June 2012 - American Association for Clinical Chemistry

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

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