December 2010 Clinical Laboratory News: A Call for Testosterone Testing Standardization

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December 2010: Volume 36, Number 12

A Call for Testosterone Testing Standardization
Consensus Statement Intended to Spur Efforts Already Underway

By Genna Rollins

AACC recently joined with 10 other professional medical organizations and the Centers for Disease Control and Prevention (CDC) to endorse a consensus statement calling for broad implementation of standardized testosterone measurements (J Clin Endocrinol Metab 2010; 95:4542–48). The new statement, “Toward Excellence in Testosterone Testing: A Consensus Statement”, incorporates stakeholders comments from a meeting held earlier this year and reflects concerns as test volumes for the hormone grow. Clinicians are ordering testosterone tests more frequently today than in the past for both patient care and research as the result of evidence linking testosterone to a variety of conditions. Interest in testosterone therapy also has boosted testing volumes.

Even as testosterone testing has increased, however, the consensus statement notes that “important discrepancies and inaccuracies in measurements” are widespread, especially in the critical low ranges of testosterone concentrations found in women, children, and hypogonadal men. Measurement issues include lack of accuracy, specificity, sensitivity, precision, and reliability. These shortcomings hinder broad and effective implementation of testosterone assays and threaten the health of patients whose treatment depends on accurate testosterone measurement, according to the statement. The measurement problems also have “significant” cost implications due to frequent retesting and unnecessary treatments. Earlier this year, Clinical Laboratory News reported on problems associated with measuring testosterone in women and children (CLN 2010;36:1–5).

In February, representatives from various professional societies, government, and industry who have a stake in ensuring accurate and reliable testosterone measurement met to discuss their concerns. Now the group has issued the consensus statement and a preliminary timeline to implement its recommendations.

“The testosterone consensus statement is a call to action on multiple fronts. Many laboratories have been reporting inaccurate testosterone results for decades, and this document is an important vector for improvement,” said Rob Fitzgerald, PhD, a professor of pathology at the University of California San Diego and associate director of clinical chemistry at VA San Diego Healthcare System. “The bottom line is that all testosterone measurements eventually will be required to be accurate and precise. Just as improvements in and standardization of hemoglobin A1c measurements have improved the care of diabetics, excellence in testosterone measurements will improve the care of patients with endocrine disorders.” Fitzgerald represented AACC at the conference.

Principal stakeholders cited in the consensus statement who want to see the quality of testosterone testing improved include physicians and other health care providers, medical societies and journals, clinical lab directors, clinical lab associations, regulatory agencies, diagnostics manufacturers, pharmaceutical companies, third-party payers, the National Institutes of Health and other funding agencies, and patients and patient support groups.

The statement calls for expert scientific and medical communities to: define performance criteria that cover the full range of expected values, from children to both male and female adults; establish reference intervals in adults and children of both sexes; and develop guidelines and protocols to ensure uniform patient preparation and handling of samples prior to analysis. In addition, third-party payers and healthcare organizations need to promote use of assays that have been standardized and work to enable payment only for these standardized assays. The group also challenged manufacturers and laboratories to continue to refine testosterone testing methodologies to ensure sensitive, specific, accurate, and cost-effective measurement of the analyte.

The statement underscores CDC’s key role in achieving testosterone measurement standardization. This year, the agency started a standardization project in which assay manufacturers and laboratories that use lab-developed methods for measuring testosterone can enroll. In addition, CDC has conducted an interlaboratory comparison to assess measurement variability among labs using mass spectrometry to measure testosterone and has assessed for commutability a new testosterone reference material developed by the National Institute for Standards and Technologies.

Moving forward, the group plans to create task forces by the end of this year to address specific recommendations. In 2011, they hope to achieve broad participation of laboratories and assay manufacturers, and by 2012 have a sufficient number of laboratories and assays standardized to CDC methods and materials.

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