June 2012 - American Association for Clinical Chemistry

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