell-Chex Control 

Cell-Chex is a spinal and body fluid control 

with distinct white (WBC) and red blood cell 

(RBC) populations for manual counts. When 

stained in the same manner as a patient 

sample, the WBCx can be differentiated. The 

two-level control is assayed for total RBC and 

WBC counts, a five-part WBC differential,


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as well as a two-part polymorph nuclear 

and mononuclear differential. Level 1 now 

contains crystals to help assess lab technicians’ 

skills in identifying accurate crystals in 

synovial fluid samples. 

Streck, Inc. 

www.streck.com 


uA-Cellular® for IQ Control 

UA-Cellular for IQ is Streck’s micro urinalysis 

control designed specifically for the Iris 

Diagnostics iQ® automated urine analyzers. 

UA-Cellular for IQ contains components 

at two clinically significant levels, providing 

thorough evaluation of the iQ instrument’s 

ability to both identify and quantify white 

blood cells, red blood cells, non-squamous 

epithelial cells, and crystals. The product is 

contained in convenient 120-mL squeeze 

bottles with a flip-top cap dispenser that accurately 

allots the amount of control needed 

into sample tubes without waste. UA-Cellular 

for IQ has an open-vial stability of 30 days 

and a closed-vial stability of 105 days. 

Streck, Inc. 



uA-Cellular® for uF Control 

UA-Cellular for UF is Streck’s micro urinalysis 

control designed specifically for the 

Sysmex® UF urine analyzers. UA-Cellular 

for UF contains cellular components at two 

clinically significant levels, providing thorough 

evaluation of the Sysmex UF analyzers’ 

ability to qualify and quantify white blood 

cells, red blood cells, epithelial cells, crystals, 

casts, and bacteria. The product is contained 

in convenient 60-mL squeeze bottles with 

a flip-top dispenser that accurately allots 

control material into sample tubes without 

waste. UA-Cellular for UF has an open-vial 

stability of 30 days and a closed-vial stability 

of 105 days. 

Streck, Inc. 



Cell-Free DNA BCT Control* 

Cell-Free DNA BCT is Streck’s 10-mL blood 

collection tube for preserving and stabilizing 

cell-free plasma DNA. The patented preservative 

in Cell-Free DNA BCT stabilizes white 

blood cells, preventing the release of genomic 

DNA during sample processing and storage 

and reducing post-sampling DNA background. 

Samples collected in Cell-Free DNA 

BCT are stable for up to 14 days at room 

temperature, allowing convenient sample 

HO 

D 2 

Controls 

H 

CH3 

CH3 

H 

CH2 

collection, transport, and storage. Processing 

patient samples for detection and analysis of 

circulating cell-free DNA requires minimal 

sample manipulation. Sample handling is 

less labor-intensive and time-consuming 

than traditional methods of plasma sample 

preparation. *For research use only. 

Streck, Inc. 



Philisa® Thermal Cycler 

The Philisa Thermal Cycler by Streck is an 

innovative, high-speed polymerase chain reaction 

(PCR) instrument with the potential 

to improve laboratory efficiency and flexibility. 

Industry-leading ramp rates, excellent 

thermal control, and thin-walled plastic PCR 

CH3 

CH3 

CH3 

ergocalciferol 

tubes enable users to perform reliable PCR 

in less than 15 minutes. The small footprint, 

intuitive Windows-based software, and 

access to Streck’s team of technical experts 

make the Philisa Thermal Cycler an excellent 

choice for any lab. 

Streck, Inc. 



Why UTAK is the “Real” Market Leader in Vitamin D Controls 

Because we manufacture our Vitamin D controls in 100% REAL human serum 

for testing 100% REAL humans. 

cholecalciferol 

UTAK Laboratories, Inc. 25020 Avenue Tibbitts Valencia, CA 91355 Tel: (800) 235-3442 Fax: (661) 294-9272 

www.UTAK.com inquiries@UTAK.com 

HO 

D 3 

Controls 

CH3 

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H 

H 

100%REAL 

Visit VitaminDcontrols.com for the 100% REAL story. 


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CD-Chex® Plus BC Control 

CD-Chex Plus BC is a whole blood assayed 

control for immunophenotyping on Beckman 

Coulter® flow cytometry systems. 

CD-Chex Plus BC determines the accuracy 

and reproducibility of all the steps involved 

in the process of immunophenotyping, 

including red blood cell lysis. CD-Chex Plus 

BC provides the most assayed CD markers 

in the industry, including T lymphocytes, B 

lymphocytes, granulocytes, monocytes, and 

NK cells. CD-Chex Plus BC CD4 Low offers 

a depressed CD4 absolute number often 

indicated in patients with immunodeficiency 

diseases. Each level has 30-day open-vial 

stability and 90-day closed-vial stability. 

CD-Chex Plus BC and CD-Chex Plus BC 

CD4 Low are available in plastic vials with 

pierceable caps containing 3 mL. 

Streck, Inc. 



CD-Chex® Plus Control 

CD-Chex Plus is a whole blood assayed control 

for monitoring immunophenotyping by 

flow cytometry. CD-Chex Plus determines 

the accuracy and reproducibility of all the 

steps involved in the process of immunophenotyping, 

including red blood cell lysis. 

CD-Chex Plus provides the most assayed 

CD markers in the industry, including T 

lymphocytes, B lymphocytes, granulocytes, 

monocytes, and NK cells. CD-Chex Plus 

is assayed for normal levels of CD34+ cells 

found in peripheral blood. CD-Chex Plus 

CD4 Low offers a depressed CD4 absolute 

number often indicated in patients with immunodeficiency 

diseases. Compatible with 

most popular flow cytometry systems, CD- 

Chex Plus and CD-Chex CD4 Low are available 

in the 2.5-mL and 3-mL cap-pierceable 

fill volumes. Both levels have an open-vial 

stability of 30 days and a closed-vial stability 

of 90 days. 

Streck, Inc. 



Cell-Free RNA BCT* 

Cell-Free RNA BCT is Streck’s 10-mL blood 

collection tube for preserving and stabilizing 

cell-free RNA in plasma for up to 3 days at 



ambient temperature. The patented preservative 

in Cell-Free RNA BCT preserves cellfree 

RNA in plasma and prevents the release 

of cellular RNA during sample processing 

and storage, reducing background RNA 

level. With Cell-Free RNA BCT, processing 

patient samples for detection and analysis of 

circulating cell-free RNA requires minimal 

sample manipulation. Sample handling is 

less labor-intensive and time-consuming 

than traditional methods of plasma sample 

preparation. *For research use only. 

Streck, Inc. 



Streck Product Selection Guide 

Streck, Inc., introduces a new feature on its 

redesigned website, www.streck.com. The 

Product Selection Guide is a quick reference 

to help customers determine which Streck 

products work best with their instruments. 

Customers may search by instrument or 

instrument manufacturer to find the right 

controls and calibrators. The website also 

provides access to technical support from an 

experienced team of medical technologists 

and access to STATS, Streck’s inter-laboratory 

quality control program that gives participating 

labs monthly computerized reports comparing 

their values with a peer group using 

the same instrument type and control lot. 

Streck, Inc. 



Minivette® POCT Device 

The new Minivette POCT device from 

Sarstedt is designed for precise and hygienic 

collection, transfer, and subsequent 

dispensing of small capillary blood samples 

for point-of-care tests. Blood is easily collected 

via capillary action into the end of the 

Minivette POCT device. The sample is held 

securely in the capillary without spills during 

transfer and then dispensed onto the test 

field with a slight push of the opposing 

integral piston. The Minivette POCT device 

is available for blood volumes of 20 µL and 

50 µL, and the collection capillary is offered 

plain or prepared with EDTA or heparin. 

Sarstedt, Inc. 

www.sarstedt.com 


13 x 75-mm Tubes for 

Automation and Analysis 

The new 13 x 75-mm screw cap aliquot tubes 

with round bases from Sarstedt are designed 

for compatibility with common laboratory 

automation and analysis platforms. A full volume 

13 x 75-mm tube accommodates 5 mL 

of sample, features printed writing block and 

graduations, and is available in clear or amber 

for light sensitive analytes. A 2.5-mL falsebottom 

version with an elevated conical base 

raises small sample volumes to an optimal 

height for analysis. The corresponding tall 

screw cap for improved gripping provides 

a leak-resistant closure that meets IATA 

requirements for transport. Alternatively, a 

flanged anti-evaporation push cap may be 

used to cover samples or to archive samples. 




PVS 1625 with Screw-Cap Recapper 

The Sarstedt PVS 1625 is a comprehensive, 

modular, laboratory automation system 

for pre- and post-analytical processing. 

Independent from an analytical platform, the 

PVS 1625 can be customized according to a 

laboratory’s needs with available modules for 

loading, identification, decapping, sorting, 

aliquoting, and recapping. A new screw-cap 

recapper module is available that places a 

screw cap onto Sarstedt aliquot tubes. Aliquots 

can be made directly into compatible 

screw-cap tubes and immediately recapped 

for send-outs or capped post-analysis for 

archiving. The PVS 1625 is compatible with 

most analyzer racks and common tube types 

and dimensions. 




Electrolyte Analyzer with 

Ion Selective Electrode 

The EX-D is a fully automated electrolyte 

analyzer with ion-selective electrode for 

measuring sodium, potassium, and chloride 

in whole blood, serum, and diluted urine. 

It also offers a solution for hemodialysis 

applications, allowing acid concentrates and 

sodium bicarbonate to be balanced. Twenty 

samples can be processed in one run and 

results are available within 36 seconds. The 

newly developed high-sensitivity electrodes 

allow calibration to be performed only once 

a day. The electrode produces very accurate 

results with a CV of


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new interactive rules building and testing 

tool streamlines rules configuration. A clear 

drill down structure gives immediate access 

to all essential parameters such as TAT, test 

status, and alarms. Thanks to its autoverification 

and monitor functionalities, HALIA 

allows lab managers to improve performance 

and efficiency, addressing the challenging lab 

automation environment. *Available for sale 


NoemaLife SpA 

www.noemalife.com 


HemoCue® Glucose 201 RT Analyzer* 

HemoCue Glucose 201 RT is the newest 

addition to the HemoCue line of point-ofcare 

glucose analyzers. If refrigerated cuvettes 

have kept you from using HemoCue® to 

measure glucose at the point-of-care, the new 

HemoCue Glucose 201 RT system is for you. 

HemoCue Glucose 201 RT retains our easy 

testing method and the lab quality results so 

vital in patient care, but it uses room-temperature 

cuvettes. *Pending FDA clearance. 


HemoCue, Inc. 

www.hemocue.com 


A2o Advanced Automated osmometer 

The A2O from Advanced Instruments is a 

fully automated, multi-sample osmometer 

that incorporates more than 50 years of 

applied technology experience in the field 

of freezing-point osmometry. The A2O 

combines a functional design, exceptional 

analytical performance, and an intuitive software 

control package that is both powerful 

and elegantly simple to operate. Every aspect 

of the A2O has been intelligently engineered 

to fully automate osmolality testing with ease 

and simplicity. It is ideally suited for today’s 

busy laboratories that are being asked to 

achieve more results faster but with fewer 

resources. 

Advanced Instruments, Inc. 

www.aicompanies.com/A2O 


Dropper A1c - Diabetes Control* 

We crafted the Dropper A1c Control to make 

your laboratory and point-of-care hemoglobin 

A1c quality control simple. Six months of 

refrigerated, open-vial stability reduces waste, 

and our dropper bottles make dispensing 

outrageously simple. The liquid, human 

blood-based matrix and 21 days of open-vial, 

room-temperature stability eliminates storage 

problems and provides maximum portability—perfect 

for sites without refrigeration. 

The Dropper A1c Control is designed for use 

with most major immunoassay and boronate 

affinity laboratory and POCT analyzers, including 

Siemens DCA 2000/2000+/Vantage 

and Dimension, Beckman Coulter Synchron, 

Roche Cobas Integra and Hitachi, Ortho- 

Clinical Vitros, and Primus PDQ/ultra2. The 

Dropper A1c Control offers longer stability 

and is super convenient. *Pending FDA 

clearance. Available for sale outside the U.S. 

Quantimetrix 

www.4qc.com 


Pluggo RH Decapper System 

The Pluggo RH Decapping System for 

ADVIA® Centaur racks is an automated, 

bench-top decapper designed to use 

instrument-specific, sample-tube racks for 

the ADVIA Centaur or ADVIA Centaur XP 

System. The small footprint Pluggo RH System 

(22” w x 24” d x 14” h) automatically 

decaps all standard vacuum collection tubes 

at speeds up to 35 tubes/ minute. The Pluggo 

RH is designed to protect lab workers from 

repetitive motion injuries and from exposure 

to biohazardous material. The system 

provides walk-away operations with input 

capacity of up to 15 racks and output of up 

to 15 racks of uncapped tubes. 

m-u-t America, Inc. 

www.mut-group.com 


ReQuest Immunoassay kits* 

ReQuest Immunoassay Kits are manufactured 

in the U.S. and provide outstanding 

sensitivity, specificity, accuracy, and precision, 

thereby meeting the productivity needs of a 

wide range of laboratories. In today’s highly 

competitive environment, ReQuest Immunoassay 

Kits assures reliable, user-friendly, 

and cost-effective diagnostic test methods 

for TORCH, autoimmune panels, infectious 

disease markers, and more. *Available for sale 


Awareness Technology, Inc. 

www.awaretech.com 


Clinical Chemistry Analyzer Global 4500DR* 

BPC BioSed srl is very proud to inform all 

customers and end-users of the new Analyzer 

Global 4500DR launch. The main features 

meet the needs of the market, including two 

arms and others main features on the right 

side for medium-to-high-volume hospital 

labs. The new analyzer is the latest development 

from our company and is based on 

recent customer requests. BPC BioSed is 

an Italian company founded in 1986 that 

produces markets and services automatic 

and semi-automatic chemistry analyzers 

for the human, veterinary, water analysis, 

oenology, and drugs analysis markets. *In 

development. 

BPC BioSed srl 

www.bpcbiosed.it 


FLAIR Microarray Scanner* 

FLAIR, Sensovation’s fluorescence array 

imaging reader, is a compact and affordable 

microarray reader designed for routine 

applications. It is used for multiplexed 

diagnostics in clinical research and routine 

analyses. FLAIR allows fast measurement of 

planar fluorescent microarrays with up to 

three colors. Originally designed for array-in 

well applications, FLAIR accommodates 96well 

plates or four conventional slides on the 

four-slide holder. FLAIR is an easy-to-use, 

standalone instrument with integrated 

processor, including array analysis software 

and touchscreen. FLAIR offers the full 

performance of a microarray scanner for 

multiplexed diagnostics on an exceptionally 

small footprint. *For research use only. Pending 

FDA clearance. Available for sale outside 


Sensovation 

www.sensovation.com 


Vision MINI ultra-Compact Smart Camera* 

Microscan’s new Vision MINI ultra-compact, 

smart camera is designed for reliable vision 



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performance in embedded identification and 

inspection applications. As the world’s smallest 

fully integrated vision system, the Vision 

MINI’s small size, autofocus lens, and wide- 

angle optics provide the best performance 

available for vision tasks, such as cap presence/absence, 

cap type, and cap color. The 

Vision MINI delivers both excellent results 

and reliability, along with Microscan System’s 

assurance of long-term availability and support. 

This is essential for OEMs that require 

uninterrupted availability throughout the 

life-cycle of their products, and it enables 

them to focus on new development instead 

of obsolescence issues. *Available for sale 


Microscan Systems Inc. 

www.microscan.com 

Booth No. 239 

DENV Detect IgM Capture ELISA 

InBios is pleased to announce the first FDAcleared 

test manufactured in the U.S. for 

diagnosis of dengue infection. The DENV 

Detect IgM Capture ELISA is a qualitative 

enzyme immunoassay that detects IgM 

antibodies to dengue virus in human serum. 

This easy-to-use kit contains all the readyto-use 

reagents and controls. Storage is at 

2–8ºC. The sensitivity and specificity was 

thoroughly evaluated with clinically confirmed 

cases of dengue 1-4 serotypes with 

excellent results. This product is CE Marked 

and represents the latest product offering by 

InBios for the detection of flaviviruses. 

InBios International, Inc. 

www.inbios.com 


ASiManager Digital Agglutination Analyzer 

The ASiManager AT is an integrated digital 

particle analyzer that objectively interprets 

slide agglutination tests manufactured by 

Arlington Scientific Inc. Laboratory managers 

perform qualitative and semi-quantitative 

tests using the ASiManager AT to provide 

standardized test interpretation using criteria 

that define positive- and negative-agglutination 

reactions. The ASiManager AT also 

delivers an initial predictive titer analysis for 

the ASI-RPR Card Test for syphilis. It also 

provides tools that enable creation, storage, 

retrieval, and transmittal of the test results. 



This innovative technology provides a lowcost, 

state-of-the-art, digitally enhanced, 

integrated system for objective interpretation 

of proven particle agglutination immunoassay 

tests. 

Arlington Scientific, Inc. 

www.arlingtonscientific.com 

Booth No. 352 

Automated Laboratory Assistant* 

The Iris Automated Laboratory Assistant 

automates a variety of protocols for FISH, 

WISH, Western Blot, as well as many other 

slide-based applications that are labor-intensive, 

time- consuming, and require multiple 

washes and incubation times. The new unit 

is a small, highly flexible platform consisting 

of a fluid-exchange system that delivers 

reagents sequentially with temperature agitation 

and control. It frees lab personnel from 

time-consuming, repetitive procedures and 

improves data reliability. A flexible user interface 

allows labs to store and save multiple 

protocols and modifying them as needed. *In 

development. 

Iris Sample Processing 

www.proiris.com 

Booth No. 419 

Liquichek Specialty Immunoassay Control 


is the first and only liquid, human serum- 

based control with a comprehensive menu 

that includes 25-OH vitamin D, iPTH, anti- 

TPO, and anti-Tg. The 25-OH vitamin D 

insert listing has been expanded to include 

all major automated methods, as well as 

LC-MS/MS values for vitamins D2 and D3. 

The control’s long, open-vial stability and 

multi-analytes provide convenience and 

cost savings to laboratories. When using 


with our powerful Unity software, you join 

more than 17,000 laboratories worldwide 

that already benefit from Unity’s superior 

analytical capabilities and the most comprehensive 

inter-laboratory comparison. 

Bio-Rad Laboratories 



unity Alert QC Software* 

Unity Alert is a new add-on module for 

Unity Real Time®, an expert QC data 

management solution from Bio-Rad. The 

software module continuously monitors QC 

status and alerts laboratories if QC data is 

missing or rejected against statistical process 

control rules such as the Westgard rules. Alert 

notifications can be provided by email or 

visually through taskbar icons. Unity Alert 

runs in the background as a service and operates 

even when Unity Real Time is closed. 





Hicera Series 

Iwaki’s new precision dosing pumps are 

designed to accurately dispense critical fluids. 

The Hicera Series provides 0.1% repeatable 

performance for volumes as low as microliters/ 

sample. Much smaller than traditional 

syringe pump designs, Iwaki piston metering 

pumps eliminate the need for re-calibration 

while providing more than 40,000 hours 

of no-touch, maintenance-free service life. 

The APN Series is built to handle the most 

aggressive fluid handling requirements on 

analyzers. APN’s molded diaphragm maintains 

the pump’s accuracy whether handling 

fluids or gas. The solids-handling diaphragm 

ensures dependable performance under adverse 

operating conditions. Custom designs 

and prototype quantities are available. 

Iwaki America Inc. 

www.iwakicustompumps.com 


mLabs® D-Dimer Test* 

Micropoint’s mLabs D-Dimer test is 

designed for point-of-care applications. 

The mLabs D-Dimer test is a quantitative 

microfluidic immunoassay that provides 

rapid test results for evaluation of pulmonary 

embolism or deep vein thrombosis. Patented 

mLabs microfluidic control technology 

enables high precision and highly reliable 

D-Dimer testing, featuring wide measureable 

range, fool-proof operations, and excellent 

correlations with central lab equipment, such 

as the mini-VIDAS. The test uses 250 µL of 

citrated whole blood or plasma. Testing time 

is


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one protocol for both routine and intraoperative 

testing with results available in 18 

minutes. The VITROS iPTH Assay runs in a 

fully automated, random-access format on 

the VITROS ECi/ECiQ and 3600 Immunodiagnostic 

Systems and can also run on the 

VITROS 5600 Integrated System. Equivalent 

analytical results are generated across all 

three systems. 

Ortho Clinical Diagnostics 

www.orthoclinical.com 


VITROS® Anti HBe and HBeAg Assays* 

Ortho Clinical Diagnostic announces the 

pending FDA approval of the VITROS 

Anti-HBe and HBeAg assays for use on the 

VITROS ECi/ECiQ Immunodiagnostic 

Systems. These fully automated, randomaccess 

assays will complete the full hepatitis 

panel and compliment HIV and rubella 

infectious disease assays, as well as 29 routine 

immunoassays. HBeAg in serum is a strong 

indicator of high infectivity of HBV. Presence 

of Anti-HBe indicates the convalescent stage 

of HBV infection and is found in carriers 

of HBV who are able to clear HBeAg from 

the circulation. HBeAg/anti HBe assays are 

important to define the specific HBV disease 

state. *Pending FDA clearance. 




Centrisart® Concentrator for 

Antigens and Antibodies 

The Sartorius Centrisart centrifugal ultrafiltration 

device can be used for concentrating 

fungal antibodies in serum prior to 

complement fixation or immunodiffusion. 

The sensitivity of these tests for Coccidioides 

antibodies has been improved greatly by this 

method. The Centrisart may also be used 

for concentrating bacterial antigens in urine, 

serum, or cerebrospinal fluid. Antigens associated 

with H. influenzae and S. pneumoniae 

can be concentrated and tested with latex 

particle agglutination or other methods. This 

has been useful in the diagnosis of sepsis in 

newborns. The Centrisart features a unique 

design in which the ultrafiltration takes place 

in the opposite direction to the centrifugal 

force. This is effective in greatly reducing 

blockage of the filter and improving flow. 

Vivaproducts 

www.vivaproducts.com 


AWEL Centrifuges 

The new AWEL range of centrifuges has 

been launched, including the multifunction 

format. Bringing practical innovation to 

our customers, each model in the MF series 

offers a large sample capacity for its class and 

accepts a variety of swing-out, microplate, 

and angle rotors. New features include the 

AWELight system that displays blue lid 

lights at the end of the run, indicating the 

samples are ready to be removed. This not 

only increases operator efficiency, but it also 

improves process results. The AWELock 

system permits rotors to be exchanged and 

safely locked in position without using tools. 

A low profile adds to the convenience. *Available 


NuAire, Inc. 

www.nuaire.com 


Vitamin D Total Assay* 

on ADVIA Centaur® System 

Laboratories can now meet the increased demand 

for vitamin D total testing with precise 

consistent results in as little as 18 minutes. 

The ADVIA Centaur Vitamin D Total Assay 

is an equimolar, fully automated vitamin D 

total assay that is traceable to LC-MS/MS, 

considered the gold standard in vitamin D 

Accurate and precise 

• Sensitivity: < 1pg/ml 

• Intra-assay CVs: < 5% 

• Inter-assay CVs:


Advertisement 

VersaCell Connectivity to 

Dimension® ExL Systems 

The VersaCell system’s newest connectivity 

options include the Dimension EXL with 

LM, Dimension EXL 200, and RxL Max 

Systems. These Dimension platforms join 

the ADVIA® 1800 Chemistry, IMMULITE®, 

and ADVIA Centaur® Immunoassay Systems 

as VersaCell connectivity options. The 

Dimension EXL with LM systems combine 

the power of a uniform reagent system, 182 

concurrent onboard assays, QuikLYTE® 

electrolytes, and LOCI® immunoassay 

technology. VersaCell provides unique pre- 

and post-analytical sample management and 

workload balancing. The new connectivity 

options create specific, needs-based workstations, 

combining two Dimension EXL 

systems or a Dimension EXL system with an 

immunoassay platform. 

Siemens Healthcare Diagnostics 

www.siemens.com/diagnostics 


RAPIDPoint® 500* Blood Gas System* 

RAPIDPoint 500 Blood Gas Analyzers 

provide the accuracy and reliability you have 

come to trust in an easy-to-use, maintenance-free 

solution. Designed to satisfy the 

unique demands of point-of-care testing, the 

cartridge-based system delivers a complete 

critical-care test menu from a single, wholeblood 

sample: pH and blood gases, electrolytes, 

glucose, total neonatal bilirubin, and 

full CO-oximetry. Engineered to maximize 

uptime, you can count on the RAPIDPoint 

500 system to be ready to use without slowing 

down your staff with complex operating 

procedures and maintenance tasks. Longlasting 

cartridges, integrated automatic QC, 

and proven technologies free clinicians to 

focus on patient care as your workload and 

testing needs continue to grow. *In development. 




Personalized Education Plan 

The Personalized Education Plan (PEP) is 

a patent-pending, competency-based approach 

to customized laboratory education. 



Managed online, PEP blends the unique 

attributes of formal instruction, interactive 

training, state-of-the-art technology, and 

expert insight that help advance staff development 

and improve productivity. With 

a core system-based curriculum, PEP also 

provides ongoing guidance and educational 

support for a wide variety of professional 

and disease-management topics. In addition, 

PEP can be personalized to accommodate 

different needs, preferences, and learning 

styles through a multitude of convenient 

delivery vehicles. 




LOCI® CA Assays on Dimension Vista® System 

LOCI CA 125II, CA 15-3, and CA 19-9 assays 

for Dimension Vista systems are homogenous, 

sandwich, chemiluminescent immunoassays 

for the quantitative measurement of 

CA 125II, CA 15-3, and CA 19-9. LOCI CA 

assays integrate oncology testing into routine 

workflows on a consolidated platform and 

are the only CA assays to employ LOCI 

technology. When used in conjunction with 

other clinical and diagnostic procedures, 

serial testing with LOCI CA markers may 

be useful as an aid in managing previously 

treated cancers, for monitoring response to 

therapy, or for monitoring disease progress, 

recurrence, or residual disease. 




INNOVANCE® D-Dimer Assay 

The INNOVANCE D-Dimer Assay has been 

used by labs to aid in diagnosis of life-threatening 

venous thromboembolic events like 

deep vein thrombosis (DVT) and pulmonary 

embolism (PE). It is now available for use in 

conjunction with a non-high clinical pretest 

probability assessment model to exclude 

the presence of DVT and PE. Speed and 

performance make INNOVANCE D-Dimer 

a robust, cost-effective assay for both routine 

and emergency (STAT) use, capable of 

streamlining your laboratory workflow. The 

fully automated blood test runs on multiple 

coagulation systems offered by Siemens, 

including the BCS®, BCS® XP, and Sysmex® 

Coagulation Systems. 




IMMuLITE® 2000 xPi Immunoassay System* 

The IMMULITE 2000 XPi Immunoassay 

System is a continuous, random-access 

analyzer that includes enhanced hardware 

and software features designed to handle 

many of today’s immunoassay-testing chal- 

lenges. Enhancements include Auto Rack 

Load for no-pause sampling and AutoStart 

for automation of routine maintenance, 

and QC. Additionally, the IMMULITE 2000 

XPi system features an extensive automated 

routine, allergy, and specialty immunoassay 

menu and processes up to 200 tests/hour. 

*Not available for sale in the U.S. Pending 

FDA clearance. Available for sale outside the 

U.S. 




Dimension® ExL 200 

Integrated Chemistry System 

The Dimension EXL 200 Integrated 

Chemistry System is the latest addition to 

the Dimension family of analyzers. This 

new system features LOCI® advanced chemiluminescence 

technology, providing lowervolume 

laboratories with access to fast, 

sensitive immunoassay testing on a trusted, 

proven, and integrated platform. The test 

menu includes more than 90% of the critical 

methods ordered by physicians and features 

a cardiac STAT menu that delivers highsensitivity 

troponin I results in 10 minutes. 

Additionally, the Dimension EXL 200 system 

features technology new to the Dimension 

EXL line that helps increase productivity 

in the laboratory, such as a sample transfer 

module, sample clot check, and the capability 

to sample from pediatric tubes. 




syngo® Lab Data Manager* 

syngo Lab Data Manager is a new datamanagement 

system that links analyzers and 

StreamLAB® Automation Solutions to the 

laboratory information system (LIS) and 

Siemens remote services. This system provides 

a consolidated view of patient results 

and offers autoverification through which 

laboratories can automate release of test 

results, reduce errors, and increase consistency. 

The integrated quality control module 

ensures high quality result reporting through 

automated Westgard rules, custom rules, and 

real-time analysis of patient median statistics. 

syngo Lab Data Manager is future-ready, with 

a built-in growth path to process management 

the next generation of diagnostics IT. 





CEDIA® Oral Fluids Immunoassays 

These new Thermo Scientific CEDIA Oral 

Fluid assays use the same well-respected 

CEDIA technology as the urine drug monitoring 

products. The assay format makes administering 

sample collection easier during 

field visits or check-ins. Observing oral fluid 

collection also is noninvasive, reducing the 

risk of sample adulteration. Different size kits 

are available for a range of lab testing needs, 

and calibrators and controls are supplied as 

ready-to-use liquids. The CEDIA Oral Fluid 

Control Set is packaged at more than 50% 

of cutoff and can be used with any lot of 

reagent. Oral-fluid screening is now faster 

and more cost-effective with applications 

for a variety of clinical chemistry analyzers. 

Contact us at (800) 232-3342 or email us at 

sales.diagnostics.fmt@thermofisher.com. 

Thermo Fisher Scientific 

www.thermoscientific.com 


QMS® Teicoplanin Immunoassay* 

The Thermo Scientific QMS Teicoplanin 

Immunoassay is intended for quantitative 

determination of teicoplanin in human 

serum or plasma as an aid in managing patients 

receiving teicoplanin therapy. The assay 

uses the Quantitative Microparticle Systems 

technology that is based on a competitive 

inhibition principle. Teicoplanin is used to 

treat moderate-to-serious infections caused 

by bacteria. QMS liquid-stable, ready-to-use 

reagents offer superior performance and 

are widely applicable to a variety of general 

chemistry analyzers. The assay offers excellent 

curve stability and low interference with 

endogenous substances. Contact us at (800) 

232-3342 or email us at sales.diagnostics. 

fmt@thermofisher.com. *Available for sale 

outside the US. 




QMS® Everolimus Immunoassay 

The Thermo Scientific QMS Everolimus 

Immunoassay is the newest addition to a full 

menu of immunosuppressant drug monitoring 

immunoassays. There are applications for 

a variety of clinical chemistry analyzers. The 

QMS Everolimus assay was developed using 

the Quantitative Microsphere Systems technology, 

incorporating microparticle beads.


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The test is based on a competitive inhibition 

principle. This assay recently received FDA 

clearance for management of kidney transplant 

patients receiving everolimus therapy. 

Training and service is available by our highly 

trained field technical service team, and our 

24/7 hotline provides on-going support for 

your lab. Contact us at (800) 232-3342 or 

email us at sales.diagnostics.fmt@thermofisher.com. 




Indiko Clinical Chemistry Analyzer* 

Introducing the new Thermo Scientific 

Indiko, a superior benchtop photometric 

analyzer. Indiko’s compact design occupies 

a small footprint, is easy-to-install, and does 

not require external water or drainage connections. 

An easy-to-use graphic interface, 

combined with the unique low-volume 

cuvette design, reduces reagent usage and 

operating cost. A flexible loading system with 

combined sample and reagent disks allows 

for continuous access to samples, reagents, 

and cuvettes without interrupting the testing 

process. Once loaded, the analyzer automates 

all necessary steps, providing a walk-away 

time of up to 2 hours. Contact us at (800) 

232-3342 or email us at sales.diagnostics. 

fmt@thermofisher.com. *Pending FDA 

clearance. 




MAS® Omni•IMMUNE Control* 

Thermo Scientific MAS Omni•IMMUNE 

and MAS Omni•IMMUNE PRO consolidates 

immunochemistry QC testing. Com- 

bining the analytes for routine immunoassays, 

cancer markers, and newer specialty 

tests into a single, three-level QC material 

streamlines lab QC testing process by 

rolling three historically distinct products 

into a single vial. MAS Omni•IMMUNE 

PRO provides anti-Tg, anti-TPO, and 

SHBG in addition to assays provided in the 

standard Omni-IMMUNE. Value assignment 

is provided for the newer generation 

of consolidated instrument systems that 

use multiple technologies. The new MAS 

Omni products help align lab QC requirements 

with these new instrument options. 

Contact us at (800) 232-3342 or email us at 

sales.diagnostics.fmt@thermofisher.com. 

*Pending FDA clearance. 




MAS® Omni•CORE Control* 

Thermo Scientific MAS Omni•CORE 

provides the highly requested consolidation 

of general chemistry and immunology QC 

products. Combining CRP, Rheumatoid 

Factor, and key serum protein tests with a 

general chemistry panel into a single, threelevel 

QC material streamlines lab QC testing, 

rolling two historically distinct products into 

a single vial. MAS Omni•CORE provides 

class-leading QC stability while maintaining 

distinct level separation. Value assignment 

is provided for the newer generation of 

consolidated instrument systems that use 

multiple technologies. The new MAS Omni 

products help align lab QC requirements 

with these new instrument options. Contact 

us at (800) 232-3342 or email us at sales.diagnostics.fmt@thermofisher.com. 

*Pending 





MAS® DOA Total Control 

The new Thermo Scientific MAS DOA 

TOTAL Control is a multi-constituent urine 

toxicology control offering 19 analytes with 

four distinct levels at drug concentrations 

25% above and below commonly used 

screening and SAMHSA cutoffs. A drug-free 

level and high-positive level are also available 

(six levels total). The MAS DOA TOTAL 

Control is a liquid, ready-to-use product 

available for use on a variety of instrument 

platforms. Each level of control is individually 

packed, which gives you the flexibility to 

choose your levels according to your drug- 

screen panel cutoffs while keeping the number 

of control vials to a minimum. Contact 

us at (800) 232-3342 or email us at sales. 

diagnostics.fmt@thermofisher.com. 




Fluoro-Max Fluorescent Particles* 

Fluoro-Max Fluorescent Particles are internally 

dyed with europium chelate and come 

in carboxylate-modified and streptavidincoated 

versions. The particles produce a very 

broad Stokes shift so that any non-specific 

fluorescent interference can be avoided. This 

characteristic makes these particles ideal for 

lateral flow, diagnostic assay, nucleic acid hybridization, 

immuno/histological, research, 

point-of-care, membrane, and other timeresolved 

microfluorescent applications. Available 

in 0.1-, 0.2-, and 0.3- µ diameters, these 

particles excite at 333 nm and emit at 613 

nm, and they do so for an extended lifetime 

of approximately 0.5 milliseconds. *Available 



www.thermoscientific.com/ 

particletechnology 


Sera-Mag® SpeedBeads 

Magnetic Protein A/G Particles* 

Sera-Mag SpeedBeads Magnetic Protein A/G 

Particles provide a fast and convenient method 

for both manual and automated magnetic 

isolation of proteins using affinity binding. 

These nominal 1-µm diameter, uniform, colloidally 

stable, monodispersed, non-porous 

super paramagnetic particles can be used for 

isolating antibodies from serum, cell culture 

supernatant, or ascites, as well as for immunoprecipitation 

and co-immunoprecipitation 

of antigens from cell or tissue extracts. 

The particles are supplied at 1% solids (10 

mg/mL) in 0.05% sodium azide and are 

available in 1-, 15-, and 100- mL bottles. 

Manufactured under strict quality and GMP 

controls in our medical device-registered, 

ISO 13485-certified facility. *In development. 





Labmaster® ABC-CB200R 

The Labmaster Automatic Balancing Compact 

Benchtop Centrifuge with refrigeration 

features a built-in, auto-balancing mechanism 

that measures imbalance and corrects 

it automatically. It has a maximum RCF of 

19,839 x g and a maximum speed of 13,000 

rpm. The centrifuge is very stable and operates 

silently. You can choose from four differ- 



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ent rotors. Redesign your lab with Labmaster 

Auto Balancing Centrifuge and save yourself 

time and money. 

Hanlab Corporation 

www.hanlab.co.kr 


Qualiris by Stago Hemostasis QA Program 

Qualiris by Stago is the new hemostasis 

quality assessment program. The program 

offers the broadest range of routine and 

specialty parameters for proficiency testing 

with the flexibility to meet the needs 

of your laboratory. The Qualiris program 

is an easy-to-use, web-based system, with 

thousands of participants worldwide, ensuring 

the maximum statistical comparison of 

your results. With Qualiris, Stago is pleased 

to provide real-time, peer-group reports, 

advanced technical support, and diagnostic 

challenges—an additional level of confidence 

for your hemostasis lab. 

Diagnostica Stago, Inc. 

www.stago-us.com 

Booth No. 731 

STA®-Staclot® dRVV Screen and Confirm 

The FDA-cleared STA-Staclot dRVV Screen 

and Confirm are fully automated assays 

for detecting lupus anticoagulants (LA) in 

patient plasma by the diluted Russell viper 

venom method. Each reagent is barcoded for 

ease-of-use on the STA line of analyzers. The 

STA Staclot dRVV Screen uses a reagent with 

a low phospholipid concentration, enhancing 

its sensitivity and prolonging the clotting 

time. The STA Staclot dRVV Confirm uses a 

reagent with a high phospholipid concentration 

that neutralizes the LA present in the 

plasma, shortening the clotting time. The 

tests are not affected by contact factor deficiencies, 

factor VIII, and IX deficiencies, or 

other specific inhibitors, as well as by samples 

containing therapeutic levels of heparin. STA 

Staclot dRVV Screen and Confirm in conjunction 

with Staclot LA are complimentary 

in fulfilling the recommendations established 

by ISTH. 



Booth No. 731 



CY-Quant VASP/P2712* 

CY-Quant VASP/P2Y12 by Stago is a 

ELISA-based assay for measuring patient 

responsiveness to thienopyridines or other 

drugs that target the platelet P2Y12 receptor. 

Responsiveness by patients to these drugs 

exhibits bell-shaped curve behavior, with low 

responders at risk of ischemic injury due to 

clot formation. Due to this fact, research into 

how patients respond to and factors that 

affect this response will serve extremely useful 

for future efforts to treat patients using 

this class of drugs. *For research use only. 



Booth No. 731 

Ecarin Chromogenic Assay* 

The Ecarin Chromogenic Assay (ECA) is an 

enhancement of the Ecarin Clotting Time 

(ECT), the reference method for determining 

direct thrombin inhibitors (DTIs) such as 

argatroban (Argatra®). Although general 

monitoring of these drugs is not recommended, 

many high-risk patients require an 

adapted dosage to minimize dangerous side 

effects. *For research use only. 



Booth No. 731 

STA Coag Connexion 

STA Coag ConneXion is an easy-to-use, 

Windows® 7-based user interface that offers 

comprehensive QC management, remote 

QC capability, and standardized result 

reporting with the use of expert rules for 

autovalidation. Automatic re-runs reflex 

test capability, and delta checks also are 

included in the Coag ConneXion system. 

Coag ConneXion gives you the flexibility 

of a completely paperless solution with the 

ability to record all of your patient samples, 

quality control samples, service calls, reagent 

logs, and maintenance logs. Future features, 

such as automated lot conversion templates, 

will further enhance your lab’s ability to 

automate and simplify time-consuming 

processes. STA Coag ConneXion is the 

perfect compliment to any Diagnostica Stago 

analyzer and provides the highest level of 

data automation in the industry. 



Booth No. 731 

AlfaLYZER Saliva Parent 

THC Low-Cutoff System 

Alfa Scientific Design announces our new 

breakthrough in parent THC detection for 

our rapid drugs-of-abuse tests. Stop by our 

booth to hear about this exciting, new breakthrough 

in THC testing that is a quantum 

leap ahead of the competition. It didn’t take 

a genius to realize that up until now, rapid 

drug testing products that were on the market 

were really not detecting parent THC. 

This year we will be showing a new product 

at our booth that will make it relatively easy 

to detect parent THC at levels that previously 

were not achievable. 

Alfa Scientific Designs, Inc. 

www.alfascientific.com 

Booth No. 315 

iRICELL® 1500 Automated urinalysis System 

The iRICELL 1500 consists of the iQ 

200SELECT Automated Urine Microscopy 

Analyzer connected to the iCHEM® VELOC- 

ITY Automated Urine Chemistry analyzer. 

Iris Diagnostics, 

a Division of IRIS International 

www.irisdiagnostics.com 

Booth No. 419 

OVA1 Test 

OVA1 is the first FDA-cleared test for aiding 

in pre-surgical evaluation of an ovarian mass 

for cancer, and also is the first protein-based 

in vitro diagnostic multi-variate index assay, 

a new class of state-of-the art, software-based 

diagnostics. The test uses five biomarkers— 

transthyretin, apolipoprotein A-1, beta2microglobulin, 

transferrin (Tfr), and CA 125 

II—and a proprietary software to determine 

the likelihood of malignancy in women 

with an ovarian mass for whom surgery is 

planned. OVA1 is indicated for women who 

meet the following criteria: >18 years; ovarian 

adnexal mass present for which surgery is 

planned; and not yet referred to an oncologist. 

Additional product information can be 

found at www.ova-1.com/. 

Vermillion, Inc. 

www.vermillion.com 

Booth No. 236 

Assayed VIROTROL® I Controls 

Assayed VIROTROL I Controls are liquid, 

human serum-based controls, providing 

laboratories with the ability to monitor assay 

precision. With a long shelf-life and openvial 

stability, these products are packaged in 

a convenient dropper bottle. These products 

include anti-CMV, anti-HBc, anti-HCV, anti- 

HIV-1, anti-HTLV-1, and HBsAg analytes 

with expected values provided for major 

instrument platforms. 




VIROCLEAR® Control 

VIROCLEAR Control is a liquid, human 

serum-based control designed as a negative 

control for 18 commonly tested analytes for 

hepatitis, retrovirus, syphilis, and antibodies 

to CMV. With a long shelf-life and open-vial 

stability, these products are packaged in two 

convenient dropper bottle sizes and primary 

tube. 




MAGO® 4S Analyzer 

The MAGO® 4S is the only analyzer capable 

of providing laboratories infinite possibilities 

in ELISA and IFA testing. By allowing ELISA 

and IFA samples to be processed simultaneously, 

the MAGO 4S offers multiple solutions 

to increase laboratory productivity. Additionally, 

with an expanded menu, the MAGO 

4S introduces a level of automation that is in 

a class by itself. This analyzer also performs 

serial, two-fold dilutions, self-cleans and 

calibrates daily, and performs pre-assay plate/ 

reagent volume checks. Windows®- based 

software adds inverse curve capability and a 

full-color screen simplifies setup. Diamedix 

provides a one-stop solution that increases 

productivity, efficiency, and economy. 

IVAX Diagnostics, Inc. 

www.ivaxdiagnostics.com 


Interlab G26 Agarose Gel 

Electrophoresis Analyzer 

The INTERLAB G26 is a compact, benchtop, 

fully automated agarose gel electrophoresis 

analyzer that delivers precise walk-away 

electrophoresis with simplified robotics, 

primary tube sampling, positive sample ID,


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simultaneous assay processing, and automated 

sample dilutions. The robotic arm, 

with its electromagnetic head, controls all 

the automated steps. Simply load barcodelabeled 

sample tubes for positive sample 

identification from tube to completed result. 

Neat samples, and those requiring dilutions, 

are prepared with ease using the on-board 

sampler. The migration chamber peltier uses 

vacuum-controlled gel adhesion with disposable 

electrode sponges for precise band focalization 

and easy set-up and maintenance. 

Grifols USA 

www.grifols.com 


Enzymatic Creatinine Reagent Set 

Pointe Scientific has introduced a new enzymatic 

creatinine assay for automated chemistry 

analyzers. This two-part, liquid-stable 

reagent eliminates endogenous creatine and 

ascorbic acid and offers 18-month shelf-life 

and up to 30-day, on-board stability. Hemoglobin 

to 500 mg/dL, conjugated bilirubin to 

32 mg/dL, and unconjugated bilirubin to 40 

mg/dL has been shown not to interfere with 

the assay. The assay shows excellent correlation 

to other creatinine assays. Precision studies 

conducted according to CLSI: EP 5 protocol 

yielded excellent precision with CVs below 2%. 

Pointe Scientific, Inc. 

www.pointescientific.com 


DYNEx Agility System 

Magellan Biosciences has redefined ELISA 

processing with the new DYNEX Agility—an 

ingenious, state-of-the-art system featuring 

the most advanced walkaway automation in 

the category. Agility allows up to 12 microplates 

to be loaded on-board as they are 

prepared and can process 16 assays simultaneously. 

Agility also minimizes hands-on 

time thanks to revolutionary reagent loading 

technology, eliminating nearly all liquid transfer 

steps with Agility SmartKits. SmartKits 

contain all the reagents needed for each assay 

in a durable kit that is loaded directly onto the 

instrument in one step—no manual reagent 

pipetting is required! Achieve optimal turnaround 

and productivity with Agility. 

Dynex Technologies, Inc. 

www.dynextechnologies.com 


EasyRA Clinical Chemistry Analyzer 

The EasyRA is a fully automated, clinical 

chemistry analyzer for use in low-to- 

moderate volume hospital and physician 

office laboratories. New software capabilities 

allow for both standard chemistry testing 

and now urine drugs-of-abuse testing, as well 

as turbidimetric and enzymatic immunoassay 

tests. The EasyRA sets a new standard in 

its class with a combination of unprecedented 

ease-of-use, intuitive user interface, and 

limited maintenance. 

Medica Corporation 

www.medicacorp.com 


ST AIA-PACk ACTH and ST AIA-PACk DHEA-S* 

Tosoh introduces two new assays to add to 

its AIA test menu: ST AIA-PACK ACTH 

and ST AIA-PACK DHEA-S. ST AIA-PACK 

ACTH is designed for in vitro diagnostic use 

only for quantitative measurement of ACTH 

in human EDTA plasma on Tosoh AIA System 

Analyzers. ST AIA-PACK DHEA-S 

is designed for in vitro diagnostic use only 

for quantitative measurement of dehydroepiandrosterone 

sulfate (DHEA-S) in 

human serum, heparinized or EDTA plasma, 

on TOSOH AIA System Analyzers. Both 

ACTH and DHEA-S use Tosoh’s unit-dose 

test cup technology, and the assay time is 

approximately 20 minutes. Both assays offer 

a calibration stability of 90 days. *Pending 


Tosoh Bioscience 

www.tosohbioscience.us 

Booth No. 401 

AIA-900 Automated Immunoassay Analyzer* 

Tosoh introduces the highly anticipated AIA- 

900 Automated Immunoassay Analyzer. This 

flexible new addition to Tosoh’s respected 

family of AIA analyzers has a throughput 

of 90 tests/hour and is available in three 

different options: the AIA-900, the AIA-900 

with the nine-tray sorter, and the AIA-900 

with the 19-tray sorter. The three models 

present customers with a unique opportunity 

to grow with their testing volumes. 

For example, a laboratory that purchases 

the AIA-900 can add the nine-tray sorter to 

increase testing capacity without changing 

their instrument. The AIA-900 uses the same 

Unit-Dose Test Cup reagent technology as 

all Tosoh AIA immunoassay analyzers. The 

AIA-900 is being launched with the full AIAtest 

menu*. *Pending FDA clearance for ST 

AIA-PACK PA. 

Tosoh Bioscience 

www.tosohbioscience.us 

Booth No. 401 

Rx suzuka Clinical Analyzer* 

The RX suzuka is a fully automated, 

random-access clinical analyzer capable of 

performing up to 1200 tests/hour includ- 

ing ISEs, providing laboratories with increased 

efficiency and productivity. The RX 

suzuka offers: unparalleled productivity via 

economic reagent handling; guaranteed flexibility 

with our comprehensive and diverse 

test menu, allowing for complete consolidation 

of routine and specialized tests on one 

platform; and unique system reliability, 

resulting in greater accuracy and efficiency. 

Unrivaled versatility and flexibility make the 

RX suzuka suitable for a variety of settings, 

including clinical chemistry, research, veterinary, 

toxicology, and food and wine testing 



Randox Laboratories 

www.randox.com 


Aution Max Ax-4030 

urine Chemistry Analyzer 

The Aution Max AX-4030 is the latest 

advancement from U.S. ARKRAY, Inc. The 

Aution Max AX-4030 is a high-capacity, fully 

automated, urine chemistry analyzer with 

true walk-away capabilities. The Aution Max 

AX-4030 can hold up to 100 samples and 

400 test strips, meeting your workflow 

demands. The Aution Max AX-4030 allows 

for batch, continuous loading, and STAT 

capabilities and provides a throughput of 225 

samples/hour. Key technological features include: 

a refractometer for specific gravity and 



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a test strip feeding mechanism with a sensor 

that ensures a single strip is dispensed and in 

the correct position, eliminating waste. 

Arkray, Inc. 

www.arkrayusa.com 


HE4 Antigen* 

Human epididymis protein 4 (HE4) is a secreted 

glycoprotein that is expressed by ovarian 

carcinomas. HE4 is an FDA-approved 

biomarker for monitoring the recurrence or 

progression of ovarian cancer. Bioprocessing, 

Inc. has been providing the diagnostic market 

with high-quality tumor marker antigens 

for clinically approved and novel immunoassays 

for 20 years. We now offer HE4 Antigen 

from cell culture sources to add to your control, 

calibrator, or standard. Available as either 

a highly purified or a partially pure product 

with low cross-reactivity, Bioprocessing, Inc.’s 

HE4 products will be a valued addition to your 

multi-analyte control. *For research use only. 

BioProcessing, Inc. 

www.bioprocessinginc.com 

Booth No. 39 

Thunderbolt TM ELISA Platform 

The GSD ThunderBolt is a powerful, compact, 

multi-language, fully automated, completely 

open, user-friendly, ELISA platform. 

The features of the instrument include: three 

microtiter plates; intelligent sample racks for 

positive patient identification; LED reader; 

built-in barcode scanner; bi-directional 

interface; orbital shaker; incubator; and onboard 

optics for remote troubleshooting. Up 

to 192 results can be generated in one run on 

a combination of up to eight different assays. 

The innovative design provides customers 

with a flexible, cost-effective, highly efficient, 

automated laboratory solution. 

Gold Standard Diagnostics, Inc. 

www.gsdx.us 


ProbeTec Herpes Simplex 

Viruses 1 & 2 Qx Assays 

The new BD ProbeTec Herpes Simplex 

Viruses (HSV 1 & 2) Qx Amplified DNA 

Assays (HSV Qx Assays) run on the BD 

Viper System with XTR Technology 

that uses strand-displacement amplification 

technology to qualitatively detect and differentiate 

HSV1 and HSV2 DNA. The new 

BD ProbeTec HSV Qx Assays offer 



excellent sensitivity and specificity and a 

significant improvement in the time-toresults 

over culture methods that often take 

2–10 days. BD’s new automated HSV assays 

also provide laboratories with the capability 

to read up to 96 positive or negative results in 

about 2.5 hours. Using the BD Viper System 

with XTR Technology, laboratories also will 

be able to test other samples for chlamydia 

and gonorrhea on the same automated run 

used for the BD ProbeTec HSV1 and HSV2 

Qx Assays. 

BD Diagnostics 

www.bd.com/ds 

Booth No. 820 

CleanAmp PCR kits 

CleanAmp PCR Kits are powered by 

TriLink’s innovative, heat-activated dNTP 

chemistry. Activation of the CleanAmp 

chemistry occurs during the initial heat cycle 

of hot start PCR and each subsequent denaturation 

step, releasing just enough reagents 

to allow efficient amplification. CleanAmp 

PCR Kits benefit basic applications, as well 

as more advanced variants, such as real-time, 

multiplex, and reverse-transcription PCR. 

Customers can eliminate or reduce off-target 

amplification, significantly increase amplicon 

yield and specificity, and commercialize for 

less with reasonable licensing options. 

TriLink Biotechnologies, Inc. 

www.trilinkbiotech.com 


ultra-Sensitive Gold Sol 

BioAssay Works has developed unique 

colloidal-gold nanoparticle manufacturing 

technology, producing 15- to 100-OD concentrated 

gold particles in sizes ranging from 

10–120 nm. These higher concentrations 

confer demonstrable performance advantages, 

especially increased test sensitivity, when 

applied to immunoassays. BAW’s nanoparticles 

are used to develop ultra-sensitive, 

point-of-care rapid tests, molecular circuitry, 

evanescent wave backscatter technologies, 

and forward, light-scattering, flow cytometric 

immunoassays. BAW nanoparticles’ high 

concentration allows the user to rapidly coat 

the surface of the particles with biomolecules 

and use the coated particles in various testing 

formats without further concentration or 

purification. 

BioAssay Works 

www.bioassayworks.com 


LIAISON® Measles and Mumps IgG Assays 

The LIAISON Measles and Mumps IgG 

Assays use chemiluminescent immunoassay 

technology on the LIAISON Analyzer 

for detecting IgG antibodies to measles and 

mumps viruses in human serum to aid in 

determining serological status to measles and 

mumps virus. With first result in 35 minutes 

and throughput of 90 results/hour, these chemiluminescent 

immunoassays for measles 

and mumps IgG complete the MMRV IgG 

assay panel. DiaSorin is a worldwide specialty 

immunoassay leader in vitamin D and 

infectious disease testing with a history of 

expertise that spans more than 25 years. 

DiaSorin, Inc. 

www.diasorin.com 


syngo® Lab Process Manager* 

syngo Lab Process Manager integrates data 

management with process control to deliver 

next-generation diagnostics IT. This breakthrough 

IT solution provides a consolidated 

view of the lab’s testing processes and equipment 

so the operator can quickly identify 

and resolve problems before they impact 

quality and turnaround times. *Available for 

sale outside the U.S. 




EHIV Assay on ADVIA Centaur® CP Sys 

The ADVIA Centaur HIV 1/O/2 Enhanced 

(EHIV) Assay is an immunoassay for qualitative 

determination of antibodies to human 

immunodeficiency virus (HIV) type 1, 

including Group O, and/or HIV type 2, in 

serum or plasma. Addition of the highperformance 

EHIV assay on the ADVIA 

Centaur CP extends the total available menu 

to 64 assays. The EHIV assay is developed, 

manufactured, and sold by Siemens Healthcare 

Diagnostics, Inc. for Ortho-Clinical 

Diagnostics, Inc. 




LOCI® TPSA and FPSA Assays 

on the Dimension Vista®* 

LOCI TPSA and FPSA for the Dimension 

Vista 1500 system consolidate PSA testing on 

a single platform and are the only PSA assays 

on the market to employ LOCI technology, a 

homogenous, sandwich, chemiluminescent 

immunoassay for quantitatively measuring 

total prostate-specific antigen (TPSA) and 

free prostate-specific antigen (FPSA). 

Measurements of TPSA and/or FPSA aid 

in detecting prostate cancer when used in 

conjunction with digital rectal exam in men 

≥50 years, in management of prostate cancer, 

and with calculations of percent FPSA in 

distinguishing cancer from benign prostate 

conditions. *Pending FDA clearance. 




LOCI® Free T3 Assay on the 

Dimension® ExL System 

The Dimension EXL Free T3 Assay is a 

homogenous, chemiluminescent immunoassay 

based on LOCI technology. The LOCI free 

T3 methodology provides rapid turnaround, 

high analytical sensitivity, and excellent precision 

to assist physicians in diagnosing and 

treating thyroid patients. The free T3 assay 

completes the common panel of thyroidfunction 

assays on the Dimension EXL with 

LM system. This panel includes ultrasensitive, 

third-generation TSH, total T4, 

FT4, and FT3. Consolidation of these assays 

on a single, integrated platform enhances 

the laboratory’s workflow efficiency without 

compromising on results. 




BRAHMS PCT Assay* on ADVIA Centaur® 

The ADVIA Centaur BRAHMS PCT 

(procalcitonin) Assay is a one-step, sandwich, 

chemiluminescent immunoassay used for 

determining PCT in human serum and plasma 

on the ADVIA Centaur Immunoassay 

System. This PCT assay provides additional, 

specific information that may be helpful 

in increasing the accuracy of sepsis 

diagnosis at an early stage to aid in risk 

assessment of critically ill patients. Sepsis 

is a serious medical condition caused by 

the body’s response to an infection. Early 

detection and targeted clinical intervention 

have been demonstrated to be crucial 

for improved outcomes in septic patients. 

*Not available for sale in the US. Pending 




Booth No. 1605


Advertisement 

25-OH Vitamin D Assay 

Diazyme’s 25-Hydroxy Vitamin D assay is an 

innovative homogenous assay that measures 

the true total 25-hydroxy vitamin D, the sum 

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Diazyme Laboratories 

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Enzymatic Glycated Albumin Assay kit 

Diazyme’s Glycated Albumin Assay Kit is a 

two-part, liquid-stable reagent that can be 

used with most automated clinical chemistry 

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Diazyme Laboratories 



MAx Open System* 

Announcing the BD MAX Open System 

for molecular testing—the first and only 

system capable of performing user-defined 

protocols, IVD assays, and life science 

research with full automation. The BD MAX 

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BD Diagnostics 

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Booth No. 820 

VITROS® 4600 Chemistry System 

The VITROS 4600 Chemistry System is 

Ortho Clinical Diagnostics’ most recent 

addition to the VITROS Family of analyzers. 

Like its siblings the VITROS 5600 Integrated 

System and the VITROS 3600 Immunodiagnostic 

System, our newest analyzer offers 

standardized, high-quality test results using 

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VITROS 4600 System leverages our patented 

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ease-of-use and productivity. The VITROS 

4600 System answers the essential healthcare 

challenges you face everyday: improve patient 

care while balancing staffing, compliance, and 

total operating cost containment. 




APTIMA® Trichomonas vaginalis Assay 

The Gen-Probe APTIMA Trichomonas 

vaginalis Assay is the first NAAT to be FDAcleared 

for the detection of Trichomonas 

vaginalis, a sexually transmitted parasite that 

is more prevalent than Neisseria gonorrhoeae 

and Chlamydia trachomatis. Untreated infections 

can negatively impact reproductive 

health and increase risk for HIV acquisition 

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NAATs offer improved sensitivity for detection 

of Trichomonas compared with current 

testing methods, including wet mount and 

culture. The APTIMA Trichomonas vaginalis 

Assay is cleared for use with the TIGRIS DTS 

System to test clinician-collected endocervical 

or vaginal swabs, urine, and PreservCyt 

solution specimens from symptomatic or 

asymptomatic women. 

Gen-Probe Incorporated 

www.gen-probe.com 


i-STAT 1 Wireless 

On February 14, 2011, Abbott Point-of-Care 

received FDA clearance in the U.S. to market 

its i-STAT 1 Wireless. The i-STAT 1 Wireless 

is a new wireless version of the i-STAT pointof-care 

testing system that is widely used in 

hospitals, emergency rooms, and physicians’ 

offices. The new system allows for the real-time 

transmission of diagnostics test results wirelessly 

from the patient’s bedside via 802.11 

technology. The wireless, handheld device can 

potentially save precious time by allowing caregivers 

to perform critical tests at the bedside 

and then transmit test results immediately. 

Abbott Point-of-Care 

www.abbottpointofcare.com 


AliFax Test 1 and Roller 20 Analyzers 

Excalibur Lab Specialists, Inc. announces the 

U.S. introduction of the Test 1 and Roller 20 

lab analyzers from Alifax® Italy. These new 

analyzers offer a unique new approach to 

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measuring erythrocyte sedimentation rate 

(ESR). Both the Test 1 and Roller 20 provide 

results in as little as 20 seconds. This is made 

possible by a novel approach that uses the 

kinetics of red-cell aggregation. The test’s 

fast turnaround time and the system’s ability 

to use only a 150-µL sample from standard, 

primary blood-collection tubes enables 

improved batch processing that establishes a 

new benchmark for ESR automation. 

Alifax SpA 

www.excaliburlabspecialists.com 


Vitamin D Control* 

The Fujirebio Diagnostics, Inc. Vitamin D 

Control is an assayed, tri-level vitamin D 

control containing both 25(OH) vitamin 

D2 and 25(OH) vitamin D3. The control 

contains clinically relevant concentrations 

of 25(OH) vitamin D, as well as excellent 

reconstitution stability. Manufactured to the 

highest quality standards and value assigned 

across platforms, the Vitamin D Control 

ensures accurate precision monitoring of in 

vitro diagnostics laboratory testing procedures 

and techniques. Reconstituted, openvial 

stability is 14 days at 2–8ºC. All analytes 

are stable for 60 days when stored at ≤–10ºC. 

The control sustains nine freeze/thaw cycles. 


Fujirebio Diagnostics, Inc. 

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8867 


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OnlineLearning_CLN_ad_may2011.indd 1 5/11/11 8:36 AM

hhs announces Proposed 

changes to hiPaa Privacy rule 

under a rule proposed by the U.S. Department 

of Health and Human Services 

Office for Civil Rights, individuals 

would be given the right to get a report on 

who has electronically accessed their protected 

health information. The proposed 

rule is a change to the Privacy Rule under 

the Health Insurance Portability and Accountability 

Act (HIPAA). 

With this change, people could obtain 

this information by requesting an electronic 

access report that would document 

the particular persons who electronically 

accessed and viewed their protected health 

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protected health information, they are not 

required to share this information. The 

proposed rule also requires an accounting 

of more detailed information for certain 

disclosures that are most likely to affect a 

person’s rights or interests. 

To effect the change, all healthcare organizations 

will be required to update their 

privacy notices under HIPAA to educate 

patients about requesting access reports. 

The new rule will take effect January 1, 

2013, if adopted. 

Comments on the proposed rule will be 

accepted through August 1, 2011. To read 

the proposed rule or submit a comment, go 

to www.regulations.gov. 

reform to net $120 billion 

in savings for medicare 

an analysis issued by the Centers for 

Medicare and Medicaid Services (CMS) 

www.optima-usa.com 

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Meet us at AACC, Atlanta, July 26–28, 2011 

booth no. 1953 

outlines $120 billion in 5-year projected 

savings resulting from improvements to the 

Medicare program, including implementation 

of many provisions in the Affordable 

Care Act. The report summed up projected 

savings from several sources, including new 

tools to combat fraud, waste, and abuse 

in the Medicare system, as well as delivery 

system reforms, such as those that deter 

hospital readmissions. 

The report looked at five general areas 

of projected savings: reforming provider 

payments to reward quality of care, $55 

billion; lowering hospital readmission and 

hospital-acquired infections, $10 billion; 

fraud and abuse prevention, $1.8 billion; 

improvements in durable medical equipment 

purchasing, $2.9 billion; reducing 

payments to insurance companies, $50 billion. 

The full report is available from the 

CMS website, www.cms.gov/apps/files/ 

medicare-savings-report.pdf. 

sured. Most uninsured people have virtually 

no savings, and the median per-family 

financial assets for uninsured families are 

just $20. Even among higher-income families, 

assets are low: half of families with income 

at 400% of the Federal Poverty Level, 

or $89,400 a year for a family of four in 

2011, have financial assets below $4,100. 

The report is available from the HHS 

website, https://aspe.hhs.gov/health/reports 

/2011/ValueofInsurance/rb.shtml. 

hhs begins broad 

battle over Payment 

advisory board continues 

The Affordable Care Act established a 

15-member Independent Payment Advisory 

Board (IPAB) charged with making 

cuts to Medicare in years that spending exceeds 

a target growth rate. Under the Act, 

IPAB recommendations will automatically 

become law unless blocked by both Congress 

and the President. The Congressional 

Budget Office (CBO) recently estimated 

that repealing IPAB would inevitably mean 

stronger spending growth, adding up to 

regulatory review 

$2.4 billion between 2018 and 2021. 

The U.S. Department of Health and Hu- The CBO report is bad news for House 

man Services (HHS) released its pre- Republicans who have targeted IPAB in 

liminary plan for retrospective review of their effort to defund or repeal healthcare 

existing rules based on a comprehensive reform provisions. This year Representative 

inventory of each of its agencies’ existing Phil Roe (R-Tenn.) introduced legislation, 

regulations. The plan highlights regulations H.R.452, the “Medicare Decisions Account- 

already being modified or streamlined and ability Act,” to abolish IPAB. The projected 

identifies additional candidates for further costs of doing away with IPAB means that 

review. 

the bill would also need to offset these costs 

Earlier this year, President Obama out- somewhere else in the budget. 

lined his plan for ongoing review of regula- Beginning April 2013, the Affordable 

tions in the federal government with the in- Care Act requires the chief actuary of the 

tention of culling rules that are out-of-date, Centers for Medicare and Medicaid Servic- 

unnecessary, excessively burdensome, or in es to project whether Medicare per capita 

conflict with other rules. 

spending exceeds the average Consumer 

The HHS plan outlined several areas Price Index, based on a 5-year period. If 

for improvement, including conflicting so, beginning January 15, 2014, IPAB must 

requirements between Medicaid and Medi- submit recommendations to cut Medicare 

care; reviewing the criteria used to define spending. The board must also submit rec- 

health professional shortages and mediommendations every other year to slow the 

cally underserved areas; and using more growth in national private health expendi- 

cost-effective technologies like electronic tures while preserving quality of care. The 

signatures and document storage. 

threshold target will then change begin- 

The full regulatory review plan for the ning in 2018, when it becomes Medicare 

agency is available on www.whitehouse. per capita spending that exceeds gross do- 

gov. 

mestic product per capita plus 1%. The law 

specifically prohibits IPAB from submitting 

proposals that would ration care, increase 

report: most uninsured 

revenues, or change benefits, eligibility, or 

can’t Pay bills 

Medicare beneficiary cost sharing. 

new report released by the U.S. De- More information is available from the 

a partment of Health and Human Ser- CBO website, www.cbo.gov. 

vices (HHS) shows that few families without 

health insurance have the financial 

assets to pay potential hospital bills. On 

average, uninsured families can only afford 

to pay in full for approximately 12% next in CLN 

of hospital stays they may experience, and 

even higher-income uninsured families are 

unable to pay for most potential hospitalizations, 

the report found. 

Hospital stays for which the uninsured 

cannot pay in full account for 95% of the 

total amount hospitals bill the uninsured. 

Platelet 

function 

Testing 

The idea that people without heath insurance 

can get care with little or no problem 

is an enduring myth, said HHS Secretary 

Kathleen Sebelius. 

According to the new report, approximately 

50 million Americans are unin- 

30 years of 

hiv Testing

iNdustry 



Quest completes 

in pre-clinical development for advanced 

non-small cell lung cancer (NSCLC) pa- 

acquisition of celera 

tients, will run on Roche’s Cobas 4800 sys- 

Quest Diagnostics has successfully tem and is intended for the identification 

completed acquisition of Celera Cor- of mutations, including the EGFR T790M 

poration for approximately $671 million. mutation, in patients with NSCLC. “Our 

According to Quest, the deal was com- agreement with Clovis Oncology strengthpleted 

through a short-form merger, after ens our position as the partner of choice for 

its tender offer expired. Quest announced the development of companion diagnos- 

plans to purchase Celera in March in an eftics. Roche hopes that through this collabofort 

to strengthen its molecular diagnostics ration we will be able to advance oncology 

portfolio. 

diagnostic testing and drug therapy for the 

benefit of many patients worldwide,” said 

Paul Brown, head of Roche Molecular Di- 

danaher extends offer 

agnostics. 

for beckman coulter 

danaher has extended for a third time 

its cash tender offer to acquire all of Thermo fisher signs deal to 

the outstanding shares of Beckman Coulter, 

Inc. for $83.50 per share in cash. All 

other terms and conditions of the offer 

expand specialty dx Portfolio 

Thermo Fisher Scientific has inked a 

definitive deal to acquire Phadia, an al- 

remain unchanged. Danaher continues to lergy and autoimmunity diagnostics firm. 

anticipate completing the acquisition in The deal is designed to significantly expand 

2011. The deal is valued at approximately Thermo Fisher’s specialty diagnostics port- 

$6.8 billion. 

folio. Currently, Thermo Fisher’s diagnostics 

business focuses on tissue-based cancer 

diagnostics, microbiology technologies for 

myriad Genetics licenses cancer detecting pathogens in food and infectious 

diagnostic Technology from chronix diseases, and specialty assays, such as drugs- 

myriad Genetics has licensed the of-abuse testing and its biomarker business. 

rights to technology for early detec- “Phadia is a strong fit strategically with our 

tion of cancer from Chronix Biomedical. existing specialty diagnostic platform, sig- 

Under the terms of the deal, Myriad has nificantly increasing our penetration of a 

the rights to commercialize tests derived high-growth market,” said Thermo Fisher 

from the technology for the early detection 

of breast, colon, and prostate cancers 

in North America, South America, 

president and CEO, Marc Casper. 

and Europe. Myriad Genetics will pay nestle health science acquires 

upfront fees, milestone payments, and 

royalty payments in exchange for access 

to Chronix Biomedical’s technology. 

Prometheus laboratories 

nestle Health Science has finalized an 

agreement to buy Prometheus Labo- 

“The technology we have licensed from ratories for an undisclosed amount. The 

Chronix Biomedical has the potential to deal is aimed at moving the company into 

revolutionize the early detection of cancer the gastrointestinal diagnostics sector. Nes- 

through the analysis of unique DNA setle Health Science is a wholly owned subsidquences 

in blood samples,” said Mark Caiary of Nestle and is focused on developing 

pone, president of Myriad Genetics. science-based nutritional solutions for personalized 

medicine. Joseph Limber, president 

and CEO of Prometheus, said that as 

metabolon moves into the 

a result of the acquisition, his company will 

diagnostics business 

“accelerate the development of our innova- 

metabolon will expand its offerings by tive diagnostics platforms for gastroenterol- 

moving into the diagnostics market. ogy and oncology and potentially into ad- 

The metabolomics firm anticipates the 

launch of its first test for insulin resistance, 

called Quantose. The company will focus 

ditional important therapeutic areas.” 

its attention on developing metabolomics- labcorp Purchases clearstone 

based diagnostics. Two tests for prostate 

cancer are also planned, as well as tests for 

determining the aggressiveness of cancers 

central laboratories 

laboratory Corporation of America has 

signed a definitive deal to buy central 

and for assessing tolerance to chemothera- laboratory service provider Clearstone 

pies, directed at bladder and kidney cancers. Central Laboratories in an effort to bolster 

the company’s companion diagnostics 

business. According to LabCorp, the deal 

roche and clovis collaborate on will provide it with a global network of cen- 

companion dx for eGfr mutations tral laboratories and access to Clearstone’s 

roche and Clovis Oncology have part- clinical trials management system, Apollo 

nered to develop an in vitro PCR- CLPM, which offers real-time access to 

based companion diagnostic test. The as- global data. The deal is expected to close 

say for CO-1686, a compound currently this summer. 

myriad Genetics finalizes 

rules-based medicine Purchase 

myriad Genetics has completed its 

purchase of Rules-Based Medicine 

for $80 million. According to Myriad, Rules- 

Based Medicine will continue its collaborations 

with pharmaceutical partners in companion 

diagnostics discovery. The deal is 

expected to further develop Myriad’s companion 

diagnostics franchise. In addition, 

the acquisition will help expand the company’s 

product portfolio into new disease areas 

including psychiatric disorders, infectious 

diseases, and inflammatory conditions. 

siemens signs agreements to 

strengthen microbiology Portfolio 

siemens Healthcare Diagnostics has 

signed a strategic partnership with 

Copan and a co-marketing agreement 

with Bruker Corporation in an effort to 

strengthen the analytical workflow and 

molecular identification functionality of 

its microbiology portfolio. The new agreements 

grant laboratories access to enhanced 

analytical workflow efficiency and 

advanced mass spectrometric identification, 

designed to support their microbiology 

testing needs. 

neoGenomics laboratories 

inks distribution deal with 

signal Genetics 

Laboratories has signed 

neoGenomics a deal to distribute Signal Genetics’s 

new gene expression profile test for multiple 

myeloma to pathologists and hospital-based 

hematologists and oncologists 

nationwide. Under the terms of the deal, 

Signal Genetics’s Myeloma Prognostic Risk 

Signature test (MyPRS) will be performed 

at its CLIA-certified laboratory in Little 

Rock, Ark. The MyPRS test analyzes a defined 

number of relevant genes to determine 

the gene expression profile associated 

with a patient’s condition, giving physicians 

a predictive view of the patient’s progress 

and enabling personalized treatment decisions. 

NeoGenomics has also obtained 

the right of first negotiation to market any 

genomic and transcriptomic-based diagnostic 

test developed and/or launched by 

Signal Genetics in the future. 

Coagulation Reagents 

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• Anti-Thrombin III 9-35 mg/dL 

• D-Dimer 0.5-30 µg/mL 

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• Factor XIII (plasma) 2.3%-140% 

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Coagulation CLN 05-2011.indd 1 3/28/2011 1:42:51 PM 


hba1c alone not a reliable 

diagnostic Tool in obese 

adolescents 

new research by Yale University investigators 

indicates that a hemoglobin 

A1c (HbA1c) level of 6.5% underestimates 

the prevalence of prediabetes and diabetes 

in obese adolescents (Diabetes Care 

2011;34:1306–11). The results suggest that 

HbA1c alone is a poor diagnostic tool in 

this population, according to the authors. 

The researchers investigated the utility 

of HbA1c in obese adolescents because 

clinical guidelines recently endorsed HbA1c 

to diagnose diabetes and identify patients at 

risk for developing diabetes did not include 

studies involving adolescent populations. 

Studies evaluated to make those recommendations 

all involved adults, and little is 

known about the use of HbA1c in children 

and adolescents. 

The study involved 1,156 obese adolescents 

with a mean age of 13.3 years who 

were not taking medications that might affect 

glucose metabolism and who were not 

already known to have type 2 diabetes. All 

subjects had baseline oral glucose tolerance 

tests (OGTT) and HbA1c testing, and a 

subgroup of 218 subjects had repeated testing 

after a mean of 1.68 years. 

At baseline, 77% of subjects had normal 

glucose tolerance with HbA1c levels 

6.5%. 

However, 27% of subjects considered to 

have normal glucose tolerance based on 

HbA1c results were classified as being prediabetic 

based on OGTT. Among subjects 

diagNostiC 




placed in the at-risk group by HbA1c results, 

53% were considered to have normal 

glucose tolerance and 47% prediabetes or 

diabetes based on OGTT. Finally, 12.5% of 

subjects considered to have diabetes based 

on HbA1c results were designated as having 

normal glucose tolerance and 24% to 

have prediabetes by OGTT. 

Based on these findings, the researchers 

called for further investigation about the 

role of HbA1c levels in diagnosing prediabetes 

and diabetes in adolescents and children. 

ovarian cancer screening does not 

reduce cancer-related mortality 

findings from the landmark Prostate, 

Lung, Colorectal and Ovarian (PLCO) 

Cancer Screening Trial indicate that for 

women in a general population, annual 

screening with CA-125 biomarker testing 

and transvaginal ultrasound compared 

with usual care did not reduce ovarian cancer 

mortality (JAMA 2011;305:2295–2303). 

At the same time, this testing algorithm increased 

invasive medical procedures and 

associated harms. 

The ovarian cancer arm of PLCO involved 

78,216 women age 55–74 years at 

enrollment, 39,105 of whom underwent 

annual screening, and 39,111 of whom 

received usual care. Those in the intervention 

arm had CA-125 testing for 6 years and 

transvaginal ultrasound for 4 years, with a 

median follow-up of 12.4 years. 

The investigators found 212 and 176 

ovarian cancer cases in the intervention 

arm and usual care arms, respectively. 

There were 118 ovarian cancer-related 

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deaths in the intervention arm, compared 

with 100 in the usual care group or 

3.1/10,000 person-years versus 2.6/10,000 

person-years, respectively. The difference 

in survival between the intervention and 

usual care groups was not statistically significant, 

and no stage shift was observed, 

meaning that over the course of the study 

among intervention arm subjects in comparison 

to normal care subjects, there was 

not a decline in cases first diagnosed in later 

stages of the disease. 

In addition, there was an approximate 

5% false-positive rate for each screening 

round. Although this rate is comparable to 

or even lower than false-positive rates for 

mammography screening, the researchers 

noted that “the nature of the diagnostic 

follow-up, which often included invasive 

procedures, was a serious concern.” They 

concluded that “even an optimized program 

of annual screening may be insufficient 

to detect cancers early enough to reduce 

mortality.” 

different centrifugation 

conditions Produce similar results 

an analysis of centrifugation conditions 

on clinical chemistry and immunology 

results found that three different conditions 

delivered identical test results (BMC 

Clinical Pathology 2011 doi:10.1186/1472– 

6890-11-6). The results are significant because 

they suggest that laboratories may 

be able to reduce centrifugation times 

and consequently lower their overall turnaround 

times. 

The researchers conducted the investigation 

because although pre-analytical 

centrifugation occurs countless times every 

day in laboratories around the world, 

the influence of the process on lab results 

has only rarely and recently been investigated. 

World Health Organization (WHO) 

guidelines issued in 2002 recommended a 

centrifugation time of at least 10 minutes 

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for serum and 15 minutes for plasma with 

a relative centrifugation force (RCF) of 

2,000–3,000g. 

The study involved 74 tests on six samples 

from 44 consecutively admitted patients, 

for a total of 444 results per patient. 

The investigators compared three centrifugation 

conditions, including 15 minutes at 

2,180g RCF, 10 minutes at 2,180g RCF, and 

7 minutes at 1,870 g RCF, all at 15°C and 

with a deceleration time of 32 seconds. Two 

different plasma separators were used for 

each centrifugation condition. 

The researchers found “identical” results 

in all parameters. They conducted Deming 

fit, alpha error, and beta error analyses, 

and found that only 3.6% of statistical test 

results fell outside the p

news from the fda 

Pcr-based hepatitis c Test Gets nod 

abbott has received FDA approval to 

market its RealTime PCR (polymerase 

chain reaction) test for measuring hepatitis 

C (HCV) viral load. The Abbott RealTime 

HCV assay is designed to be used as an aid 

in managing HCV-infected patients undergoing 

antiviral therapy, and helps physicians 

predict sustained and non-sustained 

virological response to HCV therapy. 

Test to monitor lung cancer cleared 

fujirebio Diagnostics has received FDA 

clearance to market the first biomarker 

assay to aid in the management of patients 

with lung cancer. The CYFRA 21-1 EIA 

test monitors disease progression during 

the course of disease and treatment of lung 

cancer patients. 

Q fever mdx Test cleared 

fDA has cleared the first nucleic acid 

amplification test for the diagnosis of 

Q fever infection in military personnel 

serving overseas. The test was developed 

by Idaho Technology and funded by the 

SamPLE PrEParaTiON daTabaSE 

Chemical Biological Medical System Joint 

Project Management Office within the U.S. 

Department of Defense. The test identifies 

and detects the bacteria that cause Q fever, 

Coxiella burnetii, within 4 hours. 

clearance for biomérieux’s 

mrsa Test 

bioMérieux has received FDA clearance 

to market its automated molecular test 

for methicillin-resistant Staphylococcus aureus. 

The NucliSens EasyQ MRSA test detects 

seven MRSA types, covering the most 

prevalent strains. 

siemens Gets clearance for 

heroin use screening Test 

siemens Healthcare Diagnostics has 

received FDA clearance for its newest 

drugs-of-abuse test, the Emit® II Plus 

6-Acetylmorphine assay. The test allows 

labs to selectively test for heroin use. The 

Emit II Plus 6-Acetylmorphine assay differentiates 

heroin from other opioids with no 

cross-reactivity to structurally related substances 

and is part of Siemens’ Syva® Emit 

drugs-of-abuse testing assay menu. 

Clinical Analytes in plasma, 

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index To adverTisers 

Please visit these websites to learn more about the products in this issue. 

arK diagnostics ............................................. 6 


bio-rad laboratories ........................................ 7 

www.bio-rad.com/diagnostics 

biotage ...................................................... 47 

www.biotage.com 

clinical and laboratory standards institute .................. 46 

www.statispro.org 

diazyme ..................................................... 48 


Greiner bio-one vacuette na ................................ 13 

http://us.gbo.com 

ids ltd. ...................................................... 9 

www.idsplc.com/en-us/home/ 

Kamiya biomedical company .......................... 6, 12, 45 


Kronus ....................................................... 29 


medicon Gmbh .............................................. 44 

www.optima-packaging-group.de 

nova biomedical ............................................. 25 

www.statstrip.com 

Phadia us inc. ............................................... 19 

www.phadia.us 

randox laboratories ........................................ 5 

www.randox.com 

roche diagnostics corp. ..................................... 2 

www.roche.com 

sarstedt inc. ................................................. 27 


sysmex corporation ......................................... 23 

www.sysmex.com/us 

Wako diagnostics ......................................... 8, 33 

www.wakodiagnostics.com 

oem 

biosPacific ................................................... 39 

www.biospacific.com 

cis-bio us ................................................... 35 

www.cisbio.com 

fluid metering inc. ........................................... 37 

www.fmipump.com 

utak laboratories ........................................... 31 

www.utaK.com 

Wheaton industries .......................................... 41 

www.wheaton.com 


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