June 2012 - American Association for Clinical Chemistry

news brief
RepoRt Details
U.s. NUtRitioN statUs
A newly released report from the
Centers for Disease Control and
Prevention (CDC) evaluating the
U.S. population’s intake of specific
nutrients found that most Americans
are getting adequate daily doses of
vitamins A and D and folate, but that
age, sex, and race/ethnicity were closely
linked to deficiency rates for certain
vitamins and nutrients. Only 10% of
Americans showed some nutritional
deficiency.
According to CDC’s “Second
National Report on Biochemical
Indicators of Diet and Nutrition,”
children and adolescents were rarely
deficient in vitamin B12, while older
adults were more likely to be deficient.
In the case of vitamin C, men were
more likely to be deficient compared
to women. Non-Hispanic blacks and
Mexican-Americans were more likely
to be vitamin D-deficient compared to
non-Hispanic whites.
snaPshoT
nutrition Deficiencies*
Vitamin B6
(≥1 y)
10.5
Iron
(women 12–49 y)
9.5
Vitamin D
(≥1 y)
8.1
Iron
(1–5 y)
6.7
Vitamin C
(≥ 6 y)
6.0
Vitamin B12
(≥ 1 y) 2.0
0 2 4 6 8 10 12
* Percentage of people
Source: CDC’s Second Nutrition Report.
The report used results from blood
and urine samples collected from
participants in the National Health and
Nutrition Examination Survey from
2003–2006 and measured 58 indicators
of diet and nutrition, including fatand
water-soluble vitamins, iron-status
indicators, iodine, and other dietary
biomarkers that are important to human
health.
For the first time, CDC assessed
iron deficiency using serum soluble
transferrin receptor (sTfR), a relatively
new marker of iron status. The agency
also evaluated iron deficiency using
the sTfR/ferritin ratio. The report
revealed higher rates of iron deficiency
in Mexican-American children age
1 to 5 years (11%), non-Hispanic
black women (16 %), and Mexican-
American women of childbearing age
(13%) when compared to other racial
and ethnic groups.
Notably, vitamin D deficiencies were
closely tied to race and ethnicity. Non-
Hispanic blacks had the highest rate of
vitamin D deficiency at 31%, followed
by Mexican-Americans at 12%, and
non-Hispanic whites at 3%. However,
the data showed that deficiency levels
generally decreased as age increased and
that males and females had similar levels.
The full report is available at www.
cdc.gov/nutritionreport.
nonprofit org.
u.s. postage
PaiD
greenfield, oH
permit no. 436
2 0 1 2 a a C C a n n u a l M e e t i n G P R e v i e w
Clinical
Laboratory
News
Screening Tests in
the Age of Austerity
Who Will Define Their Value?
By Bill Malone
Tension over healthcare spending is at a new high as the
country prepares for the Supreme Court’s imminent
ruling on the Obama administration’s healthcare law,
the 2010 Affordable Care Act. Laboratorians have long
felt the squeeze on healthcare spending, as screening
and diagnostic tests have been among the primary targets over the
years. Now with renewed controversy about the value of screening
tests like prostate-specific antigen (PSA), it seems clinical labs will
increasingly face the assumption that overuse and wasteful testing
is rampant—a reality laboratorians will have to deal with even as
they work to bring in new, innovative tests to improve care. However,
the current evidence on overuse of lab testing is slim. And
even where evidence does exist, a clear picture has yet to form of
how physicians and patients could make better decisions—especially
about screening tests.
Healthcare will need the expertise of the lab community because
screening remains “inherently messy,” according to Russell
Harris, MD, MPH, a professor of medicine and director of the
program on prevention in education and practice for the University of North Carolina School of Medicine
in Chapel Hill. “With false positives, false negatives, and overdiagnosis, screening is not clean—that’s just the
See screening Tests, continued on page 3
Urine Drug Monitoring in Pain Therapy
What’s the Best Testing Strategy?
By Genna Rollins
During the past decade more attention rightly has been placed on effective pain management due
to its role in contributing to the healing process and improving the quality of patients’ lives. At
the same time, however, prescription pain medication overdoses have skyrocketed and are at
epidemic levels, according to the U.S. Centers for Disease Control and Prevention. Given the
potential for both benefit from and abuse of these drugs, professional associations and various
regulatory bodies recommend urine drug monitoring for chronic pain patients, but none specify particulars
about whom to test, when to test, how and how often to test, and the crucial issue of how to interpret test results.
Seeking to fill this knowledge gap and start a broader discussion that one day might lead to formal guidelines, a
group of 11 pain management and addiction specialists recently proposed a series of recommendations around
urine drug monitoring for patients on long-term opioid therapy.
“We thought about all these issues and tried to come up with
thoughtful incisive recommendations for physicians, recognizing that
a formal guideline requires a much more robust evidence base than
currently exists,” said co-author Perry Fine, MD. “Our hope is that
people won’t be lost over this but will be able to read through and
think, for every individual patient, is this a patient for whom I can optimize
care and improve safety by using urine drug testing? Then, depending
on what I find with that urine drug testing, how do I interpret
the result and move forward in order to strengthen the therapeutic
Clinical Laboratory News
The American Association
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outcomes rather than weaken them.” Fine is a professor of anesthesiology
at the University of Utah School of Medicine in Salt Lake City.
See Pain management, continued on page 8
The auThoriTaTive
source for The
clinical laboraTorian
june 2012
volume 38, number 6
www.aacc.org
in This issue
Lab 2012
10 Testosterone
Standardization
Annual Meeting Preview
14
15
16
17 Exhibitors
Plenary Speakers
Q&A with the
Annual Meeting Chair
Division Events
20 Ultrasensitive
C-Peptide Assay
24
27
Regulatory, Industry,
& Diagnostic Profiles
News from the FDA
@cln_aacc

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Screening Tests Spark Controversy
Screening Tests, continued from page 1 The Choosing Wisely Campaign
dilemma we face,” he said. “But I think
people trained in clinical lab science have
a lot to offer here, and I hope they can help
us educate clinicians.” Harris was a member
of the United States Preventive Services
Task Force (USPSTF) from 2003–2008.
Overuse Looms, But Evades
Easy Measurement
Whether they be regulators, lawmakers, or
pundits on the evening news, all seem to
agree that the cost of healthcare is becoming
unsustainable. Most recently, Medicare
has projected that by 2020, national health
spending could reach $4.6 trillion and
comprise nearly 20% of gross domestic
product. Making matters worse, it appears
that the nation is addicted to profligate
testing and treatments that by some estimates
consume up to 30% of healthcare
spending.
Despite this highly charged atmosphere,
professional and consumer groups have
chosen to team up and weigh in on how
the nation should grapple with its healthcare
spending problem. In a first-of-itskind
response to overuse, a new campaign
called Choosing Wisely from the American
Board of Internal Medicine Foundation
has brought together nine top medical
societies as well as Consumer Reports to
educate both physicians and patients about
common unnecessary tests and treatments.
Each physician specialty society published
a list of “Five Things Physicians and Patients
Should Question.” Many of the 45
items implicate unnecessary imaging or
laboratory screening tests (See Box, right).
Two separate but related initiatives from
the American College of Physicians (ACP)
parallel Choosing Wisely. ACP, a Choosing
Wisely participant, has announced its own
partnership with Consumer Reports. The
two organizations are developing patientoriented
brochures and other resources
to help patients understand the benefits,
harms, and costs of tests and treatments
for common clinical issues. The resources
will be derived from ACP’s evidence-based
clinical practice recommendations published
in Annals of Internal Medicine and
on the Consumer Reports website. This
patient-centered initiative comes 2 years
after ACP’s other project, the High Value,
Cost-Conscious Care Initiative, which was
aimed at physicians.
The most recent product from the
High Value, Cost-Conscious care series,
published in January 2012, focused on
screening and diagnostic tests. ACP convened
a workgroup of physicians under a
consensus-based process to identify tests
that did not reflect high-value care (Ann
Intern Med 2012;156:147–149). Similar to
Choosing Wisely, ACP’s list of 37 clinical
scenarios includes many imaging tests, but
about half encompass clinical lab tests (See
Online Extra).
Despite testing being a target, many
of the group’s recommendations may
not provoke much controversy in the lab
community. But if laboratorians do disagree
with such recommendations, new
research reveals that the medical literature
on overuse of lab tests is extremely limited.
A study published as part of the Archives of
Internal Medicine’s Less Is More series re-
viewed 114,831 publications over 21 years
and found only 172 articles that addressed
overuse of healthcare (Arch Intern Med
2012;172:171–178). The majority of the
studies focused on four interventions: antibiotics
for upper respiratory tract infections,
and three cardiovascular procedures.
Just a handful addressed lab tests, notably
PSA and fecal occult blood testing (FOBT).
According to study coauthor Salomeh
Keyhani, MD, MPH, the reason for the
paucity of studies on overuse of lab tests is
clear: too few definitive guidelines. “If you
want to eliminate inappropriate care, you
have to designate what exactly is inappropriate,
which is not an easy thing,” she said.
“Diagnostic tests are a particular challenge
in terms of establishing when it’s appropriate
to order them. The indications for diagnostic
testing are not routinely evaluated in
the same way as indications for therapeutic
procedures.” Keyhani is an assistant professor
of medicine and of health evidence and
policy at the Mount Sinai School of Medicine
in New York.
Moreover, where guidelines do exist,
whether for tests or treatments, they often
conflict, Keyhani noted. “In the U.S., we
have a free market for guidance,” she said.
“We have every single medical specialty society
with its own emphasis and own focus
putting out guidelines, and to some extent,
they disagree.”
Data and Decision-Making
With screening tests showing up on lists
of questionable practices and under the
spotlight for research on overuse, there
should be no surprise that screening tests
also stimulate the most public controversy.
To be sure, the public has strong opinions.
A seminal study in 2004 found that
74% of American adults believed that
finding cancer early via screening saved
lives most or all of the time, and many
said that an 80-year-old who chose not
to be screened was irresponsible (JAMA
2004;291:71–78). In addition, two-thirds
of respondents indicated they would
want to be screened for a cancer even if
no treatment was available.
More recently, in 2011 a draft “D” recommendation—the
strongest negative
statement—from USPSTF against PSA
screening at any age led to public outcry
and widespread media coverage (CLN
2011;37:11). USPSTF also took a more
cautious view of Pap testing in March of
this year, recommending women ages 21
to 65 be screened only every 3 years. Then
in April, USPSTF published draft recommendations
on screening for chronic kidney
disease that contains an “I” statement
for insufficient evidence. In recent years,
USPSTF advisories have taken on more
weight as most payers, including Medicare,
rely heavily on their recommendations to
make decisions about coverage and reimbursement.
Evidence suggests that cancer screening
tests in particular have unusual patterns of
utilization: potentially significant overuse
in some cases, and underuse in others. A
Government Accountability Office (GAO)
report released in January found that use
of some screenings—for cardiovascular
disease and cervical cancer—by Medicare
beneficiaries generally aligned with clini-
Group Urges Patients, Physicians to Question Tests
Nine leading physician specialty societies have identified specific
tests or procedures that they say are commonly used but not always
necessary in their respective fields and put forward “Five Things
Physicians and Patients Should Question.” Created by the American
Board of Internal Medicine (ABIM), the ABIM Foundation spearheaded
the campaign.
Consumer Reports—the world’s largest independent product
testing organization—is working with the ABIM Foundation and
the specialty societies to lead the effort. Consumer Reports will also
work with other consumer-oriented organizations such as AARP.
The nine participating specialty societies include the American
Academy of Allergy, Asthma and Immunology, American Academy of
Family Physicians, American College of Cardiology, American College
of Physicians, American College of Radiology, American Gastroenterological
Association, American Society of Clinical Oncology,
American Society of Nephrology, and American Society of Nuclear
Cardiology.
“By identifying tests and procedures that might warrant additional
conversations between doctors and patients, we are able to
help patients receive better care through easy-to-use and accessible
information,” said James A. Guest, JD, president and CEO of Consumer
Reports. “We’re looking forward to being a part of this innovative
effort working with the ABIM Foundation, the specialty societies,
and our eleven consumer communications collaborators to get this
important message out to diverse populations of patients.”
In addition, the campaign announced eight new participating
specialty societies that will release lists in fall 2012: American
Academy of Hospice and Palliative Medicine, American Academy of
Otolaryngology–Head and Neck Surgery, American College of Rheumatology,
American Geriatrics Society, American Society for Clinical
Pathology, American Society of Echocardiography, Society of Hospital
Medicine, and Society of Nuclear Medicine.
Examples from “Things Physicians and Patients Should
Question”:
® Don’t perform unproven diagnostic tests, such as immunoglobulin
G (IgG) testing or an indiscriminate battery of immunoglobulin
E (IgE) tests, in the evaluation of allergy.
® Don’t routinely do diagnostic testing in patients with chronic
urticaria.
® Don’t perform Pap smears on women younger than age 21 or
who have had a hysterectomy for non-cancer disease.
® In patients with low pretest probability of venous thromboembolism
(VTE), obtain a high-sensitivity D-dimer measurement as the
initial diagnostic test; don’t obtain imaging studies as the initial
diagnostic test.
® Do not repeat colorectal cancer screening by any method for 10
years after a high-quality colonoscopy is negative in average-risk
individuals.
® Don’t perform surveillance testing (biomarkers) or imaging (PET,
CT, and radionuclide bone scans) for asymptomatic individuals
who have been treated for breast cancer with curative intent.
® Don’t perform routine cancer screening (mammography, colonoscopy,
PSA, Pap smears) for dialysis patients with limited life expectancies
and without signs or symptoms of conditions detected by
these tests.
cal recommendations, but other cancer
screening tests did not. For example, even
though USPSTF recommends biannual
breast cancer screening in women ages 65
to 74, only two out of three beneficiaries
in this age group received a mammogram
in 2008 or 2009. In the case of colorectal
cancer screening, only one in four beneficiaries
ages 65 to 75 received any of the
recommended regimens. With PSA testing
for prostate cancer, overuse was the
problem: almost half of men age 75 or
older were tested, contrary to USPSTF
recommendations.
In a more striking example, researchers
at the University of Chicago Medical Center
evaluated changes in national screening
rates before and after the USPSTF 2008
recommendation against PSA screening in
men older than 75. They found that PSA
screening rates were unchanged from 2005
to 2010 in all age groups (JAMA 2012;
307:1692–1694). Apparently, physicians
See Screening Tests, continued on page 4
CliniCal laboratory news June 2012 3

Clinical
Laboratory
News
eDiTorial sTaff
editor—Nancy Sasavage, PhD
senior editor—Genna Rollins
senior editor—Bill Malone
editorial assistant—Laura Kachin
contributors—Hubert W. Vesper, PhD,
and Julianne Cook Botelho, PhD
boarD of eDiTors
chair—Amy Saenger, PhD
Mayo Clinic, Rochester, Minn.
members—Lorin M. Bachmann, PhD, DABCC
VCU Health System, Richmond, Va.
Andrew Don-Wauchope, MD
Juravinski Hospital and Cancer Center,
Hamilton, Ontario
Jacqueline Fisher
Children’s Hospital Boston, Boston, Mass.
Steven Goss, PhD
Siemens Healthcare Diagnostics, Newark, Del.
Pamela Steele, PhD
Covance, Inc., Indianapolis, Ind.
aacc officers
President— W. Greg Miller, PhD, DABCC,
FACB
President-elect—Robert H. Christenson, PhD,
DABCC, FACB
Treasurer—D. Robert Dufour, MD
secretary—Elizabeth L. Frank, PhD, DABCC,
FACB
Past-President—Ann Gronowski, PhD
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Few Understand the Evidence
screening Tests, continued from page 3
and patients had completely ignored the
USPSTF recommendation.
Patients’ enthusiasm alone may not be
to blame for such a discrepancy between
recommendations and practice. There also
is reason to doubt that physicians themselves
can comprehend or communicate
even the basic facts about evidence when
it comes to screening tests. A nationally
representative survey of internal medicine
physicians found that a majority were easily
stumped by questions about basic statistics
and would recommend a screening test
to save lives based on irrelevant evidence
(Ann Intern Med 2012;156:340–349).
The researchers expected that physicians
would understand that in screening
tests, survival statistics are susceptible to
lead-time and overdiagnosis biases. In fact,
more than 20 years ago the National Cancer
Institute concluded that reduced mortality
in a randomized trial could be the
only reliable evidence that a screening test
saved lives. However, when presented with
evidence about two hypothetical screening
tests, physicians in the study overwhelmingly
favored a test backed by evidence of
improved 5-year survival over one with an
improved mortality rate.
The inability of some physicians to interpret
data about screening tests appears
even more dire considering how USPSTF
and other groups have leaned toward optional
shared decision-making in their recommendations.
This concept emphasizes
the importance of doctor-patient collaboration
to arrive at healthcare decisions and
puts greater emphasis on patient autonomy
and choice. The concept gained momentum
especially with PSA testing after
USPSTF’s 2008 “I” recommendation for
prostate cancer screening in men younger
than 75, which suggested that these men
“should be assisted in considering their personal
preferences before deciding whether
to be tested.”
Many opinion leaders in healthcare
expressed deep frustration with this strategy,
questioning shared decision-making
for controversial screening tests for which
the evidence perplexes both doctors and
patients. For example, Allan Brett, MD, is
among those who welcomed USPSTF’s
more conservative 2011 draft recommendations
against using PSA tests to screen for
prostate cancer.
After those draft recommendations
were published, Brett, a professor of medicine
at the University of South Carolina
School of Medicine and member of the
university’s Center for Bioethics and Medical
Humanities, wrote an editorial praising
USPSTF for giving physicians clearer guidance
(N Engl J Med 2011; 365:1949–1951).
“For two decades, primary care physicians
have been expected to present a flawed
online extra
low-value scenarios
for lab Tests
go to the June issue
of CLN at
www.aacc.org
screening test to patients, cloaking the flaws
in an elaborate ritual of informed decision
making. In turn, men have been expected
to make sense of a confusing mix of hypothetical
outcomes,” he wrote. Due to the
difficulty of digesting the data on screening,
these patient-physician discussions about
PSA testing were “essentially a charade,”
and their decisions “reflected their general
concerns about cancer or their general inclination
to accept or resist medical interventions.”
Brett is also the editor-in-chief of
Journal Watch General Medicine.
Brett also recently wrote about coping
with patient pressure for unnecessary tests
and procedures more generally (JAMA
2012;307:149–150). Physicians have been
overcorrecting for their traditionally paternalistic
tendencies since the 1980s, he
argued. Now the pendulum has swung too
far, with physicians’ intellectual authority
routinely questioned. “Yes, there should be
a partnership between doctors and patients
in decision-making, but when it crosses the
boundary into things that don’t plausibly
confer medical benefit, physicians should
be able to say no,” he told CLN.
These pressures on physicians are one
reason that Harris advocates the use of outcomes
tables that do a better job of capturing
all of the potential benefits and harms
of a particular screening test. “If you don’t
lay it out for people, it’s hard for them to
see what is meant by harms,” he said. “We
need to help people see that the benign
blood test that you agree to when you have
a doctor visit can end up being the first step
in a cascade of events that, after a while, you
won’t be able to control. And that cascade
can end up with your being helped, but it
might also result in your being hurt.”
But is it possible that giving patients
more choices can boost screening where
underutilization is a problem? New evidence
suggests that in the case of colon
cancer screening, offering patients choices
about the type of test boosted compliance
(Arch Intern Med 2012;172:575–582). The
researchers viewed these results as particularly
significant because patients frequently
avoid recommended colon cancer screening.
They found that patients for whom
colonoscopy was recommended were less
likely to complete colorectal cancer screening
than either those for whom FOBT was
recommended or those who were given
a choice between FOBT or colonoscopy.
Only 38.2% of the participants in the colonoscopy
group completed that procedure,
compared with 67.2% in the FOBT group
and 68.8% of those allowed to choose their
own screening method.
In an invited commentary on the study,
Theodore Levin, MD, urged physicians to
See screening Tests, continued on page 6
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Value Means More Than Cost
screening Tests, continued from page 4
embrace the study’s findings. “If having too
many choices leads to confusion, the study
… demonstrates that not having enough
choice may lead to inaction when the only
choice is colonoscopy,” he wrote. “When it
comes to colorectal cancer screening, providing
an option other than colonoscopy
for our patients is not overwhelming, but
necessary.” Levin is a research scientist at
the Kaiser Permanente Northern California
Division of Research and a gastroenterologist
at Kaiser Permanente Medical Center,
Walnut Creek.
When Evidence Agrees, the Lab Can Shine
When physician groups and others in
healthcare talk about overuse of lab tests, it
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can sound like bad news for the lab. However,
even when the quest for high-value
care is driven by forces outside the lab,
sometimes the results promote lab testing
over other options. For example, highsensitivity
D-dimer testing is a clear winner
in the Choosing Wisely campaign, as well
as the ACP High-Value, Cost-Conscious
Care Initiative. Both lists emphasize that
physicians should chose a high-sensitivity
D-dimer assay instead of imaging studies
for patients with low pretest probability
of venous thromboembolism (VTE) (See
Box, p. 3).
D-dimer testing is an example of how
clear evidence for clinical utility of an assay
can boost recognition of the value of
the lab’s contribution to patient care. Not
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coincidentally, it also is an area where laboratorians
have worked with physicians on
clinical practice guidelines. For example, a
representative from AACC contributed to
the American College of Chest Physicians’
(ACCP) 9th edition of its authoritative
clinical practice guidelines for prevention
and treatment of VTE, and AACC was invited
to review and endorse the guidelines
(Chest 2012;141:S). The collaboration
with ACCP grew out of the involvement
of AACC’s Evidence-Based Laboratory
Medicine Committee with the Agency for
Healthcare Research and Quality.
AACC endorsed the guidelines out of
a desire to emphasize the utility of high-
sensitivity D-dimer testing versus more
costly and complex interventions, according
to Stephen Kahn, PhD, chair of the
AACC committee. “We were pleased to
work with the American College of Chest
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Physicians. They are really a top-notch association
when it comes to guideline development
and are the premier experts in this
area, recognized internationally by people
in evidence-based medicine,” Kahn said.
“In addition, one of AACC’s long-term
goals is to work more closely with clinical
organizations and be recognized as an
important player when it comes to issues
involving laboratory medicine.” Kahn is
a professor of pathology and director of
laboratories at Loyola University Medical
Center in Maywood, Ill.
Considering the difficulty physicians
have with understanding and communicating
complex information about screening
tests, the healthcare community needs
the help of laboratorians, said USPSTF
Chair, Virginia Moyer, MD, MPH. “People
in the lab should be thinking about how
they can best communicate with their customers,
but that obviously goes both ways.
If the people ordering the test can be clear
about why and in whom they’ve ordered it,
then the people reporting the results can be
much more helpful in the interpretation of
the results,” she said. Moyer is also a professor
of pediatrics at Baylor College of Medicine
in Houston.
In an editorial that accompanied the
study on physician’s understanding of
screening statistics, Moyer argued that the
research underscored the need for highquality,
evidence-based guidelines, and
noted that many organizations have moved
to align with the Institute of Medicine’s
(IOM) standards for guideline development
(Ann Intern Med. 2012;156:392–
393). AACC’s National Academy of Clinical
Biochemistry is among the guideline
development bodies that have embraced
the IOM recommendations.
Moyer said that she also looks to researchers
in the lab community for continued
improvements in the tests themselves.
“There are many, many screening tests
which we sure wish were better,” she said.
“Part of it is that right now, many of them
are a little bit like x-rays—they’re shadows.
PSA is an example. It rises not only in prostate
cancer, but also in anything that irritates
the prostate. It says something is going
on, but not what. And it doesn’t even always
rise when something is wrong.”
According to Kahn, the emphasis for
laboratorians will not be in terms of more
testing or less, but making sure the right
tests are used at the right time. This means
a focus on evidence-based laboratory
medicine, and more interdisciplinary collaborations
like AACC’s contribution to the
ACCP guidelines. Laboratorians need to be
objective about their own lab services and
try to keep abreast of the key clinical practice
guideline recommendations to be considered
in making changes in clinical practice
at their own institutions. CLN
next month
in CLN
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Evidence Needed for Firm Guidelines
Pain management, continued from page 1
Filling the Knowledge Gap
The panelists and other experts agreed that
the need for such guidance is high. Studies
have shown that physicians generally have
difficulty navigating the complicated terrain
of urine drug testing. This is an even more
daunting challenge for internists and family
practitioners, who are more likely than ever
before to be overseeing care of patients with
chronic pain who often have other comorbidities
and may be taking medications that
could affect urine drug test results. Indeed,
when the authors drafted the recommendations
they particularly had primary care
practitioners in mind, according to panelist
Joseph Couto, PharmD, MBA, assistant professor
of health economics and outcomes
research at the Thomas Jefferson University
School of Population Health in Philadelphia.
“Ideally, it’s meant to be a resource for both
specialists and primary care physicians.
While we don’t have great data on how many
pain physicians are using drug monitoring,
just anecdotally, we think it’s quite a few. We
don’t think they’re as naïve to this as primary
care physicians who may have used it once
or twice but aren’t as conversant with it. So
it’s maybe more a resource to the latter.”
The knowledge gap about how to
use and interpret urine drug monitoring
8 CliniCal laboratory news June 2012
results is so substantial that it affords laboratorians
an excellent opportunity to shine
as informed consultants, not only to pain
management specialists but also internists
and family practitioners, experts said. Pain
management physicians often use toxicology
reference labs, but that may not be the
case with primary care providers. “So many
hospitals have an opportunity to reach out to
them and provide guidance in the selection
of tests and interpretation of results. That’s
a huge opportunity for AACC members,”
said Gwendolyn McMillin, PhD, chair of
AACC’s therapeutic drug monitoring and
toxicology division. “The opportunity is
there for our hospital labs to support
their clinics if they want to, by consulting
and/or providing point-of-care testing—
perhaps by providing the personnel to
operate a small analyzer in the office—or
by doing the testing in the hospital lab.”
McMillin is medical director of clinical toxicology
and trace elements at ARUP Laboratories
and associate professor of pathology
at the University of Utah in Salt Lake City.
Guidance on Key Questions
The authors used a modified delphi consensus-building
process to address five key
issues related to urine drug monitoring in
chronic patients, including whom to test,
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how to conduct testing, when testing should
be started and repeated, how to interpret
results, and how to deal with discrepant results.
The panel recommended that all patients
on opioids for more than 3 months
should be tested. The authors also suggested
that physicians might wish to adopt written
treatment agreements and that the practice’s
drug testing policy should be specified
during the patient’s first office visit.
The panel called for comprehensive
urine drug testing that covers not only
commonly prescribed opioids and other
prescription medications with potential for
abuse, but also illicit drugs. Ideally, test results
should be available on the day of the
office visit; CLIA-compliant point-of-care
testing (POCT) is an acceptable method of
accomplishing this. However, if POCT results
are inconsistent with prescribed therapy,
the patient’s urine sample should be
sent to a lab for further analysis, preferably
with gas chromatography mass spectrometry
(GC/MS) or liquid chromatography
tandem MS (LC/MS/MS).
The panel recommended adjusting testing
frequency based on each patient’s risk
level. Patients at low-risk of misuse should
be tested at least once every 6 months, while
those at moderate-to-high risk should
be tested at least quarterly. Offices that
use POCT also should assess low-risk patients
at least annually with comprehensive
GC/MS or LC/MS/MS testing, and highrisk
patients every 6 months.
Earlier this year, the authors presented
their recommendations at the annual meeting
of the American Academy of Pain Medicine
and have submitted their findings for
publication. They emphasized that due to
a paucity of evidence, their recommendations
amount to expert opinion only. “This
is all based on very weak evidence,” said
co-author John Peppin, DO, director of the
clinical research division of The Pain Treatment
Center of the Bluegrass in Lexington,
Ky. “We hope the pain community and other
interested individuals will begin to do the
research to give us a much clearer understanding
of when, where, how often to test,
and whether that testing actually makes a
difference in terms of abuse and diversion
of prescription pain medications. Certainly
we look forward to research that would either
verify or refute our recommendations.
We’d be supportive of either direction if
we could get a clear understanding of how
these should be used.”
Patterns of Drug Use
What is clear is that patients don’t strictly
adhere to their medication regimens. In
one study, Couto found that results from
nearly 1 million patient test samples indicated
that three-quarters of patients probably
were not taking their medications in
keeping with their prescription (Popul
Health Manag 2009;12:185-190). Overall,
38% did not have detectable levels of their
prescribed medication, while 27% had
higher drug levels than would be expected,
and 15% had lower-than-expected levels.
“This was a skewed sample representing
only people who were tested, and each
clinic could have had a different testing
policy,” Couto explained. “But it does go to
show that if you’re testing people, chances
are you’ll find something that’s worthy of a
conversation with patients.”
Couto stressed that in their recommendations
the authors strove to balance fiscal
online extra
universal Precautions
in Pain management
go to the June issue
of CLN at
www.aacc.org
realities with the legitimate interest in improving
patient outcomes through urine
drug testing. “Practices have to try and balance
what they’d like to do clinically with
what the healthcare system realistically can
afford. This is a public health problem, but
it’s not a problem that comes with cheap
solutions.”
Beyond the Gottcha Moment
The panelists and other experts cautioned
that urine drug monitoring in chronic pain
populations should not be about gottcha
moments with patients. “I think urine drug
testing is best used as a tool to support behaviors
that appear to be healthy and to
challenge patients who don’t appear to be
on track. It should give clinicians insight
into what might be going on in their lives,”
said Douglas Gourlay, MD, MSc, educational
consultant for the Wasser Pain Management
Center at Mt. Sinai Hospital in
Toronto. He has written extensively about
urine drug testing, and he and Howard
Heit, MD, in 2005 proposed the concept
of universal precautions in urine drug
monitoring, similar to universal precautions
used for infection control purposes
(See Box, Online Extra) (Pain Med 2005;6:
107–112). “The theme of universal precautions
is you can’t judge a book by its cover.
The idea behind it was, let’s apply a reasonably
thought-through strategy of risk
containment until we can get a handle on
the patient’s actual risk on an individual
level. We also recognized that risk is dynamic
and may need to be periodically reassessed
in the context of the information
the individual is providing to the clinician.
It’s all about balance.”
Gourlay’s campaign to educate colleagues
about not only the technical insand-outs
of urine drug testing but also the
philosophy behind it began after he learned
about an experienced pain management
specialist misinterpreting a test result and
discharging the patient in question, who
subsequently committed suicide. “The
stakes here are very high. Urine drug testing
is not a benign practice in so far as it
can adversely impact on the doctor-patient
relationship with respect to trust. When it’s
overly used it can literally cripple the subject
of the testing by over-medicalizing their
already complicated life,” he contended.
The Complexity of Interpreting Results
Opportunities abound for misinterpreting
test results, from analytical issues to a host
of factors that influence the absorption,
distribution, metabolism, and elimination
of drugs. Examples of the latter include
drug-drug and drug-food interactions, and
the patient’s body mass index, age, genetic
polymorphisms, and renal and liver function.
“There are so many variables up in the
air that to use quantitative testing as a way of
sorting out who is or isn’t complying with
treatment, is something I couldn’t support
scientifically or clinically,” said Gourlay.

urine Drug Testing cutoffs
standard forensic models of urine drug testing assume most specimens
will test negative for the drugs of interest and therefore use higher
cutoffs. therapeutic monitoring in chronic pain patients assumes most
samples will be positive and uses much lower cutoffs. researchers
recently proposed cutoffs designed to identify 97.5% of a chronic pain
population for therapeutic monitoring purposes.
Analyte Cutoff
Standard Proposed
amphetamine
(values in ng/mL)
1,000 76
benzodiazepines 300
7-amino-Clonazepam 19
alpha-hydroxyalprazolam 15
lorazepam 30
opiate metabolites 2,000
Codeine 29
Morphine 59
oxycodone 100 25
Methadone 300 89
Source: Pain Medicine 2012; DOI: 10.1111/j.1526-4637.2012.01350.x.
Complicating result interpretation further,
pain prescriptions often give patients
leeway in adjusting the dosage or dosage
frequency depending on their level of pain.
Recently, algorithms have been proposed to
account for some of these factors and extrapolate
dose adherence, but experts suggested
such approaches are not ready for
primetime just yet.
The POCT Challenge
From the analytical perspective, single-use
POC devices with built-in immunoassays
pose particular opportunities for misinterpretation.
These devices, commonly used
in pain management offices, are low-cost
and have rapid turnaround times, which
enable clinicians to discuss results with
patients before they leave the office. However,
they also have some distinct disadvantages,
such as targeting only certain drugs
in a class and cross-reacting to a variety of
other prescription and over-the-counter
medications. How well these subtleties
are understood is unclear. For instance, “a
common misconception is that an opiate
screen will include all opiates and opioids.
However, in general, opiate immunoassay
screens will not reliably detect oxycodone,
oxymorphone, meperidine, and fentanyl,”
explained Amadeo Pesce, PhD, DABCC,
lab director of Millennium Laboratories
and principal investigator for the Millennium
Research Institute in San Diego.
Peppin pointed out that despite its
popularity, little research has been done
on POCT urine drug monitoring. “When
it comes to point-of-care testing, the literature
is almost non-existent when we
talk about monitoring patients on opiates.
My opinion is that it should be used as a
screen, if you will, with the results verified
by GCMS,” he said. “The whole point of
point-of-care testing is that you expect to
have a lot of false-positives and few falsenegatives
because that’s how it’s set up. I’d
be concerned about a practice that was only
using point-of-care testing.”
One research team recently compared
POCT against LC/MS/MS in detecting
benzodiazepines and opioids and illicit
drugs, respectively. In the case of benzodiazepines,
they found that POCT had an
overall efficiency—a measure of how often
the test was right—of 78.4% in comparison
to LC/MS/MS. For opioids and
illicit drugs, test efficiency in comparison
to LC/MS/MS ranged from 90% for oxycodone
to 99.4% for cocaine (Pain Physician
2011;14:175–1187 and 259–270).
Forensic Versus Therapeutic Cutoffs
Experts also emphasized the importance
of determining appropriate cutoffs for the
population in question. Hospital labs tend
to use higher cutoffs based on a forensic
model that assumes most specimens will
test negative for the drugs of interest. In
contrast, urine drug testing for therapeutic
monitoring assumes most samples will be
positive and uses much lower cutoffs.
As an example, the standard cutoff for
morphine, the target analyte for codeine/
morphine testing, is 2,000 ng/mL. However,
Pesce’s lab, which recently evaluated optimal
cutoffs to identify 97.5% of the pain
patient population, recommends a 59 ng/mL
cutoff for morphine in a therapeutic monitoring
paradigm (See Table, above) (Pain
Medicine 2012; DOI: 10.1111/j.1526–
4637.2012.01350.x).
“A 2,000 ng/mL cutoff for opiates is not
good for a pain doctor. You want to find
out, since the patients often take as little
medicine as possible or they’re at end of
their dose, what cutoff really captures as
much of the population as possible,” he
explained. “We published our way of looking
to determine what the appropriate cutoff
should be in this population and to try
to capture 97.5 percent on any particular
medication. You can’t let the manufacturer
set the cutoffs. The lab has to set the cutoffs.”
What Labs Can Do
Within the next couple of years, the panelists
hope to review the evidence base
and revisit their recommendations. In the
meantime, they and other experts stressed
that labs would do well to reach out to
both pain specialists and generalists to be
a trusted resource in this arena. “I’ve been
doing this for years and I try to keep up
with the literature, but I don’t claim at all to
be an expert in interpreting urine drug test
results,” said Peppin. “They’re very complicated
and I frequently call the lab and
say, what does this mean? So encouraging
doctors to call whatever company or lab
they’re using and try to get an understanding
as much as possible of the drugs
and metabolites and what the cutoffs
mean—all those types of things would be
good. This is something doctors would be
very interested in.”
McMillin suggested that in addition
to educating providers, labs might help
practices find the best POCT solution for
their needs. “We’ve evaluated several different
point-of-care options for clients.
We base selection of a device on how well
its performance characteristics match the
needs of the clinic in question. A high level
of expertise from the lab and cooperation
of the clinic is required to evaluate the
options and select the best approach,” she
explained.
Gourlay stressed that strong physicianlab
working relationships are essential for
physicians to understand the nuances of
interpreting test results and improving
patient care. “The time has come for valueadded
lab medicine, where the clinician is
able to ask challenging questions of the lab
director and the lab director is able to offer
information about how the clinician is attempting
to use the information. Together,
by asking more challenging questions, we
gain a deeper understanding of how best
to order tests and interpret and act on the
results,” he said. “I hope the panel’s recommendations
will create that kind of dialogue.
It’s time to dismiss the notion that
either physician or lab can do their job in
isolation.” CLN
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CliniCal laboratory news June 2012 9

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10 CliniCal laboratory news June 2012
Testosterone
An Overview of CDC’s Standardization Initiative
By HuBeRt w. vesPeR, PHD, anD Julianne Cook BotelHo, PHD
The androgen steroid hormone, testosterone, plays a significant physiological role in both men and
women, so being able to measure it accurately and reliably has important clinical implications. in
men, testosterone test results are crucial in diagnosing hypogonadism, and in women, they assist in
the work-up of suspected polycystic ovary syndrome. testosterone measurements also aid in monitoring
treatment response in men taking enzyme inhibitors for prostate cancer.
However, a number of concerns exist about the reliability of testosterone assays, especially when it comes to
measuring free testosterone with homogenous assays. other issues involve the ability of assays to detect subtle
differences in testosterone levels, for example identifying individuals with androgen deficiency or detecting low
levels in women and children. additionally, comparability of testosterone data from different assays is lacking, which
makes it very difficult for researchers to compare and compile data and to develop evidence-based guidelines.
Given these challenges, the Centers for
Disease Control and Prevention (CDC),
with broad input from various professional
societies, is leading a Hormone Standardization
Program with an initial focus on
standardizing testosterone measurements.
Standardization in measuring any analyte
is desirable so that test results are accurate
and reliable independent of both the assay
used and the time and place of measurement.
In this article, we will outline the
scope, progress of, and next steps for this
important initiative.
Testosterone Standardization Program
In collaboration with The Endocrine Society,
CDC held a workshop in 2008 to dis-
cuss concerns and challenges in testing testosterone
and other steroids. Participants
representing several professional societies
such as the American Association for Clinical
Chemistry, The Endocrine Society, and
the American Cancer Society, addressed
clinical and research applications of steroids
in areas as diverse as male androgen
deficiency, cancer, pediatrics, and reproductive
medicine. Based on recommendations
from the participants, CDC started
the Hormone Standardization Program
with an initial focus on standardizing tes-
tosterone measurements.
The conceptual approach of the testosterone
standardization program is built on
experiences gained from successful standardization
programs CDC maintains or
has supported, such as the cholesterol standardization
program and the National Glycohemoglobin
Standardization Program.
The testosterone standardization program
consists of three basic steps: developing
a reference system, calibrating individual
assays, and verifying end-user test performance
(Figure 1).
Creating a Reference System
As the first step towards creating a reference
system for testosterone, CDC developed a
reference method using high-performance
liquid chromatography coupled with tandem
mass spectrometry (HPLC/MS/MS)
that was calibrated with the pure compound
reference material, NMI-M914,
from the Australian National Metrology Institute.
SRM 971, a serum-based reference
material from the National Institute for
Standards and Technology (NIST) served
as the trueness control. CDC also initiated
further comparison studies with other
reference laboratories, including those of
Linda Thienpont, PhD, at the University
of Ghent (Belgium) and Susan Tai, PhD, at
NIST, to assure accuracy and comparability
to other reference laboratories. Through
these activities, the CDC reference laboratory
assured metrological traceability as
described in ISO 17511.
Using its testosterone reference method,
CDC is in the process of assigning values
to single-donor sera, which are produced
following a standard protocol developed
by the Clinical Laboratory and Standards
Institute (Protocol C37- A). Sera obtained
with this protocol can be considered commutable,
meaning they contain minimal
matrix effects and behave very similar to
regular patient samples. Use of commutable
sera enables immunoassay manufacturers,
as well as laboratories operating
laboratory-developed MS–based tests, to
use the materials as calibrators or trueness
controls. This ultimately assures that measurements
in patient samples are accurate
and comparable.
Calibrating Individual Assays
Assay calibration also is critical to measuring
testosterone accurately and reliably.
CDC is therefore working with immunoassay
manufacturers to help calibrate their
assays, as well as with laboratories on their
lab-developed tests. These activities are being
accomplished through the CDC Hormone
Standardization Program (HoSt)
started in 2010. The HoSt Program is open
to all manufacturers and laboratories interested
in accurate testosterone testing.
The HoSt Program consists of two
phases (Figure 2). The first involves assessing
participants’ accuracy and performance
in measuring testosterone and
subsequently addressing any performance
problems. The second phase involves evaluating
HoSt Program participants’ measurement
performance and calibration
stability via quarterly blinded challenges
conducted during a 12-month period.
The data from all four challenges are used
to determine measurement bias, which is
compared to the desirable measurement
bias of 6.4%. Laboratories that meet this
bias criterion are considered standardized
to CDC.
HoSt Program performance criteria are
derived from data on the biological variability
of testosterone. The concept of using
biological variability to derive measurement
performance criteria was suggested
during a 1999 conference in Stockholm
on strategies to set global analytical quality

figure 1
steps for achieving accurate and
comparable Patient results
specifications in laboratory medicine. Using
biological variation to drive analytical
performance sets the minimum criteria of
analytical variability to detect true biological
or physiological changes.
Now in its second year, the HoSt Program
for testosterone has 20 participants,
all at varying stages of the program. Eight
have successfully completed at least 1 year
of Phase 2 (Figure 3). Information about
participants meeting current performance
criteria is available online at: www.cdc.gov/
labstandards/hs.html. The information is
updated quarterly and certification is valid
for 1 year.
CDC also provides Phase 1 material to
those laboratories not able to participate in
the certification portion of the HoSt Program.
Furthermore, to assure the accuracy
of testosterone testing over time, especially
as reagents and methodologies change, the
program offers ongoing assistance with calibration
and performance evaluation to the
clinical laboratory community.
Verifying End-User Test Performance
In addition to establishing a reference system
and helping calibrate individual assays,
CDC collaborates with proficiency testing
(PT) programs to assess the accuracy of
testing performed in clinical laboratories.
Using its testosterone reference method,
CDC assigns reference values both for the
College of American Pathologists (CAP)
accuracy-based survey for testosterone and
estradiol and to materials used in the New
York State PT program. The CDC testosterone
standardization program also provides
accuracy-based quality control materials to
investigators and laboratories performing
large epidemiological studies and clinical
trials, thereby enabling them to monitor
the accuracy of measurements in these
studies over time.
Data from the New York State PT program
show the initial impact of the CDC
standardization program (Figure 4). Variability
expressed as the coefficient of vari-
Develop
reference system
calibration of
individual assays
verify “end-user”
Test Performance
the first step is to establish a point of reference by developing a refer-
ence method and materials. in the second step, these reference methods
and materials are used to calibrate assays and assure that they have
an appropriate accuracy and precision. the last step involves verification
of end-user performance to ensure actual patient results are
accurate and comparable.
ability in data among mass spectrometry
laboratories decreased from 2006 to 2011,
indicating that improvement in the accuracy
of testosterone measurements is being
achieved.
The Benefits of Testosterone
Standardization
Accurate and reliable testosterone measurements
are beneficial in many ways. For
example, they support establishment of
clinical guidelines, such as The Endocrine
Society’s guideline that recommends specific
testosterone levels as an aid to diagnosing
androgen deficiency in men. Standardization
also facilitates the use of common testosterone
reference ranges, which not only
saves laboratories time but also the resources
required to establish their own reference
ranges. Together these benefits allow further
assessments of research findings across
studies, which in turn facilitates translation
of research findings into clinical practice.
One illustration of how standardization
impacts lab practices and patient care
comes from a collaboration CDC formed
with Shalender Bhasin, MD, professor of
medicine and section chief of endocrinology,
diabetes and nutrition at Boston
University. Dr. Bhasin conducted a study
to establish normal testosterone ranges for
males using the Framingham Gen 3 study
population. He standardized his laboratory
measurements to the CDC methods, and
CDC provided accuracy-based quality control
materials to assure accuracy of study
data over time. As a result, it now will be
easier for other CDC-standardized laboratories
to use the normal ranges established
by Dr. Bhasin in this study.
In addition, CDC currently is using
its isotope dilution HPLC/MS/MS assay
to analyze samples from men, women,
and children age 6 years and older in the
2011/2012 NHANES cycle. Because assays
are standardized, data from NHANES
can be compared easily with data from the
Framingham study. Furthermore, CDC-
figure 2
cDc hormone standardization
(host) Program Process
standardized labs can compare their data to
the NHANES results.
Partnership for Accurate
Testing of Hormones
In 2010, The Endocrine Society convened a
consensus conference with representatives
from the National Institutes of Health, Food
and Drug Administration, CDC, and other
professional organizations and stakeholders,
with the goal of creating a framework
to implement standardized testosterone
measurement. This conference led to both
a consensus document endorsed by 11 organizations
and formation of the Partnership
for the Accurate Testing of Hormones
(PATH). PATH serves several purposes, not
the least of which includes providing ongo-
ing advice and coordinating activities that
facilitate the use of standardized hormone
tests. PATH also monitors the progress of
standardization efforts and promotes the
use of standardized testing through education
and policymaking.
PATH’s Technical Advisory subcommittee,
chaired by AACC representative,
Robert Fitzgerald, PhD, provides scientific
and technical expertise to support standardization.
The subcommittee is currently
reviewing research data on biological variability
to re-evaluate current performance
criteria. The findings from this study will
help to further refine method performance
criteria and to identify data gaps. PATH also
is working with Dr. Bhasin to establish normal
ranges in men.
figure 3
The cDc host Program
these laboratories have successfully performed the CdC standardization
program. Certification is valid for one year.
® endocrine and Metabolic research lab of los angeles biomedical
research institute, lC/Ms/Ms
® labCorp, lC/Ms/Ms
® boston university steroid Hormone assay laboratory, lC/Ms/Ms
® roche diagnostics gmbH, electrochemiluminescence
® Quest diagnostics, lC/Ms/Ms
® Mayo Clinic, lC/Ms/Ms
® arup laboratories, inc., lC/Ms/Ms
® Covance Central laboratories services, lC/Ms/Ms
Updated May 2012.
Calibration/ Calibration Verification
Phase 1
challenge 1 Phase 2a (1st Quarter)
challenge 2 Phase 2b (2nd Quarter)
challenge 3 Phase 2c (3rd Quarter)
challenge 4 Phase 2D (4th Quarter)
bias estimation
using all 4 challenges
in phase 1, single donor patient samples with known values are provided
to the participating laboratory to assess and adjust calibration. in
phase 2, the laboratory is challenged four times with 10 samples each
quarter. after the fourth challenge, data from all challenges are used to
assess bias to the CdC reference method. laboratories with a mean bias
± 6.4% are considered standardized to CdC and sufficiently accurate.
www.cdc.gov/labstandards/hs.html
CliniCal laboratory news June 2012 11

Towards Better Patient Care
Standardization of clinical laboratory measurements
improves the diagnosis and treatment
of diseases. Achieving standardization
requires collaboration among all groups
and stakeholders involved in the measurement
process and use of the measurement
results. The CDC testosterone standardization
program is an example of how different
organizations and stakeholders can work
together successfully to improve patient
care and public health through better diagnosis
and treatment of diseases.
12 CliniCal laboratory news June 2012
Figure 4
Testosterone Interlaboratory Variability
Shown are data from the New York State Proficiency Testing program
expressed as percent of coefficient of variation (%CV). The study used
five samples analyzed by MS-based assays in May 2006, before the start
of the CDC standardization program, and in May 2011, after 1 year of
Onboard
reagent cartridge
How does your current workflow compare?
CDC is conducting similar collaborative
initiatives to standardize other biomarkers
for cardiovascular disease, cancers, and
bone health. For example, vitamin D is
now part of the Vitamin D Standardization
Program (VDSP), a collaboration with the
Office of Dietary Supplements at the National
Institutes for Health, and estradiol
has been added to the HoSt Program this
year. For further information on the CDC
Hormone Standardization Program contact
HoSt@cdc.gov or visit www.cdc.gov/
labstandards/hs.html. CLN
Any test. Any time. Any patient.
standardization. The variability between laboratories decreased from
2006 to 2011, with all participating laboratories reporting values within
5% of each other for all five test samples.
SuggeSTed ReadingS
Clinical Laboratory Standards Institute.
Preparation and validation of commutable
frozen human serum pools
as secondary reference materials for
cholesterol measurement procedures
(CLSI document C37-A). Wayne, Pa:
Clinical Laboratory Standards Institute;
1999.
Herold DA, Fitzgerald RL. Immunoassays
for testosterone in women: better than a
guess? Clin Chem 2003; 49:1250–1251.
BIO-FLASH ®
Rapid-Response Chemiluminescent Analyzer
Progressive. BIO-FLASH gives you the power to run any test you want at
any time on any sample, no batching or waiting required.
Advance to a new level of performance in autoimmunity. Using BIO-FLASH
for your autoimmune diagnostics saves time, improves your workflow and
makes even the most specialized test efficient to perform.
• Full menu random access eliminates the need for batching
• Convenient onboard reagent cartridges have stable calibration
• Achieves excellent throughput with a small benchtop system
• Provides the first result in as little as 30 minutes
Any way you look at it, life just got a lot easier.
Let us show you. Visit us at the 8th International
Congress on Autoimmunity Booth #1, at AACC
Booth #1954 or at www.inovadx.com/workflow. Redefining Autoimmunity.
NOVA View is a registered trademark of INOVA Diagnostics, Inc. © 2012 INOVA Diagnostics, Inc. All rights reserved.
690246 Rev.0
Matsumoto AM, Bremner WJ. Serum testosterone
assays—accuracy matters, J Clin
Endocrinol Metab 2004;89:520–524.
Rosner W, Vesper HW, Endocrine Society
and endorsing organizations. Toward
Excellence in Testosterone Testing: A
Consensus Statement. J Clin Endocrinol
Metab 2010; 95:4542–48.
Rosner W, Vesper HW. CDC Workshop Report:
Improving steroid hormone measurements
in patient care and research
translation. Steroids 2008;73:1285.
Sacks SS. Are routine testosterone assays
good enough? Clin Biochem Rev 2005;
26:43–45.
Stanczyk FZ, Lee JS, Santen RJ. Standardization
of steroid hormone assays: why,
how, and when? Cancer Epidemiol Biomarkers
Prev 2007;16:1713–1719.
Swerdloff RS, Wang C. Free testosterone
measurements by analog displacement
direct assay: old concerns and new evidence,
Clin Chem 2008;54:458–459.
Vesper HW, Botelho JC. Standardization of
testosterone measurements in humans.
J Steroid Biochem Mol Biol 2010;121:
513–519.
Hubert W. Vesper, PhD is the
director of Clinical Standardization
Programs and Chief
of the Protein Biomarker
Laboratory in the Clinical
Chemistry Branch, Division of Laboratory
Sciences at the CDC, Atlanta, Ga.
Email: hav2@cdc.gov.
Julianne Cook Botelho, PhD
is the lead research chemist
in the hormone reference
Laboratory and Standardization
Program in the Clinical
Chemistry Branch, Division of Laboratory
Sciences at the CDC, Atlanta, Ga.
Email: gur5@cdc.gov.
Disclaimer: The findings and conclusions
in this report are those of the authors and
do not necessarily represent the views of the
Centers for Disease Control and Prevention.

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Annual Meeting Preview
Join Us and
Your Professional Peers
The 2012 aacc annual meeting
los angeles, california
july 15–19
n eXPerience more than 200 exciting educational opportunities
conducted by dynamic presenters.
n inTeracT with colleagues, meet new peers, and build long-term
professional relationships.
n Discover new technology at the world’s largest Clinical lab expo.
Entering the Era of Genomic Medicine:
Research Opportunities and Challenges
eric green, mD, PhD
national institutes of Health
bethesda, Md.
2012 Wallace h. coulter lectureship award
dr. green is widely recognized for his start-to-finish involvement
in the Human genome project and most recently for establishing
a program in comparative genomics that involves the generation
and comparative analyses of sequences from targeted genomic
regions in multiple evolutionarily diverse species. don’t miss this
opportunity to hear dr. green discuss the changes and challenges
associated with genomic medicine.
9p21 DNA Variants Associated
with Coronary Artery Disease Risk?
robert roberts, mD
university of ottawa
ottawa, Canada
generally regarded as one of the founders of molecular cardiology,
dr. roberts’s talk will address 9p21 dna variants and explain
their connection with coronary artery disease risk.
14 CliniCal laboratory news June 2012
five Plenary sessions Top the Program
To see the complete program and
to register online, go to
www.aacc.org/2012am.
advance registration closes june 22.
onsite registration will be available in
the los angeles convention center.
The Ethics of Human Tissues in Research
michael christman, PhD
Coriell institute for Medical research
Camden, n.J.
robert cook-Deegan, mD
duke’s institute for genome sciences & policy
durham, n.C.
Pilar n. ossorio, PhD, jD
university of wisconsin law school
Madison, wis.
drs. Christman, Cook-deegan, and ossorio will describe the latest
advancements involving the ethics of human tissues in research
pertaining to informed patient consent and broader use of
genomic information in clinical medicine.
Whole Genome Sequencing
in the Clinical Setting
elaine mardis, PhD
washington university school of Medicine
st. louis, Mo.
dr. Mardis is leading the effort to create methods and automation
pipelines for sequencing the Human genome. learn more about
next-generation and third-generation sequencing technologies
and how to transition them into production sequencing
capabilities.
Diet and CVD Prevention,
Where Should the Emphasis Be
alice h. lichtenstein, Dsc
tufts university
Medford, Mass.
preventing cardiovascular disease is a hot topic in healthcare.
dr. lichtenstein will explain how nutrition is linked to prevention,
as well as the relationship between cholesterol homeostasis
biomarkers and cardiovascular disease.

Meet the 2012 Annual Meeting Chair
a team of hardworking aaCC
members plan the annual
meeting program over the
course of many months. this
year’s organizing committee is
chaired by paolo fortina, Md,
phd. originally from turin, italy,
dr. fortina has spent the last 20
years in philadelphia, pa. He is
currently professor of medical
oncology and cancer biology
at thomas Jefferson university
Medical College where his laboratory
conducts cutting-edge research in genomics and genetics
with the ultimate goal identifying novel diagnostic tools.
with more than 130 publications, dr. fortina is considered one
of the world’s experts on genomics-based diagnostics. using his
expertise, he put together an innovative chair’s invited session entitled,
“trends in diagnostics technology,” which will take place on
wednesday, July 18th. this full-day session will present an overview
of novel technologies that span the continuum of clinical
testing, starting with new methods for blood collection, nucleic
acid extraction, microchip devices, and gene signature and digital
rna analysis in clinical settings.
in this interview, dr. fortina shares his enthusiasm for the 2012
aaCC annual Meeting program.
What do you want people to know
about the 2012 Annual Meeting?
We have a very exciting program with
many experts in the fields of genetics,
cardiology, pediatrics, and bioinformatics.
The organizing committee has
carefully selected topics and presentations
that cover both the most advanced
research and the latest findings.
Importantly, we have asked speakers to
focus on how laboratory professionals
will actually apply the results of this research
to their routine work in laboratories
and clinics.
What’s the best part of being the
chair of the 2012 Annual Meeting?
I think that being able to work with the
organizing committee to identify the
invited speakers, especially the presentations
selected from the many proposals
submitted to the meeting, has been the
best part of chairing the meeting. It also
is gratifying to know that all the work we
do will have important repercussions
on how laboratorians will perform their
work in clinical laboratories, not only
here in the U.S., but everywhere in the
world. People will come to this meeting
and share their work and research and
learn from each other. They will then
take this new knowledge back to their
home laboratories and improve the
scope and quality of laboratory services.
What are the hot topics
at the meeting?
I would definitely single out highthroughput
sequencing and personalized
medicine, applications of mass
spectrometry in clinical settings, bioinformatics,
biobanking, laboratory
management, and the current status of
healthcare reform
What advice do you have for someone
who has never attended an
AACC Annual Meeting?
Plan in advance! This is a large meeting
with many parallel sessions. Attendees
need to look carefully at the program
in order to optimize attendance at the
sessions that most correspond to their
interests. I encourage everyone to use
our online planning tool, AACC Pathfinder,
to keep track of their schedule.
This mobile app will automatically put
you in the sessions you have registered
for, as well as allow you to make appointments
and connect to exhibitors.
If an individual only has only one
day to spend at the meeting, what
would you recommend?
That’s pretty hard! I am especially
looking forward to the opening plenary
on Sunday night by Dr. Eric
Green, who will talk about the era of
Genomic Medicine. But then my per-
sonal interests are molecular biology
and genetics. I don’t think anyone will
be disappointed in any day that they
pick to come. I strongly encourage you
to spend as much time as you can because
this meeting and exposition has
so much to offer for everyone involved
in laboratory medicine. CLN
sYcl invites you to its 2012 aacc
annual meeting Workshop
The Evolving Clinical Laboratory Landscape:
Key Elements
as a current or future laboratory director, are you able to traverse rapid
changes in laboratory testing and understand how the transformations
of healthcare affects you? this workshop, presented by aaCC’s society for
Young Clinical laboratorians (sYCl), is geared toward younger members of
aaCC and will offer valuable insights and information from experts in various
areas of laboratory medicine.
bill Clarke, phd, Johns Hopkins, will help you navigate through uncharted
waters in his presentation, laboratory developed tests (ldts): what’s
all the fuss about? dr. Clarke will define ldts and how they are regulated,
discuss their importance, as well as identify ongoing challenges for laboratories
that perform them.
elaine Jeter, phd, palmetto gba, and Michael astion, Md, phd, seattle
Children’s Hospital, will help you cultivate the fertile earth and understand
how to protect your laboratory’s bottom line while optimizing patient care.
dr. Jeter will provide her insight on understanding lab payments in her
presentation, Molecular diagnostics Coding, Coverage and reimbursement:
a new paradigm, and dr. astion will focus on appropriate lab test utilization
in his talk on getting the waste out. this session of the workshop will
describe linking unique codes to rendered services, understanding valuebased
pricing, and the unnecessary bundling of laboratory tests. You will
also gain insight into how third-party payers and the government are working
to improve the use of the clinical laboratory through reimbursement.
allan Jaffe, Md, Mayo Clinic, and James faix, Md, stanford university
will help you harness the changing winds of lab testing. they will use a tag
team approach to deliver, life Cycle of lab tests: Creation to obsolescence.
this part of the workshop will cover ways new markers come into use,
strategies to eliminate outdated tests and to replace them with proven,
cutting-edge assays, as well as how to assess effectiveness of new tests in
your laboratory.
don’t miss your opportunity to join us for the 2012 sYCl workshop and
invest in the future landscape of the clinical laboratory. the workshop will
culminate with a sYCl workshop mixer. Come and mingle with fellow current
and past sYCl members and try your hand at aaCC trivia!
registration is open to all sYCl members, but space is limited! sign up
for the workshop when you register for the aaCC annual Meeting. the
registration fee is only $30!
saturday, july 14th
jW marriott hotel los angeles
Workshop 1:00–5:15 p.m.
Platinum ballroom salon c
mixer 5:30–7:30 p.m.
Platinum ballroom salons a&b
Help us Plan Next Year’s Workshop
the 2013 sYCl workshop Committee is interested in your ideas! planning
for the 2013 sYCl workshop is underway and we want to know
which topics interest you. Contact the committee chair,
Mark Cervinski, phd, at mark.a.cervinski@hitchcock.org with your ideas.
CliniCal laboratory news June 2012 15

Annual Meeting Preview
Divisions Offer Special Programs
17th Annual Leadership Seminar
Work Life Balance in a Time of High
Unemployment and Shortage of Trained Staff
Saturday, July 14, 5:30 p.m.–8 p.m.
JW Marriott Los Angeles at LA LIVE
Larry Crolla, PhD, recipient of the 2011 Outstanding Contributions to
Management Sciences award, will discuss how to maintain quality
laboratory service when workers are asked to do more with less.
Registration Fee: $20 AACC member/non-member (includes reception).
To Register: www.aacc.org/members/divisions/management/events/
pages/default.aspx
AACC—What a Great Idea!
The Los Angeles Movie Premier
Monday, July 16
2:30 p.m.–5 p.m.
Los Angeles Convention Center
Room 407
Plan to walk down the carpet for this exciting event! On Monday,
July 16th, AACC’s History Division will premier its original
production, “AACC—What a Great Idea.” The movie takes
an in-depth look at the 50 plus years of AACC’s history and
features the contributions of individuals as well as a look back
at how technology has changed the laboratory.
The 30-minute movie will be preceded by a short
documentary entitled, “Movie Molecules: Clinical Chemistry
in Hollywood,” which takes a fun look at how Hollywood
portrays the laboratory.
Grab some popcorn at the door and join in an afternoon
of fun and entertainment! Open to all registered attendees.
Current Topics in Cardiovascular Disease
Monday, July 16, 5:30 p.m.–9:30 p.m.
JW Marriott Los Angeles at LA LIVE
Alan Remaley, PhD, of the National Institutes of Health, will give the
Cooper Award Lecture on Translating New Discoveries in HDL Biology
into Novel Therapies and Jay Heinecke, PhD, of the University of Washington
will give the PBRF Award Lecture, Inflammatory Remodeling of
the HDL Proteome Renders the Lipoprotein Dysfunctional.
Registration Fee: $50 Limited to the first 90 LVDD Members
(includes reception and dinner).
To Register: www.aacc.org/members/divisions/lipids/events/pages/
default.aspx
16 CliniCal laboratory news June 2012
Malnutrition in Hospitalized Patients:
Is the Clinical Laboratory Keeping Up?
Tuesday, July 17, 5:30 p.m.–9:30 p.m.
JW Marriott Los Angeles at LA LIVE
Speakers will discuss pathophysiology and assessment of malnutrition
in hospitalized patients, nutrition screening tools, and markers of
nutritional assessment.
Registration Fee: $20 AACC member/non-member (includes reception).
To Register: www.aacc.org/members/divisions/nutrition/events/pages/
default.aspx
Japan Healthcare Technology Foundation and
Pacific Biometrics Research Foundation
International Lipoprotein
Standardization Forum
Tuesday, July 17, 6 p.m.–9:30 p.m.
JW Marriott Los Angeles at LA LIVE
LVDD members are invited to join international leaders in a discussion
of recent findings related to lipoproteins, with a focus on new technologies
and standardization efforts.
Registration Fee: $40 Limited to the first 60 LVDD members
(includes reception and dinner).
To Register: www.aacc.org/members/divisions/lipids/events/pages/
default.aspx
The OEM Lecture Series
Tuesday and Wednesday, July 17and 18, 8 a.m.–Noon
Los Angeles Convention Center
The OEM Lecture Series offers an opportunity for meeting participants
to see the latest advances from OEM vendors—those organizations
that supply components, subsystems, and contract services to IVD
manufacturers. These sessions are intended for those involved in product
research and development.
Registration Fee: There is no additional charge for this lecture series.
To Register: Basic conference registration is required.
Contact: Tony Maiorino, Scherago International, tonym@scherago.com
10th Annual POCC Forum
Coagulation II at the Point-of-Care
Thursday, July 19, 7:30 a.m.–10 a.m.
Los Angeles Convention Center
In this year’s forum, two renowned experts discuss and compare
advancements in anticoagulant drugs and how they are being used at
the point-of-care.
Registration Fee: $20 AACC member/non-member (includes breakfast).
To Register: www.aacc.org/members/divisions/cpoct/events/pages/
default.aspx

See the Largest Clinical Laboratory Exposition in the World
aacc clinical lab expo
july 17–19 at the los angeles convention center
This is your opportunity to see all the latest products in every clinical lab discipline. Plan now to attend.
Visit www.aacc.org/2012am for details.
AACC
A/C Diagnostics LLC
A2LA American Association
for Laboratory Accreditation
AAFP- Proficiency Testing
Aalto Scientific, Ltd.
AB SCIEX
Abaxis
Abbott Diagnostics
AbD Serotec
Access Biologicals, LLC
AccuBioTech Co., Ltd.
Accumax Lab Technology
Accumetrics, Inc
Acon Laboratories, Inc.
Action Bag Company
Adaptive Mfg. Technologies, Inc.
ADEMTECH
Adhesives Research, Inc.
ADVANCE/Merion Matters
Advanced Instruments, Inc.
Advanced Microdevices Pvt. Ltd.
AdvanDx
Advantec MFS Inc.
Aesku Diagnostics
Agilent Technologies
Ahlstrom Filtration LLC
Aim Lab Automation Technologies Pty
ALCOR Scientific Inc.
Alfa Scientific Designs, Inc.
ALIFAX SPA
ALPCO Diagnostics
Alpha-Tec Systems, Inc.
Am. Society for Clinical Pathology
Amano Enzyme USA Co., Ltd.
Amedica Biotech, Inc.
American Board of Clinical Chemistry
American Medical Technologists
American Proficiency Institute
AmeriWater
Anaerobe Systems
Analis
Analyticon Biotechnologies AG
Ani Biotech Oy
Ani Labsystems Ltd. Oy
Anteo Diagnostics
Antibodies Inc.
Aperio
Applied Biocode, Inc.
Apricot Designs
Aptiv Solutions
Arab Health
Arista Biologicals Inc.
ARK Diagnostics, Inc.
ARKRAY
Arlington Scientific Inc.
Army Medical Recruiting
Artel
Artron BioResearch Inc.
ARUP Laboratories
ASCLS
ASCO Numatics
Associates of Cape Cod, Inc.
Audit MicroControls, Inc.
Aureus Medical Group
Aurora Biomed Inc.
Autobio Diagnostics Co. Ltd.
AutoGenomics, Inc.
Avantes, Inc.
AVE Science & Technology Industrial
Co., Ltd.
Aviir
Awareness Technology, Inc.
AWEX
AXA Diagnostics s.r.l
Axela, Inc.
Axxin
AZOG, Inc.
B&E Scientific Instrument Co., Ltd.
Bangs Laboratories/Polysciences
BB International
BD
BD Lee Laboratories
Beckman Coulter
Beija Biochemistry Reagent Company
Beijing Chemclin Biotech Co., Ltd.
Beijing JinYiMing Science &
Technology Co. Ltd.
Beijing Kinghawk Pharmaceutical Co.
Beijing Strong Biotechnologies, Inc.
Beijing Wantai Biological Pharmacy
Benson Viscometers Ltd.
Berthold Detection Systems GmbH
BG Medicine
Big C: Dino-lite Scopes
Binding Site Inc., The
BioAssay Works, LLC
Bio-Chem Fluidics Inc.
Biochrom Corp
BioCision
BIOCRATES Life Sciences
BioDot, Inc.
BioHelix Corporation
BioHit OYJ
BIOHIT, Inc.
Biokit S.A.
Biolabo
BIOLYPH, LLC
BioMedica Diagnostics Inc.
Biomedix, Inc.
BIOMERICA
Biometrix Technology Inc.
Bioneer Corporation
Bionostics Inc./RNA Medical
BioPorto Diagnostics A/S
Bio-Rad Laboratories
BioRx Laboratories
Biosearch Technologies
BioSell Solutions
Biosensia
BiosPacific
Biosynex
BioTek Instruments
BIOTRON DIAGNOSTICS INC
BIT Companies
Block Scientific
Boditech Med Inc.
Bomi Group
Boson Biotech Co., Ltd.
Broadmaster Biotech
Bruker Daltonics
BUHLMANN Laboratories AG
Burkert Fluid Control System
C & A Scientific Co., Inc.
C/D/N Isotopes Inc.
CalBioreagents
Calbiotech, Inc
Calzyme Labs, Inc.
Cambridge Consultants
CapitalBio Corporation
Capp (Denmark) APS
Capralogics Inc
Capricorn Products LLC
Cardinal Health
CARE Diagnostica International
Caretium Medical Instruments Co, Ltd
Carolina Liquid Chemistries
Carville Ltd
CDC / TTO
Cedarlane
CellaVision
Centers for Medicare &
Medicaid Services
Cepheid
Ceragem Medisys, Inc.
Ceramaret SA
Cerilliant
CERTEST BIOTEC S.L.
CETAC Technologies
Chembio Diagnostics Systems, Inc.
Chengdu Rich Science Industry Co.
Chongqing Tianhai Medical Equipment
Co. Ltd.
Chromsystems GmbH
Chungdo Pharm Co. Ltd.
Cisbio US
Clarity Diagnostics
Cleveland Clinic Laboratories
Clinical and Laboratory Standards
Institute
Clinical Diagnostic Solutions, Inc.
Clinical Innovations, LLC
Clinical Lab Products
CLINIQA Corporation
Clontech Laboratories, Inc.
CLTech International Corp.
CMEF
COLA
College of American Pathologists
CompuGroup Medical
Conductive Technologies Inc.
Cone Bioproducts
Constitution Medical
Contec Medical Systems Co., Ltd.
Cooper-Atkins Corporation
Copan Diagnostics, Inc.
Corgenix
Coris Bioconcept
Creation Technologies Design Services
Crystal Chem Inc.
CSP Technologies, Inc.
CTK Biotech, Inc.
Daan Diagnostics Ltd./DAAN Gene Co.
Ltd. of Sun Yat-san University
DAS Sr
Data Innovations, LLC.
Data Unlimited International, Inc.
Dawning Technologies, Inc.
De Novo Software
Deardorff Fitzsimmons Corporation
Delta Industrial Services
Denka Sieken Co., Ltd.
DenLine Uniforms, Inc.
Desert Biologicals/Omega Biologicals
diaDexus, Inc.
Diagam
Diagnostic Automation/
Cortez Diagnostics
Diagnostic Consulting Network
Diagnostica Stago, Inc.
Diagnostics Biochem Canada Inc.
DiagnostikNet-BB
DIALAB GmbH
Diametra SRL
Diamond Diagnostics Inc.
DiaSorin, Inc.
Diasource
DiaSys Diagnostic Systems
Diatron
Diazyme Laboratories
DIBA Industries, Inc.
Dickson
DIESSE Diagnostica Senese S.p.A
Dirui
DOCRO, Inc.
DRG International, Inc.
Drummond Scientific
DSI S.r.l
DSM
D-Tek
DTx Inc.
DVG Packaging
Dynex Technologies
EastCoast Bio, Inc.
Egemin Automation, Inc.
Elga Labwater
Elitech Group
EMD Millipore
Entrocomponent Solutions (ECS)
EntroGen, Inc.
Epitomics, Inc.
Epitope Diagnostics, Inc.
Eppendorf
Equal Access to Scientific Excellence
Equitech-Bio Inc.
Erba Diagnostics Manneim GmbH
Escalon Clinical Diagnostics
EUROMEDLAB MILANO
Eurospital S
Eurotrol, Inc.
EVERGREEN SCIENTIFIC
Excel Scientific, Inc.
Express Diagnostics
FANUC Robotics America Corporation
Fapon Biotech Inc.
Far East Bio-Tec Co., Ltd.
Filtrona Porous Technologies
Fitzgerald Industries Int’l
FlexLink Systems, Inc.
Fluid Metering, Inc.
Focus Diagnostics
Foliage
Freezerworks, A Division of
Dataworks Development
Fujirebio Diagnostics, Inc.
Fuller Laboratories
Gale Force Software Corporation
Gems Medical Sciences
GeneDireX (TAQKEY Science Co.)
Genemed Biotechnologies, Inc.
General Biologicals Corp.
Genisphere, LLC
GenMark Diagnostics, Inc.
Genolution Pharmaceuticals
GenomeWeb LLC
GenPrime, Inc.
Gen-Probe Incorporated
Gentura Dx
GenWay Biotech, Inc.
Getein Biotechnology Co., Ltd
Globe Scientific Inc.
Gold Standard Diagnostics
Golden West Biologicals, Inc.
GOMA Biotec
Greiner Bio-One
GRIFOLS
GSI Technologies
Guangzhou Improve Medical
Instruments Co., Ltd.
Guangzhou Wondfo Biotech Co., Ltd.
GVS Filter Technology
Haemonetics Corporation
Haiyan Everbright Co., Ltd
Hamamatsu Corporation
Hamilton Company
Hanlab Corporation
Harlan Bioproducts for Science, Inc.
HB Optical Technology Co., Ltd.
Healgen Scientific LLC
Heathrow Scientific
Helena Laboratories
Helica Biosystems, Inc.
HELMER
HemoCue, Inc.
A Quest Diagnostic Company
Hemosure Inc
Hettich
Hi-Tech Products
Hoover Precision Products, LLC
HORIBA Medical
HTL-Strefa Inc.
Hycor Biomedical
HyTest Ltd.
I2A
IBL America
IBL International Corp.
Idaho Technology Inc.
IDEX Health & Science
IFCC—International Federation of
Clinical Chemistry & Laboratory
Medicine
IKO International, Inc.
Iline Microsystems
ILS Innovative Labor Systeme GmbH
IMMCO Diagnostics
Immucor, Inc.
Immundiagnostik AG
Immuno Concepts
Immunodiagnostic Systems Inc.
ImmunoReagents, Inc.
Impak Corp.
InBios International, Inc.
IND Diagnostic Inc.
Innova Biosciences
Innovize
INOVA Diagnostics, Inc.
Instru-med Inc.
Instrumentation Laboratory (IL)
InTec Products, Inc.
Integra
Inteplast Healthcare
Inter Bio-Lab, Inc.
International Immunodiagnostics/
Teknolabo
International Immunology Corp.
Inverness Medical Innovation
Invetech
Ionics Mass Spectrometry Group
IQuum, Inc.
IRIS International Inc.
ISEC/Kewaunee Scientific
Isensix, Inc.
IT4IP
ITC Nexus DX
IVD Research, Inc.
IVD Technologies
IVEK Corp.
Iwaki America Inc.
Japanese Association of Clinical
Laboratory Automation
Jiangsu Zhengji Instruments Co. Ltd
JSR Micro, Inc.
K & K Consultant Group, Inc.
Kaiser Permanente
Kamiya Biomedical Company
Kem-En-Tec Diagnostics
Key Tech
Kikkoman Biochemifa Company
Kinematic Automation Inc.
Kingmed Diagnostics
KMC Systems, Inc.
KNF Neuberger Inc.
KPL, Inc.
KRONUS, Inc.
Lab Medica
LabCorp - Esoterix
LABiTec GmbH
Labnovation Technologies, Inc
Labotix Automation, Inc.
LabProducts, Inc.
Labtest
Lampire Biological Laboratories, Inc.
Landwind Medical
LasX Industries, Inc.
Lathrop Engineering Inc.
LDN Labor Diagnostika Nord
Lee Company, The
LGP Consulting, Inc.
Life Technologies
LifeSign LLC
Liming Bio-products Co., Ltd.
LipoScience
Lohmann Precision Die Cutting
LPS Industries, LLC
LRE Medical
Luminex Corporation
Lunginnov
M&D, Inc.
Maestrogen, Inc.
MagnaBioSciences
MagneMotion
Magnisense
Magsphere Inc.
Maine Biotechnology Services
Maine Manufacturing, LLC
Maine Standards Company
MAKER Biotechnology
Man & Machine, Inc.
Market Diagnostics International
MAXMAT S.A.
Mayo Medical Laboratories
McKesson
MediaLab, Inc.
Medica 2012/Messe Duesseldorf
North America
Medica Corporation
Medical Device Safety Service GmbH
Medical Electronic Systems
Medical Laboratory Evaluation
MediSensor, Inc.
Medix Biochemica
MedTest DX, Inc.
MEDTOX Laboratories
Megatone Electronics Corp.
Meizhou Cornely Hi-Tech Co. Ltd.
Mercodia Inc.
Mercy Ships
Meridian Bioscience, Inc.
Meridian Life Science, Inc.
Metabolon
Mettler Toledo
Michigan Diagnostics, LLC
Microbix Biosystems Inc.
MicroDigital Co., Ltd.
microfluidic ChipShop GmbH
Microliter Analytical Supplies, Inc.
Micropoint Bioscience, Inc.
Microscan
Microvisk Technologies Ltd.
Midland BioProducts Corp
Mini Fab
MiniGrip
Minitubes
Mitsubishi Chemical Medience Corp.
Mitsubishi Gas Chemical America, Inc.
MLO-Medical Laboratory Observer
Moduline Systems, Inc.
Monobind Inc.
Moss, Inc.
MP Biomedicals
mSPEC Group
MT Promedt Consulting GmbH
Multisorb Technologies
m-u-t AG
Nanjing Perlove Medical Equipment
Co. Ltd
Nano-Ditech Corporation
Nanoq
Nanosphere, Inc.
Nantong Egens Biotechnology Co., Ltd.
National Academy of
Clinical Biochemistry
National Registry of Certified Chemists
Neogen Corporation
Netlims, LLC
New England Biolabs, Inc.
New England Small Tube
NewScen Coast Bio-Pharmaceutical
Co., Ltd.
Nextslide Imaging, LLC
NICHIREI BIOSCIENCES, INC.
Nikon Instruments Inc.
Ningbo Kanghe Biology Technology Co.
NIST/MSD
NOEMALIFE SpA
NOF America Corporation
Norgren Kloehn, Inc.
Nor-Lake Scientific
Normand Info
Nova Biologics, Inc.
Nova Biomedical
Novatec Immundiagnostica GmbH
NuAire Inc
Nuclear Laser Medicine SRL
OAKRIDGE PRODUCTS
OAPI Medical Devices
Omega Diagnostics Group PLC
OMNICA - Product Development
OMNIPrint, Inc.
OPERON, S.A
OPTI Medical Systems, Inc.
OraSure Technologies, Inc.
Orchard Software Corp
Orphee S.A.
Ortho Clinical Diagnostics
Ovizio Imaging Systems
OYC Americas, Inc.
Oyster Bay Pump Works, Inc.
Pacific Die Cut Industries/
PDCI Medical
Pacific iD
Pall Life Sciences
Panagene, Inc.
Panasonic
Peripheral Resources, Inc.
Phenomenex, Inc.
PICDI
Plasma Services Group
Pointe Scientific, Inc.
Polymed Therapeutics, Inc.
Polymedco, Inc.
POLYMICROSPHERES
Precise Automation
Precision Systems Inc.
Preco, Inc.
Premstar Medical (HK) Limited
Primera Technology
PrimeraDx
Princeton Biomeditech (PBM)
Progenika, Inc.
Proliant Health and Biologicals
Propper Manufacturing Co.
Pulssar Technologies
Puritan Medical Products
PZ CORMAY S.A.
Qarad
QBC Diagnostics
Qiagen Lake Constance
QualTex Laboratories
Quantimetrix Corporation
Quantum Analytics
Quest Diagnostics
Quidel Corporation
Radiometer America
Rainin Instrument, LLC
Randox Engineering
Randox Laboratories US Ltd
Randox Life Sciences
Rayto Life & Analytical Sciences Co, Ltd
R-Biopharm AG
Rees Scientific
RepExact, LLC
Research Organics, Inc.
Reszon Diagnostics International
Rheonix, Inc.
Ridgewood Medical Media
RND Group, Inc., The
Roche Diagnostics Corporation
Rockland Immunochemicals, Inc.
ROHM CO., Ltd.
Rotek Industries
Runlab Labware Manufacturing Co.
SA Scientific LTD
SACACE Biotechnolgoies Srl
SAKAE Corporation
Samsung/Nexus Dx, Inc.
Sansure Biotech, Inc.
Sarstedt, Inc.
Sartorius Stedim Biotech
Scantibodies Laboratory Inc.
SCC Soft Computer
SCETI K.K.
Scientific Device Laboratory
Scientific Specialties Inc.
Scimedx Corporation
Scripps Laboratories
ScyTek Laboratories, Inc.
SDIX
Sebia Electrophoresis
Seegene, Inc.
Sekisui Diagnostics
Sekisui Medical Co. Ltd.
Select Science
Senso Scientific, Inc.
Sensovation
SENTINEL CH SpA
Separation Technology, Inc.
SeraCare Life Sciences
Seraplex, Inc.
Serion Immundiagnostica GmbH
Serosep
Shanghai Kehua Bioengineering Co.
Shanghai Chemtron Biotech Co., Ltd.
Shanghai Fosun Long March Medical &
Science Co., Ltd.
Shanghai Kang Xiang Medical Co. Ltd.
Shanghai Tellgen Life Science Co.,Ltd.
Shanghai Upper Biotech Pharma Co.
Shanghai ZJ Bio-Tech Co., Ltd.
Shel Lab (Sheldon Manufactoring Inc.)
Shenzhen Emperor Electronic
Technology Co., Ltd
Shenzhen Genius Electronics Co., Ltd.
Shenzhen iCubio Biomedical
Technology Co
Shenzhen Mindray Bio-Medical
Electronics Co., Ltd.
Shenzhen Procan Electronics Inc.
Shijiazhuang Hipro Biotechnology Co.
Shin Jin Medics Inc.
Sias AG
Siemens Healthcare
Siemens Industry, Inc.
SIFIN Institut fu Immunpraparate
Siloam
SimPort
Sinnowa Medical Science & Technology
Co., Ltd.
Skannex AS
SLR Research Corporation
SMC Corporation of America
SNIBE CO., LTD
Softtech Health
SolGent Co., Ltd
Sony DADC
Source Scientific, a BIT Company
SouthernBiotech
Sparton Medical
Spherotech, Inc.
Spinreact S.A.U.
Stanbio Laboratory
STRATEC Biomedical Systems AG
Stratos Product Development
Streck Laboratories, Inc.
Sunostik Medical Technology Co., Ltd.
Sunquest Information Systems
Super Brush LLC
SurModics IVD
Swisslog
Syntron Bioresearch, Inc.
Sysmex America, Inc.
Systelab Technologies
Taidoc Technology Corporation
Taigen Bioscience Corporation
TAKASAGO FLUIDIC SYSTEMS
TANOS
Tecan
Technidata
Techno Medica Co. Ltd.
Teco Diagnostics
TELCOR
Testo, Inc.
Therapak Corporation
Thermo Fisher Scientific
Thermo Scientific
thinXXS Microtechnology AG
Tianjin Era Biology Engineering Co.
TOKYO BOEKI MACHINERY LTD.
Topscien Instrument (Ningbo) Co., Ltd.
Tosoh Bioscience
Toyobo Co. Ltd c/o Toyobo Specialties
(USA) Inc.
Tricontinent
TriLink Biotechnologies, Inc.,
TRINA BIOREACTIVES AG
Trinity Biotech
TubeWriter
Turklab A.S.
U.S. Export Pavilion
UBIFRANCE
UCLA Health System
UCP Biosciences, Inc.
UCSF Medical Center
Ulti Med Products GmbH
UNICO/United Products
& Instruments
University of Michigan - Mlabs
URIT Medical Electronic Co., Ltd
UTAK Laboratories, Inc.
ValuMax International
VEDALAB
Veracity Group, Inc.
ViraLab Inc
Vircell
ViroStat, Inc.
Vital Diagnostics
Viva Products, Inc.
Vivacta Ltd.
Vonco Products
Wako Diagnostics
WAMA Diagnostica
Warde Medical Laboratory
Waters Corporation
Weidmann Plastics Technology AG
Weifang Kanghua Biotech Co., Ltd.
Werfen Group
WesTgard QC, Inc.
Wheaton
WHPM
Wi Inc.
Wiener Laboratorios SAIC
Wiley
Wisepac Active Packaging Components
Co., Ltd.
Worthington Biochemical Corporation
XEMA Co. Ltd.
Xiril AG
Yaskawa America Inc.
YD Diagnostics Corporation
Zentech
ZeptoMetrix Corporation
Zeta Corporation
Zhejiang Gongdong Medical
Technology Co Ltd.
As of May 4, 2012
CliniCal CliniCal laboratory laboratory news June 2012 17

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Rethinking ß-Cell Function After Type 1 Diabetes Onset
Ultrasensitive Assay Detects C-Peptide Decades Post-Diagnosis
By Genna Rollins
aaCC members enjoy many benefits, including a
members-only newsletter, Clinical Laboratory Strategies.
this online publication provides readers with insight
into new research of importance to laboratory practice.
each issue features a discussion of a recently published
study selected by the Strategies editorial advisory board,
with commentary by both a study author and outside
reviewer. articles also are available as podcasts.
this month, CLN is pleased to present a recent article
from Strategies.
In selecting the study discussed in this article,
the Editorial Advisory Board commented
that use of a new high-sensitive
assay broke down some long standing
opinions on the destruction of pancreatic
ß-cells. It also presents a paradigm shift in
thinking about treatment options for patients
with type 1 diabetes. With potential
therapies on the horizon for ß-cell stimulation,
this type of assay could be critical
to identifying patients who might benefit
from therapy, as well as monitoring treatment
effectiveness.
For decades, treatments for and clinical
trials involving type 1 diabetes have
been based on the understanding that
the disease’s autoimmune process rapidly
curtails pancreatic ß-cell function,
as measured by C-peptide levels. However,
research involving a new, ultrasensitive
C-peptide assay is providing fresh
insight into the course of diabetes. The
study findings are covered in this issue of
Strategies.
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20 CliniCal laboratory news June 2012
The conventional understanding of the
pathophysiology of type 1 diabetes is that
pancreatic ß-cell function drops off dramatically
and soon—within a few years—
after diagnosis. This well-described process
can be tracked through declines in C-peptide
values over the same period, C-peptide
being the protein clipped when A- and
B-chain proteins of proinsulin synthesized
by pancreatic ß-cells form insulin. Rapid
ß-cell death and the associated drop in insulin
production have led to what researcher
Denise Faustman, MD, PhD, has called
therapeutic nihilism. “The thought has
been that the pancreas is not functioning
after about one-to-two years, so our treatment
approach has been kind of fatalistic.
‘Oh, your pancreas is dead, we don’t have
anything to save the remaining pancreas’,”
she explained. Faustman is director of im-
munobiology at Massachusetts General
Hospital and an associate professor of medicine
at Harvard Medical School in Boston.
However, diabetologists also have recognized
that some residual ß-cell function
remains after diagnosis and that early, aggressive
treatment with insulin or immunosuppressive
drugs can slow the autoimmune
destruction of ß-cells, enabling
patients to go a little longer before they
need full doses of insulin routinely. Equally
well-known is that some newly diagnosed
diabetics run quickly into complications of
the disease, while others fare much better
clinically for years. Often this has been attributed
to the latter managing their disease
better, but new evidence is casting a
different light on this.
ß-Cell Function Endures
Faustman and her colleagues recently used
a new ultrasensitive C-peptide immunoassay
to measure serum C-peptide levels in
long-term type 1 diabetics (Diabetes Care
2012;35:465–70). To their surprise, the
subjects not only had detectible C-peptide
levels—including 10% of those who had
had diabetes 3–4 decades—but also functioning
ß-cells. “We found using a new
ultrasensitive assay that the time course
of the disease is totally altered. Even at
30 years out, 20 percent still have a pancreas
making some insulin, as assayed by
C-peptide,” said Faustman. “It’s a whole
new way to view the disease as it relates to
the pancreatic function two years out after
diagnosis. It’s all come about because of
this ultrasensitive assay, which has altered
understanding of the kinetics of this disease
in a good way.”
The study involved two components,
including 182 type 1 diabetics, who were a
median of 39 years, had had the disease a
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median of 15 years, and were a median of
age 13 at disease onset. C-peptide values for
all these subjects were measured first with
an ultrasensitive C-peptide assay, and
only those with values higher than the
detection range of the ultrasensitive assay
also were measured using a standard assay.
The second part of the study involved
four diabetics who provided serum
samples weekly for up to 20 consecutive
weeks. C-peptide values in these samples
were measured using a different standard
C-peptide assay but with the same
ultrasensitive assay that had been used to
measure samples from the 182 patients.
The standard C-peptide assays have lower
limits of detection of 15 pmol/L and
33.1 pmol/L, respectively, whereas the
ultrasensitive assay has a lower limit of
detection of 1.5 pmol/L with inter- and
intra-assay coefficients of variation of 5.5
and 3.8% at 37 pmol/L.
Researchers categorized the 182 samples
into six groups based on the patients’
years of disease duration and found declining
levels of C-peptide detection across the
groups; however, the decline was gradual
over decades, rather than a few years. Nearly
80% of samples in the 0–5 years’ duration
of disease group had C-peptide levels
above the ultrasensitive assay’s limit of detection,
versus 10% from patients who had
had diabetes for 31–40 years. C-peptide
was not detected in subjects who had had
diabetes 31–40 years. In the group of four
subjects who provided a total of 54 serial
samples, the standard C-peptide assay did
not detect C-peptide in any of the samples,
whereas the ultrasensitive assay detected
C-peptide in 63%.
The researchers also assessed subjects’
ß-cell functional capacity by evaluating
fasting and/or non-fasting glucose levels in
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oth the group of four patients who provided
serial samples and in samples from
the 182 patients. In both groups, samples
from hyperglycemic subjects with glucose
values >150 mg/dL had significantly higher
C-peptide levels than those from normoglycemic
subjects.
New Research Paradigms
These findings have important clinical ramifications,
according to Daniel Stein, MD,
who was not involved in the study. “The
implications of this study are two-fold. One
is that people even 30 years out from the
diagnosis of diabetes may have minimal
C-peptide levels that are not detectable by
the normal assays but when an ultrasensitive
C-peptide assay is brought to bear they
have measurable levels,” he observed. “Perhaps
just as important, is the finding that
C-peptide responds in a biologically appropriate
way to stimulation of the beta cells to
secrete insulin. These long-standing diabetics
don’t have a lot of beta cells. They have
a few of them. But that’s a very important
finding because the clinical trial data suggests
both in terms of intervention studies
of immunosuppressants or in conventional
therapy with insulin, patients maintain better
glycemic control if they have some residual
beta cell function. These patients also
have a lower risk of complications.” Stein
is professor of medicine and scientific director
of the Einstein/Montefiore Institute
for Clinical and Translational Research at
Albert Einstein College of Medicine in
New York City.
Faustman agreed that the findings could
reshape diabetes-related research. “The
standard C-peptide assay drove every clinical
trial protocol in this field for the past
25 years because everybody thought that
if were you’re going to do an immune intervention
trial in type 1 diabetics you had
to get the kids within a week, or a month
of diagnosis or do very complicated things
and try to identify them in populations before
they even get a high blood sugar. That’s
because the drugs being developed weren’t
stopping the disease, they were slowing
the disease. So that meant you had to have
C-peptide present to slow the destruction
of the pancreas,” she explained. “This new
assay will open up the field tremendously
to say people who have had the disease two
to even 40 years shouldn’t be rejected from
these kinds of trials and we should be doing
more clinically for these people.”
Faustman and Stein both predicted that
clinicians would be eager to use the ultrasensitive
assay in clinical practice, which
is available in the U.S. as a kit from the
manufacturer, Mercodia. “There’s value in
knowing whether a patient has C-peptide
positivity even at low levels detected by
an ultrasensitive assay,” said Stein. “These
patients may have a small amount of residual
beta cell function, may respond better,
and potentially have a better prognosis
in terms of their ability to maintain good
glycemic control without an insulin pump.
They might do better on intensive insulin
therapy, such as four times per day insulin
injections or an insulin pump, compared
to someone who truly has no detectible
C-peptide.”
Faustman urged laboratorians to stay
abreast of developments involving the ultrasensitive
assay. A spokesperson for Mercodia
indicated that the company may seek
additional Food and Drug Administration
clearance for the assay as a marker of ß-cell
decay, based on findings from this study.
Stein’s lab also is developing a mass spectrometry-based
method to measure very
low levels of the analyte.
Faustman predicted ultrasensitive Cpeptide
measurement would fit a particular
niche in diabetology. “For an endocrinologist
evaluating a patient with a suspected
tumor that’s making too much insulin
from the tumor, the standard assays with
range of detection from 40 to 660 pmol/L
are totally appropriate,” she said. “However,
I would think clinicians following people
with type 1 diabetes would want to pair
results from this ultrasensitive assay with
HbA1c measurements to discern whether
a patient is struggling with compliance or
if their pancreatic function is shutting
down.” CLN
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CliniCal laboratory news June 2012 21

Subscribe Today—It’s FREE!
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publication, Clinical Laboratory News.
Considered by many to be the best at
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Clinical Laboratory News is a mustread
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Each month, CLN tackles critical current
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new icD-10 Transition
Deadline announced
The Department of Health and Human
Services (HHS) announced that the
nation’s transition to the ICD-10 medical
coding set will be delayed for a second
time until October 1, 2014. The most recent
deadline was October 1, 2013, a 2-year
deferral from the original 2011 date. ICD-10
will introduce more than 100,000 new diagnostic
and procedure codes, affecting
everything from medical research to reimbursement.
Physician groups had turned up the
pressure in recent months to delay implementation,
criticizing HHS for requiring
too much from providers in a short timeframe,
such as the transition to electronic
health records. In addition, some in the
lab community had warned that payers
were not prepared for ICD-10, and that
labs could be stuck between physicians and
payers, both of whom appeared equally illprepared
for the transition to a new coding
scheme.
More information about ICD-10 is
available from the government’s ICD-10
website, www.cms.gov/Medicare/Coding/
ICD10.
medicare long-Term health at risk
report from the Medicare Trustees
a shows that the Hospital Insurance
(HI) trust fund may run out of money in
2024. In 2011, the HI trust fund expenditures
were lower than expected. However,
HI expenditures have exceeded income
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p r o f i L e s
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gress were to take no further action, projected
revenue would be adequate to cover
87% of estimated expenditures in 2024 and
67% of projected costs in 2050. In practice,
Congress has never allowed a Medicare
trust fund to exhaust its assets. Medicare
has bought some time due to the Affordable
Care Act, which cut some payments.
Without this law, the trust fund would expire
8 years earlier, in 2016.
The full report is available from the
Centers for Medicare and Medicaid Services
website, www.cms.gov.
Proposed Payment rule for
hospitals Pushes Quality metrics
The Centers for Medicare and Medicaid
Services (CMS) issued a proposed rule
that would update Medicare payment policies
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to CMS, the proposed rule is a continuation
of efforts to promote improvements
in care designed to produce better patient
outcomes while slowing healthcare cost
growth.
The rule implements elements of the
Affordable Care Act, including value-based
purchasing programs and the hospital readmissions
reduction program. It also lays
groundwork for expanding Medicare’s
quality reporting requirements. These programs
will adjust hospital payments beginning
in 2013 and annually thereafter based
on how well they perform or improve their
performance on a set of quality measures.
Beginning in 2015, the value-based purchasing
program would include all Part A
and Part B payments from 3 days prior to
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The proposed measure would be
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customersupport@ark-tdm.com
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Reduction Program will reduce payments
to certain hospitals that have excess readmissions
for three selected conditions:
heart attack, heart failure, and pneumonia.
The proposed rule includes a methodology
and the payment adjustment factors to
account for excess readmissions for these
three conditions.
Overall, CMS estimates that under the
proposed rule, rates to general acute care
hospitals will increase by 2.3% in 2013.
The 2.3% is a net update after inflation,
improvements in productivity, a statutory
adjustment factor, and adjustments for hospital
documentation and coding changes.
CMS will accept comments on the proposed
rule until June 25. The proposed rule
can be downloaded from the Federal Register,
https://federalregister.gov.
report: more oversight
needed of ehr Program
The Centers for Medicare and Medicaid
Services (CMS) should improve its
process for verifying that healthcare providers
qualify for incentive payments through
the meaningful use program of electronic
healthcare records (EHR), according to a
K-ASSAY ®
report by the Government Accountability
Office (GAO).
Under the 2009 federal economic stimulus
package, healthcare providers who
demonstrate meaningful use of EHRs can
qualify for incentive payments from CMS.
After 2015, providers will face cuts to reimbursement
if they fail to implement EHRs.
GAO found that CMS has implemented
proper systems to verify whether providers
have met eligibility requirements before
any incentive payments are processed.
However, GAO noted serious problems
with how exceptions are handled. CMS allows
providers to exempt themselves from
reporting certain measures if they report
that the measures are not relevant to their
patients or practices. However, GAO found
that among participants in the first year of
the Medicare EHR program, the majority
of providers chose to exempt themselves
from reporting on at least one meaningful
use measure. In addition, many providers
reported at least one clinical quality measure
based on less than seven patients. GAO
recommended that CMS collect more detailed
information about providers.
The full report is available from the
GAO website, www.gao.gov.
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2011.09 CLN Insulin.indd 1 8/5/2011 5:19:18 PM

abbott acquires Prostate cancer
biomarkers for mDx Test
abbott obtained an exclusive license
from Stanford University for several
novel prostate cancer biomarkers that it intends
to use in developing molecular diagnostics
tests that will differentiate aggressive
from nonaggressive prostate cancer. The
molecular assay will be based on Abbott’s
fluorescence in situ hybridization technology
and will be designed to detect rearrangements
of the ERG and ETV1 genes, as well
as loss of the PTEN gene.
roche Will not extend
offer for illumina
after months of negotiations, Roche decided
not to extend its tender offer for
Illumina, ending its hostile bid for the Swiss
pharmaceuticals and diagnostics firm. “We
continue to hold Illumina and its management
in very high regard, but with access
only to public information about Illumina’s
business and prospects, we do not believe
that a price above Roche’s offer for Illumina
of $51.00 per share would be in the interest
of Roche’s shareholders,” said Severin
Schwan, CEO of Roche. In January, Roche
commenced a tender offer to acquire all
outstanding shares of Illumina for $44.50
per share in cash and increased its offer in
March to $51.00 per share in cash.
genmark Diagnostics and advanced
liquid logic ink ivD Deal
genMark Diagnostics, Inc., and Advanced
Liquid Logic, Inc., (ALL)
forged a collaborative deal to develop an
all-electronic, fully integrated in-vitro diagnostic
platform combining ALL’s proprietary
electrowetting technology and
GenMark’s proprietary electrochemical detection.
According to GenMark President
and CEO Hany Massarany, the collaboration
will focus on multiplex molecular testing,
followed by efforts in other diagnostic
areas including protein detection and
point-of-care testing.
roche licenses Pcr Technologies
To life Technologies
roche and Life Technologies Corporation
signed two licensing deals allowing
Life Tech access to polymerase chain reaction
(PCR) technologies. Under the terms
of the deal, Roche is granting Life Tech an in
vitro diagnostic product license to all of its
PCR patents for real-time PCR and other
PCR-related technology in the diagnostic
field. “Roche has a broad, active out-licensing
program for its PCR-based intellectual property
portfolio. By continuing to out-license
this technology, we contribute to the development
of well-validated techniques within
the diagnostics field,” said Paul Brown, head
of Roche Molecular Diagnostics.
iNdustry
p r o f i L e s
p r o f i L e s
hologic to acquire gen-Probe
hologic announced that it is purchasing
Gen-Probe for approximately $3.7
billion, creating what company officials are
calling the largest diagnostics company concentrated
on women’s health. The purchase
allows Hologic to combine Gen-Probe’s automated
Tigris and Panther platforms and
Use in combination with our web based inter-laboratory
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associated menu of sexually transmitted disease
tests, including the Aptima chlamydia/
gonorrhea, human papillomavirus, and
Trichomonas products, with its own menu
of women’s health testing platforms. “This
transaction combines best-in-class technology
with strong market presence and global
distribution to target the rapidly growing
molecular diagnostics market,” said Rob Cascella,
president and CEO of Hologic. The deal
is expected to close in the second half of 2012.
The deal comes a year after Gen-Probe hired
Morgan Stanley to seek a buyer for the firm.
Though reports suggested that several companies
were interested, none of them went
through with a deal to acquire Gen-Probe.
SAVE MONEY
rapid Pathogen screening awarded
contract to Develop Dx Test
u
.S. Department of Homeland Security’s
Chemical and Biological Defense
Division awarded Rapid Pathogen Screening,
Inc. a contract to develop and manufacture
a rapid, point-of-care diagnostic
test to help in diagnosis in the event of biological
attacks or pandemic events. According
to the company, an emerging developer
of point-of-care diagnostic tests, the test is
innovative in its ability to accurately confirm
and differentiate a viral infection from
a bacterial infection using a finger stick
of blood.
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CliniCal laboratory news June 2012 25

higher hba1c levels linked
To better outcomes in
advanced heart failure
study of patients with advanced heart
a
failure found higher levels of HbA1c
to be associated with improved outcomes
in patients who also had diabetes
(Am J Cardiol 2012; doi:10.1016/j.amj
card.2012.02.022). The authors called for
further investigations to understand the
mechanisms underlying this finding.
Despite the evidence linking diabetes, insulin
resistance, and hyperglycemia to worse
outcomes in patients with heart failure, there
is insufficient data and guidance on optimal
strategies to manage diabetes in patients with
chronic heart failure. This prompted the researchers
to reevaluate the relationship between
HbA1c levels and outcomes in a large
cohort of advanced heart failure patients.
The study involved 845 patients followed
by physicians at the University of California
Los Angeles’ David Geffen School of Medicine.
The patients had baseline HbA1c and
other diagnostic testing at the time of referral
and were followed for 2 years. Nearly
three-quarters were men, more than threequarters
had New York Heart Association
class III or IV heart failure, and 42% had
diabetes. In those with diabetes, the mean
HbA1c level was 7.6% compared with 6.0%
in those without. The researchers stratified
patients both with and without diabetes by
HbA1c quartiles. The primary endpoints
of the study were death or need for urgent
heart transplant, or all-cause mortality.
When the authors analyzed HbA1c as a
continuous variable in multivariate analysis,
they found that for each unit increase
diagNostiC
and CPOCT Division Present
Promoting a Culture of
Quality and Consistency in
Critical and Point-of-Care Testing
26 CliniCal laboratory news June 2012
p r o f i L e s
p r o f i L e s
in HbA1c, there was an 8% decreased risk
for death or need for urgent heart transplantation.
In the cohort with diabetes,
survival free from death or urgent heart
transplantation was significantly higher in
the highest HbA1c quartile. In this group,
analyzing HbA1c as a continuous variable,
the authors found that for each unit increase
in HbA1c there was a 15% decrease
in risk of death, urgent heart transplantation,
and all-cause mortality. In the cohort
without diabetes, there was no difference in
outcomes by HbA1c quartile.
in-hospital lipid Testing falls short
of guideline recommendations
canadian researchers found over the
course of a decade a significant temporal
increase in in-hospital statin therapy
in patients with acute coronary syndrome
(ACS), but only a modest increase
in in-hospital lipid testing (Am J Cardiol
2012;109:1418–24). However, at the same
time they also found a strong association
between lipid testing and in-hospital
statin therapy. Patients who had lipid testing
performed and had higher low-density
lipoprotein cholesterol (LCL-C) levels were
more likely to be treated with a statin during
hospitalization. The authors concluded that
a substantial portion of patients with ACS
are not receiving guideline-recommended
lipid testing, and that strategies to boost
adherence to these guidelines would likely
improve patient outcomes.
The authors examined temporal trends
in lipid testing and statin therapy in hospitalized
patients using prospective registry data
that had been collected in a standardized
format for adult patients with a presumptive
diagnosis of ACS and diagnostic findings
consistent with ACS. The researchers
accessed data from 57 hospitals representing
13,947 patients and stratified the study population
into three groups based on the years
in which the participants were registered.
Overall, 70.8% of patients had lipid testing,
and 79.4% received in-hospital statin
therapy. However, during the 9-year study
period, while there was a significant increase
in in-hospital statin therapy—rising from
70% in the 1999–2004 cohort to 84.5% in
the 2007-2008 group—there was only a
minor increase in in-hospital lipid testing,
from 69.4% in the 1999–2004 group to
72.4% in the 2007–2008 cohort. Lipid testing
was independently associated with inhospital
statin use, and patients with LDL-C
levels >130 mg/L were more than twice as
likely as those with levels 99th percentile
in 13–40% of CAD patients with an adjudicated
diagnosis of AMI. The high incidence
of elevated cTn levels in this patient population
challenges application of the 99th percentile
as the decision limit for diagnosing
AMI. The authors also determined that cutoffs
for CAD patients tended to be higher
than in patients without a history of CAD,
and that the performance of the sensitive
cTn assays was most pronounced in CAD
patients with recent onset of chest pain.
However, the accuracy of these assays in diagnosing
acute coronary syndrome was significantly
lower in patients with pre-existing
CAD than in those who did not have preexisting
CAD.
esr, crP, and Wbc markers
of Pre-arthroplasty infection,
not just inflammation
sedimentation rate (ESR),
e rythrocyte
C-reactive protein (CRP) level, and
synovial fluid white blood cell (WBC)
count with differential are useful for diagnosing
periprosthetic joint infection
in patients with inflammatory or non-
inflammatory arthritis (J Bone Joint Surg
Am 2012;94:594–600). The findings dispel
the common belief that these markers do
not accurately identify periprosthetic joint
infection in patients with underlying inflammatory
conditions.
The study involved 871 consecutive patients
who underwent hip or knee arthroplasty
and who were evaluated for periprosthetic
joint infection. All had serum ESR
and CRP levels tested at the time of initial
evaluation, and joint aspiration for synovial
fluid WBC count with differential culture.
The researchers found the rate of periprosthetic
joint infection to be significantly
higher in patients with inflammatory arthritis
versus those without (31% versus
18%). Optimal ESR cutoffs for patients
with noninflammatory and inflammatory
arthritis were 32 and 30 mm/hr, respectively;
for CRP, 15 and 17 mg/L, respectively;
and for WBC, 3450/µL and 3444/µL,
respectively. Areas under the curves, sensitivities,
specificities, negative- and positivepredictive
values for all tests were comparable
in both sets of patients.
Based on these findings, the authors
concluded that physicians evaluating patients
with failed or painful total hip or knee
arthroplasty should not assume that elevated
ESR, CRP levels, and WBC with differential
are secondary to inflammatory arthritis.
Instead, these biomarkers may indicate
periprosthetic joint infection and should
prompt further evaluation for infection.

news from the fda
Clearance for Siemens
Syphilis Assay
FDA cleared Siemens Healthcare Diagnostics’
ADVIA Centaur Syphilis Assay
for market. The test is designed to detect
antibodies against Treponema pallidum,
a bacterium known to cause the sexuallytransmitted
disease, syphilis.
Qiagen’s Influenza A/B Assay Cleared
Qiagen received FDA clearance to market
its multiplex real-time polymerase
chain reaction test for detecting Influenza
A/B, the Artus Infl A/B RG RT-PCR Kit. It is
designed to help in differential diagnosis of
Influenza A and B infections by qualitatively
detecting and identifying virus in nasopharyngeal
swab samples. The test runs on the
company’s Rotor-Gene Q MDx instrument.
Great Basin’s C. difficile
Test Approved
Great Basin received FDA approval for
its first molecular diagnostic test for
Clostridium difficile. The C. difficile test is
based on a technology that uses an integrated
disposable cartridge containing all
necessary reagents. It runs on a benchtop
analyzer that executes the assay, interprets
the results, and provides electronic output
to the clinician.
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Index To AdverTISerS
Please visit these websites to learn more about the products in this issue.
ArK diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
www .ark-tdm .com
Bd Biosciences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
www .bdbiosciences .com/go/cd4
Bd diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
www .bd .com/ds
Bio-rad Laboratories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
www .bio-rad .com/qualitycontrol
Cerilliant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
www .cerilliant .com
College of American Pathologists . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
www .cap .org
Greiner Bio-one . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
us .gbo .com
Immunodiagnostic Systems Holdings PLC . . . . . . . . . . . . . . . . . . 7
www .idsplc .com/int/home/
InovA diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
www .inovadx .com/workflow
Kamiya Biomedical Company . . . . . . . . . . . . . . . . . . . . . . . . . . 4, 24, 27
www .k-assay .com
LifeSign . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
www .lifesignmed .com
Mercodia Inc. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
www .mercodia .com
randox Laboratories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
www .randox .com/Quality%20Control .php
roche diagnostics Corp. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
www .cobas .us/think
SdIx . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
www .sdix .com/ivd
Wako diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
www .wakodiagnostics .com
Waters Corporation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
www .waters .com/clinical
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CliniCal laboratory news June 2012 27
2011.09 CLN Lipoprotein.indd 1 8/5/2011 5:15:25 PM

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