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IVD Market Growth
Looks FaVorabLe
The global market for in vitro diagnostics
(IVD) devices is expected to
grow 6% annually in the next 5 years,
according to a report from Kalorama
Information, a market research company
based in New York. In 2007, total
IVD sales worldwide were almost $42
billion and are projected to reach more
than $56 billion by 2012, the company
reported.
This forecast of significant growth
for the technology is due in part to the
projected rise in the 45- to 75-year-old
population of many countries. Emerging
markets will experience 10%–20%
annual growth in IVD device sales,
compared with 3%–6% for the rest of
the world.
Other trends will also promote
rapid growth in the IVD market, the
report noted. Developing countries
will shift their diagnostic emphasis
from infectious diseases to chronic
conditions. However, ongoing surveillance
will require IVD devices to
diagnose H5N1, SARS, and WNV,
as well as HIV and other infectious
diseases. Rising incomes and living
standards in developing countries
will also increase demand. China in
2007
2012
Forecast: Worldwide IVD Market
(in billions)
Source: Kalorama Information
$41.95
particular, with its recent entry into the
World Trade Organization, is expected
to double its use of IVD devices in the
next 5 years. Increased privatization of
healthcare will likewise add to demand.
Future sources of additional demand
include research related to the Human
Genome Project, as well as patient
home monitoring.
IVD manufacturers, while experiencing
rapid growth in demand, will
also face pressure to reduce prices, the
authors noted. Moreover, an increasing
focus on home healthcare raises
questions of insurance reimbursement,
and laws in some areas prohibit crossborder
delivery of such devices.
North America, excluding Mexico,
currently leads in sales, with 44%
of market share, followed by the
European Union, which has nearly
a third of the market. A total of 16
companies accounted for 86% of the
market share, with the remaining firms
constituting the remaining 14%.
The report, titled The Worldwide
Market for In Vitro Diagnostic Tests, 6th
Edition, was based in part on data provided
by AACC, the FDA, and sources
in private industry. It is available for
purchase at www.kaloramainformation.com.
Clinical Laboratory News
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Clinical
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The Prospect of a
National Lab Service
Will Creating Standard Methods and Samples
Speed Approval of New Markers?
By DeBorah Levenson
for many diagnostics companies, the road to FDA approval
of a new cancer biomarker assay is long, twisted,
and costly. Compiling the necessary data can take years
and significant capital. First companies must make a
case for a test’s robustness by showing similar results
from multiple labs, and then they must prospectively validate the
marker to prove its clinical relevance. Company officials have long
complained to the FDA that the lack of standard methods and
samples complicates and extends this process. Furthermore, they
fear that the actual clinical use of an approved assay may not conform
to the methods used to produce data for the FDA submission.
Such inconsistencies raise questions about how physicians interpret
the test’s results and could ultimately undermine the clinical
utility of new cancer biomarkers.
Now the Critical Path Institute (C-Path, Tucson, Ariz.) aims to
overcome these issues and to help hasten approval of new cancer
biomarker assays. C-Path plans to establish a national lab that it hopes would become an important facet of the
nation’s system for validating in vitro diagnostics. Known as the United States Diagnostic Standards (USDS),
the lab would design testing protocols and provide standardized clinical sample procurement, data processing,
See national lab service, continued on page 3
After Long Wait, GINA Becomes Law
Will Labs See an Increase in Demand
For Genetic Testing?
By PhiL KiBaK
after stalling in Congress for more than a decade, the Genetic Information Nondiscrimination
Act, otherwise known as GINA, won unanimous approval in the Senate earlier this year by a vote
of 95–0 and near-unanimous approval in the House of Representatives by a vote of 414–1. The
act finally became law when President Bush signed it on May 21. Proponents of GINA say it will
boost the demand for genetic tests performed in clinical labs because it protects an individual’s
genetic privacy and bars employers from using genetic information when making hiring, firing, job placement,
and promotion decisions. The new law also prohibits health insurers from denying coverage to healthy individuals
or charging higher premiums based solely on the possibility of developing a genetic disease, a prospect that
many considered a major stumbling block to widespread genetic testing for some forms of hereditary cancer.
Supporters of the legislation described it as the first civil rights legisla-
nonprofit org.
u.s. postage
paid
greenfield, oH
permit no. 436
tion of the 21st century.
Francis Collins, MD, PhD, Director of the National Human Genome
Research Institute, was among those who spearheaded efforts
to pass a federal law protecting genetic privacy. “This law allows more
people to consider genetic testing without fears that employers or
health insurers will use the results against them,” he noted. Under his
leadership, scientists completed the Human Genome Project, a complex,
multidisciplinary, scientific enterprise directed at mapping and
sequencing the 3 billion DNA base pairs in the human genetic blue-
print (See Box, page 6).
See Gina, continued on page 6
The auThoriTaTive
source for The
clinical laboraTorian
july 2008
volume 34, number 7
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in Children
NEW Patient Safety Focus
Q&A: Disclosure of Errors
Communication: Teaching
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Annual Meeting Section
List of Exhibitors
2008 New Product Review
Regulatory, Industry,
Diagnostic Profiles
News from the FDA

USDS Concept Raises Questions
national lab service, continued from page 1
and readouts. “USDS would be a way to do
premarket testing of diagnostics and would
generate standardized data that would improve
the evaluation of diagnostic tests for
approval by the FDA,” explained Maryellen
de Mars, C-Path’s Director, Clinical Biomarkers.
“The idea is to provide standardized
samples and procedures. It’s quality
assurance, in a way.” According to the organization’s
Web site, C-Path is an independent
nonprofit research and education
institute that helps FDA’s Critical Path Initiative
by spurring “collaborations among
the FDA, academia, and regulated business
to improve the process of developing new
medical products, making them faster, safer,
and smarter” (See Box).
Laboratory directors familiar with the
effort believe it has the potential to benefit
manufacturers, clinical labs, and patients,
but say that the concept of a national diagnostic
testing service raises some serious
questions. How will C-Path fund what
promises to be a huge and costly project and
still maintain the lab’s independence? Will
the existence of the USDS increase pressure
on FDA to regulate lab-developed tests?
And will USDS compete with academic
labs that currently partner with companies
on validation studies?
Fulfilling a Need
Right now, FDA submissions often raise
questions about variations in sampling
methodologies, assay procedures, and how
well clinical data correlates to particular
samples, a process known as clinical annotation,
noted Fred R. Hirsch, MD, PhD,
Professor of Medicine and Pathology at
University of Colorado Cancer Center in
Denver. Differences in how individual labs
handle these processes sometimes make
FDA, labs, and physicians question that
data. “When there is variation in procedures,
it’s difficult to interpret the data. You
want to be sure that results reflect true biological
variation and not just variation in
methodology,” he explained.
Standardization of cancer biomarker
assays could be an aid to FDA, according
to AACC Past President Gary Myers, PhD,
Chief of the Clinical Laboratory Branch
in CDC’s Division of Laboratory Sciences,
which has helped create important standards
for cholesterol and HbA1c assays.
That’s because the FDA must often evaluate
data presented in different formats. “Having
a lab where standard sample sets are
used to devaluate diagnostic products, and
evaluation results all follow common, standardized
formats would make it easier for
FDA to review and evaluate product submissions.
It could compare apples to apples
and oranges to oranges,” Myers explained.
A Menu of Useful Services
An executive summary of a proposal describing
USDS lists several benefits that
C-Path hopes to offer diagnostics companies.
These include standardizing the validation
process, a ready supply of standardized
samples, data that compare potential
products to those of competition, and neutral
third-party evaluation. The summary
goes on to provide details of the proposed
repository, which would be “a collection of
highly qualified, annotated clinical sam-
ples.” The repository would include tissues
and fluids with confirmed diagnoses, clinical
outcomes, and controls. USDS would
be subject to CLIA, CAP, and International
Organization of Standardization requirements,
the summary adds.
De Mars emphasized that C-Path is
in the early stages of planning for USDS.
“We’re in the process of compiling an advisory
board for the project to define scope
and strategy. But there’s general support
and excitement throughout the industry
about creating standards in this area.”
A key FDA official confirmed that discussions
about the project are still preliminary
and that C-Path is “working out the
bugs” in its concept. But Steven Gutman,
MD, Director of the Office of In Vitro Device
Evaluation and Safety, also emphasized
that FDA’s role is minimal at this point.
While the agency supports the concept of
a national diagnostic service lab, C-Path
initiated the current proposal for how the
lab would operate. FDA has given C-Path
advice but no money so far. “FDA’s position
on USDS, as with many C-Path activities,
is that we offer our perspective and maybe
funding for small studies, and form partnerships,”
Gutman explained.
While he minimizes FDA’s role in
USDS, Gutman says its planned contribution
to the development of new assays
would be valuable. “It will improve the
quality of the science in submissions. With
or without regulation, if you can improve
science, that’s always a plus,” he said. Any
type of assay that isn’t well-standardized
might benefit, he added, noting that USDS
might be particularly helpful in preparing
proteomic assays for FDA submission. “We
haven’t cleared one yet. There’s a paucity
of methods, materials, and standards for
proteomics. If the new enterprise improved
standardization for these assays, it could really
move the field forward.”
The Pilot: A Focus on EGFR
C-Path expects that an NCI clinical study,
now in its early stages, will help establish a
USDS pilot program by determining the
infrastructure necessary to provide planned
services. The phase III trial will screen almost
1,200 non-small cell lung cancer patients
to determine EGFR copy number
by FISH. The trial will retrospectively determine
the presence of EGFR mutations
by sequencing and protein expression by
immunohistochemistry (CLN, February
2008). Afterward, researchers will randomize
patients, who have already had first-line
therapy, to receive either the tyrosine kinase
inhibitor (TKI) erlotinib or chemotherapy
with pemetrexate. The trial’s primary goal
is to determine the most suitable EGFR
biomarker and to identify the patients who
benefit most from TKI inhibitors, according
to Janet Dancey, MD, Associate Chief of
the Investigational Drug Branch in NCI’s
Cancer Therapy Evaluation Program. She
is coordinating the trial.
De Mars identified other goals that are
more directly related to USDS’s mission.
The study’s first phase will not only determine
the best method for measuring EGFR,
but will also help establish a standardized
process for FDA to validate and assess predictive
biomarkers. Future phases could
also help diagnostic companies access valu-
c-path initiative Targets
preclinical safety biomarkers
another C-path project aims to establish new ways of determining
experimental drugs’ human toxicity before they are tested in patients.
launched in March 2006, the predictive safety testing Consortium
plans to help fda and its european equivalent, the european
Medicine evaluation agency (eMea), qualify new biomarkers of
human safety.
the consortium’s director, william Mattes, phd, says there is a major
need for new biomarkers of toxicity. for example, some preclinical
tests of toxicity are as much as 60 years old, and in certain cases,
related data comes from anecdotal reports, not actual scientific
scrutiny.
through their membership in the consortium, 16 pharmaceutical
companies are now sharing their internally developed preclinical
safety biomarkers and testing each other’s methods to see if they
are reproducible. the consortium’s ultimate goal is to present the
companies’ data to the fda and eMea, which will deem some of
the markers the consortium examines as qualified for use in drug
development, according to Mattes. last year, the consortium submitted
seven urinary biomarkers of kidney injury, and in May 2008, the
fda and eMea confirmed their joint review and acceptance of these
tests.
C-path plans to submit data on more potential biomarkers. other
consortium projects are focused on markers of harm to the liver,
muscle, and vascular system. another is examining focuses on carcinogenicity
in rodents.
the consortium hopes that the companies’ shared experience
with the safety biomarkers will go a long way toward establishing
consensus about them. “we want to develop new, better, and more
sensitive and specific tools for determining safety and get broad
industry, regulatory, and scientific agreement about their safe use,”
explained elizabeth walker, phd, the consortium’s assistant director.
able clinical samples for developing new
biomarkers and technologies, cross-validate
new tests, and support a standardized process
for evaluation of diagnostics by FDA.
C-Path has proposals from a total of 14 diagnostics
companies with technologies that
measure EGFR or other potential targets.
Future phases of the trial might use these
technologies, with the goal of identifying
new predictive or prognostic markers.
Colorado Cancer Center’s Hirsch is coordinating
the biomarker studies for the trial
on behalf of Southwest Oncology Group,
which has headquarters in Ann Arbor,
Mich., and researchers at about 550 institutions.
He described the study as a prospective
biomarker-driven trial that is unique in
its scope. While various groups have studied
outcomes of patients whose treatment was
based on assessment of their EGFR status,
this trial is the first to join a large number of
oncology cooperatives, NCI, and diagnostics
companies, he explained. “The trial is
also a demonstration that prospective biomarkers
can be validated in a collaborative
way among all of these partners. They have
spent a lot of time building up a complex
infrastructure.”
At the end of the study’s first phase, researchers
hope to have 970 patients’ blood
and tumor samples, all collected according
to standardized methods for analysis of mutations,
gene copy number, and protein expression.
Meanwhile, the data will be based
on standard mutation, gene copy number,
and mutation methods. “While this type
of standardization exists in individual labs
and centers, we will have several centers and
cooperatives all using a standardized methodology,”
Hirsch noted.
The samples will be both precious and
well-suited for tests of other markers, ac-
cording to Dancey. Specifically, she noted
that each of the samples will be linked to
outcomes data for a certain therapy, so in
the future, researchers investigating toxicity
or survival will be able to trace particular
data back to specific samples.
A similar but smaller study has already
dealt with many of the questions the NCI
trial aims to answer, noted Marc Ladanyi,
MD, Chief of the Molecular Diagnostic Service
and Attending Pathologist at Memorial
Sloan-Kettering Cancer Center. Led by
CliniCal laboratory news JuLy 2008 3

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University of Illinois Medical Center at
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Thomas Daly, MD,
Eli Lilly and Company, Indianapolis, Ind.
David Grenache, PhD, University of Utah and
ARUP Laboratories, Salt Lake City, Utah.
Elia M. Mears, MS, MT (ASCP), SM
Chabert Medical Center, Houma, La.
Alan T. Remaley, MD, PhD,
National Institutes of Health, Bethesda, Md.
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4 CliniCal laboratory news JuLy 2008
Vince Miller, MD, also at Memorial Sloan-
Kettering, the trial involved 101 patients
and found that the presence of an EGFR
mutation was a much stronger predictor of
both responsiveness to and prolonged survival
on erlotinib than EGFR amplification.
Tumors with EGFR amplification without
mutation showed only rare responses and
minimal survival benefit (Journal of Clinical
Oncology 2008; 26: 1472–1478). He also
questioned whether other aspects of the
NCI trial are new. “In some earlier, major
studies, predictive statements were based
only on the small subset of patients in
which paraffin samples could be retrospectively
obtained for testing. But now, most
major cancer centers are running clinical
trials with procurement of more complete
sample sets, so there is nothing special or
unique about what is being proposed by
Critical Path.”
Questions from the Lab Community
While USDS could provide a valuable service
to diagnostic manufacturers—access
to high quality samples for validating new
assays according to standard procedures—
Myers predicts that lab directors at academic
hospitals will have many questions
about it.
The first concerns funding. “C-Path has
taken on a daunting task. Who will pay
for it?” he asked. According to de Mars,
the Science Foundation of Arizona has
granted the seed money, and USDS is still
developing a business model and raising
more money for the project. She did not
divulge the identities of potential funders,
but she did note that C-Path is eying federal
legislation introduced last year by U.S.
Rep. Gabrielle Giffords (D-Ariz.). The
Safe and Effective Drug Development Act
(H.R. 2592) would allow FDA to enter into
public-private partnerships that would accelerate
development of medical products.
While the legislation would prohibit these
partnerships from accepting manufacturers’
money, it would also establish an exception
that allows partnerships to accept
funds from a consortium of companies
with FDA-regulated products. The HHS
Secretary would have to deem the situation
free from conflicts of interest and issue a
waiver, according to the bill.
Current C-Path plans do not call for
diagnostics companies to fund USDS directly.
Rather, companies would pay fees
for services that would generate validation
data. “The data would be theirs, and they
could use it for FDA submission,” de Mars
explained, adding that USDS would base
fees on the scope of services provided.
Competition for Academic Labs?
Another concern is that several academic
medical centers already provide many
of the services USDS hopes to offer, Myers
added. That’s a sentiment shared by
Ladanyi. “The C-Path sample set will be
nice. But this type of sample set is already
being created at many cancer centers,” he
pointed out.
Gutman agrees that much of what C-
Path proposes that USDS do isn’t exactly
new. “The idea of collecting samples is
good, and any mechanism for creating a
panel of reference samples is good. But
they already exist,” he said. “However, this
[USDS] would be more deliberate and focused
than other activities. It would be interesting
if it got some formal status.”
USDS would compete with academic
labs that diagnostics companies now support
by paying for studies to validate experimental
assays, Myers continued. Addressing
this concern, de Mars noted that FDA
usually requires that submissions include
data from three laboratories, one of which
is usually a diagnostic company’s own
facility. She sees room for both USDS and
academic medical center labs in the process,
because USDS and an academic lab
could be the second and third locations.
According to deMars, “USDS will initially
focus on development of standards for
cancer statistics. In its neutral position,
USDS would have the capacity to run com-
peting assays, from any manufacturers, on
the same set of standard samples. Also,
with eventual growth and expansion of
services, USDS may need to outsource to
other labs.”
Honing in on Homebrews
Both the USDS proposal summary and de
Mars point to another role Myers believes
will be of concern to many lab directors:
review of laboratory-developed assays. De
Mars said USDS could provide standardized
evaluation of lab-developed tests, in
a process she likened to certification. “This
USDS ‘certification’ would aid in marketing
tests that manufacturers develop inhouse,”
she explained, adding that companies
could have USDS test their reagents on
standard sample sets and publicize the data
in the hope that it spurs sales.
Myers also wondered if USDS could be
a mechanism for FDA regulation of labdeveloped
tests. Members of the HHS Secretary’s
Advisory Committee on Genetics,
Health and Society are among those who
support FDA oversight. At its most recent
meeting in February, the committee said it
would recommend that all lab-developed
tests come under the FDA’s watch to ensure
their effectiveness and patients’ safety.
At that meeting, Gutman said that while
FDA does have authority to regulate these
assays, it lacks the resources to do so. “It’s
not possible [to oversee all assays], but the
high-risk tests belong at the FDA,” he said
during the meeting. But Gutman told CLN
that FDA “has not established specific goals
for how USDS work might be applied to
FDA testing oversight.”
Whatever USDS’s scope, de Mars hopes
it will bring the benefits of pharmacogenomics
to more cancer patients. “Companion
diagnostics are really the dawn
of a new era. Before, cancer patients were
all treated with a ‘one-drug-fits-all’ strategy,”
she explained. “Now drugs have been
developed that benefit a subset of patients.
We are moving toward personalized medicine,
and USDS can help advance that
further.” CLN

GINA May Spur Genetic Testing Growth
Gina, continued from page 1
“In the past, surveys have shown that
many Americans, even including some
healthcare providers, were reluctant to
seek reimbursement for genetic tests or to
include genetic test results in their health
records because of concerns about discrimination,”
Collins added. “By guarding
against genetic discrimination in health
insurance and employment, this law will
encourage more Americans to take part
in research that involves the collection of
genetic information.” Collins also believes
GINA will be a tremendous boon to many
types of biomedical research, including
genome-wide association studies aimed
at uncovering the genetic risk factors for
common diseases.
Gregory Tsongalis, MHS, PhD, Director
of Molecular Pathology at Dartmouth
Hitchcock Medical Center and President
of the Association for Molecular Pathology,
heads a lab that conducts a large volume
of genetic tests. He agrees that GINA will
encourage genetic research. “GINA certainly
has the potential to open the door
to expand genetic testing,” he said. “I don’t
expect the floodgates will open and that
6 CliniCal laboratory news JuLy 2008
there will be major increases in test volumes
overnight, but I think we will see an
increase in traditional genetic disease testing
and screening. Also, I suspect that now
people will be more willing to participate in
genetics research trials.”
Useful But Not Perfect
Yet the new law has shortcomings. For example,
it does not prohibit life insurance
or disability insurance companies from
taking genetic information into account
in coverage decisions. “One could not help
but assume that [GINA] is a revolutionary
piece of legislation that…would provide
extensive, effective, and comprehensive
protection against genetic discrimination
in health insurance and employment.
Unfortunately, such an assessment would
be incorrect,” wrote Mark Rothstein, JD,
in an article titled “Is GINA Worth the
Wait?” (Journal of Law, Medicine & Ethics
2008:36(1), 174–178). Rothstein is the Herbert
F. Boehl Chair of Law and Director of
the Institute for Bioethics, Health Policy
and Law at the University of Louisville
(Ky.) School of Medicine.
GINA applies only to those individu-
francis collins steps down
as nhGri director
francis s. Collins, Md, phd, the director of the national
Human genome research institute, part of the niH,
recently announced his intention to step down on
august 1 to explore writing projects and other professional
opportunities.
Collins, 58, a physician-geneticist, has served as
nHgri’s director since april 1993. He led the Human
genome project (Hgp) to its successful conclusion in
2003 and subsequently initiated and managed a wide
range of projects that built upon the foundation laid
by the sequencing of the human genome. following the precedent set by
the Hgp under Collins’ leadership, these projects have made their data rapidly
and freely available to the worldwide scientific community. Collectively,
these projects and their data have transformed biomedical research and
empowered researchers all around the world.
in addition to his leadership of the public effort to sequence the human
genome, Collins initiated and guided a wide range of follow-up projects in
large-scale genomics. He also played a leading role in applying the tools of
genomics to understanding the risk factors for common diseases, such as
diabetes, heart disease, various types of cancer, and mental illness.
als who may have a susceptibility to develop
a genetic disease but currently are
asymptomatic. For example, GINA would
prohibit discrimination against a woman
who tested positive for one of the genetic
mutations associated with an increased risk
of breast cancer. But if the woman actually
developed the disease, GINA would no longer
apply. Likewise, in accordance with the
Americans with Disabilities Act, employers
may require that individuals submit to a
medical examination and authorize the release
of their medical records as a condition
of employment. Even if GINA resulted in
healthcare providers releasing only nongenetic
information, there may be no practical
way to do so.
But whatever deficiencies the new law
has, many experts believe it will have a
positive impact by creating greater ease,
access, and openness about genetic testing
and research.
Those who perhaps stand to benefit
most from GINA are people who currently
are not covered by state nondiscrimination
laws who are at risk of developing a genetic
disorder but are asymptomatic. “It may be
presumed that these people will develop
the condition, but they never do, and they
are subject to discrimination. These people
will gain protection,” said Rothstein.
Why Do We Need a Federal Law?
The degree of protection against genetic
discrimination provided by state laws varies
widely. “GINA was needed to set a minimum
standard of protection that must
be met throughout the nation,” explained
Collins. “As for the HIPAA, GINA goes significantly
further by extending protections
to individual health plans and by limiting
the ability of insurers to use genetic information
to raise rates for an entire group.”
At this point—5 years after the human
genome has been sequenced—the average
person doesn’t have a lot of genetic information
in a medical record, Rothstein noted,
because people without a family history
of genetic illness are not subject to routine
genetic testing. “But increasingly, people
will have this kind of information in their
medical records. The real reason GINA was
enacted was to protect those people who do
have a family history of genetic disease but
were reluctant to undergo testing because
of concern that the information would not
remain private.”
That sentiment is echoed by Aravinda
Chakravarti, PhD, Professor of Medicine,
Pediatrics, and Molecular Biology and
Genetics at the Johns Hopkins University
School of Medicine (Baltimore, Md.), and
President of the American Society of Human
Genetics. “GINA would bring some
degree of relief to those people who need
to make serious decisions about serious
genetic disorders, many of which are associated
with effective tests. I think now
there will be an increasing demand for all
types of genetic tests.” He added that policy
makers also might want to consider similar
legislation for life insurance.
Some view GINA as an important first
step to personalized medicine in the 21st century. “This is an important but initial
piece of legislation,” said Kevin FitzGerald,
SJ, PhD, Associate Professor of Oncology
and David Lawler Chair for Catholic
Health Care Ethics at Georgetown University
Medical Center’s Lombardi Comprehensive
Cancer Center in Washington,
D.C. “As things move along, I think we’ll see
other forms of legislation that are needed
to steer things in the generally agreed direction
of personalized medicine and to keep
obstacles and problems from derailing
them. For instance, a significant part of the
personalized medicine promise will require
large public databases of comprehensive
medical records tied to biological samples.
These databases will engender security and
privacy issues beyond those covered by
GINA. This is just one issue that may foster
additional legislation. GINA is not a ‘onebill-does
everything,’ but it established a
very important beachhead.”
But which tests might be most in demand
as a result of GINA? Michael Stocum,
Managing Director of Personalized Medicine
Partners LLC (Research Triangle Park,
N.C.), a company that focuses on integrating
diagnostics and therapeutics, offered
his best guess. “My gut feeling is that it will
be tests that are prognostic and predictive,
but particularly those that may predict risk
for diseases like Alzheimer’s, cardiovascular
conditions, and Type 2 diabetes—illnesses
that tend to occur later in life and are expensive
to manage,” he noted. “On a personal
note, I feel far more comfortable
about subjecting myself and my family
members to testing for a range of genetic
markers with this new law in place.”
See Gina, continued on page 8

GINA Opens Door for Research Participation
Gina, from page 6
Chakravarti also pointed out that genetic
testing is already done on a routine
basis but that not many people would
recognize it as such. “Newborn screening
is performed in all 50 states and has been
done so for decades, so there’s a very large
number of Americans who have taken a
genetic test. And, blood typing is another;
you can’t do transfusions without knowing
someone’s genotype, and that information
has led to a system for donating blood, organs,
and bone marrow.”
GINA and Research Efforts
Medical researchers anticipate that GINA
will pave the way for individuals to take
part in research without worrying about
repercussions. “GINA removes a significant
barrier to participation in clinical research
protocols,” said Collins. “For example, at the
National Institutes of Health, fear of genetic
discrimination is the most commonly cited
reason that people decline to participate in
research on potentially life-saving genetic
testing for colon cancer and breast cancer.
One-third of eligible participants have declined
on this basis.”
Along with greater participation in
clinical trials involving genetics, GINA is
expected to have a positive impact on the
growing field of pharmacogenomics, in
which an individual’s genotype is used
to guide drug therapy and/or dosage. Research
in this field also has the potential to
increase the safety and effectiveness of new,
existing, and failed drugs, and could enable
8 CliniCal laboratory news JuLy 2008
more drugs to reach the market by targeting
them to genetically defined subgroups
of patients. “People will be more inclined
to undergo genetic testing for responses to
medications if they know that their test results
will not affect their job or health insurance
status,” explained Collins.
One active area of pharmacogenomic
research centers on using genetic information
to reduce the high incidence of adverse
drug reactions, Collins added. “Consider
the example of warfarin. Healthcare providers
have found this anticoagulant drug
notoriously difficult to administer because
its dose requirements vary widely among
patients and because of its relatively narrow
margin for error, with either too much or
too little of the drug triggering potentially
life-threatening problems. Now, thanks to
the identification of two genetic variations
that appear to account for much of the differences
in warfarin sensitivity, the National
Heart, Lung, and Blood Institute is launching
a clinical trial to evaluate a pharmacogenomic
strategy for warfarin that will weigh
the potential safety benefits with the costs
of genetic testing.”
So far, FDA has approved label changes
for two drugs based on pharmacogenomic
data. In 2005, the agency approved label
changes for the chemotherapy agent irinotecan
to include a warning that patients
with a particular UGT1A1 genotype should
receive a lower initial dose of the drug. And
in 2007, the Coumadin (warfarin) package
label was updated to provide information
about genetic testing for warfarin sensitivity.
Although the FDA stopped short of
personalized medicine coalition
applauds enactment of Gina
the personalized Medicine Coalition—a partnership of academic, industrial,
patient, provider, and payer communities that includes aaCC—endorses
the passage of gina into law, saying that the privacy and protection of
genetic information is essential to the progress of medicine, as well as improving
the quality of care for every person.
“the guarantees provided by this legislation will encourage millions of
americans to use their genetic information to improve their healthcare and
to help prevent cancer and other inheritable diseases,” said edward abrahams,
phd, the pMC’s executive director.
only a few states have strong protections against genetic discrimination,
he added, which left some individuals more vulnerable to this type
of prejudice depending on where they lived. “gina provides a national
framework of enforceable protections needed to advance medical research
and public health. and under gina, there now are federal rules in place to
protect those who are privately insured,” abrahams said.
abrahams noted that gina’s path through Congress prompted two corporate
members of the pMC—ibM (armonk, n.Y.) and eli lilly (indianapolis,
ind.)—to add genetic nondiscrimination to their employment policies in
advance of the law’s passage. the organization noted that another pMC
member, aetna (Hartford, Conn.), also has publicly announced its support of
the new law.
the pMC believes that gina, along with improvements in regulatory
and reimbursement policies that acknowledge the realities of geneticsbased
medicine, will set the stage for the discovery of new treatments and
cures, as well as an accelerated path toward personalized medicine.
requiring genetic testing prior to taking
the drug, it recognized that adverse bleeding
events could be reduced in patients
with certain variations in the CYP2C9 and
VKORC1 genes involved in metabolism
and uptake of the drug. Now that the barrier
to individual genetic privacy has been
lifted, both patients and clinicians could
become more comfortable with using genetic
information for drug dosing. This, in
turn, could result in an increased demand
for such tests.
Testing for Inherited Breast Cancer
One of the most highly impactful areas of
genetic testing involves inherited forms of
breast cancer. Gregory Critchfield, MD,
President of Myriad Genetic Laboratories,
Inc. (Salt Lake City, Utah), the first company
to offer testing for the BRCA1 and
BRCA2 genes that are linked to breast
cancer, is optimistic about GINA’s effect
on genetic testing. “There have been some
patients for whom potential insurance discrimination
was an issue, and the passage

of GINA removes that barrier. I think the
new law will have a positive impact on genetic
testing in general.”
Critchfield noted that Myriad’s revenues
have increased despite not having a national
nondiscrimination law. “Revenue growth
for our company was 44% last fiscal year
and has increased thus far this year,” he said.
Myriad’s success is based in large part on
the BRCA1/2 genetic tests, which have been
commercially available in the United States
since 1996. According to the National Cancer
Institute, more than 192,000 women
each year learn that they have breast cancer,
and about 5–10% of them have a hereditary
form of the disease. A woman’s lifetime
chance of developing breast and/or ovarian
cancer increases if she inherits a mutated
BRCA1 or BRCA2 gene.
Myriad’s list price for the comprehensive
test, which analyzes the entirety of the gene
for sequence changes and structural rearrangement
is $3,120. There are two other
testing options: once the mutation has been
found by the comprehensive screening test,
family members can be tested for the mutation
at a cost of $350; and analysis for a
panel of three mutations that are common
in people who have Ashkenazic Jewish ancestry
is $415.
“Insurance coverage for BRCA analysis
testing is excellent, with well over 2,500
insurers who reimburse for the test,” explained
Critchfield. “And as we remove barriers
to testing, there are more people who
To read more about Gina, as
well as the text of the legislation,
go to http://thomas.loc.gov/.
pharmacogenomic Testing still faces challenges
SACGHS Releases Final Report
experts believe that gina will likely involve more people
in genetic testing, partly through enhanced participation
in pharmacogenomic research. one challenge to this
relatively new discipline has been the issue of privacy,
especially when large amounts of personalized information
may be just a mouse click away.
“this is where the passage of gina into law becomes
even more relevant,” noted Kevin fitzgerald, sJ, phd,
associate professor of oncology and david lawler, Chair
for Catholic Health Care ethics at georgetown university
Medical Center’s lombardi Comprehensive Cancer
Center in washington, d.C. fitzgerald is a member of
the secretary’s advisory Committee on genetics, Health,
and society (saCgHs), which recently finalized its report
Realizing the Potential of Pharmacogenomics: Opportunities
and Challenges. He served as a member and then the
chair of the task force that wrote the document, which
outlines a number of recommendations and considerations
in relation to pharmacogenomics research and
development and its integration into clinical practice
and public health. “pharmacogenomics itself is very
much still in its infancy. it’s one piece of this personalized
medicine arena that is exploding around us.”
although pharmacogenomics has significant potential
to improve drug research and development, healthcare
delivery, and, ultimately, patient health, it also faces
considerable challenges, according to the report. for
will decide to make use of these predictive
assessments.”
Time to Gear Up?
Although tests involving genetic mutations
won’t soar overnight now that GINA has
become law, labs may want to take another
look at expanding their menu of genetic
tests. “Labs need to prepare for potential
new tests and any anticipated increase in
volume,” Tsongalis recommended, adding
that such tests may be “a good marketing
tool for the larger reference labs.”
A similar opinion was voiced by Gualberto
Ruaño, MD, PhD, President of
Genomas, Inc. (Hartford, Conn.) and
Director of Genetic Research at Hartford
Hospital. “GINA is very salubrious for personalized
medicine. It will not change the
day-to-day operations of genetic testing
example, some healthcare payers have been reluctant to
cover pharmacogenomics products due to limited evidence
of their health and economic impacts, the absence
of clinical practice guidelines and dosing recommendations,
and a lack of education and training in genetics.
and until the passage of gina into law, the question of
privacy was very much an issue.
“but perhaps the major challenge revolves around
information,” fitzgerald noted. “You’ve got to have large
bodies of genetic and genomic health record information,
because that’s the basis on which we will come to
a new and better understanding of how drugs actually
work in different individuals. we know generically how
things work, but on an individual basis, everyone—even
identical twins—is different. so to get an answer to the
question of how this particular drug works in this particular
person at this particular time under these particular
circumstances, we need enormous amounts of data.
and gina will help to keep that data protected.”
the next challenge, he said, is assembling that information
in such a way that it is translatable to research
scientists and clinicians. “and then, once we understand
what we think it is that we want to know, we need to
prepare a roadmap and determine the logistical hurdles
that need to be addressed.” to read the saCgHs report,
go to www4.od.nih.gov/oba/sacghs/reports/saCgHs_
pgx_report.pdf.
in 2008, but it is very positive in terms of
growth of the field for the rest of this decade
and beyond. However, one of the
biggest concerns people have about these
tests is whether or not the cost will be reimbursed,”
he said. “This is one of those factors
that affect the translation of scientific
research to real-world medicine. And these
tests need to demonstrate economic value
to assure reimbursability.” CLN
CliniCal laboratory news JuLy 2008 9

CLN’s
Lab 2008:
improviNg
heaLthCare
series
10 CliniCal laboratory news JuLy 2008
Lipid Biomarkers
Identifying Dyslipidemia in Children
By Katherine Morrison, MD, FrCPC, anD vi J ay L a x M i grey, PhD, FCaCB
in the past decade, cardiovascular disease (CVd) risk factors have been increasingly recognized in children.
More children are overweight, and obesity in the pediatric population is now considered a major u.s.
health problem. increased obesity rates are attributed to an imbalance between energy intake and energy
expenditure. Children’s diets today include many foods with a high number of calories and low nutrient
value, and children tend to be less physically active. because we now know that the atherosclerotic process
begins in youth and culminates with the development of vascular plaques in the third and fourth decades of life,
these trends raise major concerns about the future health of overweight children.
to identify cardiovascular risk factors in children, pediatricians are increasingly using lab measurements of
lipid biomarkers to identify dyslipidemia. Characterized by the elevation of total cholesterol (tC), ldl-C and/or
triglycerides (tg) or low levels of Hdl-C, dyslipidemia contributes to the development of atherosclerosis. Causes
of dyslipidemia may be primary (genetic) or secondary.
While dyslipidemia seldom results in adverse
clinical outcomes during childhood,
epidemiologic studies conducted longitudinally
demonstrate that cholesterol levels in
children track into adulthood (1). Similarly,
children whose TC was above the 90th percentile
on two occasions had a positive predictive
value for elevated TC (≥200 mg/dL
or 5.2 mmol/L) in early adulthood of 76%
for females and 81% for males (2). Such data
suggest that it is possible to identify children
who are likely to continue to have high TC
levels as adults. Furthermore, longitudinal
studies of childhood LDL-C levels also predict
the thickness of the intima-media of
the carotid artery, a non-invasive marker of
atherosclerosis, in young adults (3,4).
But research also shows that good nutrition,
a physically active lifestyle, and absence
of tobacco use can lower an individual’s
risk and delay or prevent the onset of
CVD. Therefore, identifying children who
are at risk is important to preventing health
problems later in life. Here we describe the
most recent recommendations for assessing
lipids and lipoproteins in children.
Lipid and Lipoprotein Primer
Cholesterol and triglycerides are transported
in the body in lipoprotein particles
associated with apolipoproteins and phospholipids.
Table 1 summarizes the four
main classes of lipoproteins and their primary
apolipoproteins and lipid compo-
nents. LDL-C is the primary transporter of
cholesterol in blood, and HDL plays an
important role in reverse cholesterol transport.
Particles called chylomicrons carry
TG from the gut that originate from an
individual’s diet, and very low-density lipoprotein
(VLDL) carries TG from the liver.
Dyslipidemia in Childhood
Dyslipidemias are disorders of lipoprotein
metabolism resulting in abnormal excesses
of TC, LDL-C, or TG, or deficiency
of HDL-C. Large epidemiologic studies
indicate that children’s lipid levels correlate
with those of adult family members. Furthermore,
children of parents with coronary
heart disease (CHD) have a higher
prevalence of dyslipidemia.
Genetic Dyslipidemia
Familial hypercholesterolemia (FH) is a
monogenic disorder in which the LDL-
receptor is defective, resulting in high
LDL-C levels. The rare homozygous form
results in markedly elevated LDL-C, as high
as 575–965 mg/dL or 15–25 mmol/L. Physical
signs include planar and tendon xanthomas
and corneal arcus by 10 years of age
and clinical evidence of CAD by the second
decade of life (5). More common is the
heterozygous form, with a population frequency
of approximately 1 in 500. Children
with heterozygous FH have elevated LDL-C
(154–386 mg/dL or 4.0-10.0 mmol/L) and
early vascular changes (6) that may regress
with lipid-lowering therapy (7).
Although those with heterozygous FH
are generally asymptomatic in childhood,
these children may develop tendon xanthomas
in the second decade of life. By
65 years of age, 50% of these females will
develop CVD if the FH is left untreated;
among males, this will occur 10 years sooner.
Children with heterozygous FH are most
easily identified if there is a family history
of dyslipidemia or coronary artery disease.
Recommendations for treatment of these
children from an expert panel of the American
Heart Association (AHA) include lowering
saturated and trans-fats in the diet,
increased physical activity, counseling to reduce
other risk factors, and lipid-lowering
therapy (Table 2) (8).
A number of other genetic dyslipidemias
are less common in children. For example,
familial combined hyperlipidemia is commonly
observed in adults but rarely youths.
An autosomal dominant disorder with
variable presentation within the same family,
affected individuals have elevated LDL-C
and apolipoprotein B levels and may have
elevated TG levels.
Rare genetic forms of hypertriglyceridemia
have also been recognized. Some

table 1
lipoprotein classification
Lipoprotein Apolipoprotein Lipid
low density lipoprotein (ldl-C) apob-100 Cholesterol
High density lipoprotein (Hdl-C) apoa-i; apoa-ii Cholesterol
Chylomicron apob-46 triglyceride
Very low density lipoprotein (Vldl) triglyceride
monogenic disorders, such as lipoprotein
lipase deficiency, result in marked TG elevation
(fasting TG>5 mmol/L) and/or chylomicronemia,
and they may be associated
with pancreatitis in childhood.
Familial Obesity
The classic dyslipidemia associated with
obesity includes elevated fasting TG levels
and suppressed HDL-C levels. Therapy
includes diet, lifestyle changes, and implementation
of a heart-healthy lifestyle to
assist the individual and the family. This
type of dyslipidemia is often clustered with
other CVD risk factors such as hypertension
and dysglycemia. This cluster of factors,
also called the metabolic syndrome, is
associated with a 14-fold increased risk of
clinical CVD by 50 years of age, highlighting
the importance of early recognition and
treatment of this disorder (9).
Secondary Causes of Dyslipidemia
In addition to obesity and the primary disorders
resulting in dyslipidemia, numerous
other clinical conditions are recognized
causes of dyslipidemia in children. Important
secondary causes include diabetes, hypothyroidism,
chronic renal insufficiency
or renal failure, and liver disease. Medications
that adversely influence the lipid profile
include retinoids used for the treatment
of acne in youth, glucocorticoids, estrogen,
progestins, and ß-blockers.
Lipid Measurements
Laboratory measurements of lipids should
follow good quality control procedures.
The National Cholesterol Education Program
(NCEP) has developed criteria for
the analytical performance of cholesterol
assays. In addition, the CDC’s Cholesterol
Reference Method Laboratory Network
(CRMLN) certifies clinical diagnostic
products that measure TC, HDL-C, and
LDL-C. The FDA has recognized the value
of the CRMLN’s certification program and
encourages manufacturers to certify their
products through the CRMLN. Today, TC
measurements on most analyzers meet the
NCEP’s 1992 criteria of 3% bias versus the
reference method and imprecision. CDC’s
Division of Laboratory Sciences also maintains
lists of the clinical diagnostic products
that have been certified by the CRMLN that
can be found at www.cdc.gov/labstandards/
crmln.htm.
Various methods are available to determine
HDL-C, but the direct method is
the most widely used. This method typically
involves the selective measurement
of HDL-C after shielding cholesterol in
the non-HDL fractions. While direct homogeneous
methods for assessing LDL-C
are available on many automated analyzers,
most laboratories continue to calculate
LDL-C by the Friedewald equation,
which is based on routinely measured TC,
HDL-C, and TG. The NCEP recommends
that LDL-C be calculated using one of the
following equations:
LDL-C (mg/dL) = TC – HDL-C – TG/5
or
LDL-C (mmol/L) = TC – HDL-C – TG/2.2
Labs can use these equations to calculate
LDL-C levels except when the TGs are very
high or when the sample is obtained under
non-fasting conditions. At very high concentrations
(400 mg/dL or 4.52 mmol/L),
TG/5 or TG/2.2, which is an estimate of
VLDL, will not be valid due to the presence
of chylomicrons. The Friedewald equation
is also not valid for patients with Type
III hyperlipoproteinemia. The enzymatic
measurement of TG is standardized to the
methylene chloride-salicylic acid chromotropic
reference method of the CDC.
Screening for Dyslipidemia in Youth
Population-wide screening for dyslipidemia
in children is not currently recommended.
However, the AHA recommends screening
children who are most likely to have dyslipidemia
or who are at increased risk of CVD
(8). The two primary target groups are
children with genetic dyslipidemias, often
identified by a family history of hyperlipidemia
and/or premature coronary artery
disease (CVD onset at < 55 years of age in
male relatives, < 65 years of age in female
relatives), and children who are obese.
table 3
classification of cvd risk
in children
Total Cholesterol LDL-Cholesterol
mg/dL mmol/L mg/dL mmol/L
acceptable < 170 4.40 < 110 2.85
borderline 170–199 4.4–5.15 110–129 2.85–3.34
High > 200 5.15 > 130 3.34
Source: References 10 and 11.
table 2
recommended interventions
for children with heterozygous
familial hypercholesterolemia
Intervention Type Parameter Target
Dietary < 30% calories from fat
< 7% calories from saturated fat
no trans fat
Physical Activity Active play > 1 h/d
Screen time < 2 h/d
Other CV Risk Factors Assess and counsel:
blood pressure
cigarette smoking
glycemic status
Pharmacotherapy Consider statin therapy if :
male patient is at least 10 years old,
female patient has undergone menarche,
LDL-C persists at ≥4.9 mmol/L or ≥4.2 mmol/L
with other CV risk factor(s) or family history
of PCAD
Source: Reference 8.
In addition, the 2006 scientific statement
from AHA recommends lipid screening
profiles for children with a number of
pediatric disorders that increase their risk
of CVD in young adulthood (8). Diabetes
type 1 and 2, Kawasaki disease with coronary
aneurysms, and chronic and end-stage
renal disease may predispose children to
very early coronary events. Hyperglycemia
in type 1 diabetes is a primary mediator
of atherosclerosis, while in type 2 diabetes,
both hyperglycemia and insulin resistances
are implicated in endothelial dysfunction.
In children with chronic kidney disease,
morbidity and mortality is related not only
to the kidney disease but also to CVD. The
recommendations and goals for intervention
have been tailored to risk (2).
Target Values
Elevated LDL-C is the most clinically significant
marker of dyslipidemia in children
and is used as the basis for treatment.
Table 3 summarizes the NCEP (10) and
< 200 mg/dL
total cholesterol
< 3.35 mmol/L or
130mg/dL LDL-C
American Academy of Pediatrics (AAP)
(11) classification categories based on TC
and LDL-C levels. A major concern among
pediatric care givers has been that a single
cutoff value does not reflect the changes
associated with sex, growth, and maturation.
The Lipid Research Clinics (LRC) Prevalence
study also defined target values for
TC. This 1972–1976 study, sponsored by
the National Heart, Lung, and Blood Institute,
used fasting samples from a cross-
sectional survey of various North American
populations. More age-specific and
sex-specific data from the LRC prevalence
data are shown in Table 4. Levels above the
95th percentile are considered abnormal.
More recently, researchers developed
age- and sex-specific lipoprotein threshold
concentrations for adolescents 12–20 years
of age based on data from the National
Health and Nutrition Examination Surveys
(NHANES) (13). They linked the cut points
to the adult health-based thresholds for
table 4
lipid prevalence data by age
Total cholesterol
Age
(years)
Males Females
75 th 95 th 75 th 95 th
mg/dL mmol/L mg/dL mmol/L mg/dL mmol/L mg/dL mmol/L
5–9 168 4.34 189 4.89 176 4.55 197 5.09
10–14 173 4.47 202 5.22 171 4.42 205 5.30
15–19 168 4.34 191 4.94 176 4.55 207 5.35
ldl-cholesterol
Age
(years)
Males Females
75 th 95 th 75 th 95 th
mg/dL mmol/L mg/dL mmol/L mg/dL mmol/L mg/dL mmol/L
5–9 103 2.66 129 3.34 115 2.97 140 3.62
10–14 109 2.82 132 3.41 110 2.84 135 3.52
15–19 109 2.82 130 3.36 111 2.87 137 3.54
Source: Reference 12.
CliniCal laboratory news JuLy 2008 11

abnormal lipoproteins. Using the NHANES
database for risk stratification may be problematic,
however, as it does not take into account
the measurement variability of lipids
and lipoproteins. Until the clinical applicability
of these threshold concentrations has
been more thoroughly investigated, single
measurements on at least two different occasions
are recommended to establish an
individual’s cholesterol value.
Although AAP recommends measuring
HDL-C in children with hypercholesterolemia,
its usefulness in managing risk
is also not clear. A target value of < 5th
percentile (< 40mg/dL or 1.04 mmol/L) is
considered low.
Measurement of
Apolipoproteins in Children
Measurement of apolipoproteins for predicting
CVD risk in children is controversial.
Recent studies in adults have suggested
that apolipoprotein B may be superior to
LDL-C in vascular disease risk prediction
and that the apo-B/apo A-1 ratio may be
superior to TC/HDL-C as an overall index.
Apo A-1 is the major structural protein of
HDL. On the other hand, apo-B is mostly
associated with LDL, but it is also a component
of chylomicrons, VLDL, IDL, and
lipoprotein(a). In general, apo-B levels
12 CliniCal laboratory news JuLy 2008
may be useful to guide therapy, but its use
in managing dyslipidemia in adults is still
discretionary.
Researchers have also studied apolipoprotein
levels in children 4 years of age and
older in a population from NHANES III
(14,15). Measuring apoB levels has the advantage
of not requiring the patient to fast,
and in one study researchers demonstrated
that it was a better screening tool than TC
for identifying elevated LDL-C in youth
(15). However, medical groups have not
reached a consensus on using apolipoproteins
to screen for dyslipidemia in children.
Further investigation will be needed before
any consensus can be reached.
Avoiding CVD in the Future
Based on the knowledge that atherosclerosis
begins in youth and that childhood
elevated cholesterol levels usually persist
into adulthood, identifying dyslipidemia in
children is important for prevention of the
vascular changes associated with increased
CVD risk later in life. Currently the management
of hypercholesterolemia is aimed
at reducing LDL-C, and appropriate agerelated
target values for intervention have
been recommended. The appropriate use
of HDL-C and apolipoproteins in managing
risk requires further investigation. CLN
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in children age 4–11 years: the Third National
Health and Nutrition Examination
Survey. J Clin Epidemiol 2001;54(4):367–
375.
15. Dennison BA, Kikuchi DA, Srinivasan
SR, Webber LS, Berenson GS. Measurement
of apolipoprotein B as a screening test
for identifying children with elevated levels
of low-density lipoprotein cholesterol. J Pediatr
1990;117(3):358–363.
Katherine M. Morrison, MD,
FRCPC, is associate professor
in the Department of Pediatrics
at McMaster University,
Hamilton, Ontario, and a
physician in the Pediatric Lipid Clinic at the
McMaster Children’s Hospital.
Vijaylaxmi Grey, PhD,
FCACB, is a laboratory
scientist responsible for pediatric
clinical biochemistry
in the Hamilton Regional
Laboratory Medicine Program at McMaster
University and is an associate professor in
the Department of Pathology and Molecular
Medicine, as well as an associate member of
the Department of Pediatrics.
ask the authors
need clarification or more information
on the subject in the article?
go to the article on www.aacc.
org, then click “ask the authors”
to send your question. CLN will
post all questions and answers
on aaCC’s web site so that the
information is shared in the clinical
laboratory community.
silent auction
& reception
fundraiser
Wednesday, july 30th, 5:30 p.m.–7:30 p.m.
The arts club of Washington
silent auction offerings will include travel and dining certificates, a 2009
aaCC annual Meeting registration and suite package, framed photographs
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plus much more! if you would like to donate a prize or cash contribution,
please contact grace won at gwon@aacc.org or (202) 835-8712.
tickets are $75 each. order yours by calling grace won, or see page 73
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All monies from your ticket purchase and the silent auction will go directly to
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14 CliniCal laboratory news JuLy 2008
PATIENT SAFETY FOCUS
Current Concepts in the
Disclosure of Serious Medical
Errors to Patients
An Interview with Thomas Gallagher, MD
thomas gallagher, Md, is an
associate professor of Medicine
and Medical History & ethics in
the university of washington
school of Medicine. an internist
who cares for both inpatients and
outpatients, gallgher is also an internationally
recognized expert in
the field of error disclosure, having
recently served on a consensus
group that developed a national
quality standard on the subject.
michael astion, md, phd,
conducted this interview.
Q: What is your view on errors in medicine
and the way they relate to disclosure?
A: Errors and adverse events are unavoidable
because healthcare is a human enterprise.
The patient safety movement supports
transparency between patients and
care providers regarding the disclosure of
errors. Proper handling of error disclo-
sures has the potential to enhance patient
satisfaction, to help patients and caregivers
develop mutual trust, and to decrease
the chances that patients will sue their care
providers.
Q: What is the attitude of patients regarding
error disclosure?
A: Patients define errors broadly. They include
many aspects of low quality in their
“my handwriting can be difficult for the staff to interpret…”
TAkING AIM AT REDUCING LAB ERRORS
introducing CLN’s new
special section
I am pleased to welcome CLN’s readers to this new quarterly section
focused on reducing medical errors in the lab. Laboratorians play a vital,
but often unrecognized, role in providing high quality patient care.
Here, Michael Astion, MD, PhD, a recognized leader in patient safety
and the clinical lab, along with Peggy Ahlin, BS MT(ASCP), James
Hernandez, MD, MS, and Devery Howerton, PhD, provide insights
into how laboratorians can improve patient care. The section features
interviews and articles from thought leaders, as well as case studies
and other useful resources. On behalf of the CLN Board of Editors, I
thank Dr. Astion and his colleagues for their efforts and ARUP Laboratories
for their sponsorship of these pages.
—Nancy Sasavage, PhD
Editor, CLN
definition of error: unnecessary waiting,
poor bedside manner, and unpreventable
complications of care. Patients want caregivers
to disclose errors because they believe
caregivers have the ethical obligation
to be truthful. They want truthful error
disclosure, but they also believe it is human
nature for healthcare workers to hide or
minimize errors.
Q: What do patients want when a harmful
laboratory error occurs?
A: Patients want an explicit, comprehensible
statement that an error occurred; a description
of what happened, including the
implications for their health; a description
of why it happened and how future recurrences
will be prevented; and for caregivers
to say that they are sorry about the error.
Q: How do healthcare workers differ
from patients regarding attitudes and
experiences about disclosure?
A: Most of the healthcare worker data on
error disclosure have been collected from
physicians, nurses, and risk managers. These
healthcare workers define errors more narrowly,
often using medical definitions of
error that emphasize undesirable patient
outcome. Therefore, healthcare workers
tend to emphasize the need to disclose errors
to patients in those circumstances
when errors harm patients or force patients
to make unexpected decisions about their
care. However, by focusing primarily on errors
impacting patients, caregivers often feel
it is justified to not inform patients if the
error does not harm patients. Like patients,
healthcare workers endorse the concept of
error disclosure, and they want to be truthful.
However, caregivers experience a variety
of barriers that block them from making a
full error disclosure and vary significantly
regarding what they think should be revealed
during a disclosure.
Q: Are most harmful errors disclosed to
patients?
A: Currently, most harmful errors are not
disclosed to patients. Estimates vary regarding
the frequency of disclosure, but a
reasonable estimate is that about 30% of
harmful errors are disclosed. This appears
to be the case internationally and across
medical disciplines.
Q: What are some barriers to disclosure
that create the gap between the desire to
disclose and actual disclosure?
A: One group of barriers is ethical considerations.
A question that frequently arises

among healthcare workers is whether the
disclosure will do more harm than good to
the patient.
Q: Can you give some examples of when
caregivers feel that disclosure might do
more harm than good?
A: Consider a case where a patient is hopelessly
ill and will die soon. Caregivers sometimes
do not disclose a serious or fatal error
in such cases because they feel it will only
compound the agony of family and friends
of the patient. Or consider a case when an
error is minor and the patient experiences
minimal or no harm. Some providers will
not disclose in this type of case, because
they feel the error disclosure will demoralize
the patient and perhaps make the patient
feel worse.
Q: What are some of the other barriers to
disclosure mentioned by care providers?
A: Caregivers are worried that the disclosure
could precipitate a lawsuit and financial
damages (See Box below). They are
concerned that error disclosure may cause
them to be emotionally harmed due to loss
of reputation and acknowledgement of
personal failure. They report being uncomfortable
reporting errors made by other
care providers, some of whom are close
colleagues or superiors. Last, care providers
find these conversations awkward and feel
they do not have the training or communication
skills to provide error disclosure
correctly.
Q: Is the fear of litigation and accompanying
financial damage justified?
A: This question is not decided and will
not be decided for a long time. Early studies
from a Veteran’s Affairs hospital, the
University of Michigan, and a malpractice
insurer in Colorado suggest that, overall,
there will be less litigation as error disclosure
practices spread. These results are limited,
however, and it is too early to draw a
strong conclusion.
Q: What are the implications of the barriers
to disclosure?
A: There are two major implications. The
first is that the barriers decrease the fre-
quency of disclosure. The second is that
when caregivers choose to disclose, they
choose their words too carefully.
Q: Can you explain what you mean by
“choosing their words too carefully”?
A: One scenario that we have used in research
is to ask physicians what they would
do if their bad handwriting on an insulin
order caused an insulin overdose that seriously
harmed the patient. In this example,
the patient is found unresponsive with critically
low glucose. The patient is transferred
to intensive care and then fully recovers.
More than 65% of the physicians said they
would disclose this error. If they were disclosing
this error, more than 70% of the
physicians would describe what happened
as an error, saying something like: “Your
blood sugar went too low because an error
happened and you received too much insulin.”
The remaining physicians would use
a more generic description, saying, “Your
blood sugar went too low because you got
more insulin than you needed.”
Q: Would they mention the handwriting?
A: This is the interesting part. When given
choices regarding what they would specifically
say about the error, only one-third of
physicians would specifically mention the
cause of the error—in this case, their bad
handwriting. Rather, physicians favored
saying, “This occurred because of a miscommunication
in your insulin order.”
They would only volunteer more information
if the patient asked for clarifying information.
Q: Are you saying there is a gap between
what patients want and what physicians
are giving them regarding the description
of the error?
A: Yes. Patients want to know what specifically
happened and how it will be prevented
in the future. If you do not come out
and say that a specific error occurred, you
cannot meet the patient’s desire to know
why it occurred and how recurrences will
be prevented. In our studies, the approach
favored by most physicians was to provide
a nugget of information but not necessarily
to share the information that patients have
said they would like to hear, unless the patient
asks clarifying questions. The patients
want more than that nugget.
Q: Are patients receiving the apologies
they desire?
A: Physicians are split regarding their approach
to apology. For the bad handwriting
scenario, we gave physicians three choices
regarding how they would apologize. The
first choice was no apology, the second was
an expression of regret stating “I am sorry
barriers that hinder error disclosure
by healthcare Workers
® fear of harming the patient or the patient’s friends or family
® fear of litigation
® fear of financial or emotional damage (loss of reputation)
® awkwardness of the disclosure conversation
® lack of confidence regarding communication skills
that this happened,” and the third was an
apology stating, “I am so sorry you were
harmed by this error.” Patients want the
apology, but physicians split 50-50 between
the expression of regret and the apology.
Q: Besides choosing their words too carefully,
what are the other errors made in
error disclosure?
A: Occasionally, we see too much disclosure,
which is the opposite behavior. The caregivers,
in their desire to be truthful and reduce
some of the emotional burden of the error,
examples of disclosure of a
laboratory error by a laboratory
Technologist to a nurse
The error was a data entry on a troponin, which caused an
incorrect diagnosis of myocardial infarction. The request
for read back has been omitted from the disclosure.
choosing words too carefully: “i am calling to correct a troponin
result. the troponin result on patient John doe from March 14 at 14:52,
which was reported as 57 ng/ml, has been changed to 0.02 ng/ml.”
reasonable disclosure: “i am calling to inform you about a laboratory
error. the troponin result on patient John doe from March 14 at 14:52,
which was reported as 57 ng/ml, has been changed to 0.02 ng/ml.
this was due to a manual, data-entry error. in the laboratory, there was
a specimen for troponin from another patient at the same time as John
doe’s specimen. that patient had a troponin of 57 ng/ml, and we incorrectly
entered that patient’s results into John doe’s record. we are sorry
that we made this error. we are doing a further analysis on this error to
look for ways to prevent its recurrence. we will contact you about this
further analysis in the next 48 hours. please feel free to call the laboratory
supervisor if you have questions.”
disclosing too much: “i am calling to inform you about a laboratory
error. the troponin result on patient John doe from March 14 at 14:52,
which was reported as 57 ng/ml, has been changed to 0.02 ng/ml.
this was due to a manual, data-entry error by a technologist named
Joey. there was a specimen for troponin from another patient in the
laboratory at the same time as John doe’s specimen. that patient had
a troponin of 258 ng/ml, and Joey got all confused as usual and incorrectly
entered the patient’s results into John doe’s record. we are sorry
that Joey made this error. Joey has been having personal problems. He
is in the middle of a messy relationship and taking care of his elderly
parents. He has been making lots of these errors, and everybody has
been talking about it. but management around here is too timid to do
anything, and they are never around anyway, as they are usually taking
some kind of fancy retreat or driving around in their boats. nobody
listens to us, and that is why these things happen. it is a good thing we
didn’t kill the patient. this place stinks. if i had more money, i would
retire. we are doing a further analysis, even though we all know what is
going on. please feel free to call the laboratory supervisor in a few days
if you have additional questions.”
hastily give the patient more information
than the patients desire. Many times, this
information is not accurate, since an accurate
description of an error requires the
time to collect and analyze data.
Q: What are some of the important developments
occurring in the area of error
disclosure?
A: Perhaps the most important development
is the National Quality Forum’s
(NQF) addition of standards for disclosure
to its list of safe practices. I was part of the
committee that developed the standard.
Q: Could you describe NQF’s standards
for safe practices and why they are influential?
A: The NQF endorses a set of safe practices
that are considered fundamental to quality
care. Currently there are 32 such practices.
These practices are based on evidence as
well as expert opinion. The standards were
developed by individual stakeholders working
in collaboration with representatives
from organizations interested in healthcare
quality such as the Joint Commission,
CMS, and the Agency for Healthcare Research
and Quality.
Q: What are some of the key points of the
NQF’s standard?
A: The standard contains the basic charac-
teristics of an effective system for medical
error disclosure. There are two key areas
addressed by the safe practice list. The first
is what information should be given to the
patient. The second set of issues addressed
by the safe practice list is the institutional
support of disclosure so that care providers
can be supported while meeting the needs
of patients.
Q: What are the patient issues?
A: The standard supports the list of patient
desires discussed previously. It supports
giving the patient facts about the error, especially
those facts that support decision
making. In addition, the standard states
that formal apologies, rather than expressions
of regret, should be given when a
clear-cut error or system failure occurs.
Q: What are the institutional requirements
to support disclosure?
A: One of the main institutional requirements
is to give disclosure education to all
healthcare workers who might participate
in an error disclosure. Another requirement
is to make sure that help, in the form
of mentoring or coaching, is available to
healthcare workers. The last recommendation
is to provide emotional support to
everybody involved in the error and the
disclosure. This means healthcare workers,
patients, and the families of patients.
CliniCal laboratory news JuLy 2008 15

Q: Who acts as the coach?
A: Coaches should be experienced people,
and they are often in positions of authority.
One frequently used coach is the medical
director of the practice or the hospital.
The chief nursing officer and risk managers
can also be helpful coaches. No matter
who is doing the coaching, the communication
between the care provider, who is
knowledgeable about the error and who
may have played a role in the error, and the
coach needs to be protected.
Q: What do you mean by protected communication?
A: It means that the communication cannot
be legally construed as an admission of
guilt regarding an error.
Q: By emotional support, do you mean
employee counseling by a therapist?
A: That could be part of it in some unusual
cases. More frequently, the basis of
the emotional support is a little less formal.
Specifically, I am referring to support by the
medical director’s office, by departmental
leadership, by supervisors, and by peers.
Q: Why does the NQF safe practice standard
matter?
A: Hospital scores on NQF patient safety
practices are part of a number of pay-forperformance
initiatives and show up on
publicly accessible Web sites that grade
hospital performance. Although it will not
be possible to grade hospitals on individual
disclosures, it will be possible to grade them
on whether they have the elements of an effective
disclosure system in place, and that
is a great start.
Q: Are you saying that organizations
tend to behave better when they are being
monitored?
A: Yes. The hope for error disclosure is that
the spread of the NQF patient safety practice
and posting of hospital scores regarding
carrying out the practice will lead to
strong error disclosure programs in every
hospital.
sponsored by the Agency for
Healthcare Research and Quality
and edited at the University of
California, San Francisco, Morbidity
and Mortality Rounds on the Web
is a valuable resource that deserves more
visibility among clinical laboratory professionals.
The site contains a 5-year archive of
actual cases submitted by healthcare providers,
along with expert commentary and
numerous references. Each case and commentary
is a succinct, well-edited piece of
about 1,500 words that supervisors could
assign to lab staff or trainees as a continuing
education activity. Many cases include
laboratory medicine issues, but other cases
are often applicable to the lab.
16 CliniCal laboratory news JuLy 2008
Q: What are some other key advances in
disclosure?
A: The other important developments are
legal and are mostly taking place at the state
level. Seven states have now mandated that
serious errors be disclosed to patients, and
many other states are developing similar
legislation. To address legitimate concerns
about legal actions caused by error disclosure,
the laws usually include language stating
that these disclosures cannot be used as
evidence of guilt regarding the event described
in the disclosure.
Q: Why are the legal developments important?
A: The most important aspect of the legal
developments is that they represent a public
policy endorsement of error disclosure.
Along with the NQF safe practice standards,
this endorsement provides a strong
and probably irreversible movement toward
effective error disclosure.
Q: Overall, you seem optimistic about
error disclosure?
A: I told you that currently about 30% of
errors that harm patients are disclosed. I
am optimistic that transparency regarding
errors including effective error disclosure,
which meets the needs of both patients and
care providers, will become the norm over
the next several years.
Q: In most cases of laboratory errors,
laboratorians do not disclose errors to
the patient. Typically, the laboratorian
discloses the error to a nurse or physi-
A large set of cases about communication
issues can be accessed by typing “communication”
into the Web site’s search field.
Here is a synopsis of a few such cases that
specifically involve problems in communicating
lab test results.
lost in Transition
Case id #116
This case deals with a delay in receiving
a critical platelet value that was due to a
number of failures, including a handoff
problem between caregivers in the emergency
department and the hospital ward
where the patient was admitted.
cian, who then makes a choice regarding
disclosing the error to the patient. What
are your recommendations regarding
disclosure of laboratory errors by laboratorians
to direct care providers?
A: The NQF safe practice standards describe
an effective system for error disclosure
for all healthcare workers. Therefore,
the safe practice should be extrapolated to
the situation you describe. To meet the patient’s
needs, the laboratorian must give the
caregiver the information needed to provide
an optimal disclosure to the patient.
This means speaking in comprehensible
language and avoiding the most common
problem, which is choosing words too carefully.
Laboratory staff should also avoid the
less common problem of hastily, emotionally,
and inaccurately disclosing too much.
elements of an effective
disclosure support system
® education to care providers and other healthcare workers
® 24-hour availability of coaching /mentoring
® emotional support available to healthcare workers, patients, families
of patients
Q: When talking with physicians and
nurses about laboratory errors, can
laboratory staff talk about QC intervals,
Westgard rule violations, out-of-range
high instrument flags, universal aliquotting,
Levy-Jennings charts, instrument
linearity, and delta-checking?
A: Laboratory workers should not assume
that physicians and nurses understand laboratory
jargon.
Q: What about institutional support to
laboratory workers and other workers in
ancillary services?
A: The basic elements of a disclosure system,
which are education, support by
coaches, and emotional support, need to
be available to laboratory staff, supervisors,
and medical directors. When disclosing
Communication: Teaching Cases on the Web
AHRQ’s Web Morbidity and Mortality Rounds
To lp or not lp
Case id #34
In this case, communication failures between
a physician and the patient’s family
led to delays in performing lumbar puncture
and associated laboratory testing. The
delay in the diagnosis of meningitis placed
the child at serious risk.
The result stopped here
Case id # 65
This case involves serious patient harm
caused by failure to communicate a result
that was actionable but not on the hospital’s
critical value list. The commentary
discusses some of the complexities sur-
laboratory errors to nurses and physicians,
laboratory staff faces some of the barriers
to disclosure experienced by direct care
providers when they disclose errors to patients.
Laboratory staff may fear litigation,
job loss, or emotional damage through loss
of reputation, and they may find the disclosure
conversation awkward. Institutional
support is critical for overcoming the barriers
that block error disclosures between
healthcare professionals.
Q: Thanks for an informative interview
on a topic not frequently addressed in
clinical laboratory publications. You
provided some great information here
and during your presentation at AACC’s
2007 Annual Meeting.
A: It is my pleasure to work with the AACC
on issues related to error disclosure, since
communication about errors is significant
for clinical laboratorians.
MORE ON THIS TOPIC
A recent lecture by Dr. Gallagher, "Disclosing
harmful medical errors to
patients: what are the data telling
us?" can be viewed at http://www.
uwtv.org/programs/displayevent.
aspx?rID=21557&fID=1793. Lecture
date: November 7, 2007.
Gallagher TH, Studdert D, Levinson W.
Disclosing harmful medical errors to patients.
N Engl J Med 2007;356:2713–9.
Gallagher TH, Waterman AD, Ebers AG,
Fraser VJ, Levinson W. Patients’ and
physicians’ attitudes regarding the
disclosure of medical errors. JAMA.
2003;289:1001–1007.
Gallagher TH, Waterman AD, Garbutt JM
et al. US and Canadian physicians’ attitudes
and experiences regarding disclosing
errors to patients. Arch Intern
Med 2006; 166:1605–1611.
Safe practices for better healthcare. Washington,
DC: National Quality Forum,
2007. http://www.qualityforum.org/
projects/completed/safe_practices/
rounding creating adequate policies and
procedures for reporting results. Like the
“Lost in Transition” case, this case points
out the implications of failing to follow-up
on a laboratory test order.
lost in the black hole
Case id #31
This case describes problems in communicating
an HIV PCR result that delayed
diagnosis of acute HIV. It illustrates many
of the communication gaps that arise as
patients move between the inpatient and
outpatient settings.
www.webmm.ahrq.gov

Quality Gaps in Communicating Laboratory Results
An Interview with Dana Grzybicki, MD
devery howerton, md, and
michael astion, md, phd, conducted
this interview.
Q: Based on your analysis of data from
the labs in your study, what are the largest
quality gaps in communicating test
results?
A: There are several significant quality gaps:
poor laboratory documentation related to
success in communicating test results to
care providers; failure to use data about
result communication to drive continuous
quality improvement (QI); poor communication
with clinicians regarding what
information they want to receive; and lack
of data on the success of communicating
critical lab values on outpatients to care
providers.
Q: Can you give an example of poor documentation
involving communication
of critical test results?
A: In the institutions we studied, lab staff
frequently did not record the name of the
care provider who received the result. In
addition, staff did not document how many
phone calls had to be made to successfully
communicate one critical result. Also, most
labs did not monitor the time interval between
the appearance of the critical result
and the receipt of the critical result by a care
provider who could act on it.
Q: Does the failure to use data to drive QI
mean that labs frequently fail to use the
data they collect?
A: Yes. For example, almost all the labs collect
data regarding the percentage of critical
values that were successfully communicated
to a care provider, but many of the
laboratories just warehouse these data and
do not use it as part of a QI project.
Q: Can you give an example of poor communication
with clinicians?
A: For example, most nephrologists do
not want to be called about hypercalcemia
values on patients with chronic renal disease
unless a patient-unique threshold is
reached. A large amount of time appears
to be wasted by lab professionals making
calls about lab values that fall within a
dana grzybicki, Md, is an associate professor of pathology at the university of Colorado.
a practicing pathologist with a wide-ranging interest in patient safety, she has written extensively
on quality issues in anatomic pathology and laboratory medicine and has published seminal work
on improving screening for cervical cancer. she currently receives funding from the CdC to perform
a multi-institutional study on laboratory quality. Here, she talks about some of her early findings on
how laboratories communicate test results.
predetermined critical range and yet have
no impact on management or patient outcomes.
In fact, these events often serve to
negatively impact clinician-laboratorian
relationships.
Q: Why do you specifically point out
communication of test results on outpatients?
A: The outpatient setting is distinct from
the hospital setting because for outpatients,
there might be a single care provider responsible
for receiving and acting on the
critical result, and the patient may be at
home, decompensating and not visible to
the care provider. In the hospital setting,
there are multiple care providers accessing
the patient and the medical record; the patient
is visible and is often being observed
for signs of distress. Even if the critical value
is missed, there are other clinical data being
collected and analyzed on the hospitalized
patient.
Q: Are reporting practices for lab critical
values highly variable among the organizations
you have studied? If so, what are
some of the common variations?
A: Most of the labs have a reporting protocol
for a set of “critical values” commonly
recommended by accrediting organizations
and professional societies, and most
of these values are communicated through
phone calls to a healthcare professional associated
with the patient. However, there is
great lab-to-lab variability regarding what
specific values of a particular analyte are
considered critical; which personnel are
authorized to call critical values; which
personnel are authorized to receive critical
values; how receipt of the critical values is
documented; and how the clinical actions
taken as a result of the critical value are
documented.
Q: Is there a specific problem regarding
oral communication of test results that
you find troubling?
A: A major problem is the lack of surety at
the lab end that the correct provider got the
information that was reported from the lab.
Many times, a technician or technologist
phones a result to a hospital ward and gives
the result to whoever answers the phone or
to another designated non-physician provider.
The laboratorian has no idea if the
information is going to be dropped or used
in patient care. Even though a relationship
of trust often exists between lab and clinical
staff, the continued lack of a closed loop
on results communication is problematic
because it keeps the lab disconnected from
patient care. Connection to the patient
helps lab learn about patient care and helps
give urgency to lab quality improvement.
Q: What types of solutions exist for these
communication problems?
A: A number of lab informatics tools have
been developed to address some of these
problems. For example, a closed system
has been developed whereby clinicians are
automatically notified by pager when a desired
lab result is available in the hospital
information system. In some cases, the result
is paged directly to a wide-screen pager.
These systems are mostly experimental.
They have rarely been used clinically, because
their success requires care providers
to accurately log in and out of the system
to identify when they are on and off service.
Errors regarding which care providers are
actually working are common and cause
the computer system to page the wrong
person.
A more successful method, now in common
clinical use, is e-mail notification to
physicians. In simple systems, the e-mail
may be used to automatically notify clinicians
when results are ready for the physician
to retrieve. In more advanced systems
that use electronic medical records, results
can be e-mailed to the physician's electronic
inbox. This is especially useful for pushing
abnormal results to the physician. One
potential advantage of e-mail notification
is that the lab may also request a return email
from the clinician, requesting notification
of receipt of the lab result. This closes
the loop on the result.
Q: Do you have any information on how
often critical values resulted in changes
in patient management?
A: We have nearly completed a study involving
critical potassium values. In this
study, more than 50% of the patients who
had a critical potassium value underwent
some change in their management—for
example, a change in medication—as a
consequence of the lab communicating the
critical value. Clearly, a critical value was
critical to patient care.
MORE ON THIS TOPIC
Grzybicki DM, Raab SS. Measuring health
care performance: identification and
standardization of laboratory quality
indicators. Am J Clin Pathol 2006;126
(S1):S48–S52.
Grzybicki DM, Turcsanyi B, Becich MJ,
Gupta D, Gilbertson JR, Raab SS. Database
construction for improving patient
safety by examining pathology errors.
Am J Clin Pathol 2005;124:500–9.
Grzybicki DM. Barriers to the implementation
of patient safety initiatives. Clin Lab
Med 2004;24:901–11.
Raab SS, Grzybicki DM, Zarbo RJ, Jensen
C, Geyer SJ, Janosky JE, Meier FA, Vrbin
CM, Carter G, Geisinger KR. Frequency
and outcome of cervical cancer prevention
failures in the United States. Am J
Clin Pathol 2007;128:817–24.
Raab SS, Grzybicki DM. Anatomic pathology
workload and error. Am J Clin
Pathol 2006;125:809–12.
Poon EG, Kuperman GJ, Fiskio J, Bates
DW. Real-time notification of laboratory
data requested by users through
alphanumeric pagers. J Am Med Inform
Assoc 2002;9:217–22.
Matheny ME, Gandhi TK, Orav EJ, Ladak-
Merchant Z, Bates DW, Kuperman
GJ, Poon EG. Impact of an automated
test results management system on
patients’ satisfaction about test result
communication. Arch Intern Med
2007;167:2233–9.
patient safety focus editorial board
chair
michael astion, md, phd
department of laboratory Medicine
university of washington, seattle
members
peggy a. ahlin, bs, mT(ascp)
arup laboratories
salt lake City, utah
james s. hernandez, md, ms
Mayo Clinic College of Medicine
rochester, Minn.
devery howerton, phd
Centers for disease Control and prevention
atlanta, ga.
CliniCal laboratory news JuLy 2008 17

3M Medical diagnostics . . . . . . . . . . . .3921
a/C diagnostics llC . . . . . . . . . . . . . . . .2148
a2la ................................344
aaCC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3629
aafp-laboratory proficiency testing .162
aalto scientific, ltd. . . . . . . . . . . . . . . . .3833
abaxis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .366
abbott diagnostics .................1507
abbott diagnostics labs are Vital . . .1811
abd serotec . . . . . . . . . . . . . . . . . . . . . . .3733
access bio, inc. . . . . . . . . . . . . . . . . . . . . .4149
access biological . . . . . . . . . . . . . . . . . . .1965
accutest, inc. . . . . . . . . . . . . . . . . . . . . . . .3910
aCon laboratories, inc. . . . . . . . . . . . . .1038
acroMetrix . . . . . . . . . . . . . . . . . . . . . . . . .4109
adaltis us inc. . . . . . . . . . . . . . . . . . . . . . .3215
adaptive Mfg. technologies inc. . . . .2353
adeMteCH . . . . . . . . . . . . . . . . . . . . . . . . . .109
adhesives research, inc. . . . . . . . . . . . .1847
adicon Clinical laboratories, inc. . . . .1042
advance . . . . . . . . . . . . . . . . . . . . . . . . . . .3049
advanced instruments, inc. . . . . . . . . . .230
advanced liquid logic . . . . . . . . . . . . . .164
advanced Microdevices pvt. ltd. . . . .1769
aesku diagnostics . . . . . . . . . . . . . . . . . .1653
affymetrix, inc. . . . . . . . . . . . . . . . . . . . . . .410
agilent technologies . . . . . . . . . . . . . . .3148
ahlstrom . . . . . . . . . . . . . . . . . . . . . . . . . . .4108
aid gmbH ...........................126
alfa scientific designs, inc. . . . . . . . . . . .156
alfa wassermann
diagnostic technologies . . . . . . . . .1031
alifaX spa . . . . . . . . . . . . . . . . . . . . . . . . .3315
alpCo diagnostics . . . . . . . . . . . . . . . . .1546
aMa scientific, llC . . . . . . . . . . . . . . . . .4104
amano enzyme usa Co., ltd. . . . . . . . .130
amedica biotech, inc. . . . . . . . . . . . . . . .1963
american bio Medica Corporation . . . .258
american diagnostica inc. . . . . . . . . . .1044
american Medical technologists . . . . .118
american proficiency institute . . . . . .3628
asCls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3039
american society for
Clinical pathology . . . . . . . . . . . . . . . .4125
ameritek usa . . . . . . . . . . . . . . . . . . . . . . .113
amic ab . . . . . . . . . . . . . . . . . . . . . . . . . . . . .261
analis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1129
analyticon biotechnologies ag . . . . .1461
anew international . . . . . . . . . . . . . . . . .3703
ani biotech oy &
anilabsystems ltd ...............1756
antek Healthware . . . . . . . . . . . . . . . . . .2115
applied biosystems ..................903
aps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2067
argene inc. . . . . . . . . . . . . . . . . . . . . . . . . .2268
aries filterworks,
division of resintech .............1859
arista biologicals inc. . . . . . . . . . . . . . . .2152
arlington scientific - asi . . . . . . . . . . . .1524
artel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .757
arup laboratories . . . . . . . . . . . . . . . . .1039
arup laboratories . . . . . . . . . . . . . . . . .4032
asahi Kasei pharma Corporation . . . . .120
asCo numatics .....................2253
assel - aMs ........................1563
asuragen, inc. . . . . . . . . . . . . . . . . . . . . . .3046
athera biotechnologies .............1359
atherotech . . . . . . . . . . . . . . . . . . . . . . . . . .133
atlas link, inc. . . . . . . . . . . . . . . . . . . . . . . .169
audit MicroControls, inc. ............3829
autobio diagnostics Co. ltd. . . . . . . . . .204
autogenomics inc. . . . . . . . . . . . . . . . . .1023
awareness technology, inc. . . . . . . . . .1803
aweX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1130
axis-shield . . . . . . . . . . . . . . . . . . . . . . . . . .357
aZog, inc. ...........................142
bangs laboratories, inc. .............1014
baytree leasing ......................123
bbinternational . . . . . . . . . . . . . . . . . . . . .3431
bd . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .339
bd lee laboratories . . . . . . . . . . . . . . . .1661
beaufort advisors ....................115
beckman Coulter, inc. . . . . . . . . . . . . . . .2025
beijing Kinghawk pharmaceuticals . .2954
beijing shining sun
technology Co., ltd. . . . . . . . . . . . . . .3716
berthold detection systems gmbH . .1863
bertHold teCHnologies gmbH ...1355
bestgen biotech Corp. . . . . . . . . . . . . . .3929
binding site inc., the . . . . . . . . . . . . . . . . .923
binding site inc., the . . . . . . . . . . . . . . . .2153
bioassay works, llC .................3923
bio-bottle ltd . . . . . . . . . . . . . . . . . . . . . .1466
bioCheck, inc. . . . . . . . . . . . . . . . . . . . . . .2262
bio-Chem fluidics . . . . . . . . . . . . . . . . . .1960
biodot, inc. . . . . . . . . . . . . . . . . . . . . . . . . .3912
bioer teCHnologY Co., ltd ........1553
bioHelix Corporation . . . . . . . . . . . . . . . .362
bioHit, inc. . . . . . . . . . . . . . . . . . . . . . . . . .3615
bioKit sa . . . . . . . . . . . . . . . . . . . . . . . . . . . .543
biological specialty Corporation . . . .2364
biologix research Co. . . . . . . . . . . . . . . .2160
biolYpH, llC . . . . . . . . . . . . . . . . . . . . . . .1860
biomat . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1358
bioMed resource inc. . . . . . . . . . . . . . . .2358
biomedix . . . . . . . . . . . . . . . . . . . . . . . . . . . .465
bioMerieux, inc. . . . . . . . . . . . . . . . . . . . .1743
bioneer Corporation . . . . . . . . . . . . . . . .1662
bioporto diagnostics . . . . . . . . . . . . . . .1259
bioprocessing, inc. . . . . . . . . . . . . . . . . . . .208
bio-rad laboratories . . . . . . . . . . . . . . .1239
biosearch technologies, inc. . . . . . . . . .101
biosigma s.r.l. . . . . . . . . . . . . . . . . . . . . .1554
biosino bio-technology
& science inc. . . . . . . . . . . . . . . . . . . . .2851
biosource . . . . . . . . . . . . . . . . . . . . . . . . . .1127
biospaCifiC . . . . . . . . . . . . . . . . . . . . . . . .1760
bio-synthesis, inc. . . . . . . . . . . . . . . . . . . .960
biotek instruments, inc. . . . . . . . . . . . . . .244
biotest diagnostic Corp . . . . . . . . . . . . .3011
biotX automation, inc. . . . . . . . . . . . . . .768
bioVentures, inc. . . . . . . . . . . . . . . . . . . . .4051
biowin . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1125
bit analytical instruments . . . . . . . . . .2267
bloodCenter of wisconsin . . . . . . . . . . .968
blue Cross bio-Medical
beijing Co., ltd. . . . . . . . . . . . . . . . . . .1357
boditeCH Med inc. . . . . . . . . . . . . . . . . .161
boMi iberiCa, s.a. . . . . . . . . . . . . . . . . . . .349
brady Corporation . . . . . . . . . . . . . . . . . .4043
burkert fluid Control systems . . . . . . . .657
C & a scientific Co., inc. . . . . . . . . . . . . .4145
Calbioreagents . . . . . . . . . . . . . . . . . . . . .3812
Calbiotech inc . . . . . . . . . . . . . . . . . . . . . .2910
Caldon bioscience . . . . . . . . . . . . . . . . . .3808
Calypte biomedical Corporation . . . .4045
Calzyme laboratories, inc. . . . . . . . . . .2249
Cambridge Consultants . . . . . . . . . . . . . .311
Capitalbio Corporation . . . . . . . . . . . . .1667
Capralogics inc . . . . . . . . . . . . . . . . . . . . . .112
Capricorn products llC . . . . . . . . . . . . . .214
Cardinal Health . . . . . . . . . . . . . . . . . . . . . .843
Care diagnostica int’l . . . . . . . . . . . . . .1046
Careevolve . . . . . . . . . . . . . . . . . . . . . . . . . .868
Carolina Chemistries . . . . . . . . . . . . . . . .1910
Carville ltd . . . . . . . . . . . . . . . . . . . . . . . . .1767
CCs robotics . . . . . . . . . . . . . . . . . . . . . . . .869
CellaVision . . . . . . . . . . . . . . . . . . . . . . . . . .959
Cellestis, inc. . . . . . . . . . . . . . . . . . . . . . . . .238
Centerchem inc. . . . . . . . . . . . . . . . . . . . .1845
Centers for disease Control
& prevention . . . . . . . . . . . . . . . . . . . . .4018
Centers for Medicare &
Medicaid svcs . . . . . . . . . . . . . . . . . . . .9006
Cepheid . . . . . . . . . . . . . . . . . . . . . . . . . . . .2715
Certest bioteC s.l. . . . . . . . . . . . . . . . . .448
Chembio diagnostic systems, inc. . . . .160
Chempaq inc. .......................163
Chemtron biotech inc. . . . . . . . . . . . . . .1867
Childlab . . . . . . . . . . . . . . . . . . . . . . . . . . .3713
China diagnostics Medical
Corporation . . . . . . . . . . . . . . . . . . . . . .1265
Chongqing tianhai Medical
equipment Co. . . . . . . . . . . . . . . . . . . .3146
CHroMsYsteMs gmbH . . . . . . . . . . . .2442
Chungdo pharm. Co. ltd. . . . . . . . . . . .1467
Cis biotech, inc & grace laboratories 1864
Cleveland Clinic reference
laboratory . . . . . . . . . . . . . . . . . . . . . . . .564
Clinical & laboratory standards inst 9008
Clinical diagnostic solutions, inc. . . . .308
Clinical lab products . . . . . . . . . . . . . . .3824
CliniQa Corporation . . . . . . . . . . . . . . . .312
CMef/iVd - China int’l
Med. equip. fair . . . . . . . . . . . . . . . . . .1354
Cola . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3714
College of american pathologists . . .2215
CompHealth . . . . . . . . . . . . . . . . . . . . . . .4012
Comtron Corp. . . . . . . . . . . . . . . . . . . . . . .769
Conductive technologies inc. . . . . . . .2157
Cooper - atkins Corporation . . . . . . . . .132
Copan diagnostics, inc. . . . . . . . . . . . . . .220
Corgenix . . . . . . . . . . . . . . . . . . . . . . . . . . .3529
Coris bioconcept . . . . . . . . . . . . . . . . . . .1224
CorMaY s.a. . . . . . . . . . . . . . . . . . . . . . . .1267
Creative laboratory products inc. . . .4009
Creatv Microtech . . . . . . . . . . . . . . . . . . .4016
Critical diagnostic . . . . . . . . . . . . . . . . . .3931
Crony instruments s.r.l. . . . . . . . . . . . . .1064
Cryo bio systems . . . . . . . . . . . . . . . . . . . .669
Csp technologies, inc. . . . . . . . . . . . . . .4047
Ctd inc. & beijing bio dev. ltd. . . . . . .2368
CtK biotech, inc. . . . . . . . . . . . . . . . . . . . .1263
da’an gene Co., ltd. . . . . . . . . . . . . . .1465
dartmouth Hitchcock
Medical Center . . . . . . . . . . . . . . . . . . .3811
das srl . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1453
data innovations, inc. . . . . . . . . . . . . . . .2009
david g. rhoads associates, inc. . . . . .1030
dawning technologies, inc. . . . . . . . . .3830
denKa seiKen Co., ltd. . . . . . . . . . . . .3207
denline uniforms, inc. . . . . . . . . . . . . .3045
desert biologicals/omega biologicals 202
dexter Magnetic technologies, inc. . .964
dgp group ltd. . . . . . . . . . . . . . . . . . . . .2850
diadexus, inc. . . . . . . . . . . . . . . . . . . . . . .4239
diagam . . . . . . . . . . . . . . . . . . . . . . . . . . . .1226
diagnostic automation /
Cortez diagnostic ................3531
diagnostic Consulting network . . . . .2252
diagnostic laminations engineering 209
diagnostica stago, inc. . . . . . . . . . . . . .3027
dialab g.m.b.H. . . . . . . . . . . . . . . . . . . .1356
diamedix Corporation ..............2521
diametra srl . . . . . . . . . . . . . . . . . . . . . .1668
diaMond Jordan . . . . . . . . . . . . . . . . . . .4148
diasorin . . . . . . . . . . . . . . . . . . . . . . . . . . .2139
diasys diagnostic systems gmbH . . .3417
diatron Messtechnik aMbH . . . . . . . . .1362
diazyme laboratories . . . . . . . . . . . . . .2421
diba industries, inc. . . . . . . . . . . . . . . . .1957
diesse diagnostica senese s.p.a . . .3321
dirui industrial Co., ltd. .............1468
dld diagnostika gmbH . . . . . . . . . . . .1861
dna genotek inc. . . . . . . . . . . . . . . . . . .4049
dna Vision . . . . . . . . . . . . . . . . . . . . . . . . .1228
doCro, inc. . . . . . . . . . . . . . . . . . . . . . . . .1753
double Q lab . . . . . . . . . . . . . . . . . . . . . . .111
double-dove group Co., ltd. . . . . . . .4142
dragon Medical (shanghai) ltd. . . . .3915
drew scientific, inc. . . . . . . . . . . . . . . . . .1930
drg international, inc. ...............945
drucker Company, the . . . . . . . . . . . . . . .200
drummond scientific . . . . . . . . . . . . . . .2625
d-tek . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1230
dXs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2414
dYneX technologies inc. . . . . . . . . . . .3111
e2V biosensors ltd . . . . . . . . . . . . . . . . .2956
eastCoast bio, inc. . . . . . . . . . . . . . . . . . .2063
egemin automation inc. . . . . . . . . . . . . .861
eMd Chemicals, inc. . . . . . . . . . . . . . . . .1953
enV services inc. . . . . . . . . . . . . . . . . . . .2846
epocal inc. . . . . . . . . . . . . . . . . . . . . . . . . . .264
eppendorf north america . . . . . . . . . .1431
eQuiteCH-bio, inc. . . . . . . . . . . . . . . . . .4143
erba diagnostics Mannheim gmbH 2515
ercon inc. . . . . . . . . . . . . . . . . . . . . . . . . . .2949
esa biosciences, inc. . . . . . . . . . . . . . . . .3210
estapor/eMd Chemical . . . . . . . . . . . . .4243
eurogentec na inc. . . . . . . . . . . . . . . . . .4106
euroimmun ag . . . . . . . . . . . . . . . . . . . . .1061
eurotrol . . . . . . . . . . . . . . . . . . . . . . . . . . . .1902
eVergreen sCientifiC . . . . . . . . . . . . .4005
excel scientific, inc. . . . . . . . . . . . . . . . . .1866
express diagnostics inc. int’l . . . . . . . . .110
fapon biotech inc. .................3717
ferrotec (usa) Corporation . . . . . . . . .1868
fertility technology resources, inc. .3715
filtrona fibertec . . . . . . . . . . . . . . . . . . . .1853
fine Care biosystems . . . . . . . . . . . . . . .2946
fisher Healthcare . . . . . . . . . . . . . . . . . . .1911
fluid Metering, inc. . . . . . . . . . . . . . . . . .2049
fluidigm Corporation . . . . . . . . . . . . . . .2052
focus diagnostics . . . . . . . . . . . . . . . . . .2015
foliage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .565
fujirebio diagnostics, inc. . . . . . . . . . . .2727
furuno electric Co., ltd. . . . . . . . . . . . . .2943
g&l precision die Cutting, inc. . . . . . .2315
gale force software Corporation . . . .1958
ge Healthcare . . . . . . . . . . . . . . . . . . . . . .2406
gema Medical, s.l. . . . . . . . . . . . . . . . . . .451
gems sensors & Controls . . . . . . . . . . .2347
genefluidics . . . . . . . . . . . . . . . . . . . . . . . .265
genisphere, inc. . . . . . . . . . . . . . . . . . . . .1765
genius . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1464
gen-probe . . . . . . . . . . . . . . . . . . . . . . . . .3019
genVault Corporation . . . . . . . . . . . . . .1663
genway biotech, inc. . . . . . . . . . . . . . . .2256
genzyme diagnostics . . . . . . . . . . . . . .1231
gerresheimer wilden gmbH . . . . . . . .3411
globe scientific inc. . . . . . . . . . . . . . . . . .100
gMi, inC. . . . . . . . . . . . . . . . . . . . . . . . . . . .2948
gMl . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2356
gold standard diagnostics Corp . . . .4129
golden west biologicals, inc. . . . . . . . . .145
greiner bio-one, inc. . . . . . . . . . . . . . . .3327
grifols diagnostics-
diagnostic division . . . . . . . . . . . . . .4025
Haemoscope Corporation . . . . . . . . . .4022
Hamilton Company . . . . . . . . . . . . . . . . .2043
Handylab, inc. . . . . . . . . . . . . . . . . . . . . .1143
Hanlab Corporation . . . . . . . . . . . . . . . .3906
Hardy diagnostics . . . . . . . . . . . . . . . . . . .128
Harlan bioproducts for science . . . . .1659
Haydon switch & instrument, inc. . . .2053
Health Care logisitics . . . . . . . . . . . . . . .1167
Helena laboratories . . . . . . . . . . . . . . . . .556
Helena laboratories - poC . . . . . . . . . . .457
HelMer . . . . . . . . . . . . . . . . . . . . . . . . . . . . .915
Hemagen diagnostics, inc. . . . . . . . . .3310
HemoCue inc. . . . . . . . . . . . . . . . . . . . . . . .360
Hemosure, inc./wHpM, inc. . . . . . . . . .4031
Himedia laboratories pvt. limited . . .2319
Historx, inc. . . . . . . . . . . . . . . . . . . . . . . . . .969
Hoover precision products, llC . . . . .2154
Horiba abX diagnostics ...........1053
Hra research . . . . . . . . . . . . . . . . . . . . . . .309
Htl - strefa inc. . . . . . . . . . . . . . . . . . . . .4147
Hubit Co., ltd. . . . . . . . . . . . . . . . . . . . . . .1469
Human gmbH . . . . . . . . . . . . . . . . . . . . . .1656
Hytest ltd. . . . . . . . . . . . . . . . . . . . . . . . . .3802
i.C.a. Corporation . . . . . . . . . . . . . . . . . . . .867
ibl - america . . . . . . . . . . . . . . . . . . . . . . . .243
ibl - transatlantic Corp. . . . . . . . . . . . . . .106
idex Health & science . . . . . . . . . . . . . . .1903
ifCC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9001
illumina . . . . . . . . . . . . . . . . . . . . . . . . . . . .2711
ils innovative labor systeme gmbH 864
imageinterpret gmbH . . . . . . . . . . . . . . .865
iMMCo diagnostics . . . . . . . . . . . . . . . .3905
immucor, inc. . . . . . . . . . . . . . . . . . . . . . .2926
immunicon Corporation . . . . . . . . . . . .3807
immuno Concepts . . . . . . . . . . . . . . . . . .3705
immunodiagnostic systems, inc. . . . .2449
iMpaC Medical systems, inc. . . . . . . . . .138
inbios international, inc. . . . . . . . . . . . . .114
ind diagnostic inc. . . . . . . . . . . . . . . . . .1669
indiana pathology images . . . . . . . . . . .218
indicia biotechnology . . . . . . . . . . . . . .2261
2008 ANNUAL MEETING
CliniCal laboratory news JuLy 2008 19
List of Exhibitors

20 CliniCal laboratory news JuLy 2008
infolab international Corporation . . .4041
innovacon inc. . . . . . . . . . . . . . . . . . . . . .4013
inoVa diagnostics, inc. . . . . . . . . . . . . . .551
instru-Med inC . . . . . . . . . . . . . . . . . . .3928
instrumentation laboratory ........2703
intec products, inc. . . . . . . . . . . . . . . . . .2856
integrated dna technologies, inc. . .1857
integrated lab automation
solution, inc. . . . . . . . . . . . . . . . . . . . . .1647
interbiolab, inc. . . . . . . . . . . . . . . . . . .4004
international immuno-diagnostics . .364
international immunology
Corporation . . . . . . . . . . . . . . . . . . . . . .1526
inverness Medical professional . . . . . .2439
invetech . . . . . . . . . . . . . . . . . . . . . . . . . . .1825
invitrogen . . . . . . . . . . . . . . . . . . . . . . . . . .965
iQuum, inc. . . . . . . . . . . . . . . . . . . . . . . . . .1047
iris diagnostics . . . . . . . . . . . . . . . . . . . .2427
i-sens, inc. . . . . . . . . . . . . . . . . . . . . . . . . .1363
isensix, inc. . . . . . . . . . . . . . . . . . . . . . . . . .4226
itC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .531
iVd research, inc. . . . . . . . . . . . . . . . . . . .104
iVd technologies . . . . . . . . . . . . . . . . . . .2264
iVd technology Magazine . . . . . . . . . .1665
iVeK Corporation . . . . . . . . . . . . . . . . . . .2416
iwaki america inc. . . . . . . . . . . . . . . . . . .1964
Jackson immunoresearch
laboratories, inc . . . . . . . . . . . . . . . . .2061
JaJ international . . . . . . . . . . . . . . . . . . .4039
Japan association . . . . . . . . . . . . . . . . . .9005
Jas diagnostics, inc. . . . . . . . . . . . . . . . .226
JCaHo . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1944
Jiangsu Kangjian Medical
apparatus Co. . . . . . . . . . . . . . . . . . . .2955
Jsr Corporation . . . . . . . . . . . . . . . . . . . .2854
Kaiser permanente . . . . . . . . . . . . . . . . .2751
Kalorama information . . . . . . . . . . . . . .3816
Kamiya biomedical Company . . . . . . .1839
Kem-en-tec diagnostics . . . . . . . . . . . . .346
KiKKoMan Corporation . . . . . . . . . . .212
Kinematic automation inc. . . . . . . . . . .851
KMC systems, inc. . . . . . . . . . . . . . . . . . . .909
Knf neuberger inc. ................3828
Kpl, inc. . . . . . . . . . . . . . . . . . . . . . . . . . . . .2266
Kronus, inc. . . . . . . . . . . . . . . . . . . . . . . .3231
lab Medica . . . . . . . . . . . . . . . . . . . . . . . .9004
labconco Corporation . . . . . . . . . . . . . .4117
labCorp-esoterix . . . . . . . . . . . . . . . . . . .1153
labitec gmbH, germany . . . . . . . . . . . .1458
labnovation technologies, inc . . . . . . .121
labtest . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1352
lampire biological laboratories . . . . .3211
lasX-precision Medical
Converting group . . . . . . . . . . . . . . . .147
lathrop engineering . . . . . . . . . . . . . . .1010
lattice inc. . . . . . . . . . . . . . . . . . . . . . . . . . .143
lee Company, the . . . . . . . . . . . . . . . . . .2747
lendell Manufacturing inc. . . . . . . . . . .141
lifepoint informatics . . . . . . . . . . . . . . .3806
lifescan inc. . . . . . . . . . . . . . . . . . . . . . . .1539
lifesign llC . . . . . . . . . . . . . . . . . . . . . . . . .266
lighthouse recruiting . . . . . . . . . . . . . . .153
liofilchem s.r.l. . . . . . . . . . . . . . . . . . . .1561
liposcience, inc. . . . . . . . . . . . . . . . . . . .1947
lre Medical, an esterline Company 2909
lucigen Corporation . . . . . . . . . . . . . . .2066
luminex Corporation . . . . . . . . . . . . . . . .525
lw scientific . . . . . . . . . . . . . . . . . . . . . . .4245
lydall . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3810
m.u.t gmbH ........................3303
Mack information systems . . . . . . . . . . .866
Magellan biosciences, inc./
dynex tech. . . . . . . . . . . . . . . . . . . . . .3115
Magna bio sciences . . . . . . . . . . . . . . . . .305
Magnasense ltd. . . . . . . . . . . . . . . . . . . . .167
Magnisense . . . . . . . . . . . . . . . . . . . . . . . .1353
MagQu Co. . . . . . . . . . . . . . . . . . . . . . . . . .2855
Magsense life sciences, inc. . . . . . . . .3044
Magsphere inc. . . . . . . . . . . . . . . . . . . . . .1763
Maine biotechnology services, inc. . .1429
Maine standards Company . . . . . . . . .4242
Man & Machine, inc. . . . . . . . . . . . . . . . . .125
Mayo Medical laboratories . . . . . . . . .2627
McKesson ..........................2343
Mechatronics . . . . . . . . . . . . . . . . . . . . . .1443
Med travelers . . . . . . . . . . . . . . . . . . . . . .3814
Medcompare . . . . . . . . . . . . . . . . . . . . . .3933
Medica 2007/ Messe duesseldorf . . .2060
Medica Corporation . . . . . . . . . . . . . . . .2307
Medical automation systems . . . . . . . .467
Medical Courier elite . . . . . . . . . . . . . . .2069
Medical device Consultants, inc. . . . . .342
Medical device safety service gmbH 3932
Medical electronic systems, llC . . . .4113
Medical laboratory evaluation(Mle) .2810
Medical staffing network inc. . . . . . .4119
Medicon Hellas s a . . . . . . . . . . . . . . . . .1654
Medifleet . . . . . . . . . . . . . . . . . . . . . . . . . .4246
Medivative . . . . . . . . . . . . . . . . . . . . . . . . .4024
Medix biochemica . . . . . . . . . . . . . . . . . .3817
MedtoX laboratories, inc. . . . . . . . . . . .316
Medtronic, inc. . . . . . . . . . . . . . . . . . . . . . .461
Melet schloesing laboratories . . . . . . .122
Mercodia inc. . . . . . . . . . . . . . . . . . . . . . .2950
Meridian life science, inc. . . . . . . . . . . .146
Merlin labs, inc. ....................3818
Metro Mold & design, inc. . . . . . . . . . .1764
MgM instruments, inc. . . . . . . . . . . . . . .3229
Michigan diagnostics, llC . . . . . . . . . . .108
MiCrolit . . . . . . . . . . . . . . . . . . . . . . . . . .1366
Microscan systems, inc. . . . . . . . . . . . . . .562
Microsens iseao . . . . . . . . . . . . . . . . . . . .3042
Midland bioproducts Corp . . . . . . . . . .2718
Millenia diagnostics, inc. . . . . . . . . . . . . .144
Millipore Corporation . . . . . . . . . . . . . . . .415
Minifab . . . . . . . . . . . . . . . . . . . . . . . . . . . .4144
Minigrip . . . . . . . . . . . . . . . . . . . . . . . . . . .4230
Minitubes . . . . . . . . . . . . . . . . . . . . . . . . . .1652
MiraVista diagnostics/ssi products . .2848
Mitsubishi Chemical Medience
Corporation . . . . . . . . . . . . . . . . . . . . . .2446
Mlo-Medical laboratory observer 3913
MnX - Midnite express
global logistics . . . . . . . . . . . . . . . . . .4014
Monobind inc. . . . . . . . . . . . . . . . . . . . . .4216
Moss, inc. . . . . . . . . . . . . . . . . . . . . . . . . . .2724
Motoman inc. . . . . . . . . . . . . . . . . . . . . . .1161
Mp biomedicals . . . . . . . . . . . . . . . . . . . .4208
Mt promedt Consulting gmbH .....1369
Multisorb technologies, inc. . . . . . . . .3611
nano-ditech Corporation . . . . . . . . . . .2167
nanoentek . . . . . . . . . . . . . . . . . . . . . . . . .1067
nanogen, inc. . . . . . . . . . . . . . . . . . . . . . .1547
nanosphere, inc. . . . . . . . . . . . . . . . . . . .3324
national Jewish Medical &
research Ctr. . . . . . . . . . . . . . . . . . . . . .216
national registry of
Certified Chemists . . . . . . . . . . . . . . .3629
neogen Corporation . . . . . . . . . . . . . . . .1261
new england small tube . . . . . . . . . . .2258
niCHirei biosCienCes, inC. . . . . . . . .1360
nikon instruments inc. . . . . . . . . . . . . .3825
nist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4028
nof Corporation ................4146
norgren inc. . . . . . . . . . . . . . . . . . . . . . . . .931
nor-lake scientific . . . . . . . . . . . . . . . . .2348
nova biomedical . . . . . . . . . . . . . . . . . . .1927
noVo 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . .1809
novx systems inc. ..................3924
nte, s.a. . . . . . . . . . . . . . . . . . . . . . . . . . . . .553
nuaire inc. . . . . . . . . . . . . . . . . . . . . . . . . . .939
olympus america, inc. . . . . . . . . . . . . . . .225
omega diagnostics group plC . . . . .1462
operon s.a. . . . . . . . . . . . . . . . . . . . . . . . .460
opti Medical system
(formely osmetech) . . . . . . . . . . . . . . .363
opus Healthcare solutions . . . . . . . . . . .566
orasure technologies, inc. . . . . . . . . . . .269
orchard software Corp . . . . . . . . . . . . .3513
orphee s.a. . . . . . . . . . . . . . . . . . . . . . . . .1255
ortho-Clinical diagnostics . . . . . . . . . .1525
osi optoelectronics . . . . . . . . . . . . . . . .1766
osmetech Molecular diagnostics . . .1002
owen Mumford inc. . . . . . . . . . . . . . . . . .165
oxonica inc. . . . . . . . . . . . . . . . . . . . . . . . .3909
oyster bay pump works, inc. . . . . . . . . .250
pall life sciences . . . . . . . . . . . . . . . . . . .1752
panacea pharmaceuticals, inc. . . . . . . .127
paragondx . . . . . . . . . . . . . . . . . . . . . . . . .3729
parker Hannifin/pneutronics . . . . . . . .1968
parter Medical products, inc. . . . . . . . . .124
pathology outlines.com, inc. . . . . . . . . .767
pbM-princeton bioMeditech
Corporation . . . . . . . . . . . . . . . . . . . . . .222
peaK-service usa . . . . . . . . . . . . . . . . . . .913
peripheral resources inc. . . . . . . . . . . . .116
perkinelmer life & analytical
sciences . . . . . . . . . . . . . . . . . . . . . . . . . .953
perlong Medical equipment
Co., ltd. . . . . . . . . . . . . . . . . . . . . . . . . . .3054
phadia (pharmacia diagnostics) . . . . .1331
pharmigene, inc. . . . . . . . . . . . . . . . . . . .4150
philosys ............................1367
phoenix diagnostics inc. . . . . . . . . . . . .4224
pointe scientific, inc. . . . . . . . . . . . . . . . .2726
polymedco, inc. . . . . . . . . . . . . . . . . . . . .3314
polYMiCrospHeres . . . . . . . . . . . . . . .1761
precision systems inc. . . . . . . . . . . . . . .1542
prodesse, inc. . . . . . . . . . . . . . . . . . . . . . . .131
proliant Health and biologicals . . . . . . .151
promega Corporation . . . . . . . . . . . . . . . .663
propper Mfg. Co., inc. . . . . . . . . . . . . . .3711
psyche systems Corporation . . . . . . . . .561
puritan Medical products Company . .129
pVt labsystems . . . . . . . . . . . . . . . . . . . .3423
Qarad . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1666
Qosina/Qosmedix . . . . . . . . . . . . . . . . . .2064
Quad five . . . . . . . . . . . . . . . . . . . . . . . . . . .105
Quality assured services, inc. . . . . . . .4127
Quantimetrix Corporation . . . . . . . . . .2631
Quantum analytics . . . . . . . . . . . . . . . . . .862
Quest diagnostics . . . . . . . . . . . . . . . . . .1917
Quidel Corporation . . . . . . . . . . . . . . . . .3105
Quimica Clinica aplicada, s.a. . . . . . . .449
r&d systems, inc. ..................1016
r2 diagnostics . . . . . . . . . . . . . . . . . . . . .1906
radim spa . . . . . . . . . . . . . . . . . . . . . . . . .1560
radiometer america inc. . . . . . . . . . . .1939
ral, s.a. ............................352
randox laboratories ltd . . . . . . . . . . .1407
rayto life & analytical
sciences Co, ltd . . . . . . . . . . . . . . . . . . .242
r-biopharm ag . . . . . . . . . . . . . . . . . . . . .3510
rd plastics Company . . . . . . . . . . . . . . .2065
rees scientific Corporation . . . . . . . . .3925
research organics, inc. . . . . . . . . . . . . .1961
response biomedical Corp . . . . . . . . . . .369
rna Medical . . . . . . . . . . . . . . . . . . . . . . . .468
rnd group, inc., the . . . . . . . . . . . . . . . . .139
roche . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1007
roche diagnostics - point of Care . . .1223
rocky Mountain diagnostics . . . . . . . .2847
rotek industries . . . . . . . . . . . . . . . . . . . .3709
rtemd-real time enterprises . . . . . . .2257
sa scientific ltd . . . . . . . . . . . . . . . . . . . .2360
safe-tec Clinical products, inc. . . . . . .2068
saf-t-paK . . . . . . . . . . . . . . . . . . . . . . . . .4248
sajar plastics inc. . . . . . . . . . . . . . . . . . . .1657
saladax biomedical, inc. . . . . . . . . . . . .4232
salimetrics, llC . . . . . . . . . . . . . . . . . . . . .117
sarstedt, inc. . . . . . . . . . . . . . . . . . . . . . . .2606
sartorius stedim biotech . . . . . . . . . . .2352
scantibodies laboratory inc. . . . . . . .1831
sCC soft Computer . . . . . . . . . . . . . . . . .2915
sCeti K.K. . . . . . . . . . . . . . . . . . . . . . . . . .1566
scigene . . . . . . . . . . . . . . . . . . . . . . . . . . . . .766
sCiMedX Corporation . . . . . . . . . . . . . .2410
sCipaC ltd. . . . . . . . . . . . . . . . . . . . . . . . .1425
scripps laboratories . . . . . . . . . . . . . . .2149
sdi biomed, inc. . . . . . . . . . . . . . . . . . . . .1066
sebia electrophoresis . . . . . . . . . . . . . . .3309
seegene, inc. . . . . . . . . . . . . . . . . . . . . . . . .213
sekisui Medical Co., ltd . . . . . . . . . . . . .3055
select science . . . . . . . . . . . . . . . . . . . . .3144
sensor electronic technology, inc. .2260
sentinel CH spa . . . . . . . . . . . . . . . . . .3722
sepmag tecnologies . . . . . . . . . . . . . . . .452
seraCare life sciences . . . . . . . . . . . . . .2714
serion immundiagnostica gmbH . . .3617
shanghai Kehua
bioengineering Co., ltd. . . . . . . . . . .1762
shanghai fosun Med-tech
development .....................103
shanghai ZJ bio-tech Co., ltd. . . . . . .1660
shenzhen Mindray . . . . . . . . . . . . . . . . . .825
sias ag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .667
siemens Healthcare diagnostics . . . . .507
siemens water technologies . . . . . . . .1447
sifin gmbH . . . . . . . . . . . . . . . . . . . . . . . . .1552
simport plastics ltd . . . . . . . . . . . . . . . . .3723
sinnowa Medical science
& technology Co. . . . . . . . . . . . . . . . .1568
sKC Co., ltd.(brand: inCYto) . . . . . . . .4019
slr research . . . . . . . . . . . . . . . . . . . . . . .2056
sMC Corporation . . . . . . . . . . . . . . . . . . .2413
snibe - shenzhen new industries . . .1559
softtech Health . . . . . . . . . . . . . . . . . . . .3917
source scientific, llC . . . . . . . . . . . . . . .2265
southern biotech . . . . . . . . . . . . . . . . . . .1758
span diagnostics limited . . . . . . . . . . . .157
spherotech inc. . . . . . . . . . . . . . . . . . . . .2169
spinreact, s.a. . . . . . . . . . . . . . . . . . . . . . . .450
stanbio laboratory . . . . . . . . . . . . . . . . .2615
standard diagnostics, inc. . . . . . . . . . .3328
strateC biomedical systems ag . . . . .660
strategic diagnostics inc. . . . . . . . . . . .2163
streck . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1938
sud-Chemie performance packaging 1253
super brush llC . . . . . . . . . . . . . . . . . . . .2362
surModics, inc. . . . . . . . . . . . . . . . . . . . . . .246
swisslog . . . . . . . . . . . . . . . . . . . . . . . . . . .3930
synermed select partners, inc. . . . . . .3827
syntron bioresearch, inc. . . . . . . . . . . . .1967
sysmex . . . . . . . . . . . . . . . . . . . . . . . . . . . . .639
taidoc technology Corporation . . . . .3507
taigen bioscience Corporation . . . . . . .567
tecan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .405
technidata /Medisolution . . . . . . . . . .3306
techno Medica Co. ltd. . . . . . . . . . . . . . .763
teco diagnostics . . . . . . . . . . . . . . . . . . .3624
tekra Corporation . . . . . . . . . . . . . . . . . . .256
telCor, inc. . . . . . . . . . . . . . . . . . . . . . . . . .166
tetracore, inc. . . . . . . . . . . . . . . . . . . . . . . .262
therapak Corporation . . . . . . . . . . . . . .3719
thermo scientific . . . . . . . . . . . . . . . . . .2739
thin XXs Microtechnology ag . . . . . .2165
third wave technologies . . . . . . . . . . . .404
toKYo boeKi MaCHinerY ltd. . . . .1006
tosoh bioscience, inc. . . . . . . . . . . . . . .2403
toyobo Co., ltd.
c/o shinko american inc. . . . . . . . . .3813
trek diagnostics systems, inc. . . . . . .3214
trina bioreaCtiVes ag . . . . . . . . . . .3525
trinity biotech . . . . . . . . . . . . . . . . . . . . .2105
ttp labtech . . . . . . . . . . . . . . . . . . . . . . . .1946
tyson bioresearch, inc. . . . . . . . . . . . . .1567
uC san francisco Medical Center . . . .966
uniCo . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2166
united biotech, inc. . . . . . . . . . . . . . . . .2269
university of Virginia Health systems 2450
urit Medical electronic Co., ltd . . . . . .3710
utaK laboratories, inc. . . . . . . . . . . . . .1544
ValuMax international . . . . . . . . . . . . . .1829
Vedalab . . . . . . . . . . . . . . . . . . . . . . . . . .1865
ViraCor laboratories . . . . . . . . . . . . . . . .666
Vircell s.l. . . . . . . . . . . . . . . . . . . . . . . . . . . .351
Virostat, inc. . . . . . . . . . . . . . . . . . . . . . . . .149
Visgeneer inc. . . . . . . . . . . . . . . . . . . . . . .1569
Vista technology inc. . . . . . . . . . . . . . . . .568
Vistalab technologies, inc. . . . . . . . . .2248
Vital diagnostics . . . . . . . . . . . . . . . . . . .3403
Vonco products . . . . . . . . . . . . . . . . . . . . .119
Vr2M . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1361
Vwr international . . . . . . . . . . . . . . . . . .1956
w.b. saunders/Mosby . . . . . . . . . . . . . .2811
wako diagnostics . . . . . . . . . . . . . . . . . .1530
warde Medical laboratory . . . . . . . . . . .962
waters Corporation . . . . . . . . . . . . . . . . .3820
web industries inc. . . . . . . . . . . . . . . . . .2263
welch allyn, inc. . . . . . . . . . . . . . . . . . . . .4228
wescor, inc. . . . . . . . . . . . . . . . . . . . . . . . .3005
westgard QC, inc. . . . . . . . . . . . . . . . . . .1445
whatman inc. . . . . . . . . . . . . . . . . . . . . . .3225
wheaton science packaging . . . . . . . .1952
wiener laboratorios saiC . . . . . . . . . .1452
wisepac active packaging
Components Co. . . . . . . . . . . . . . . . . .3047
wondfo biotech Co., ltd. . . . . . . . . . . .1962
worthington biochemical
Corporation . . . . . . . . . . . . . . . . . . . . . .2161
wslH proficiency testing . . . . . . . . . . .2452
Xceed Molecular . . . . . . . . . . . . . . . . . . .2155
Xema-Medica Co., ltd. . . . . . . . . . . . . . .1564
Xiril . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3623
Yd diagnostics . . . . . . . . . . . . . . . . . . . . .3630
Yuhan nHs . . . . . . . . . . . . . . . . . . . . . . . . .1565
Zebra technologies . . . . . . . . . . . . . . . .4111
Zentech . . . . . . . . . . . . . . . . . . . . . . . . . . . .1232
ZeptoMetrix Corporation ...........2259
Zeta Corporation . . . . . . . . . . . . . . . . . . .1924
ZheJiang gongdong Medical plastic fac-
tor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .217
ZheJiang u-real Medical tech. Co., ltd. 107
as of June 6, 2008

2008 NEw Pr o d u c t rEv i Ew special section
Advertisement
Emerging Assays Product Line
Thermo Fisher Scientific—Clinical Diagnostics
is pleased to introduce the Emerging
Assays product line. Eliminate the flame and
consolidate your workstations with the Infinity
Lithium assay. Increase the sensitivity
of results and eliminate hazardous shipping
requirements with the Enzymatic Creatinine
and the erCRP assays. When patients are in
crisis provide the best turnaround time and
results to emergency room physicians with
the Infinity ACE and PGB assays. Need a better
and faster way to analyze kidney stones?
Try our Oxalate kit. Reagent applications
are available for most chemistry analyzers;
contact our Clinical Chemistry Technical
Support Department at 1-800-528-0494,
Option 2.
Thermo Fisher Scientific
—Clinical Diagnostics
Circle No. 331 in the Reader Service Card
AVOXimeter® POC Analyzer
The AVOXimeter 1000E and 4000 are
portable, easy-to-use analyzers that provide
rapid, accurate assessment of a patient’s true
oxygenation status at the bedside. Testing is
performed in single-use,disposable cuvettes.
No sample preparation is required; simply
inject a whole blood sample into the
cuvette and insert into the analyzer. Results
are displayed and recorded in less than 10
seconds, improving efficiencies and allowing
for timely diagnosis and intervention. The
AVOXimeter 4000 measures oxyhemoglobin,
carboxyhemoglobin, methemoglobin, total
hemoglobin, and oxygen content and is used
in the respiratory department, ICU, OR,
NICU, and ED. The AVOXimeter 1000E is
specifically designed for the cardiac cath lab
and provides a measured oxygen saturation,
oxygen content, and total hemoglobin
concentration.
ITC
Circle No. 332 in the Reader Service Card
IRMA TRUpoint® Lactate,
Creatinine MDRD-GFR
ITC announces a new assay to measure
lactate concentration in blood at the patient
bedside. The IRMA TRUpoint also now offers
software that calculates the modification
of diet in renal disease glomerular filtration
rate (MDRD GFR) with every creatinine
test result. The new software program takes
the IRMA TRUpoint creatinine result and
applies the NKDEP formula factoring the
patient’s age, race, and sex to assess overall
kidney function. These recent additions
further enhance IRMA TRUpoint’s value for
rapid, accurate POC testing in emergency
and critical care situations where immediate
results can make a difference in treatment
decisions.
ITC
Circle No. 333 in the Reader Service Card
Seradyn Fluoro-Max Fluorescent Particles
Thermo Scientific’s Seradyn Fluoro-Max
Fluorescent particles are monodisperse
particles prepared by unique and proprie-
tary emulsion polymerization methods.
Available in both carboxylate-modified and
streptavidin-coated versions, Fluoro-Max
Fluorescent particles are made by dyeing
OptiLink Carboxylate-Modified particles
with europium chelate and are available in
standard 0.1-μM, 0.2-μM, and 0.3-μM diameters.
They are dyed internally to prevent
dye leaching and to assure maximum surface
immunoreactivity. These particles are excellent
for quantitative membrane-based rapid
assays, heterogeneous assays, luminescent
assays, research applications, phagocytosis
studies, cell surface markers, and pore size
determination.
Thermo Scientific, Seradyn Products
Circle No. 334 in the Reader Service Card
INFINITI 5-Fluorouracil Assay
The chemotherapeutic agent 5-fluorouracil
(5-FU) is a broad-spectrum drug used
in treatment of colorectal, gastric, pancreatic,
head, neck, breast, ovarian, and cervical cancers.
Many patients are genetically predisposed
to adverse reactions to 5-FU.
Dihydropyrimidine dehydrogenase (DPD)
is responsible for more than 80% of the
drug metabolism, and its polymorphisms
are a potential cause of 5-FU chemotoxicity.
Thymidine synthase (TS) is the target
for 5-FU and may have a prognostic role in
therapy outcome. The INFINITI 5-FU assay,
automated on the Load N Go INFINITI
Analyzer, provides comprehensive analysis
of DPD, MTHFR and TS genetic variants
to predict and to help prevent 5-FU-related
adverse events.
AutoGenomics
Circle No. 335 in the Reader Service Card
INFINITI HPV QUAD Assay*
The INFINITI HPV QUAD assay simultaneously
detects 15 HPV types in a single
patient sample (16, 18, 31, 33, 35, 45, 68, 39,
56, 58, 52, 59, 51, 6, and 11) and processes
four patient samples on one BioFilmChip
Microarray. HPV types 16, 18, 33, 45 and 59
have been associated with greater risk for developing
both squamous and adenocarcinoma
cervical cancers. With a turnaround time
of 5.5 hours, 24 samples can be processed
automatically with Load N Go workflow
efficiency on the INFINITI Analyzer. *For
research use only.
AutoGenomics
Circle No. 336 in the Reader Service Card
AU3000i® Luteinizing Hormone Assay
The 28-minute, two-step, paramagnetic particle
Olympus AU3000i LH assay determines
quantitative concentrations of luteinizing
hormone using 25 μL of human serum or
lithium-hepari plasma. The measuring
range is approximately 0.20–180 mIU/mL,
and the expected working imprecision is ≤
5% (total CV). Reagents are ready to use.
Onboard reagent and open control vial
stability are 28 days. Calibration frequency is
14 days.
Olympus America Inc.
Circle No. 337 in the Reader Service Card
AU3000i® Follicle Stimulating
Hormone Assay
The 28-minute, two-step, paramagnetic
particle Olympus AU3000i FSH assay determines
quantitative concentrations of follicle
stimulating hormone using 25 μL of human
serum or lithium-heparin plasma. The
measuring range is approximately 0.20–180
mIU/mL and the expected work-
ing imprecision is ≤ 5% (total CV). Reagents
are ready to use. Onboard reagent, open control
vial stability, and calibration frequency
are all 28 days.
Olympus America Inc.
Circle No. 338 in the Reader Service Card
AU3000i® TSH Assay
4th-Generation Functional Sensitivity
The 28-minute, two-step, paramagnetic
particle Olympus AU3000i TSH assay quantifies
concentrations of TSH using 100 μL of
human serum, lithium-heparin plasma, or
EDTA plasma. The measuring range is approximately
0.001–130 μIU/mL. Achieving
4th-generation functional sensitivity, the calculated
functional sensitivity on an Olympus
AU3000i system is 0.0013 mIU/L. Reagents
are ready to use. Onboard reagent stability,
open control vial stability, and calibration
frequency are all 28 days.
Olympus America Inc.
Circle No. 339 in the Reader Service Card
AU3000i® Progesterone Assay
The 28-minute, competitive, paramagnetic
particle Olympus AU3000i Progesterone
assay determines quantitative concentrations
of progesterone using 10 μL of human serum
or lithium-heparin plasma. The measuring
range is approximately 0.1–55 ng/mL, and
the expected working imprecision is ≤ 10%
(total CV). All reagents are ready to use.
Onboard reagent stability, open control vial
stability, and calibration frequency are all 28
days.
Olympus America Inc.
Circle No. 340 in the Reader Service Card
AU3000i® Thyroid Panel
The Olympus TSH assay has a measurable
range of 0.001–130 mIU/mL and a functional
sensitivity of 0.0013 mIU/mL. The
T-uptake assay measures the saturation of
thyroid hormone binding capacities in a
patient specimen. When used with an Olympus
Total T4 determination, the FTI can be
calculated. Reagents are ready to use with
28-day stability for onboard. The calibration
frequency is 28 days.
Olympus America Inc.
Circle No. 341 in the Reader Service Card
AU3000i® Prolactin Assay
The 28-minute, two-step, paramagnetic
particle Olympus AU3000i Prolactin assay
determines quantitative concentrations of
prolactin using 50 μL of human serum or
lithium-heparin plasma. The measuring
range is approximately 0.05–300 μg/L, and
the expected working imprecision is ≤ 7%
(total CV). All reagents are ready to use.
CliniCal laboratory news JuLy 2008 23

special section
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Onboard reagent stability, open control vial
stability, and calibration frequency are all 28
days.
Olympus America Inc.
Circle No. 342 in the Reader Service Card
AU3000i® T-Uptake Assay
The 28-minute, one-step competitive,
paramagnetic particle Olympus AU3000i
T-Uptake assay quantifies the thyroxine
binding capacity of serum or lithium-
heparin plasma. The sample volume requirement
is 15 μL. The Olympus T-Uptake
results should be used with an Olympus
Total T4 determination to calculate the FTI.
Reagents are ready-to-use. Onboard reagent,
open control vial stability, and calibration
frequency are all 28 days.
Olympus America Inc.
Circle No. 343 in the Reader Service Card
AU3000i® Total ß-hCG Assay*
The 28-minute, two-step, paramagnetic particle
Olympus AU3000i Total ß-hCG assay
determines quantitative concentrations of
total ß-hCG using 50 μL of human serum
or lithium-heparin plasma. The measuring
range is approximately 0.05–1000 mIU/L
and the expected working imprecision is ≤
6% (total CV). Reagents are ready to use.
Onboard reagent stability, open control vial
stability, and calibration frequency are all 28
days. *Pending FDA clearance.
Olympus America Inc.
Circle No. 344 in the Reader Service Card
Track-based Automation System
Olympus America Inc. announces a
non-exclusive distribution agreement
with Thermo Fisher Scientific/Clinical
Diagnostics Finland for its TCAutomation
laboratory automation offering. The new
product offering will complement existing
Olympus Lab Automation products.
Customers will be able to create best-ofbreed
comprehensive solutions incorporating
Olympus AU®-series clinical chemistry
and immunoassay analyzers, including
various third-party analyzers. The open,
track-based system will offer medium-sized
to large hospital and regional laboratories
unprecedented flexibility and access to
additional test capabilities. It will also allow
customers to consolidate and automate such
sample processing procedures as decapping,
centrifugation, aliquoting, recapping, and
storage/retrieval.
Olympus America Inc.
Circle No. 345 in the Reader Service Card
26 CliniCal laboratory news JuLy 2008
2008 NEw Pr o d u c t rE v i E w
DSX® Reagent Barcode Scanning System
Save time, effort, and reduce reagent identification
error rates with Dynex Technologies’
new Reagent Barcode Scanning capability
for the DSX microplate processing system
(including software upgrade). We’ve worked
closely with our OEM solutions partners to
develop custom reagent racks for the kits
they’ve integrated with the DSX. No need to
decant reagents into other bottles; the hardware/software
package scans the kit-bottle
barcode information and automatically
incorporates it into the kit assay protocol and
report. Easy. Accurate. Automatic. And more
cost-effective!
Dynex Technologies
Circle No. 347 in the Reader Service Card
Design & Engineering Services
Introducing Dynex Technologies’ latest
business offering—design and engineering
services for collaborative product develop-
ment. We’re experts in microplate automation
for clinical diagnostics and biotechnology—
from robotic handling and fluid
pipetting and dispensing, to incubation,
detection, and washing. And we know how
to take a product from initial concept to
market-leading position. Is your unique and
proprietary assay ready for market, except a
dedicated system to run it on? Work with the
designers and engineers behind the technology
of the celebrated Dynex DSX® and DS2®
automated microplate processing systems—
we’ll help you develop custom components,
or a complete system, that’s ideal for your
application.
Dynex Technologies
Circle No. 348 in the Reader Service Card
DSX® for Bead-Based Assays
Has your lab expanded beyond ELISA to
the latest bead-based multiplexed assays?
Improve results over manual microplate
methods with the fully automated Dynex
DSX microplate processing system. You’ve
seen the benefits of DSX automation on
ELISA. Now, Dynex Technologies’ economical
dual-mode washer module expands the
capabilities of the market-leading DSX. Run
up to four microplates, each with traditional
ELISA assays using solid-bottom plates—
or bead-based assays using filter plates—
simultaneously and in any combination! For
bead-based assays, an adjustable vacuum
manifold provides optimal bottom aspiration
of a variety of plate designs and filter
pore sizes to assure critical levels of accuracy,
reproducibility, and throughput.
Dynex Technologies, Inc.
Circle No. 349 in the Reader Service Card
Deep-Well No-Waste DSX® Strips
The DSX automated ELISA processing
system from Dynex Technologies uses deep
wells for sample dilution, previously available
only in deep-well blocks of 96 (12 x 8)
wells—until now. Introducing Dynex’s
Deep-Well No-Waste Strips (with holder).
These economical deep-well strips, comprising
eight wells each, eliminate waste
from discarding and increase security from
rotating partially used deep-well blocks. If
your ELISA assay doesn’t use all 96 wells of
our deep-well block, choose deep-well strips
instead. You’ll save significantly on your
consumable costs by loading only what you
need for your assay run!
Dynex Technologies, Inc.
Circle No. 350 in the Reader Service Card
FREND Immunoassay Analyzer
This new-generation, FREND LOC-based
immunoassay analyzer was developed with
a new philosophy and technology. Sample
volume is just 10 μL with a 5-minute time to
result. This product is a total solution for
labs and represents one of the leading
near-patient testing instruments. Our first
combination panel will be very valuable for
ACS and AMI patients (CK-MB, troponin I,
and myoglobin). Research and development
will be continued for NT-pro BNP, D-dimer,
DOA, and others.
NanoEnTek Incorporated
Circle No. 352 in the Reader Service Card
FREND Cardiac Panel
Our first combination panel will be very
valuable for ACS and AMI patients. The
FREND Cardiac Panel includes CK-MB,
troponin I, and myoglobin. The panels runs
on the new generation, FREND LOC-based
immunoassay analyzer. Developed with a
new philosophy and technology, the analyzer
uses just a10-μl sample volume, and the time
to result is 5 minutes. This product is a total
solution for near-patient testing. Research
and development will be continued for NTpro
BNP, D-dimer, DOA and others.
NanoEnTek Incorporated
Circle No. 351 in the Reader Service Card
StatSpin® Centrifuge
Laboratories are going lean with single-piece
flow. Instead of batching samples and
loading them into conventional slow
centrifuges, labs can now process gel tubes
quickly with this new high-speed, horizontal
centrifuge. It spins eight samples in 3 minutes,
providing clean separation with a flat
gel barrier. Samples can be put directly on
the analyzer. It has a powerful, maintenancefree,
brushless motor, and the entire unit is
backed with a 2-year warranty. This highspeed,
horizontal centrifuge is the answer
to productivity and turnaround time in the
chemistry lab.
IRIS Sample Processing
Circle No. 353 in the Reader Service Card
Bedside Glucose and Creatinine Monitors
Nova StatStrip Glucose and StatSensor
Creatinine monitors are two new handheld,
whole-blood meters for POCT. StatStrip
Glucose test strips feature new Multi-Well
measuring technology that creates a new
class of analytical performance comparable
to central laboratory testing. The StatStrip
Glucose monitor measures and eliminates
interferences from hematocrit, maltose, oxygen,
acetaminophen, ascorbic acid, and uric
acid, while the StatSensor monitor measures
creatinine in whole blood in just 30 seconds
and calculates eGFR by MDRD or Cockroft-
Gault equations. The StatSensor Creatinine
monitor’s small 1.2-μL sample volume allows
easy and virtually painless sample acquisition
from a finger prick.
NOVA BIOMEDICAL
Circle No. 354 in the Reader Service Card
ELISA Microplate Processor
The ESP600 instrument offers the
laboratory a new, powerful level of ELISA

2008 NEw Pr o d u c t rEv i Ew special section
Advertisement
microplate processing with four probes and
an independent gripper arm that delivers fast
pipetting. In roughly the same footprint as
a standard four-plate microplate system,
the ESP600 analyzer can process in a single
run what four-plate systems often take two
runs to complete. Eliminating syringes and
disposable tips saves the laboratory thousands
of dollars a year in operating costs.
Combined with The Binding Site’s extensive
menu and open system support, the ESP600
offers the mid- to high-volume laboratory
a fast, flexible, efficient, and cost-effective
ELISA processor.
The Binding Site Inc.
Circle No.355 in the Reader Service Card
ACL TOP® 500 CTS Hemostasis Testing System
The new ACL TOP 500 CTS Hemostasis
Testing System is a bench-top, fully automated,
random-access analyzer designed
specifically for clinical hemostasis laboratories.
Used for coagulation and/or fibrinolysis
testing in the assessment of thrombosis
and/or hemostasis, this newest member of
the ACL TOP family combines the same
speed, simplicity, and intelligence as all
ACL TOP coagulation analyzers, delivering
testing-process automation in a more compact
design. In addition to routine hemostasis
analysis, the ACL TOP family, combined
with IL’s extensive offering of reagents, make
highly-specialized assays as easy as routine
assays. All ACL TOP analyzers have the same
user interface, intuitive software, reagents,
and provide the same results.
Instrumentation Laboratory
Circle No. 356 in the Reader Service Card
GEM® Premier 4000
Critical Care Analyzer
The GEM Premier 4000 is a revolutionary
analyzer with integrated CO-oximetry
that quickly provides consistent, accurate,
lab-quality results throughout your hospital,
including BG, electrolytes, metabolites, Glu,
Lac, Hct, tHb, O2Hb, COHb, HHb, MetHb,
sO2, BUN*, Creat*, Total Bili*, and HCO3-*.
Easy-to-use, touch-screen displays make it
simple to select and customize parameters,
while self-contained, maintenance-free
cartridges incorporate all components for
patient testing. The iQM® system automates
QC and continuously detects, corrects, and
documents to assure quality results and compliance
24/7, regardless of operator or testing
location. GEMweb® Plus software enables
remote access to any networked analyzer for
real-time status updates and supervision of
remote locations. *In development.
Instrumentation Laboratory
Circle No. 357 in the Reader Service Card
Stat Fax®4500 Chemistry Analyzer
The new Stat Fax 4500 is an economical
chemistry analyzer with the same high-qual-
ity, six-filter optical system used in the Stat
Fax 1904 model, with updated electronics
and a large, touch-screen user interface. This
versatile open system features calculations
using factor, single calibrator, or multiple
calibrators for kinetic and endpoint assays. It
prints results on the internal thermal printer
or outputs results to a PC to create customformatted
reports.
Awareness Technology, Inc.
Circle No. 358 in the Reader Service Card
Stat Fax® 4200 Microplate Reader
The new Stat Fax 4200 is a compact, economical,
stand-alone microplate reader. It
CliniCal laboratory news JuLy 2008 27

special section
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has a large touch-screen user interface and
reads a standard 96-well microplate in less
than 15 seconds. The versatile open system
features cutoff modes, point-to-point, and
regression calculations. It prints results on
the internal thermal printer or outputs
results to a PC to create custom-formatted
reports.
Awareness Technology, Inc.
Circle No. 359 in the Reader Service Card
MINICAP Automated SPE
With a small footprint, the MINICAP instrument
is designed to optimize and completely
automate electrophoresis testing in low- to
medium-volume laboratories. Simply place
a bar-coded primary tube on the system
and walk away. A continuous-access sample
wheel allows for the addition of samples
at any time, and true-positive sample ID is
achieved with full traceability. The MINICAP
Protein 6 assay is FDA cleared for separation
and quantitation of the six major serum
protein fractions by capillary electrophoresis..
The MINICAP reagent compartment
accommodates multiple assay buffers in
anticipation of future menu expansion.
Sebia Electrophoresis
Circle No. 360 in the Reader Service Card
STA Satellite® Analyzer
The STA Satellite, the newest addition to the
STA® family of analyzers, is a fully-automated
benchtop coagulation analyzer capable of
simultaneously performing clotting, chromogenic,
and immunological assays. The STA
Satellite analyzer offers complete automation
for low-to- medium-activity coagulation labs
and is suitable as a backup analyzer for organizations
with central and satellite labs. It offers
technological advances to ensure a high
level of system reliability, ease of operation,
and flexibility—all within a small footprint.
Diagnostica Stago, Inc.
Circle No. 361 in the Reader Service Card
Calibrated Automated
Thrombogram® Assay*
The Calibrated Automated Thrombogram,
or CAT, is an exciting new technology using
a fluorogenic substrate in an easy-to-use automated
platform to measure the initiation,
burst, and subsequent inactivation of thrombin
in clotting platelet-poor or platelet-rich
plasma. It is a global hemostasis assay for the
investigation of hypo- and hyper-coagulability
and the effects of anti-thrombotics and
28 CliniCal laboratory news JuLy 2008
2008 NEw Pr o d u c t rE v i E w
other pharmaceuticals on thrombin generation.
A unique thrombin calibrator eliminates
potential sample-specific interferences,
such as the inner filter effect, substrate depletion,
and variability in sample color and light
intensity. Diagnostica Stago, Inc. represents
Thrombinoscope as the exclusive distributor
in the U. S. *For research use only.
Diagnostica Stago, Inc.
Circle No. 362 in the Reader Service Card
STA® Liatest® FM Assay*
The STA Liatest FM is an immunoturbidimetric
assay for the quantitative determination
of soluble fibrin monomer complexes
(SFMC) on the STA line of analyzers. The
test uses microparticles coated with monoclonal
antibodies specific for SFMC that are
mixed with the test plasma. The presence of
SFMC causes agglutination of the microparticles,
resulting in a change in absorbance
that is measured at 540nm. High plasma levels
of SFMC are usually observed in patients
with disseminated intravascular coagulation
(DIC). STA Liatest FM Calibrator and STA
Liatest FM Control complete the Liatest FM
product line. *For research use only.
Diagnostica Stago, Inc.
Circle No. 363 in the Reader Service Card
STA® Control LA 1+2
STA Control LA 1+2 are a lupus anticoagulant
(LA) positive and negative control material.
The two levels of assayed controls are for
use with the STA Staclot dRVV Screen and
Confirm using the STA line of instruments.
The controls are available in 1-mL vials with
an onboard stability of 8 hours when used
on the STA line of instrumentation.
Diagnostica Stago, Inc.
Circle No. 364 in the Reader Service Card
STA® -Staclot® dRVV Screen
and Confirm Assays
The STA-Staclot dRVV Screen and Confirm
are fully-automated assays for the detection
of lupus anticoagulants (LA) in patient
plasma by the diluted Russell viper venom
method. Each reagent is bar coded for ease
of use on the STA line of analyzers. The STA
Staclot dRVV Screen assay uses a reagent
with a low phospholipid concentration that
enhances its sensitivity, resulting in a
prolongation of the clotting time. The STA
Staclot dRVV Confirm assay uses a reagent
with a high phospholipid concentration that
neutralizes the LA present in the plasma,
resulting in a shortening of the clotting time.
Diagnostica Stago, Inc.
Circle No. 365 in the Reader Service Card
ABL80 FLEX CO-OX Instrument*
The ABL80 FLEX CO-OX incorporates the
patented oximetry technology found in
Radiometer’s benchtop analyzers, making
it available in a portable, cartridge-based
instrument. Radiometer’s ultra-sonic
hemolyzation is well-established as superior
to chemical hemolyzation, demonstrating
superior measurement performance and
zero risk of contamination from chemical
agents. The ABL80 FLEX CO-OX offers
the portability and ease-of-use advantages
already benefiting users of the ABL80 FLEX
platform. Its small footprint, rapid start-up,
and fast measurement time make it ideal for
use in clinical areas, while full connectivity
and auto QC ensure the lab maintains
control of the testing process. *Pending FDA
clearance.
Radiometer America, Inc.
Circle No. 366 in the Reader Service Card
Little Dipper Processor for FISH
From day one, this robotic system automates
processing of FISH samples using Vysis or
other probes, including post-hybridization
steps. The Little Dipper processor provides
precise temperature control and washing action
that enhances test results and day-to-day
reproducibility. It also can be used for processing
microarrays used in new aCGH tests
from Agilent, Roche/NimbleGen, Illumina,
and others.
SciGene
Circle No. 367 in the Reader Service Card
LIAISON® Treponema Assay
Introducing the LIAISON Treponema Assay,
the first fully-automated, FDA-cleared
chemiluminescent immunoassay to aid in
the diagnosis of syphilis infection. With
high sensitivity, as well as excellent specificity,
the LIAISON Treponema Assay is used as a
clinical lab screening or confirmatory test. Its
ability to detect both IgM and IgG antibodies
to Treponema pallidum ensures improved
sensitivity in the diagnosis of early syphilis
infections, compared with RPR and EIA
methods. The use of recombinant antigens
limits cross reactivity and provides superior
specificity. Labs benefit from the excellent
throughput of 180 results per hour and the
total walk-away system.
DiaSorin
Circle No. 368 in the Reader Service Card
LIAISON® Borrelia burgdorferi Assay
The LIAISON Borrelia burgdorferi assay
is the only fully-automated, FDA-cleared,
chemiluminescent immunoassay available
for Lyme disease serology. The use of the
VlsE recombinant antigen provides the LIAI-
SON Borrelia burgdorferi assay with superior
specificity, reducing the diagnostic time and
cost. The truly reactive samples are identified
in the first step of the recommended testing
algorithm, reducing the amount of subsequent
Western blot testing. Thanks to the
high immunogenicity of the VlsE antigen,
Lyme infections can be identified from the
early stages and treatment can be started
promptly. The LIAISON Borrelia burgdorferi
assay has excellent throughput and random
access capability.
DiaSorin
Circle No. 369 in the Reader Service Card
LIAISON® 25 OH Vitamin TOTAL-DTM Assay
The LIAISON 25 OH Vitamin TOTAL-DTM
Assay uses chemiluminescent immunoassay
technology for the quantitative determination
of 25-hydroxyvitamin D and other hydroxylated
vitamin D metabolites in human
serum, EDTA-plasma, or lithium-heparin
plasma for assessment of Vitamin D sufficiency.
The new TOTAL-D is the only FDAcleared,
fully-automated assay measuring
100% of Vitamin D2 and D3. The improved
precision offers intra and inter CV of ≤ 10%
and functional sensitivity of < 4 ng/mL. The
automated LIAISON Analyzer offers the lab
a throughput of 100 tests per hour and time
to first result of 35 minutes.
DiaSorin
Circle No. 370 in the Reader Service Card

2008 NEw Pr o d u c t rEv i Ew special section
Advertisement
Total P1NP Assay
The total P1NP assay from Roche Diagnostics
is useful for monitoring therapy of
patients with osteoporosis. It detects increased
bone turnover in postmenopausal
women and is sensitive to significant changes
induced by anabolic or anti-resorptive therapies.
The advantages of the automated serum
total P1NP include: little diurnal variability
allowing for draws at any time, unlike previous
markers; rapid, 18-minute assay time;
and intra- and inter-assay variations lower
than 2% and 5%, respectively. Total P1NP
documents changes that exceed the LSC in a
majority of individuals.
Roche Diagnostics
Circle No. 371 in the Reader Service Card
ONLINE TDM Tobramycin Test
The ONLINE TDM tobramycin assay is a
homogenous immunoassay based on kinetic
interaction of microparticles in solution
(KIMS). Microparticles coated with tobramycin
rapidly aggregate in the presence of
a tobramycin antibody. The presence of
tobramycin in the sample inhibits particle
lattice formation, generating a classic
inhibition curve with the maximum rate
of aggregation at the lowest tobramycin
concentration. The 12-week onboard stability
of the cobas c pack, along with calibration
stability, allow for a convenient and
economical method for TDM of tobramycin
in serum, K2 or K3 EDTA, or sodium or
lithium-heparin plasma on the Roche cobas
c 501 analyzers.
Roche Diagnostics
Circle No. 372 in the Reader Service Card
proBNP II Assay
The Roche Diagnostics ProBNP II assay,
launched in April, is a 2nd-generation assay
using monoclonal antibodies for the detection
of NT-proBNP. Monoclonal antibodies
provide consistent high quality through
improved lot-to-lot consistency and excellent
precision, ranging from 1.6%–4.6% CV
over the full measuring range. The unique
NT-proBNP claim, “aid in the assessment
of increased risk of cardiovascular events
in patients who have stable coronary artery
disease (CAD),” promotes quality management
of cardiovascular risk with patients
diagnosed with CAD and creates an outreach
growth opportunity for labs.
Roche Diagnostics
Circle No. 373 in the Reader Service Card
ONLINE TDM Phenobarbital Test
The ONLINE TDM Phenobarbital assay is a
homogenous immunoassay based on kinetic
interaction of microparticles in solution
(KIMS). Microparticles coated with phenobarbital
rapidly aggregate in the presence of a
phenobarbital antibody. The presence of
phenobarbital in the sample inhibits particle
lattice formation, generating a classic
inhibition curve with the maximum rate
of aggregation at the lowest phenobarbital
concentration. The 90-day onboard stability
of the cobas c pack, along with calibration
stability and 200 test cobas c pack configuration,
allows for a convenient and economical
see us at the 2008 clin lab expo, booth no. 2421
method for TDM of phenobarbital in serum,
K2 or K3 EDTA, or sodium or lithiumheparin
plasma on the Roche cobas c 501
analyzers.
Roche Diagnostics
Circle No. 374 in the Reader Service Card
ONLINE TDM Quinidine
The ONLINE TDM Quinidine assay is
a homogenous immunoassay based on
kinetic interaction of microparticles in
solution (KIMS). Microparticles coated with
quinidine rapidly aggregate in the presence
of a quinidine antibody. The presence of
quinidine in the sample inhibits particle lattice
formation, generating a classic inhibition
curve with the maximum rate of aggregation
CliniCal laboratory news JuLy 2008 29

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at the lowest quinidine concentration. The
12-week onboard stability of the cobas c
pack, along with calibration stability, allows
for a convenient and economical method
for TDM of quinidine in serum, K2 or K3
EDTA, or sodium or lithium-heparin plasma
on the Roche cobas c 501 analyzers.
Roche Diagnostics
Circle No. 375 in the Reader Service Card
Sample Validity Testing
The new Roche Diagnostics Sample Validity
Tests for use on the Roche Hitachi MODU-
LAR ANALYTICS systems include the test
reagents, assay-specific calibrators, and
multi-constituent controls for: pH, specific
gravity, nitrites, chromates, oxidants, and
creatinine. These assays fulfill SAMSHAmandated
requirements to test for sample
adulteration in certified labs and provide
convenient system packaging and enhanced
performance for high-throughput labs.
Roche Diagnostics
Circle No. 376 in the Reader Service Card
Elecsys Anti-TSHR Assay*
Introducing the fully automated Elecsys
Anti-TSHR assay for detection of autoanti-
bodies to the TSH receptor. This highthroughput
immunoassay will add to Roche’s
broad thyroid menu. The Anti-TSHR assay
is intended to be used as an aid in the assessment
of patients with suspected Graves’
disease, the leading cause of hyperthyroidism.
Graves’ disease affects approximately
750,000 people in the U.S. and nearly 32 million
people worldwide. Early and accurate diagnosis
supports Roche’s Passion to Improve
Lives. *Pending FDA Clearance.
Roche Diagnostics
Circle No. 377 in the Reader Service Card
Elecsys PTH STAT Assay
Parathyroid hormone plays an adjunct
role as a functional measure of parathyroid
surgery, confirming the adequacy of parathyroid
gland resection. Using the 9-minute
Parathyroid Hormone (PTH) test during
parathyroid surgery provides faster results for
surgeons, which may result in shorter surgeries
for patients. Used on Roche’s Elecsys 1010
and 2010 systems and cobas e 411 analyzer,
the test was FDA cleared in late 2007 for use
during surgery. A 9-minute STAT PTH
30 CliniCal laboratory news JuLy 2008
2008 NEw Pr o d u c t rE v i E w
application is also in development for the
Roche Diagnostics cobas® 6000 analyzer
series.
Roche Diagnostics
Circle No. 378 in the Reader Service Card
ONLINE TDM Lidocaine Test
The ONLINE TDM Lidocaine assay is a
homogenous immunoassay based on kinetic
interaction of microparticles in solution
(KIMS). Microparticles coated with lidocaine
rapidly aggregate in the presence of a lidocaine
antibody. The presence of lidocaine in
the sample inhibits particle lattice formation,
generating a classic inhibition curve with
the maximum rate of aggregation at the
lowest lidocaine concentration. The 12-week
onboard stability of the 75 test cobas c pack,
along with calibration stability, allow for
a convenient and economical method for
TDM of lidocaine in serum, K2 or K3 EDTA,
or sodium or lithium-heparin plasma on the
Roche Diagnostics cobas c 501 analyzers.
Roche Diagnostics
Circle No. 379 in the Reader Service Card
ONLINE TDM Amikacin Assay
The ONLINE TDM Amikacin assay is a
homogenous immunoassay based on kinetic
interaction of microparticles in solution
(KIMS). Microparticles coated with amikacin
rapidly aggregate in the presence of an
amikacin antibody. The presence of amikacin
in the sample inhibits particle lattice formation,
generating a classic inhibition curve
with the maximum rate of aggregation at
the lowest amikacin concentration. The
12-week onboard stability of the cobas c
pack, along with calibration stability, allow
for a convenient and economical method for
TDM of amikacin in serum, K2 or K3 EDTA,
or sodium or lithium heparin plasma on the
Roche Diagnostics cobas c 501 analyzers.
Roche Diagnostics
Circle No. 380 in the Reader Service Card
Lithium Colorimetric Assay
Introducing the Lithium colorimetric assay
(Li) for the Roche Diagnostics cobas c 501
analyzer. Lithium present in the sample reacts
with a substituted porphyrin compound
at an alkaline pH, resulting in a change in
absorbance that is directly proportional to
the concentration of lithium in the sample.
The assay uses a liquid, ready-to-use reagent
packaged in a cobas c pack and the C.f.a.s.
calibrator, the calibrator common to most
general chemistry assays. Acceptable samples
include serum and K2-EDTA and Naheparin
plasma. The 100-test Lithium cobas
c pack is stable for 4 weeks onboard the
cobas c 501 analyzer, providing a convenient
method for lithium analysis.
Roche Diagnostics
Circle No. 381 in the Reader Service Card
CoaguChek® XS System
The CoaguChek XS System uses exclusive
smart technology to help ensure accurate
PT/INR results at the POC and offers the
flexibility and control healthcare professionals
need to confidently manage a wide range
of anticoagulation patients. The system
includes extended data management and QC
capabilities to help clinics and other facilities
that manage high volumes of patients. Using
the CoaguChek XS system at the POC may
help hospital-based labs realize the benefits
of systematic anticoagulation management,
such as immediate therapy adjustments and
lower indirect costs of patient management
(Wurster, M., Doran, T. Anticoagulation
management: A new approach. Disease
Management, 2006; 4:201-209.)
Roche Diagnostics/Point-of-Care
Circle No. 382 in the Reader Service Card
ACCU-CHEk® Inform II System*
The next generation in POC blood glucose
monitoring systems from Roche Diagnostics,
the ACCU-CHEK Inform II System is
designed to help healthcare professionals
ensure patient safety and enhance patient
care. Ideally suited for the ICU, the system
is designed to use ACCU-CHEK Performa
test strips that use the proven ACCU-CHEK
Aviva consumer strip technology. Design
goals include a 0.6-μL sample size, underdose
detection, optional wireless technology,
enhanced patient identification (EPID) features,
other test entry, observed test sequence,
and patient history query capabilities. *Pending
FDA clearance.
Roche Diagnostics/Point-of-Care
Circle No. 383 in the Reader Service Card
Jaguar Nucleic Acid System
Sample in, result out! HandyLab offers
the first rapid, cost-effective, easy-to-use
integrated molecular diagnostic platform
for infectious disease testing. The Jaguar is a
third-generation nucleic acid system that
provides labs with full molecular diagnostic
automation, including processing raw patient
samples into a real-time PCR and results in as
little as 45 minutes with minimal hands-on
time. This innovative system enables automation
of manual lab-developed tests and analyte
specific reagents. HandyLab is dedicated
to the development, manufacture, and sales
of novel diagnostic products based on its patented
and proprietary microfluidic real-time
PCR and nucleic acid extraction technologies.
HandyLab—Ahead of the Curve!
HandyLab, Inc.
Circle No. 384 in the Reader Service Card
StaRRsed Inversa 24M ESR Analyzer
The newly developed ESR analyzer performs
blood sedimentation in accordance with
the globally accepted Westergren method.
A built-in barcode reader, printer, credit
card charging system, QC program, and LIS
connectivity make the StaRRsed Inversa 24M
analyzer the ideal instrument for labs doing
up to 150 ESR’s a day. It works with standard
EDTA blood using an automated accurate
dilution with citrate solution, so no special
ESR tubes are needed. No disposables are
required either because the StaRRsed Inversa
24M automatically cleans pipettes for reuse.
The system performs 24 ESRs in 30 minutes,
unattended, saving time and money.
Mechatronics Instruments USA
Circle No. 385 in the Reader Service Card
Liquichek Diabetes Control
The Liquichek Diabetes Control is a liquid,
human, whole blood-based, third-party contol
for monitoring the precision of hemoglobin
A1c tests on commonly used methods
and instruments. This control provides an
unbiased assessment of the assay performance
helping to improve the quality of test
results. It is available in three levels and has
a 3-year (-10ºC to -70ºC) frozen shelf life.

2008 NEw Pr o d u c t rEv i Ew special section
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Also available for Liquichek Diabetes Control
are the Unity Interlaboratory Program
with peer group comparison, and Unity
Real Time software, a complete QC data
management software system designed to
improve the effectiveness of quality control
processes.
Bio-Rad Laboratories, Inc.
Circle No. 386 in the Reader Service Card
Liquichek Microalbumin Control
The Liquichek Microalbumin Control is
a liquid, human, urine-based, third-party
control for monitoring the precision of microalbumin
test procedures. Designed using
human albumin, the control tests microalbumin
across a wide range of popular instruments.
Assayed values for microalbumin
and creatinine are provided in two desirable
levels. The control has a 30-day, open-vial
stability at 2–8ºC and a 2-year shelf life at
2–8ºC. You may submit QC data for both
analytes to the Unity Interlaboratory Program
to obtain a monthly peer group report.
Bio-Rad Laboratories, Inc.
Circle No. 387 in the Reader Service Card
Lyphochek® Whole Blood
Immunosuppressant Control
The Lyphochek Whole Blood Immunosuppressant
Control is a lyophilized, third party,
human, whole blood-based control that can
be treated in the same manner as patient
samples. It offers five individual levels and
includes analytes cyclosporine, tacrolimus,
and sirolimus from low to very high concentrations.
Designed for use as an assayed QC
material, this control monitors the precision
of immunosuppressant drug test procedures
in the clinical laboratory. It can be used
with immunoassay or chromatographic
techniques. Routine use provides a means
to monitor the precision of test procedures
and helps to ensure quality of reported test
results.
Bio-Rad Laboratories, Inc.
Circle No. 388 in the Reader Service Card
Unity Real Time QC Online Program
The Unity Real Time online program is a
Web-based expert QC data management
solution that facilitates regulatory compliance
under CLIA and ISO 15189. It provides
advanced statistical process control with
audit trails, facilitates bench technologist and
supervisory QC data review, offers comprehensive
charts and reports, and enables
participation in the Unity program, the
most comprehensive interlaboratory program
available to clinical labs. The Unity Real
Time online program can also be used with
the Westgard Advisor online program to
automatically recommend and implement
optimum QC rules. With the WebConnect
feature, QC data can be uploaded directly
into the Unity Real Time online program,
eliminating the manual entry of data.
Bio-Rad Laboratories, Inc.
Circle No. 389 in the Reader Service Card
WebConnect 2.0 Software
The key to improved lab QC is being connected
to Bio-Rad’s Unity software,
Web services, and the Unity Interlaboratory
Program. Bio-Rad offers a complete suite of
QC connectivity solutions designed to meet
the needs of any lab environment. The
WebConnect 2.0 system is a new addition to
Bio-Rad’s suite of connectivity solutions,
offering Web-based connectivity with no
software to install. The WebConnect 2.0
Software allows labs to easily upload QC
data from an instrument, middleware solution,
and/or LIS directly into Unity software
for complete QC data management. The
WebConnect 2.0 system provides online QC
connectivity for either the Unity Real Time
online or UnityWeb 2.0 programs.
Bio-Rad Laboratories, Inc.
Circle No. 390 in the Reader Service Card
Westgard Advisor Online Module
The patented Westgard Advisor online
module is a Web-based, add-on module to
Bio-Rad’s Unity Real Time online QC data
CliniCal laboratory news JuLy 2008 31

special section
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management solution that automatically
recommends and implements optimum QC
rules. By setting up proper QC design, the
module decreases false rejections and helps
attain designated quality goals with the highest
error detection and lowest false rejection
rate possible. This reduces false error flags
and saves labs time and money associated
with the reduction of unnecessary troubleshooting
and repeats. The Westgard Advisor
online module is very easy to use with a
four-step wizard that guides users through
the rule selection process.
Bio-Rad Laboratories, Inc.
Circle No. 391 in the Reader Service Card
UnityWeb 2.0 QC Data Management System
UnityWeb 2.0 is an entry-level, Web-based
QC data management solution that facilitates
regulatory compliance under CLIA and ISO
15189. The UnityWeb 2.0 system reduces IT
dependence because no software installation
is required. The program provides statistical
process control with audit trails, charts
and reports for data analysis, and enables
participation in the Unity Interlaboratory
Program for peer comparisons. The Unity-
Web 2.0 system can also be used with the
optional Westgard Advisor online module
to automatically recommend and implement
optimum QC rules. With the WebConnect
program, QC data can be uploaded directly
into the UnityWeb 2.0 system, eliminating
manual entry of QC data.
Bio-Rad Laboratories, Inc.
Circle No. 392 in the Reader Service Card
Liquichek Tumor Marker Control
The Liquichek Tumor Marker Control is
a liquid, human serum-based, third-party
control used for monitoring the precision of
tumor marker testing. This trilevel, multi-analyte
control features 17 tumor markers: CA
15-3, CA 19-9, CA 27.29, CA 72-4*, CA 125,
AFP, β-2-microglobulin, CEA, cyfra 21-1*,
ferritin, hCG/β-hCG, IGF-1, PAP, prolactin,
total PSA, free PSA, and thyroglobulin.
The control has a 2-year shelf life when
stored frozen, and 30-day, open-vial stability
at 2–8ºC for most analytes. Assayed values
are provided for manual and automated test
methods, and participation in the Unity
32 CliniCal laboratory news JuLy 2008
2008 NEw Pr o d u c t rE v i E w
Interlaboratory Program is available.
*International use only.
Bio-Rad Laboratories, Inc.
Circle No. 393 in the Reader Service Card
Alfred 60 Urine Culture System
The Alfred 60 is a fully automated system
for urine culture that offers rapid results and
reliability in sample identification and standardized
working protocols. The patented
technology allows detection of intense bacteria
replication activity and plotting of the
specific growth curves in real time, indicating
the quantitative value expressed in CFU/
mL. Strongly positive samples are flagged
after only 45 minutes from the start of the
analysis, and the positivity threshold can be
customized according to the lab’s needs. A
user can simultaneously perform the residual
antimicrobial activity test and the culture
test to avoid false-negative results caused by
substances with antibacterial properties.
ALIFAX S.p.A.
Circle No. 394 in the Reader Service Card
POC Controls: Urine, Hb, and Occult Blood
Thermo Scientific’s Point-of-Care Controls
for near-patient testing in hospitals and physician
offices focus on urinalysis, hemoglobin,
and occult blood testing. The urinalysis
control is a ready-to-use, liquid control that
can be stored at room temperature for 6
months and works with most major brands.
The hemoglobin control is a liquid, wholeblood
control with 2-year, closed-vial dating;
60-day, open-vial stability; and 30-day,
room-temperature storage. The occult blood
control is the only commercial external
control available on the market featuring a
12-month room-temperature storage and a
2-year shelf life.
Thermo Fisher Scientific
Circle No. 395 in the Reader Service Card
OneTouch® TGC® Advisor Program
Tight glycemic control creates extra work for
hospital staff; therefore, products that facilitate
its management are needed. That’s why
LifeScan, Inc., is proud to present this new
software program that measures and manages
the information necessary for tight
glycemic control programs. The OneTouch
TGC Advisor, an upgrade for the OneTouch®
DataLink® Data Management System, is
configurable by location and reportable by
patient. It generates real-time patient graphs
and trend reports that can be distributed
via e-mail. It also helps users assess protocol
compliance and patient outcomes. The
OneTouch TGC Advisor is a key component
of LifeScan, Inc.’s Integrated IntelligenceSM
solutions for improved clinical decision
making.
LifeScan, Inc.,
a Johnson & Johnson Company
Circle No. 396 in the Reader Service Card
OneTouch® DataLink® Wireless V2 System
With this product, LifeScan, Inc., brings
a new level of efficiency to the POC envi-
ronment. Now, healthcare providers can
enjoy flexible, secure wireless connectivity
between OneTouch® Flexx Meters and the
OneTouch® DataLink® Data Management
System. The OneTouch DataLink Wireless
V2 improves workflow and the data transfer
process, with meter data reportable in near
real time for enhanced clinical decisions. The
OneTouch DataLink Wireless V2 is a key
product component of LifeScan, Inc.’s Integrated
IntelligenceSM solutions, providing
healthcare institutions with the products and
technology they need to advance care across
the continuum.
LifeScan, Inc.,
a Johnson & Johnson Company
Circle No. 397 in the Reader Service Card
StatusFirst® Drugs of Abuse 10 Panel
LifeSign introduces the StatusFirst Drugs of
Abuse 10 panel test, a rapid, POC assay that
is instrument read. A qualitative immunoassay
for the detection of drugs-of-abuse in
urine, the StatusFirst DOA 10 panel features
a simple procedure: dispense two drops of
urine into a StatusFirst DOA 10 device and
then read the results in the DXpress® Reader
in 5 minutes. The DXpress Reader eliminates
operator subjectivity and provides a hard
copy printout while delivering accurate results.
The StatusFirst DOA 10 Panel features
the following drug combination: MET/OPI/
COC/THC/PCP/BZO/BAR/MTD/TCA/
AMP. A five-panel test is also available.
LifeSign, LLC
Circle No. 398 in the Reader Service Card
STATUS-COLON ASSURE Test
LifeSign introduces the CLIA-waived
STATUS-COLON ASSURE test, a rapid
POC assay. The STATUS-COLON ASSURE
is a two-tier collection and testing system
combining the traditional fecal occult blood
detection (guaiac) method with immunochemical
testing for the detection and
confirmation of human hemoglobin on one
test card. The iFOBT portion of the test has
a sensitivity of 50 μg Hgb/g feces for a higher
detection rate of colon disease. The combo
test card can be stored up to 30 days at room
temperature without affecting the results.
LifeSign, LLC
Circle No. 399 in the Reader Service Card
EliA Autoimmune Assays
For more than 30 years, Phadia has revolutionized
immunoassay technology and advanced
the science of allergy and immunology
as the worldwide leader in specific IgE
blood testing. From this platform of proven
performance, Phadia is proud to introduce
EliA Autoimmune assays. EliA Autoimmune
assays are fully automated, moderately
complex, and run on the proven Immuno-
CAP instrument systems (100ε/250). EliA
Autoimmune assays include: CCP antibodies
(cyclic citrullinated peptide); Celikey® tTG
antibodies (tissue transglutaminase); gliadin
antibodies; and Symphony ANA and dsDNA
antibodies. Visit Phadia booth #1331 or
contact Customer Service at 800.346.4364
to learn how EliA Autoimmune assays can
enhance your lab’s performance and bottom
line.
Phadia U.S., Inc.
Circle No. 400 in the Reader Service Card
SpinGard Large Capacity Tabletop Centrifuges
NuAire’s SpinGard Large Capacity Tabletop
Centrifuges offer faster speeds for optimum
separation. The SpinGard allows instant
rotor exchange in just a matter of seconds.
The SpinGard centrifuges have automatic
recognition of all the rotors and calculate
the rotational speed. A duel-door lock and
imbalance detector enhances the safety on
each unit. All SpinGard units have a large
LCD display for all the information, from
diagnostic messages to the rotor library and
running conditions.
NuAire, Inc.
Circle No. 401 in the Reader Service Card
ELISA 5-in-1 Workstation
The walk-away solution for immunoassays in
microplate format, the ELISA 5-in-1 Workstation
combines the five basic functions to
process ELISA assays in 96-well microplate

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format: washer, shaker, dispenser, incubator,
and reader. Ideal for low-to-medium size
labs, the compact instrument presents true
walk-away functionality once the microplate
has been placed into the loading/unloading
position. The samples are fully processed
according to the individual kit instructions,
and the instrument allows easy transfer
of manual ELISA assays, as well as robotic
loading.
Berthold Detection Sytems GmbH
Circle No. 402 in the Reader Service Card
Elisys Uno ELISA Analyzer
The Elisys Uno is HUMAN’s fully automated
open ELISA processor designed for the
processing of a single microtiter plate, with
the possibility to combine up to eight tests on
one plate. The system is optimized to meet
user needs for automated ELISA testing. A
customized rack system permits the use of
original kit components. All HUMAN and
IMTEC tests are pre-programmed, and other
tests can be easily added. The flexible, selfexplanatory
software and user-friendliness
of the instrument in routine applications are
among its most notable features. Additional
useful software features have been implemented
to ensure the accuracy and consistency
of results.
HUMAN GmbH
Circle No. 403 in the Reader Service Card
HumaClot DuoPlus Coagulation Analyzer
The HumaClot DuoPlus is a new, manual,
two-channel, photo-optical instrument
that offers clotting, chromogenic, and
immunoturbidimetric testing capabilities.
The HumaClot DuoPlus can be used for a
broad range of coagulation tests, and the approved
clotting algorithm enables detection
of low fibrinogen and fibrinogen determination
from PT results. Highly reliable and
nearly maintenance free, this compact instrument
offers a broad range of implemented
features, such as microvolume testing, an
autostart function, autosensing optics to
eliminate interference, and multi-language
software—features that make this instrument
a powerful tool for small laboratories
worldwide.
HUMAN GmbH
Circle No. 404 in the Reader Service Card
34 CliniCal laboratory news JuLy 2008
2008 NEw Pr o d u c t rE v i E w
LabDAQ LIS
Antek HealthWare, LLC, is pleased to provide
new functionality that will improve lab
workflow and increase patient safety.
The LabDAQ LIS includes an extensive rules
engine, the ability to scan documents and
attachments, and a report writer. The rules
engine allows users to define a wide variety
of rules when ordering, processing results,
disseminating results, and billing. These userdefined
rules allow labs to identify and select
a wide variety of criteria and apply specific
actions to satisfy those situational criteria.
The rules are easy to use, flexible, and can accommodate
virtually any action imaginable.
Antek HealthWare, LLC
Circle No. 405 in the Reader Service Card
Cliquid® AA45 Software
for Amino Acid Analysis
New Cliquid AA45 Software from Applied
Biosystems/MDS SCIEX simplifies the
operation of LC/MS/MS for routine
amino acid analysis into a simple four-step
workflow. With an intuitive point-and-click
interface, Cliquid AA45 Software provides
pre-configured tests used with Applied Biosystems
iTRAQ® reagents and chemistry for
the analysis of up to 45 physiological amino
acids in less than 25 minutes. The software
also comes with a built-in compound
catalogue and the ability to quickly create
new assays for amino acids or other routine
analysis. Please visit booth # 903 to learn
more about our complete solution for amino
acid analysis.
Applied Biosystems/MDS SCIEX
Circle No. 406 in the Reader Service Card
EPOC Enterprise POC System
The EPOC System is the first truly costeffective,
wireless, and easy-to-manage POC
testing solution able to deliver lab-equivalent
blood gas and electrolyte results at the bedside
in just 30 seconds. The system is
composed of single-use EPOC Test Cards, an
EPOC Reader, EPOC Host Mobile Computer,
and Web-based EPOC Data Manager.
System features include: room-temperature
storage of single-use test cards barcoded for
inventory management; internal, automated
quality control; and wireless capture and
transmission of patient and quality test records.
The EPOC System is easily interfaced
to hospital LIS/HIS systems via an HL7
interface.
Epocal Inc.
Circle No. 407 in the Reader Service Card
SQA-V Gold Sperm Analyzer
The SQA-V Gold analyzer is a high-performance
sperm analysis instrument used to
test male fertility. It provides a precise and
accurate 75-second automated semen
analysis and delivers 16 clinical parameters,
including count, motility (A+B+C), morphology,
velocity, and functional sperm. Updated
features include: full dynamic range;
autotransfer to the included data manager;
user-friendly interface; and an improved
visualization system.
Medical Electronic Systems, LLC
Circle No. 408 in the Reader Service Card
ACL TOP 500 CTS System*
The ACL TOP 500 CTS system is a fully
automated, user-friendly instrument that
helps mid- to high-volume labs maximize labor
resources and improve patient care. The
CTS feature eliminates the need to decap and
recap, thereby increasing productivity and
improving operator safety. This state-of-theart
system provides clotting, chromogenic,
and immunoturbidimetric testing capabilities
with a complete menu of routine and
specialty assays, including D-Dimer HS.
This powerful, intuitive system offers 24/7
continuous operation without interruption
to workflow, allowing your lab to increase
testing efficiency and reduce turnaround
time. *In development.
Beckman Coulter Inc.
Circle No. 409 in the Reader Service Card
AutoMate 800 Sample Processing System
When you need to improve lab efficiency,
turn to the AutoMate 800 from Beckman
Coulter for an automation system that fits
your unique requirements. The AutoMate
800 has everything you need to streamline
pre- and post-analytical processes and position
your lab for optimal performance and
labor usage, including: single point of entry;
advanced, automated sample loading and
sorting; fully integrated centrifugation for
faster test turnaround time with less variability;
through-the-label sample volume
detection; decapper module for maximum
efficiency and safety; intelligent aliquotting
and tube labeling to ensure faster, more
accurate secondary tube preparation; and
intuitive software to facilitate ease of use.
Beckman Coulter Inc.
Circle No. 410 in the Reader Service Card
Cystatin C Reagent
Pointe Scientific introduces a new latexenhanced,
immunoturbidimetric assay for
the quantitative determination of cystatin C
in serum or plasma. Applied to automated
chemistry analyzers, this cystatin C reagent
shows correlation with other commercially
available cystatin C assays, excellent precision,
minimal interference, and an extended
assay range to 10 mg/L. Unlike creatinine
measurements for estimating glomerular
filtration rate (eGFR), the Pointe Scientific
Cystatin C reagent is not dependent on
age, sex, race, weight, or other parameters.
Cystatin C is widely reported to be a much
better indicator of early kidney damage and
can detect more accurately and more quickly
any changes in renal function.
Pointe Scientific, Inc.
Circle No. 411 in the Reader Service Card
Ferritin Reagent
Pointe Scientific introduces a new latexenhanced,
immunoturbidimetric assay for
the quantitative determination of ferritin in
serum or plasma. Applied to automated
chemistry analyzers, this ferritin (hs) method
shows correlation with established chemiluminescent
methods, excellent precision, and
minimal interference. Ferritin calibrators are
referenced to WHO 94/572 3rd IS reference
standard. Measurements can be obtained
within minutes along with other anemia
markers such as iron and TIBC, eliminating
the need for split sample testing on different
analyzers. Measuring ferritin is useful in assessing
iron stores for the evaluation of iron
deficiency anemia, chronic gastrointestinal
bleeding, and other chronic inflammatory
disorders.
Pointe Scientific, Inc.
Circle No. 412 in the Reader Service Card
Safe-Wrap Blood Collection Tubes
RNA Medical’s Safe-Wrap and Safe-Wrap
Combo Blood Collection Tubes are now
CE Marked. Safe-Wrap tubes are Mylar®wrapped
glass capillaries, treated with
calcium-balanced lithium heparin. The
puncture-resistant film minimizes the risk
of broken glass and is regulatory compliant.
Safe-Wrap Combo Tubes are used with
i-STAT blood gas, electrolyte, and chemistry

2008 NEw Pr o d u c t rEv i Ew special section
Advertisement
cartridges requiring samples of 95 μL or 65
μL. The line markings and adjustable porous
plug assures that the correct volume is collected,
and the plunger provides easy sample
dispensing. Safe-Wrap Blood Collection
Tubes, with markings at 55 μL, 110 μL, and
165 μL, are used with most other blood gas
systems.
RNA Medical
Circle No. 413 in the Reader Service Card
BioPlex 2200 Vasculitis kit
Bio-Rad announces the first and only
fully-automated, random-access multiplex
solution for autoimmune systemic vasculitis
testing. The BioPlex 2200 Vasculitis kit is a
multiplex flow immunoassay for the semiquantitative
detection of IgG autoantibodies
to myeloperoxidase (MPO), proteinase 3
(PR3), and glomerular basement membrane
(GBM) in human serum. In conjunction
with clinical findings, the test system is used
as an aid in the diagnosis of anti-neutrophil
cytoplasmic antibodies (ANCA)-associated
vasculitides, microscopic polyangiitis (MPA),
necrotizing glomerulonephritis, Churg-
Strauss syndrome, Wegener’s granulomatosis,
and the autoimmune renal disorder,
Goodpasture’s syndrome. The BioPlex 2200
Vasculitis Kit is intended for use with the
Bio-Rad BioPlex 2200 System.
Bio-Rad Laboratories
Circle No. 414 in the Reader Service Card
CandiSelect4 Medium
CandiSelect4 is a new chromogenic medium
used for the selective isolation of
several forms of Candida. This medium
is designed for the direct identification
of Candida albicans, the most significant
member of the Candida genus, as well as the
presumptive identification of Candida tropicalis,
Candida glabrata, and Candida krusei.
The CandiSelect4 medium is currently the
only chromogenic medium in the U.S. to
presumptively identify Candida glabrata.
Bio-Rad Laboratories
Circle No. 415 in the Reader Service Card
BioPlex 2200 ToRC IgG kit*
The BioPlex 2200 ToRC IgG kit is the first
and only fully automated, random-access,
multiplex kit for the quantitative detection of
IgG antibodies to Toxoplasma gondii and
Rubella and the qualitative or semi-quantitative
detection of IgG antibodies to cytomegalovirus
(CMV). This kit allows your
laboratory to perform one, two, or all three
of these assays simultaneously on as little as
5 μL of serum or plasma. The BioPlex ToRC
IgG Kit is the latest panel of multiplexed
assays in the expanding menu of infectious
serology tests on the BioPlex 2200 system.
*In development.
Bio-Rad Laboratories
Circle No. 416 in the Reader Service Card
MRSASelect Medium
The new MRSASelect chromogenic medium
is used for the qualitative detection of MRSA
in 24 hours. This test can be performed on
nasal specimens from patients and healthcare
workers to screen for MRSA colonization.
Chromogenic media are used to grow
bacteria in the laboratory and identify them
based on a color reaction. With this medium
MRSA can be differentiated from other
microorganisms.
Bio-Rad Laboratories
Circle No. 417 in the Reader Service Card
Hepatitis EIA Microplate Assays
Bio-Rad announces the launch of its new
microplate EIA Hepatitis line (Hepatitis A
and B): MONOLISATM Anti-HBs EIA,
MONOLISATM Anti-HBc EIA,
MONOLISATM Anti-HBc IgM EIA,
MONOLISATM Anti-HAV EIA, and
MONOLISATM Anti-HAV IgM EIA. These
are qualitative assays with common reagents,
standardized procedure, and colored reagents
for monitoring procedural steps. MONO-
LISA Anti-HBs EIA is also quantitative when
used with the calibrator kit. All assays are for
manual and automated use. With these five
new EIA assays, Bio-Rad is now offering a
comprehensive hepatitis line expanding the
current infectious disease menu of HBsAg,
HIV-1, and HIV-2 assays.
Bio-Rad Laboratories
Circle No. 418 in the Reader Service Card
in2it Hb POC Analyzer
Introducing Bio-Rad’s in2it A1C POC
analyzer. This fully-automated system is designed
for simplicity, convenience, and speed
in near-patient testing, providing results
while the patient waits. The in2it assay
requires only 10 μL of capillary or venous
blood and uses boronate affinity chromatography
for results that are free from interference
from the most common hemoglobin
variants and traceable to the worldwide
DCCT reference. The in2it analyzer is FDA
cleared for prescription home use and is
CLIA waived. The in2it supports multilanguage
screen displays and offers computer
connectivity for complete data management.
Bio-Rad Laboratories
Circle No. 419 in the Reader Service Card
Bottle Top Dispenser
During the last 17 years, Microlit has
emerged as a strong R&D-based and ISO-
certified organization. A comprehensive
range of CE-marked, liquid handling products
include: Manual Micropipette, Electronic
Micropipette, Electronic Pipette Filler,
Micropipette stand and tips. Introduction
CliniCal laboratory news JuLy 2008 35

special section
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of the new Microlit Bottle Top Dispenser at
AACC completes the liquid-handling range
of micropipette products. These general purpose,
fully autoclavable bottle top dispensers
are suitable for a wide range of routine lab
dispensing. CE certified and conforming
to ISO 8655 standards, each dispenser
undergoes strict QC and has an excellent
performance-to-price ratio.
Microlit
Circle No. 420 in the Reader Service Card
ARCHITECT® ci4100*
Immunochemistry System
The Abbott ARCHITECT® ci4100 system
delivers integration of clinical chemistry
and immunoassay for low-to-mid-volume
laboratories with productivity enhancements
normally reserved for larger labs. The system
employs identical technologies, reagents, and
software used on the ARCHITECT ci8200®
and ci16200 immunochemistry systems to
provide consistent performance and comparable
results. The ci4100 uses the innovative
Robotic Sample Handler design to deliver
consistent stat turnaround times while processing
up to 800 chemistry tests and up to
100 immunoassay tests per hour. The ci4100
is an easy-to-use system with a high level of
technical sophistication rarely seen for the
low-volume laboratory. * In development.
Abbot Diagnostics
Circle No. 421 in the Reader Service Card
MULTIGENT Creatinine (Enzymatic) Assay*
The MULTIGENT Creatinine (Enzymatic)
assay uses an enzymatic method that is
sensitive and specific for creatinine and is not
affected by endogenous substances, such as
ketoacids, cephalosporins, and bilirubin that
interfere with Jaffe methods. The MULTI-
GENT Creatinine (Enzymatic) assay is
standardized to IDMS traceable NIST SRM
967 following the NKDEP, IFCC, and EC4
recommendation promoting the use of commutable
reference material. Standardization
and accuracy of serum creatinine measurements
are critical for the estimation of renal
function using the glomerular filtration rate
(eGFR) equation. *Pending FDA clearance.
Available outside the U.S.
Abbott Diagnostics
Circle No. 422 in the Reader Service Card
36 CliniCal laboratory news JuLy 2008
2008 NEw Pr o d u c t rE v i E w
BioLis 24i Chemistry Analyzer
The new Carolina Chemistries BioLis 24i
analyzer is a 400-test/hour, bench-top
chemistry analyzer. With a menu of more
than 100 chemistries, it serves well as a
backup analyzer for hospitals that can’t afford
to be down. Requiring only 31 inches
of bench space, this instrument is also ideal
as a primary analyzer for small hospitals and
physician office laboratories where space is a
consideration.
Carolina Liquid Chemistries
Circle No. 423 in the Reader Service Card
ST AIA-PACk cTnI 3rd-Gen Assay*
The new ST AIA-PACK cTnI 3rd-Gen assay
is designed for in vitro diagnostic use for the
quantitative measurement of cardiac troponin
I (cTnI) on TOSOH AIA system analyzers.
Cardiac troponin I measurements are used
as an aid in the diagnosis of acute myocardial
infarction. *Pending FDA clearance.
TOSOH BIOSCIENCE, INC.
Circle No. 424 in the Reader Service Card
AIA-PACk RBC FOLATE Assay*
The new AIA-PACK RBC FOLATE assay is
designed for in vitro diagnostic use for the
quantitative measurement of RBC folate
in whole-blood samples on TOSOH AIA
system analyzers. Although serum folate
offers a reliable test, it fluctuates in serum
based on dietary changes. RBC folate, however,
does not become depleted as quickly
as serum folate, and is much more concentrated
in serum. RBC folate concentration
correlates well with other indices of folate
deficiency, such as bone-marrow cell morphology
and hematological changes, making
RBC folate concentration a reliable indicator
of folate status. *Pending FDA clearance.
TOSOH BIOSCIENCE, INC.
Circle No. 425 in the Reader Service Card
Automated Glycohemoglobin
Analyzer HLC-723G8*
The Automated Glycohemoglobin Analyzer
HLC-723G8 is the next generation HbA1c
monitoring system from Tosoh Bioscience.
With a fast analysis time of 1.6 minutes
and direct determination of SHbA1c with
less than 2% CV, the G8 provides the high
level of speed and reliability that labs have
come to expect from Tosoh products. The
extremely compact G8 is about 20 inches in
width, depth, and height and weighs only 75
lbs. Automated maintenance, simple operation,
and a host of time-saving features all
combine to make the G8 analyzer a highly
evolved and efficient solution for HPLC testing.
*Pending FDA clearance.
TOSOH BIOSCIENCE, INC.
Circle No. 426 in the Reader Service Card
UVA-Enhanced HPX® Halogen Lamps
Introducing a new category of highly
stable, UVA-enhanced lamps to Welch Allyn
Lighting’s HPX miniature halogen product
family. The lamps are available in wattages
ranging from 5W to 20W, and their output
extends from the 300- to 400-nm UV range
into the near IR while retaining full spectral
output. Bright, small, and efficient, these
highly stable sources exhibit 0.05% or less
output variation. Our UVA-enhanced
HPX lamps enable next-generation devices,
such as low-cost, POC, and portable analytical
equipment. To best meet each customer’s
requirements, our engineering team customizes
wattage, output, lamp life, spectral
characteristics, reflectors, bases, and optics.
Welch Allyn Lighting
Circle No. 427 in the Reader Service Card
Genesys Neonatal Hb
Variant Screening System
Trinity Biotech introduces the Primus
GeneSys Neonatal Hb Variant Screening
System, the first on the market to offer a fully
automated approach for newborn screening
while providing positive detection of key
hemoglobin variants. Our new 2-minute
HPLC neonatal assay provides automated
sample handling, sample preparation, sample
reporting, confirmatory analysis, cleanup,
and shutdown. The system also automatically
runs an 8-minute confirmation on
the same instrument for all positive results
detecting S, C, D, E, O, and Bart’s variants,
plus many more hemoglobin variants. The
GeneSys Neonatal Hb Variant Assay is one
of three assays available on the Primus ultra2
platform.
Trinity Biotech
Circle No. 428 in the Reader Service Card
TRI-stat POC A1c Analyzer
Trinity Biotech introduces the new POC
TRI-stat instrument and A1care reagent kit
for interference-free HbA1c testing. Small
and portable for office-to-office use, the
analyzer’s features include boronate affinity
technology, three tests in 10 minutes,

2008 NEw Pr o d u c t rEv i Ew special section
Advertisement
predominantly IgM antibody response associated
with primary syphilis. Trinity Biotech
is now the only company to offer the full
spectrum of syphilis testing—
syphilis IgG, polyvalent syphilis IgG, and IgM
CAPTIA syphilis IgM capture.
Trinity Biotech
Circle No. 431 in the Reader Service Card
Titin Antibody ELISA Test kit*
KRONUS®, a leading provider of specialized
autoimmune diagnostic test kits, announces
the availability of a new ELISA test kit for the
measurement of antibodies to titin (Titin-
Ab). Titin is a protein of the striated muscles
with an extremely high molecular weight.
The immunogenic region of titin is located
on a 30-kD protein fragment. Antibodies
against this fragment presumably cross-react
with the epitopes of the acetylcholine receptors,
making their measurement potentially
useful in select indications. This new ELISA
uses recombinant MGT30 peptide, providing
accurate and specific determination of titin
antibodies. *For research use only.
KRONUS, Inc.
Circle No. 433 in the Reader Service Card
TSH Receptor Antibody ELISA Test kit
KRONUS® announces the availability of an
improved, non-isotopic FDA-cleared ELISA
test kit for the detection and measurement of
antibodies to the TSH receptor (TRAb). This
improved TRAb ELISA uses the proprietary
thyroid-stimulating, human monoclonal
autoantibody M22—directly coupled to the
peroxidase reagent—which increases assay
sensitivity while simultaneously reducing assay
time. Antibodies to TRAb are detectable
in approximately 90% of untreated Graves’
disease patients. Their presence indicates that
the patient’s thyrotoxicosis is of autoimmune
etiology rather than toxic nodular goiter.
KRONUS, Inc.
Circle No. 434 in the Reader Service Card
Cystatin C Assay*
Introducing a latex-enhanced turbidimetric
immunoassay for the fast and easy determination
of cystatin C. The test uses polystyrene
particles coated with anti-human
cystatin C that form a complex with
cystatin C present in blood samples (serum
or plasma) and can be measured with routine
clinical chemistry analyzers. Its accurate
measurement range is from 0.1–10 mg/L, so
normal and abnormal values can be measured
without additional dilutions. *Pending
FDA clearance.
Denka Seiken Co., Ltd.
Circle No. 435 in the Reader Service Card
Human IgE Antibody
The DIA HE1 fully human IgE antibody is
produced in vitro from a monoclonal hybridoma.
This unique source guarantees high
batch-to-batch consistency and freedom from
contamination by other immunoglobulin
isotypes. Suitable as a standard in IgE
quantifying assays, the DIA HE1 antibody
is comparable to the WHO standard 75/502
for IgE. Other applications include immunochemistry
and cellular immunology research.
BioPorto Diagnostics
Circle No. 436 in the Reader Service Card
Mannan-binding Lectin Assay
A key test in the assessment of immune deficiencies,
the Mannan-binding Lectin (MBL)
assay is an important element in the innate
immune defense. MBL deficiency is associated
with increased susceptibility to infection.
With more than 12% of the average population
being MBL deficient, testing is a key
parameter in the diagnosis of immune deficiencies.
However, MBL deficiency is under-
diagnosed because it is neglected in practice
parameters. The MBL Oligomer ELISA Kit
(KIT 029) is used in routine diagnostics in
the EU, and it is the most cited assay for MBL
determination worldwide.
BioPorto Diagnostics
Circle No. 437 in the Reader Service Card
NGAL ELISA kit
An early biomarker of acute kidney injury,
NGAL increases significantly within 2 hours
after injury to the kidney. With the NGAL
Rapid ELISA Kit (KIT 037) physicians can
determine if patients will develop acute
kidney failure with a 90% positive predictive
value.
BioPorto Diagnostics
Circle No. 438 in the Reader Service Card
Gold Dot Test kit*
The Gold Dot test kit is an in vitro diagnostic
test that measures NR2 peptide fragments of
NMDA receptors in 30 minutes in plasma
by magnetic particles-ELISA. Increased NR2
peptide concentrations correlate with the
presence of acute cerebral ischemia (stroke)
and transient ischemic attack. NR2 peptide
levels should be interpreted in conjunction
with clinical findings and neuroimaging. The
reagents in one kit are sufficient for 41 tests.
*For research use only.
CIS Biotech, Inc.
Circle No. 439 in the Reader Service Card
Vapro® 2 Osmometer
Wescor is pleased to announce the new
Vapro 2 vapor pressure osmometer with
automatic thermocouple cleaning. This
small, bench-top vapor pressure osmometer
measures the osmolality of any body fluid.
The vapor pressure method determines
osmolality in natural equilibrium, precluding
cryoscopic artifacts due to high viscosity,
suspended particles, or other conditions
that interfere with freezing point determinations.
The Vapro 2 is easy to use, calibrate,
and clean, and it is extremely stable and
accurate. The osmometer only requires a
10-μL sample with a measurement range of
0–3,600 mmol/kg.
Wescor, Inc.
Circle No. 440 in the Reader Service Card
OnCOPro Colloid Osmometer
Introducing the new OnCOPro colloid
osmometer, a small, bench-top colloid
CliniCal laboratory news JuLy 2008 37

special section
Advertisement
osmometer for measuring colloid osmotic
pressure (COP) for prediction, onset, and
degree of edema formation. The new On-
COPro osmometer only requires a 200-μL
sample with a measurement range of 0–100
mmHg. The reference and sample chambers
are self flushing, and the instrument has
automatic zeroing and calibration functions.
The OnCOPro surpasses all others by virtue
of its ground-breaking, flow-through sample
and reference chambers, making it extremely
easy to use and a reliable and accurate partner
in your lab.
Wescor, Inc.
Circle No. 441 in the Reader Service Card
Gen5CL Data Analysis Software
The latest in BioTek’s microplate data
analysis software product line, Gen5 CL
software is designed to provide powerful data
analysis and output options in an intuitive
user interface for the routine clinical lab.
With Gen5CL, the user can select assays from
a custom-programmed database or create
open assays for optimal workload flexibility.
The laboratory can ensure operational integrity
by defining multiple permission levels
to users on the system, and an optional QC
Trending module can be installed for control
tracking in Levey-Jennings charts. Gen5CL
provides features designed for compliance to
21CFR Part 11 and the European Directive
98/79/EC (IVDD).
BioTek Instruments. Inc.
Circle No. 442 in the Reader Service Card
Instrument Manager Rules Library
Data Innovations, Inc. is pleased to announce
the launch of its latest service, the Instrument
Manager (IM) Rules Library. This easy-touse,
online reference provides examples
using the industry’s most popular middleware
product for a variety of lab efficiencyenhancing
uses, ranging from autoverification
and calculations, such as eGFR,
to connecting instruments to multiple LIS
systems. To preview the Rules Library, go to
www.dirules.com and follow the instructions
for guest access. Customers with Specimen
Management options covered under our
current support plan can enjoy full access by
contacting our Customer Services department
(support@datainnovations.com) for
your full-access login.
Data Innovations, Inc.
Circle No. 443 in the Reader Service Card
GenPlates® Room Temperature
Storage System
GenPlates storage system is a proprietary
format for storing and transporting biological
samples at room temperature in the dry
state. Samples are stored embedded in FTA®
paper, a cellulose matrix chemically treated
to inactivate bacteria and viruses, that
38 CliniCal laboratory news JuLy 2008
2008 NEw Pr o d u c t rE v i E w
preserves DNA for at least 18 years (proven
in real time). As cellular material or DNA is
added to the GenPlate medium, the cells lyse
and the released DNA binds to the paper.
When DNA is required for downstream
analysis, high-quality, double-stranded DNA
from both the FTA paper and S&S 903 paper
can be reliably recovered using GenSolve®
chemistry.
GenVault Corporation
Circle No. 444 in the Reader Service Card
CellaVision® DM96
Cell Morphology System
Now body fluids can be analyzed on the
CellaVision DM96 automated digital cell
morphology system. Using a Cytospin
slide preparation, the DM96 automatically
performs a preliminary WBC differential and
allows the user to scan the entire cell button.
Regions of interest can be tagged, comments
added, and images stored and shared anywhere
on your network. An online reference
library, access to a patient’s historical images,
and real-time collaboration ensure the accuracy
and standardization of the analysis.
Body fluid slides can be run at the same time
when performing WBC and RBC differential
on stained peripheral blood smears.
CellaVision
Circle No. 445 in the Reader Service Card
Cholesterol Concentrate LDL
The clarified Human Cholesterol Concentrate
LDL additive (cLDL) provides in vitro
diagnostic manufacturers with an LDL
cholesterol supplement with greater clarity,
stability, and lot-to-lot consistency. Bovine
Cholesterol Concentrate LDL provides an
animal source LDL cholesterol concentrate
for use in adjusting LDL values in control
serum.
Creative Laboratory Products, Inc.
Circle No. 446 in the Reader Service Card
Horizon Anatomic Pathology Application
McKesson’s Horizon Anatomic Pathology
(HAP) application is the new, next-generation
application developed by McKesson
from the ground up for pathologists,
histologists, and cytologists. Using an expert
task-based workflow engine, it drastically
improves efficiency, decreases turnaround
time, and enhances communication among
pathology areas. Incorporating industry
leading technologies like barcode patient
selection and embedded dictation, HAP
significantly improves patient safety. The
Virtual Slide Tray serves as the pathologist’s
portal to receive and perform work
from a single screen, including correlations,
additional stains and recut orders, dictation,
consultations, access to clinical pathology
results, and digital images. HAP is integrated
with McKesson’s Horizon Lab.
McKesson Provider Technologies
Circle No. 447 in the Reader Service Card
Diagnostic-Grade Fittings & Tubing
IDEX Health & Science introduces a new line
of Upchurch Scientific® products specifi-
cally designed for the low-pressure fluidic
systems in diagnostic instruments. Based
on flangeless technology proven to reduce
leaks, the new Diagnostic-Grade Fittings
and Tubing Assemblies eliminate the need
for OEMs to ever flange instrument tubing
in manufacturing or in the field. In addition
to the dependable fittings for 1/8” and 1/16”
OD tubing, custom tubing assemblies prove
especially cost effective because they are easy
for OEMs to install, and easy for owners to
replace if needed. For a quote on a custom
tubing assembly, visit www.upchurch.com/
OEMTubing.
IDEX Health & Science
Circle No. 448 in the Reader Service Card
PVM with I PV
New valve features and additional microstepping
capability make the Sapphire Engineering
Pump/Valve Module (PVM) with
Integrated Piston & Valve (IPV) compatible
with an even greater range of diagnostic
instruments. Designed for long, service-free
life—3 million cycles—the IPV requires no
preventive maintenance, increasing system
uptime. Ultra-hard ceramic pistons and
valves eliminate the premature failure issues
of competing syringe pumps, and enable the
IPV to withstand even harsh, saline solutions
common in diagnostic applications. OEMs
can now choose the PVM with IPV for easy,
plug-in replacement for the Cavro XP3000
and Hamilton® PSD/4 pumps.
IDEX Health & Science
Circle No. 449 in the Reader Service Card
ADVIA Centaur® System Cyclosporine Assay*
The new ADVIA Centaur System Cyclosporine
Assay from Siemens Healthcare
Diagnostics allows lab professionals to
mainstream immunosuppressant drug testing
into routine workflow. With a simplified
extraction method and fully-automated processing,
test results can be reported in as little
as 18 minutes. This one test can accommodate
C0 and C2 testing and is highly specific
to the cyclosporine parent compound. With
cyclosporine testing from Siemens, you
can be confident that you are assisting your
physicians in providing optimal patient
management. *Pending FDA clearance.
Siemens HealthCare Diagnostics
Circle No. 450 in the Reader Service Card
ADVIA Centaur® System HAV Assays*
ADVIA Centaur System HAV Assays (HAV
Total and HAV IgM) are the first FDAcleared
hepatitis assays for use on the ADVIA
Centaur CP Immunoassay System. Availability
of ADVIA Centaur System HAV assays on
the ADVIA Centaur CP Immunoassay
System allows further consolidation of hepatitis
and routine immunoassays for mediumvolume
labs. In a ReadyPack® format, the
ADVIA Centaur Systems HAV assays are
high performance and may also be used on
the ADVIA Centaur and the ADVIA Centaur
XP Immunoassay Systems. For the first time,
high- and medium-volume labs may offer a
testing service with concordant hepatitis test
results. *Expected release: Summer 2008
Siemens HealthCare Diagnostics
Circle No. 451 in the Reader Service Card
ADVIA Centaur® System DHEAS Assay*
The new ADVIA Centaur System DHEAS
Assay from Siemens Healthcare Diagnostics
allows labs to optimize their fertility testing
by further consolidating assays on a single
platform. It features a wide reportable range,
high specificity, and a turnaround time of 18
minutes or less. The new Siemens DHEAS
assay is available for use on the ADVIA

2008 NEw Pr o d u c t rEv i Ew special section
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Centaur XP and ADVIA Centaur CP
systems, meeting both mid-volume and
high-volume fertility testing needs. It is the
latest Siemens assay addition to a continually
expanding fertility menu. *In development.
Siemens HealthCare Diagnostics
Circle No. 452 in the Reader Service Card
DCA Vantage Analyzer
Siemens Healthcare Diagnostics announces
the launch of the DCA Vantage Analyzer, a
POC diabetes patient management platform
providing HbA1c, microalbumin/creatinine,
and albumin-to-creatinine tests for diabetes
management. The system delivers the simplicity
and convenience required at the POC
with no sample or reagent preparation steps.
The DCA Vantage Analyzer also enables
clinicians to quickly and accurately generate
patient trending reports or view them
onboard. Data can be shared easily with
other caregivers with powerful features such
as connectivity to LIS, operator ID entry, QC
reminders, test lock-out, remote access, and
adjustable correlation to reference methods.
Siemens HealthCare Diagnostics
Circle No. 453 in the Reader Service Card
ADVIA® 2120i Hematology System
Siemens Healthcare Diagnostics introduces
the next generation of practical automation
for hematology with the ADVIA 2120i
Hematology System. The ADVIA 2120i
Hematology System combines proven flow
cytometry-based analysis capabilities with an
easy-to-use touch screen user interface
to provide excellent first-pass efficiency.
Reduced maintenance requirements and the
SMART integrated slide making and staining
of the optional ADVIA Autoslide make the
ADVIA 2120i Hematology System an excellent
choice to reduce manual steps in your
lab. The ADVIA 2120i Hematology System
uses the same reagents as the ADVIA® 120
Hematology System and is fully compatible
with the ADVIA® LabCell® Automation
Solution to adapt to various-sized testing
environments.
Siemens HealthCare Diagnostics
Circle No. 454 in the Reader Service Card
Dimension® EXLTM with LOCI ® Module
Integrated Chemistry System*
Siemens Healthcare Diagnostics is pleased to
demonstrate the Dimension EXL with LOCI
Module Integrated Chemistry System, the
next level of proven, best-in-class chemistry
and immunoassay integration available on
a single platform. The Dimension EXL with
LOCI Module Integrated Chemistry System
will feature LOCI advanced chemiluminescence
technology and will include automated
calibration, control procedures, and alerts
through the QCC PowerPak onboard
system. With more than 90 available assays,
the Dimension EXL with LOCI Module
Integrated Chemistry System will provide
chemistry and immunoassay testing on
one analyzer for lower cost of ownership.
*Expected release: October 2008
Siemens HealthCare Diagnostics
Circle No. 455 in the Reader Service Card
Blood Group Serology Reagents*
Biotest Traditional Blood Bank Reagents
include ABO and Rh antisera, anti-human
globulin reagents, potentiators, and QC
products. The Reagent Red Blood Cell
products include three configurations for
antibody screening, antibody identification
panels, coombs control cells, and reverse
ABO products. Rare antisera includes anti-C,
anti-E, anti-c, anti-e, anti-Lea, anti-K, anti-k,
anti-Fya, anti-Jka, anti-Jkb, anti-M, anti-N,
anti-S, anti-s, and anti-P1. All antisera are
monoclonal and many of the clones have not
been previously available in the U. S. *Pending
FDA clearance.
Biotest Diagnostics Corporation
Circle No. 456 in the Reader Service Card
Media for Lateral Flow Assays
New and improved Filtrona Fibertec®
Transorb® rapid diagnostics media is ideal
for use as sample, absorbent, and conjugate
pads for lateral flow assay applications.
New equipment broadens the performance
characteristics and the available material
selection in fully customizing the media to
test applications. Our Transorb products
are engineered to select capillarity, providing
dependable liquid transfer of samples
and reagents. Filtrona Fibertec media will
not crimp or tear like cellulose-based and
fiberglass products. Its high tensile strength
delivers optimum processing mechanics, and
in-house fiber processing and development
yield consistency and uniformity. Product is
available in rolls, sheets, or pre-cut strips or
pads, and in color.
Filtrona Fibertec
Circle No. 457 in the Reader Service Card
CliniCal laboratory news JuLy 2008 39

special section
Advertisement
Vitamin D Serum Control
UTAK’s low-level Vitamin D serum control
contains both 25-hydroxy vitamin D2 and
D3 at 10 ng/mL. This unique lyophilized
control is made from 100% human serum
and has a 24-month shelf life with a reconstituted
stability of 25 days. This product is sold
in 5x5-mL quantities. Supplies are limited.
UTAK Laboratories, Inc.
Circle No. 458 in the Reader Service Card
Chemtrue® Rapid Diagnosis
Intelligent Test Reader*
The Chemtrue Rapid Diagnosis Intelligent
Test Reader is a new immunodiagnostic
instrument composed of a specialty optical
fiber probe, monolithic processor, and IC
card. It incorporates the principle of reflected
light intensity to carry out semi-quantitative
analysis for gold standard test bar (card). The
instrument features include: small volume;
light weight; high sensitivity; rapid measurement;
and simple operation. The reader can
perform DOA, MAU, and cTn-I rapid tests.
Worldwide distributors are wanted. *Pending
FDA clearance.
CHEMTRON BIOTECH INC.
Circle No. 459 in the Reader Service Card
Life Point.EMR Software Suite
LifePoint.EMR is a suite of software interfaces,
communications protocols, and applets
that enable data exchange between electronic
medical record (EMR) systems in physician
offices and hospital/lab systems. Data is
securely exchanged between our data center
and each source system, then a queuing and
data transformation processes transmits
data to the appropriate destination(s). The
suite comes with more than 50 pre-tested
interfaces, monitoring tools, and agents that
allow for expedited installations. Laboratory,
radiology, pathology, microbiology,
ER, CCD, and other results and orders are
supported. HL7, XML, proprietary, PDF,
and text formats can all be exchanged within
the suite’s framework. LifePoint.EMR is a
complete solution, requiring no VPN or
third-party software to operate.
Life Point Informatics
Circle No. 460 in the Reader Service Card
STAT-Site® M ß-Hydroxybutyrate
Test System*
Introducing the STAT-Site M ß-Hydroxybutyrate
test system, composed of a palm-size
40 CliniCal laboratory news JuLy 2008
2008 NEw Pr o d u c t rE v i E w
reflectance analyzer and reagent card that
measures ß-hydroxybutyrate using a single
drop of human serum or plasma. The test
is important for the diagnosis of diabetic
ketoacidosis (DKA) and monitoring the
results of its treatment. Since ß-hydroxybutyrate
is the most abundant and stable
ketone body produced, it is the more reliable
indicator of ketosis and is the ketone test
recommended by the ADA. With quick and
quantitative results, the STAT-Site M ß-HB
offers several advantages over traditional testing,
including an improvement in linearity
when compared with its predecessor and
negligible interference from other ketones.
*Pending FDA clearance.
Stanbio Laboratory
Circle No. 461 in the Reader Service Card
NanoDrop 8000 Spectrophotometer
The Thermo Scientific NanoDrop 8000
spectrophotometer takes full-spectrum UV/
Vis absorbance measurements of eight 1-μl
samples, such as nucleic acid and protein,
within one 20-second measurement cycle.
Researchers can now perform critical QC
checks that were either difficult or not feasible
using single-sample spectrophotometers
or plate readers. The new Sample Position
Illuminator keeps track of the samples to be
measured from a 96-well plate by lighting up
the wells from underneath. This new feature
helps reduce human error and improves ease
of sampling.
Thermo Scientific,
Part of Thermo Fisher Scientific
Circle No. 462 in the Reader Service Card
Cell Stabilization Reagent
Streck Cell Preservative solution is formulated
to stabilize cellular antigens for immunophenotyping
by flow cytometry. Samples
collected in Streck Cell Preservative are stable
for up to 7 days at room temperature, allowing
for convenient sample transport and
storage. Data has been collected supporting
the use of Streck Cell Preservative with
bone marrow aspirates, tissue samples, and
peripheral blood samples.
Streck, Inc.
Circle No. 463 in the Reader Service Card
Blood Collection Tube for
Cell Preservation and Analysis
Cyto-Chex® BCT is Streck’s blood collection
tube for the preservation of wholeblood
samples for immunophenotyping
by flow cytometry. This direct-draw blood
collection tube contains a patent-protected
preservative that maintains the integrity of
cellular CD markers for up to 7 days. Patient
samples collected in Cyto-Chex BCT are
stable at room temperature for convenient
transport and storage. FDA cleared for the
collection, transport, and storage of HIVinfected
patient samples, Cyto-Chex BCT
preserves the HIV CD panel of markers for
up to 14 days at room temperature.
Streck, Inc.
Circle No. 464 in the Reader Service Card
Whole Blood Cellular Control for HbA1c
Streck’s A1c-Cellular® is the only A1c control
available with intact red blood cells. This
innovative, patent-protected control tests
the entire HbA1c procedure, including
lysing of red blood cells. Controlling with
A1c-Cellular ensures that the entire system,
instrument and reagents, is working properly
and providing accurate patient results. A1c-
Cellular is appropriate for immunoassay and
ionic exchange HPLC methodologies and
is assayed for the Bio-Rad® D-10, Ortho-
Clinical Diagnostics VITROS® 5,1 FS, Arkray
Menarini ADAMS A1c HA-8160, Beckman
Coulter® Synchron CX®, Bio-Rad® Variant
II, Dade Behring® Dimension, Roche Cobas
INTEGRA®, and the Tosoh G7 and A1c
2.2 Plus instruments.
Streck , Inc.
Circle No. 465 in the Reader Service Card
Safety-coated Vacuum Tube for ESR Testing
Introducing a new safety-coated ESR-Vacuum
Tube for erythrocyte sedimentation rate
determination on the ESR-Auto Plus® and
ESR-100 analyzers and the ESR-10 Manual
Rack. Container Technologies Laboratory,
Inc., an independent packaging consultant,
reports that Safety Coated ESR-Vacuum
Tubes are 10 times more impact resistant
than glass collection tubes, significantly
reducing accidental breakage. The Mylar®
coating contains glass and blood specimens
in the event of breakage, reducing the risk of
injury from jagged glass edges and potential
exposure to blood-borne pathogens. Samples
collected in Safety Coated ESR-Vacuum
Tubes exhibit the same stability characteristics
as those collected in conventional glass.
Streck, Inc.
Circle No. 466 in the Reader Service Card
Nucleated Red Blood Cell Control for ADVIA®
nRBC-Chex for ADVIA is the first nucleated
red blood cell (nRBC) control designed
to verify the accuracy and precision of the
nRBC enumeration of the Siemens Healthcare
Diagnostics, Inc. ADVIA 2120. The assay
provides nRBC percent values as well as total
WBC and RBC values. nRBC-Chex for Advia
will allow the clinician to control instrumentreported
nRBC values without manual verification
of a stained patient smear. Packaged
in plastic, cap-pierceable vials for use with
open- or closed-mode systems, nRBC-Chex
for ADVIA offers a closed-vial stability of 105
days and an open-vial stability of 14 days.
Streck, Inc.
Circle No. 467 in the Reader Service Card
VITROS® Troponin I ES
Ortho-Clinical Diagnostics announces the
availability of the VITROS Troponin I ES
assay with improved low-end sensitivity. The
assay is for use with the VITROS® ECi/ECiQ
Immnuodiagnostic System using Intellicheck®
Technology. VITROS Troponin I ES
is used for the quantitative measurement of
cardiac Troponin I in human serum and
plasma to aid in the assessment of myocardial
damage and risk stratification. The
VITROS Troponin I ES assay is concurrent
with the recommendations as described by
the Joint European Society of Cardiology/
American College of Cardiology Committee
(ESC/ACC) for acceptable imprecision in a
high-sensitivity troponin I assay.
Ortho-Clinical Diagnostics
Circle No. 468 in the Reader Service Card
VITROS® ECi/ECiQ Immunodiagnostic System
Enhanced Productivity Module
Ortho-Clinical Diagnostics announces the
availability of the Enhanced Productivity
Module (EPM) for the VITROS ECi/ECiQ
Immunodiagnostic Systems with Intellicheck®
Technology. The EPM Increases
uninterrupted system processing time and
the number of assays processed and reported.
The Enhanced Productivity Module (EPM)
builds on the benefits and functionality of
the VITROS® ECi/ECiQ Immunodiagnostic
Systems, with the EPM providing true
productivity and workflow improvements by
upgrading the VITROS® ECi/ECiQ System

2008 NEw Pr o d u c t rEv i Ew special section
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with extended universal wash reagent and
liquid waste management.
Ortho-Clinical Diagnostics
Circle No. 469 in the Reader Service Card
VITROS® ToRC Assays
Ortho-Clinical Diagnostics announces the
availability of four new infectious disease
assays in international markets excluding the
U.S. The assays, for use on the VITROS® ECi/
ECiQ Immunodiagnostic System, are the
VITROS® Rubella IgM, the VITROS® Toxoplasma
IgM and the VITROS® Cytomegalovirus
(CMV) IgG and IgM assays. These
four new assays complement the already
available VITROS Rubella IgG and VITROS
Toxoplasma IgG assays. Infections with these
agents are most significant during pregnancy,
as they are associated with congenital defects
of the newborn. These assays provide critical
information to physicians caring for women
prior to and during pregnancy.
Ortho-Clinical Diagnostics
Circle No. 470 in the Reader Service Card
VITROS® 5600 Integrated System*
Ortho-Clinical Diagnostics is developing the
VITROS 5600 Integrated System, a high-capacity
system uniquely designed to integrate
more than 120 immunoassays and clinical
chemistry assays on one system. The system
will seamlessly integrate five proven VIT-
ROS® technologies to provide high quality
results, no sample carryover, and no reagent
carryover. It will include MicroSlide, MicroTip,
MicroWell, Intellicheck®, and
MicroSensor technologies. The system
will introduce a sample-centric design to
optimize productivity, eliminating the need
to move samples on a track or create sample
aliquots. It is being designed to be easy to
use with infrequent calibration and minimal
maintenance. Integration by design! *In
development.
Ortho-Clinical Diagnostics
Circle No. 471 in the Reader Service Card
VITROS® 3600 Immunodiagnostic System*
Ortho-Clinical Diagnostics is developing the
VITROS 3600 Immunodiagnostic System,
a high-capacity immunoassay system for
routine and specialty immunoassay testing
using three proven VITROS® technologies:
MicroWell with proprietary Enhanced
Chemiluminescence, Intellicheck®, and MicroSensor
technologies provide high quality
results without compromising workflow.
The broad menu will include cardiac,
thyroid, metabolic, endocrine, anemia,
oncology, prenatal, and infectious disease assays.
Productivity is expected to be enhanced
by using intelligent sample management
to optimize and prioritize assay processing.
Allowing reagents and consumables to
be replaced while operating also optimizes
productivity. The VITROS 3600 Immunodiagnostic
System: integrity and productivity
by design! *In development.
Ortho-Clinical Diagnostics
Circle No. 472 in the Reader Service Card
VITROS® Anti-HIV 1+2 assay
Ortho-Clinical Diagnostics announces the
availability in the U.S., Puerto Rico and U.S.
territories of a new diagnostic assay for the
detection of antibodies to HIV types 1 and/
or 2. The VITROS Anti-HIV 1+2 assay can
be run in a fully automated, random access
format on the VITROS® ECi/ECiQ Immunodiagnostic
System with Intellicheck®
technology. Results are readily available in
less than 50 minutes. This marks the first
anti-HIV 1+2 test in the U.S. capable of running
in full random access at any time, with
other tests, and providing immediate result
reporting upon test completion.
Ortho-Clinical Diagnostics
Circle No. 473 in the Reader Service Card
enGen Recapper and Flex Decapper
Ortho-Clinical Diagnostics announces two
new modules for the enGen Laboratory
Automation System. The Flex Decapper
removes both screw caps and traditional
stoppers from tubes with randomly mixed
heights and widths. This new Decapper uses
sensors to determine the height and width
of each tube and processes 600 tubes per
hour. The Recapper applies universal caps to
primary tubes ranging in size from 13mm
x 75mm to 16mm x 100mm, as well as to
aliquoter secondary tubes.The Recapper
holds 2,000 caps on board, allows reload-
ing without interrupting operation, and
processes 500 tubes per hour.
Ortho-Clinical Diagnostics
Circle No. 474 in the Reader Service Card
e-Antigram Web Site
Ortho-Clinical Diagnostics introduces a new
Web site, www.eantigram.com, that provides
blood bank customers online access to electronic
antigram profiles specific for ORTHO
Reagent Red Cell products (e.g. Selectogen®,
Surgiscreen®, Resolve® Panel A, Resolve®
Panel B, and Resolve® Panel C). Antigrams
are required for these red blood cell products
to complete the tests and give the labs the
information needed to transfuse the correct
units of blood. Previously, antigram files have
been in paper format only, requiring customers
to manually enter the data into softwareassisted
antibody identification systems.
Electronic antigram profiles increase ease of
use and eliminate non-value added work.
Ortho-Clinical Diagnostics
Circle No. 475 in the Reader Service Card
AlbaQ-Chek® Simulated Whole Blood Controls
Ortho-Clinical Diagnostics announces the
availability of the AlbaQ-Check kit for QC
testing in blood-bank laboratories. The
AlbaQ-Chek Simulated Whole Blood Controls,
manufactured by Alba Bioscience, is the
only standardized QC kit in North America
for use with Ortho-Clinical Diagnostics’
proprietary ID-MTS gel technology. It can
be used with the ID-MTS Gel Test when
performed either manually or in the automated
format on ORTHO ProVue.® The
addition of AlbaQ-Chek to the ID-MTS Gel
Test menu offers Ortho-Clinical Diagnostics’
ORTHO ProVue and Gel customers improved
efficiency, standardization, and error
reduction through a cost-effective product.
Ortho-Clinical Diagnostics
Circle No. 476 in the Reader Service Card
PATHFAST Immunochemistry Analyzer
The PATHFAST immunochemistry analyzer
is a compact, fully automatic instrument
suitable for a hospital or POCT. The PATH-
FAST comes complete with an integrated
computer, LCD touch screen, and printer.
Results for most assays are available in as
little as 15 minutes. Convenient, ready-touse,
all-in-one reagent cartridges and the
ability to use whole blood saves time. Six different
assays or up to six samples may be run
simultaneously. The PATHFAST is ideal for
use in hospitals, emergency rooms, clinics,
and the physician office lab settings.
Polymedco, Inc.
Circle No. 477 in the Reader Service Card
CliniCal laboratory news JuLy 2008 41

special section
Advertisement
Fluidic System Design & Manufacturing
Gems® Sensors & Controls will be showcasing
its expanded fluidic system engineering
and manufacturing capabilities at the AACC
Clin Lab Expo. Gems streamlines fluidic sys-
tem design and manufacturing with contract,
collaborative engineering support or turnkey
responsibility from concept to production.
With more than 50 years of engineering and
application experience, a broad portfolio of
fluid sensors and controls, and a dedication
to lean manufacturing, Gems understands
the critical need for a robust quality system
that includes the right documentation,
supplier qualification, and ISO certification.
Gems offers further benefits to our customers
including: reduced development costs,
quicker time to market, reduced supplier
base, and managed inventory.
Gems® Sensors & Controls
Circle No. 478 in the Reader Service Card
SpeciMinder Transport System
The SpeciMinder autonomous mobile robot
transports specimens within clinical labs
and related areas. Onboard sensors guide
the SpeciMinder through its environment,
eliminating the need for control markings or
external beacons. With a simple elevator-like
user interface, operating the SpeciMinder is
intuitive and uncomplicated. The robot is
designed for 24/7 continuous operation and
automatically recharges itself when batteries
are low. Specialized electronics manage
automatic doors and elevators as part of the
SpeciMinder’s normal routine. The upper
carrier section can be customized for a wide
variety of payloads.
CCS Robotics
Circle No. 479 in the Reader Service Card
One Step, Rapid Cardiac Test*
This rapid, qualitative immunoassay test is
for professional use to aid in the diagnosis
of myocardial infarctions at POC facilities,
emergency department, or other hospital
settings. The test operates with four drops of
straight human whole blood or serum, and
the results can be read within 10–15 min-
42 CliniCal laboratory news JuLy 2008
2008 NEw Pr o d u c t rE v i E w
utes. Additional reagents are not required. It
may be used along with a reader to provide
a quantitative measurement of troponin
I, CK-MB, and myoglobin. *Pending FDA
clearance.
Alfa Scientific Designs, Inc.
Circle No. 480 in the Reader Service Card
Direct Enzymatic HbA1c
This fully liquid-stable, enzymatic assay
was developed to provide accurate results
without interference from hemoglobin variants
that can decrease the reliability of other
HbA1c methods. This assay is fully NGSP
certified and provides highly precise and
accurate HbA1c results. The product is a
single-channel assay that eliminates the need
for a separate hemoglobin measurement,
simplifying test setup and maintenance.
Parameters are available for a wide variety of
clinical chemistry analyzers. In addition to
universal packaging, the assay is also supplied
pre-formatted in convenient instrument-specific
reagent cartridges for optimal operator
ease of use and efficiency.
Diazyme Laboratories
Circle No. 481 in the Reader Service Card
Cystatin C Assay
This dual-reagent, fully liquid-stable immunoturbidimetric
assay has been optimized
for use on general chemistry systems. Cystatin
C measurements have been shown to be
more reliable than serum creatinine-based
measurements in detecting the early changes
in GFR associated with diabetic nephropathy.
This method provides accurate and reliable
results across an extended testing range with
highly precise CVs of less than 5%. Parameters
are available for a wide variety of clinical
chemistry analyzers. In addition to universal
packaging, the assay is also supplied preformatted
in convenient instrument-specific
reagent cartridges for optimal operator ease
of use and efficiency.
Diazyme Laboratories
Circle No. 482 in the Reader Service Card
Vitamin D HPLC Test
Introducing ESA Biosciences’ Vitamin D
HPLC Test, the only HPLC test that is FDAcleared
for the clinical assessment of vitamin
D sufficiency. This assay meets the challenge
of detecting the individual metabolites and
reports total 25-hydroxy vitamin D. The
ESA Vitamin D Test provides accurate and
specific results as demonstrated through
comparison with other methods: HPLC-UV
and LC-MS. Composed of a reagent kit and
test system, the ESA Biosciences’ Vitamin D
HPLC Test provides high-quality results and
is cost effective.
ESA BIOSCIENCES, INC.
Circle No. 483 in the Reader Service Card
High Speed Sorter
Sarstedt’s High Speed Sorter is a modular
front- and back-end system that automates
time-consuming lab processes. Options
include identification, sorting, decapping, aliquotting,
recapping, and the new bulk loading
module that eliminates the pre-racking
of incoming specimens—tubes are simply
“dumped” into a hopper for walk-away processing.
Two components of the system, the
Decapper DC 1200 and Recapper RC 1200,
are available as benchtop or stand-alone
units that process up to 1,200 screw-cap,
push-cap, or evacuated tubes per hour.
Sarstedt, Inc.
Circle No. 484 in the Reader Service Card
Aware Messenger Oral Fluid Device
Aware Messenger is a research device for
collecting, stabilizing, and transporting oralfluid
specimens used for detecting specific
antibodies or analytes. Aware Messenger
specimens may be adapted to conventional
laboratory-based immunoassays (e.g.,
ELISA), enabling high-throughput batch
testing, automation, quantitative results, and
lower costs. The device provides a stabilized,
high-quality, and immunoassay-friendly
oral fluid specimen that is easily collected
and requires no further processing (e.g.,
centrifugation). Aware Messenger specimens
are rich in various analytes representative of
those found in blood. Applications include
detection of infectious disease antibodies and
antigens, cancer markers, nucleic acids, illicit
drugs, and hormones.
Calypte Biomedical Corporation
Circle No. 485 in the Reader Service Card
Platelia Lyme IgM and
Platelia Lyme IgG Tests*
Bio-Rad announces a new Platelia Lyme IgM
test kit and a new Platelia Lyme IgG test kit.
These tests are qualitative and intended for
use in the presumptive detection of human
IgM and IgG antibodies respectively to Borrelia
burgdorferi in human serum or plasma.
They are EIA tests that can be used to test
serum or plasma from patients with a history
and symptoms of infection with B. burgdorferi.
*Pending FDA clearance.
Bio-Rad Laboratories
Circle No. 486 in the Reader Service
InnovaStar POC Chemistry Analyzer
The InnovaStar is a small clinical chemistry
analyzer for POC testing in diabetes manage-
ment. An advanced diabetes profile with glu-
cose, HbA1c, and hemoglobin is determined
by photometric measurement. This fullyautomated
analyzer works with pre-filled,
bar-coded, ready-to-use reagents (unit dose).
Previous sample preparation is not necessary,
and all parameters are determined from the
same hemolyzate. Its excellent performance
with regard to precision and specificity is
comparable with other clinical chemistry
analyzers.
DiaSys Diagnostic Systems GmbH
Circle No. 487 in the Reader Service Card
The fe500pro Sample Processor
The fe500pro is a fully automated platform
that meets the sample processing requirements
of hospitals, research institutes, and
other clinical labs. It’s a reliable workhorse
for the whole range of sample-handling tasks
that are necessary before analytical testing
in core departments. Its flexibility and
modularity, along with the smallest footprint
and most functionality of any pre-analytical
instruments, mean it can be fitted into any
existing laboratory setup to enhance the
sample flow. Its unique security features
increase sample security to new levels. The
fe500pro—navigating you toward security
and efficiency.
Tecan U.S., Inc.
Circle No. 488 in the Reader Service Card
Parker Smart Syringe Probe
The Parker Smart Syringe Probe dramatically
shortens clinical lab instrument
design time and improves performance by
enabling simpler and more efficient processes
with its compact size and integrated
intelligence. It replaces bulky syringe pumps
in liquid handling and diagnostic equipment,

2008 NEw Pr o d u c t rEv i Ew special section
Advertisement
eliminating the use of transfer lines and
consequently improving accuracy and precision.
At 8 mm in diameter and weighing only
26 g, probes have 9-mm centers with each
syringe drive operating independently. With
its patented technology, small footprint, use
of serial communications, and easy serviceability,
the Parker Smart Syringe Probe helps
optimize instrument design.
Parker Hannifin/ Pneutronics Division
Circle No. 489 in the Reader Service Card
CVDefine Assay
CVDefine is a unique new marker for early
detection of harmful lesions caused by
immunological response and inflammation
in the artery wall. CVDefine measures
antibodies against phosphorylcholine (PC),
one of the major epitopes on oxLDL. These
antibodies are common from an early age
and have an important role in development
of cardiovascular disease. Low IgM anti-PC
Ievels indicate an increased risk for cardiovascular
disease, while high anti-PC levels
predict a favorable outcome in atherosclerosis
development in hypertensive patients.
CVDefine provides an easy-to-use standard
ELISA procedure for quantitative analysis of
PC antibodies in human serum and plasma.
Athera Biotechnologies
Circle No. 490 in the Reader Service Card
BS-400 Chemistry Analyzer
The new BS-400 fully-automatic clinical
chemistry analyzer extends the excellent
reputation of the BS series family renowned
for high performance. The BS-400 is a
truly random access and open system for
routine and special chemistries, including
specific proteins and electrolytes. It provides
a flexible work platform for end users with
reliable product quality. With throughput
of constant 400 chemistry tests per hour,
the BS-400 is an ideal workstation as a main
system, back-up system, or for specialties.
Shenzhen Mindray Bio-Medical
Electronics Co., Ltd.
Circle No. 491 in the Reader Service Card
Liquid Stable Homocysteine Reagent
The Liquid Stable(LS) 2-Part Homocysteine
reagent is intended for in vitro quantitative
determination of total homocysteine in
plasma and serum (EDTA , Li-Hep, serum,
and SST). The versatile assay employs two
ready-to-use reagents and two calibrators
and is standardized to the NIST SRM 1955
Homocysteine Reference Material. A key
feature of the assay is the onboard reagent
stability for 30 days that ensures a typical
calibration stability of 14 days. The LS 2-Part
assay demonstrates excellent correlation
with both other immunoassays and HPLC
methods. The test has a high throughput of
up to 750 tests/hr and clinical protocols are
available for many of the commonly used
clinical chemistry analyzers.
Axis-Shield
Circle No. 492 in the Reader Service Card
Evaluation Validation Software
for Clinical Lab Instruments
EP Evaluator, Release 8 is the industryleading
product line of software programs
to evaluate clinical lab methods. Flexible
design provides the features needed by small,
medium, and large labs to meet all CLIA
‘88 and CAP requirements for validating
and evaluating methods. The program also
includes three lab management modules:
Inventory Management, Cost per Test, and
Incident Tracking to monitor patient safety
events.
David G. Rhoads Associates, Inc.
Circle No. 493 in the Reader Service Card
ACU-CAP Vial Closure
The new ACU-CAP vial closure provides
convenient and precise reconstitution of
lyophilized materials, eliminating the need
for manual pipetting. The single-use device
makes the reconstitution of reagents,
calibrators, and QC materials significantly
more convenient for labs and POCT locations
and eliminates the imprecision and
pre-analytical error associated with manual
pipetting.
Eurotrol, Inc.
Circle No. 494 in the Reader Service Card
Combination QC for i-STAT Analyzers
GAS-ISE-HCT QC is the first all-in-one
control product of its kind with pH, blood
gases, electrolytes, metabolites, and hematocrit
target values. Designed for i-STAT
analyzers, the product eliminates the need to
use two separate cartridges with each control
check and cuts QC time in half. The product
is available as a three-level QC, as well as a
5-level AMR/linearity panel.
Eurotrol, Inc.
Circle No. 495 in the Reader Service Card
Po2 AMR Validation Control
Hypoxic QC is the first pre-tonometered
product of its kind to validate critically low
(35mmHg) and extra-low (15mmHg)
Po2 values. Hyperbaric QC is designed to
validate the high (460mmHg) and extrahigh
(710mmHg) Po2 range. Together, these
two products validate the full Po2 analytical
measurement range (AMR) of blood
gas analyzers. Hypoxic QC features active
hemoglobin buffering with 10-minute open
ampule stability, making it well suited to
perform method comparisons as well. The
Hyperbaric QC is an aqueous formulation
that validates high and ultra high recovered
values—ideal for cardiac catheterization labs
and OR suites.
Eurotrol, Inc.
Circle No. 496 in the Reader Service Card
Hemosure® Immunological
Fecal Occult Blood Test
The Hemosure Fecal Occult Blood Test
(IFOBT) is the most advanced screening
method for colorectal cancer available today.
The technology has eliminated the need
for patient dietary and medication restrictions
prior to testing and it has significantly
increased the chance of early detection of
this very curable disease. Easily performed
in clinics, doctors’ offices, hospitals, and labs.
The Hemosure iFOB is FDA approved and
CLIA waived.
Hemosure Inc.
Circle No. 497 in the Reader Service Card
Combiscan/Combiscreen
Urinalysis Screening System
The superior urinalysis screening products
from Analyticon, a leading company selling
around the world, are now available in the
U.S. CombiScan® readers and CombiScreen®
strips, using advanced German
product engineering, offer superior performance
plus fast and cost-effective results.
A choice of two CombiScan readers deliver
automated high throughput that can link
directly to patient and hospital databases.
Importantly, CombiScreen strips cost 25%
less than competing products from the major
manufacturers. The overall system is an ideal
entry-level, complete solution for laboratories
looking for superior performance at
affordable prices.
Analyticon Biotechnologies, Inc.
Circle No. 498 in the Reader Service Card
Lyophilized Reagent Delivery Systems*
The ReActivator reagent delivery system
incorporates manufacturers’ reagents in a
lyophilized state (LyoSpheres) and liquid
diluents together inside of an easy-to-use
disposable unit-of-use rehydrating and mixing
dispenser. ReActivator provides your
customers with pre-measured, convenient,
precise, and contaminate-free, stable
reagents. BIOLYPH has developed and designed
12 different models of ReActivator to
meet a wide variety of needs. BIOLYPH will
also customize a ReActivator model to meet
your specific requirements. *Patent pending.
BIOLYPH LLC.
Circle No. 499 in the Reader Service Card
CliniCal laboratory news JuLy 2008 43

long-awaited cdc draft report on
the status of lab medicine published
after months of anticipation, a draft
of Laboratory Medicine: A National
Status Report is available for viewing. CDC
accepted comments on the draft until June
23 and will consider them for inclusion in
the final draft, expected to be posted by the
end of July.
The report is one part of a three-task
project shepherded by the CDC to enhance
the practice of laboratory medicine by identifying
ways to improve laboratory testing
and services. The other related tasks and
accompanying reports involved developing
a process to define, identify, categorize, and
evaluate best practices and policies in laboratory
medicine and the settings in which
they apply; and evaluating the effectiveness
of U.S. proficiency testing programs
to meet quality improvement, educational,
and regulatory goals for clinical laboratories
(see CLN, June 2008).
Written by The Lewin Group, under
subcontract to Battelle Memorial Institute,
the report examines key factors affecting
laboratory medicine. It includes a
detailed profile of the laboratory medicine
sector and discusses such topics as current
standards for laboratory testing and services,
regulatory oversight including CLIA,
impact of accreditation, reimbursement
policies, performance measurement, quality
improvement, evidence-based decision
making, and trends affecting the field.
According to the report, laboratory services
account for only 2.3% of total U.S.
reguLatory
44 CliniCal laboratory news JuLy 2008
p r o f i L e s
p r o f i L e s
healthcare expenditures and 2% of Medicare
expenditures, but they play a significant
role in informing healthcare decisions
and spending. Appropriate use of laboratory
testing is essential for achieving safe,
effective, and efficient patient care. To read
the draft report, go to www.futurelabmedicine.org.
aacc calls on
laboratorians to support
The national children’s study
Children’s Health Act of 2000 au-
T he
thorized the National Institute of Child
Health and Human Development, as well
as the National Institute of Environmental
Health Sciences, the CDC, and the U.S.
Environmental Protection Agency, to conduct
the National Children’s Study (NCS).
This initiative will examine environmental
influences on the health and development
of over 100,000 children through infancy,
childhood, and early adulthood. But this
study is contingent on Congress’s providing
the $192.5 million needed to keep the
National Children’s Study moving forward.
Unfortunately, the budget proposal President
Bush submitted to Congress for FY
2009 did not provide funding for the study.
AACC has endorsed the study, and the
Pediatric Reference Range Committee
(PRRC) is working with the scientists leading
the study, advising them on laboratoryrelated
issues such as how to collect and
store samples and how to analyze them.
The PRRC hopes to use the data gathered
from the study to develop pediatric refer-
ence ranges. The PRRC also is planning to
conduct a series of adjunct studies, in conjunction
with the NIH initiative, to consider
key analytes not taken up by NCS.
AACC urges all laboratorians to contact
their legislators via AACC’s online advocacy
center on the AACC Web site, www.aacc.
org/gov/gov_affairs/pages/capwiz.aspx, to
encourage them to support this important
study.
national Quality forum
endorses consensus standards
The National Quality Forum (NQF)
has endorsed 48 voluntary consensus
standards focused on measuring the performance
of acute care hospitals. NQF anticipates
that these measures will facilitate
broad-based quality improvement within
hospitals and will help track progress toward
improved patient safety.
Six of the measures target venous
thromboembolism (VTE), a leading cause
of illness and death in the U.S. One of these
measures involves laboratory assessment of
VTE patients with anticoagulation overlap
therapy, and another focuses on unfractionated
heparin dosages/platelet count
monitoring.
NQF has categorized other measures as
Length of Stay/Readmission, Adult Patient
Safety, Pediatric Patient Safety, Pediatrics,
and Surgery and Anesthesia. To view the
entire list of measures, go to www.qualityforum.org/news/releases/051508-endorsed-measures.asp.
rWjf commits $300 million
To Tackle disparities
The Robert Wood Johnson Foundation
(RWJF) recently announced a 3-year,
$300 million initiative intended to narrow
healthcare disparities across lines of
race and geography. Officials said it would
be the largest effort to improve healthcare
quality ever undertaken by a charity in the
U.S. The initiative, focusing on communities
in 14 geographic areas that together account
for 11% of the population, will bring
together practices, hospitals, health plans,
and patients to work on ways to improve
the quality of care across different settings.
The RWJF also released new research—
conducted by the Dartmouth Atlas Project
at the Dartmouth Institute for Health
Policy and Clinical Practice—that analyzes
Medicare claims to illustrate variations in
healthcare quality nationwide. One finding
of the new study was that an estimated one
in seven patients with diabetes does not get
crucial blood tests, such as HbA1c. About
85% of white patients with diabetes received
these tests, compared with 79% of African
Americans. In Alaska, 71% of patients with
diabetes received blood sugar control tests
every year, compared with the national average
of 91%. To access more information
about the initiative, go to www.rwjf.org.
federal Grants for
school drug Testing
The White House Office of National
Drug Control Policy and the U.S. Dept.
of Education awarded federal grants for
school-based random student drug testing
totaling $5.8 million to 50 educational entities
in 20 states. It is the fifth such grant
award announcement since 2003.
States in which the grants were awarded
are: Alabama, Arizona, California, Colorado,
Florida, Illinois, Indiana, Kentucky,
Louisiana, Michigan, Mississippi, Nevada,
New Jersey, North Carolina, Ohio, Oklahoma,
Pennsylvania, Texas, Utah, and Washington.
Grant amounts range from $38,860,
given to Currituck County Schools in North
Carolina, to $228,569, given to Premier Integrity
Solutions, a drug and alcohol testing
company headquartered in Russell Springs,
Kentucky.
More than $40 million in federal grants
have gone to an estimated 140 education
and health entities since 2003 to develop,
implement, or expand random student
drug testing. The U.S. Supreme Court upheld
the constitutionality of school-based
random student drug testing in 1995 and
2002.
next month
in CLN
cdc’s
status of lab
medicine
report

iNdustry
p r o f i L e s
p r o f i L e s
Gen-probe offers $334 million
molecular diagnostics market, which we
estimate is growing at roughly double the
bid for innogenetics
rate of the U.S. market,” said Gen-Probe
seeking a deal that could make it the CEO Hank Nordhoff. “The proposed ac-
largest stand-alone molecular diagquisition would provide access to a number
nostics company in the world, Gen-Probe of complementary products, technologies,
launched a $334 million cash bid for the and markers that are generating revenue
Ghent, Belgium-based diagnostics compa- today or that we believe could be commerny
Innogenetics. The Gen-Probe offer is 6%
higher than an initial April 25 bid by Solvay
Pharmaceuticals S.A. (Brussels, Belgium).
cialized in the future.”
If Innogenetics accepts the Gen-Probe bid, siemens, labcorp planning
the combined company would boast more
than $500 million in sales for 2008, according
to Gen-Probe. “We believe our pro-
To co-develop Tests
siemens Healthcare and LabCorp announced
a preliminary agreement to
posed acquisition of Innogenetics would co-develop new clinical diagnostic tests
provide strategically valuable marketing for companion diagnostics, metabolic
and sales, distribution, and manufacturing syndrome, oncology, and diabetes. “This
capabilities to accelerate commercialization agreement establishes a framework that
of Gen-Probe products in the European gives both companies an opportunity to of-
fer new diagnostic tests to the laboratories,
physicians, and their patients more quickly
and effectively than either could do alone,”
said David Hickey, senior vice president of
strategic planning and business development
for Siemens. “Advancing healthcare
for patients is an important commitment
that we can reach through strategic relationships
such as this.” Financial terms were
not disclosed.
labcorp signs deal to offer
companion Test for new
schizophrenia drug
announced a deal with Vanda
l abCorp
Pharmaceuticals to develop and sell
diagnostic tests for pharmacogenetic markers
that Vanda identified in the course of its
development of the schizophrenia drug Fanapta
(iloperidone), which is still under FDA
review. “Working with innovative companies
like Vanda to commercialize predictive
medicine tests is a critical strategic focus for
LabCorp,” said Andrew Conrad, PhD, chief
scientist and global head of clinical trials for
LabCorp. “This collaboration is an example
of our commitment to the advancement of
personalized medicine and represents a successful
translation of a research-based assay
into a valuable diagnostic test. This relationship
is consistent with our focus on companion
diagnostics.” Financial terms of the
deal were not disclosed.
nanogen Gets cdc
contract for flu Test
for the second time, the CDC has
awarded Nanogen a contract to develop
a rapid flu test as part of the CDC’s
plan to prepare for a potential flu pandemic.
The $10.4 million, 2-year contract will
have Nanogen develop a fast molecular test
that simultaneously detects and differenti-
ates influenza A, B, seasonal flu (H1N1 and
H3N2) strains, and RSV. The agreement
also provides for a secondary test for avian
flu strains (H5N1, H7N1,and H9N1) to be
used for samples that are positive for flu A
but negative for seasonal flu. Nanogen said
the test will be significantly more sensitive
than current rapid flu tests and will take half
the time. “Recently there have been a number
of multiplexed molecular products for
respiratory targets to hit the market,” said
Nanogen CEO Howard Birndorf. “These
products, however, are expensive and test
for more pathogens than are useful in clinical
diagnosis. Having a fast molecular assay
that can be used as a confirmatory test for
influenza will improve the tools available
to clinicians for better patient health management.”
Nanogen will develop the test in
partnership with the Medical College of
Wisconsin and Handylab, Inc.
chembio awarded nih
Grant for rapid Tb Test
chembio Diagnostics announced a
$296,000 NIH Small Business Innovation
Research (SBIR) grant to develop a
simple, rapid, accurate, and cost-effective
blood test for active tuberculosis that can
be used in resource-limited settings. The
test will use Chembio’s Dual Path Platform
technology together with antigens from a
large panel of novel recombinant antigens
identified at the Infectious Disease Research
Institute (IDRI, Seattle, Wash.), a research
organization focused on technologies for
the developing world. Under the terms of
its NIH SBIR award, Chembio will share
approximately 1/3 of the grant funds with
IDRI. Chembio will develop the new test
for POC or field use, with results produced
within 15 minutes. The test will offer a visual
reading, as well as an optional automated
readout of the result.
CliniCal laboratory news JuLy 2008 45

even mildly elevated Glucose
poses risk in pregnancy
large international study shows a con-
a tinuum of risk to fetuses as mothers’
glucose levels rise (NEJM 2008; 358:
1991–2002). To settle a controversy about
whether maternal hypoglycemia that falls
short of diabetes is associated with adverse
pregnancy outcomes, a multinational team
of researchers tested glucose levels in 25,505
pregnant women at 24 to 32 weeks of gestation
at 15 centers in 9 countries. Researchers
blinded data for mothers with fasting plasma
glucose levels ≤105 mg/dL and 2-hour
plasma glucose levels ≤200 mg/dL. Primary
outcomes were birth weight above the 90th
percentile for gestational age, primary cesarean
delivery, clinically diagnosed neonatal
hypoglycemia, and cord-blood serum
C-peptide level above the 90th percentile.
Secondary outcomes were delivery before
diagNostiC
46 CliniCal laboratory news JuLy 2008
p r o f i L e s
p r o f i L e s
37 weeks of gestation, shoulder dystocia
or birth injury, need for intensive neonatal
care, hyperbilirubinemia, and preeclampsia.
For the 23,316 participants with blinded
data, the researchers calculated adjusted
ORs for adverse pregnancy outcomes associated
with an increase of 1 standard deviation
in the fasting plasma glucose level
(6.9 mg/dL), the 1-hour plasma glucose
level (30.9 mg/dL), and the 2-hour plasma
glucose level (23.5 mg/dL). For birth weight
above the 90th percentile, those ORs (95%
CI) were 1.38 (1.32–1.44), 1.46 (1.39–1.53),
and 1.38 (1.32–1.44), respectively. For cordblood
serum C-peptide level above the 90th
percentile, the ORs were 1.55 (1.47–1.64),
1.46 (1.38–1.54), and 1.37 (1.30–1.44).
ORs for primary cesarean delivery were
1.11 (1.06–1.15), 1.10 (1.06–1.15), and
1.08 (1.03–1.12). ORs for neonatal hypoglycemia
were 1.08 (0.98–1.19), 1.13 (1.03–
1.26), and 1.10 (1.00–1.12). The researchers
found no obvious thresholds for increased
risk. Associations for secondary outcomes
were significant, but weaker.
longer cholesterol Testing
intervals recommended
physicians should consider a testing interval
of 3 years or more for patients
who have well-controlled cholesterol levels
and adhere to cholesterol-lowering medications,
authors of a recent paper suggest
(Annals of Internal Medicine 2008; 148: 656–
661). Because research has not yet shown an
optimal cholesterol monitoring interval and
clinical practice varies, researchers from the
U.K. and Australia sought to estimate both
the variation in initial response to treatment
and the long-term drift from initial
response. They also aimed to estimate the
ability to detect long-term changes in cholesterol
levels during treatment (signal),
given short-term, within-person variation
(noise). The research team analyzed serum
cholesterol concentrations at baseline, 6
months, and 12 months, and annually thereafter
for the next 4 years in 9,014 patients
who participated in the LIPID (Long-Term
Intervention with Pravastatin in Ischemic
Disease) trial. Researchers randomized the
patients, who had past coronary heart disease,
to receive pravastatin or placebo. Both
the placebo and pravastatin groups showed
small increases in within-person variability
over time. The estimated within-person
standard deviation increased from 15 mg/
dL (CV, 7%) to 23 mg/dL (CV, 11%), but it
took almost 4 years for the long-term variation
to exceed the short-term variation. This
slow increase in variation and the modest
increase in mean cholesterol level, about 2%
per year, suggest that most of the variation
in the study is due to short-term biological
and analytic variability. The researchers
maintained that for patients with levels ≥19
mg/dL under target, monitoring is likely to
detect many more false-positive results than
true-positive results for at least the first 3
years after treatment.
from 136.2 to 133.5 mg/dL, and increased
over the subsequent 2 days to 141.8 mg/dL.
These changes did not seem to be clinically
meaningful, according to the researchers.
Similar changes were observed for total cholesterol
and smaller changes for HDL-C, but
fasting triglyceride levels did not change.
pca3 score predicts
prostate Tumor volume
newly published study suggests that
a the prostate cancer gene 3 (PCA3) test
might have clinical application in selecting
men with low-grade and low-volume tumors
who would be suitable candidates for
active surveillance (J Urol 2008 179:1804–
1809). To assess association of urinary
PCA3 score with prostatectomy tumor
volume and other clinical and pathological
features, a research team from the University
of Texas M.D. Anderson Cancer Center
collected urine specimens after digital rectal
examinations from 59 men scheduled
for prostate biopsy and 83 men scheduled
for radical prostatectomy. The researchers
evaluated prostatectomy findings from 96
men, using the Gen-Probe DTS 400 System
to quantify PCA3 and PSA mRNA,
and tabulated PCA3 score as ratio of PCA3
mRNA to PSA mRNA X 100. Scores for the
30 men with negative biopsies and the 29
with positive biopsies differed significantly,
with medians of 21.1 and 31.0, respectively.
PCA3 scores were significantly correlated
with total tumor volume in prostatectomy
specimens and with prostatectomy Gleason
score, but not with other clinical and
pathological features. When researchers
compared low volume/low grade cancer
(dominant tumor volume less than 0.5 cc,
Gleason score 6) and significant cancer, differences
in PCA3 scores were significant.
In multivariate analysis, PCA3 was the best
predictor of total tumor volume in prostatectomy.
ROC curve analysis showed that
the PCA3 score could discriminate low volume
cancer (total tumor volume less than
0.5 cc) well, with AUC of 0.757.
minimal change in lipids after acs low vitamin d levels linked to
mean lipid levels vary little in the 4 depression in the elderly
days after an ACS event and can help large population-based study shows
guide selection of lipid-lowering medica- a depression status and severity is assocition,
according to the results a recent study ated with decreased serum 25-hydroxyvita-
(J Am Coll Cardio. 2008; 51:1440–1445). To min D [25(OH)D] levels and increased se-
help quell a debate over how long changes rum parathyroid hormone (PTH) levels in
in lipid levels persist after ACS, researchers older adults (Arch Gen Psychiatry 2008;65:
from University of Michigan, Ann Arbor, 508–512). A team of researchers from the
analyzed data from the LUNAR (Limit- Netherlands determined if 1,282 commuing
UNdertreatment of lipids in ACS with nity residents ages 65–95 suffered from de-
Rosuvastatin) trial to assess lipid changes pression using self reports and diagnostic
1 to 4 days after ACS onset. The prospec- interviews. They assessed levels of 25(OH)
tive, multicenter, randomized, open-label D and PTH and considered potentially
study’s overall goal was to compare efficacy confounding factors such as age, sex, smok-
of the two drugs in adults hospitalized for ing, body mass index, and explanatory fac-
acute ST-segment elevation myocardial intors including the season of measurement
farction (STEMI), non-STEMI, or unstable and physical activity. 25(OH)D levels were
angina (UA). Before treatment, research- 14% lower in 169 persons with minor deers
measured serum lipid levels in blood pression and 14% lower in 26 persons with
samples at medians of 26 hours, 43 hours, major depressive disorder, compared with
and 84 hours after onset of ACS symptoms. levels in 1,087 controls. Levels of PTH were
Of the 507 patients available for analysis, 5% and 33% higher, respectively. Depres-
212 were admitted for STEMI, 176 for non- sion severity was significantly associated
STEMI, and 119 for UA. The LDL-C levels with decreased serum 25(OH)D levels and
decreased in the 24 hours after admission, increased serum PTH levels.

paragondx Gets clearance for
ambc’s rapid ToX cup cleared
Warfarin sensitivity Genotyping Kit
p
american Bio Medica announced FDA
aragonDx announced FDA clearance clearance of its Rapid TOX Cup drug
for its rapid genotyping assay that de- screen system, an all-inclusive DOA cup
tects the presence of variations in the genes platform. Available with multiple assay
CYP2C9 and VKORC1, information physi- combinations according to customer recians
can use to identify patients who are at quirements, the Rapid TOX Cup does not
greater risk for warfarin sensitivity. The test require any manipulation of the device and
can be completed within 1-hour and was includes a temperature strip affixed to the
FDA cleared using the Cepheid SmartCy- cup to ensure specimen integrity. Results
cler Dx platform.
fda clears invitrogen Transplant
can be photocopied for recordkeeping, and
the all-in-one design allows collection, testing,
and shipment for confirmation.
compatibility Test system
invitrogen announced FDA clearance for fda drops backup Testing
its DynaChip Antibody Analysis System, requirement for prodesse’s proflu+
p
the only automated chip-based system for rodesse announced that the FDA
HLA antibody detection and identification. okayed changing the package insert for
Providing fully integrated instrumentation, the ProFlu+ molecular respiratory viruses
reagents, and software, the system is com- test to remove the recommendation that
posed of a processor for automated assay negative results for flu A and B be confirmed
processing, a protein array that allows test- by culture. The agency first cleared the test
ing of multiple antibodies at the same time, in January. So far this is the only molecu-
and interpretation software for automated lar test for respiratory viruses for which the
analysis.
FDA has decided that no backup testing is
news from the fda
needed. The FDA also allowed Prodesse to
add the bioMérieux NucliSENS easyMAG
automated nucleic acid extraction system
as an acceptable extraction method for the
ProFlu+ test.
fda clears access Toxo igG assay
beckman Coulter announced the clearance
of its Access Toxo IgG assay, a
paramagnetic-particle, chemiluminescent
immunoassay for the quantitative and
qualitative determination of IgG antibodies
to Toxoplasma gondii in human serum
using the company’s Access immunoassay
instruments. The test is cleared as an aid in
the diagnosis of Toxoplasma gondii infection
and may be used to assess the immune
status of pregnant women. It’s not cleared
for screening blood or plasma donors in
the U.S.
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Territory manager
full Time regular
responsibilities
implement programs for achieving forecasted objectives with a specific list
of customers; develop and maintain customer/company relationships; and
provide in-service education functions for a specific list of customers. develop
and manage business relationships with targeted physicians and clinics;
maintain responsibility for territory management, analysis, development, and
growth. direct and implement sales support strategy, marketing operations,
and organizational structure, including sales and marketing analytics, field administration,
program administration, contract administration, and customer
service. Maintain responsibility for business development and management
of medical sales territory. utilize experience in nutrition and health product
sales with in-depth knowledge of human cellular function.
requirements
the position requires a bachelor’s degree in any field plus two (2) years of experience
in job offered or two (2) years of experience in nutrition and health
product sales with in-depth knowledge of human cellular function. employer
will accept any suitable combination of education, training or experience. significant
travel required.
send resumes to Joi robertson, spectraCell laboratories, inc., 10401 town park
drive, Houston, tX 77072. 713-621-3101.
CliniCal laboratory news JuLy 2008 47