Endocrine Insider
March 4, 2010

(See full Issue)

Last month The Endocrine Society, in conjunction with the Centers for Disease Control and Prevention (CDC), convened a meeting to reach consensus among stakeholders on the impediments and solutions to accuracy and precision in testosterone measurements.  Chaired by William Rosner, MD, of The Endocrine Society and Hubert Vesper, PhD, of the CDC, the conference was attended by representatives of professional societies, industry, and government agencies.  The participants actively engaged in the discussions throughout the day-and-a-half meeting, during which they agreed upon areas of concern and means for improvement, and committed to continue to work together toward the common goal of accurate testosterone assays. 

The use of testosterone assays in both the clinical and research settings is increasing as the population ages, and there is an increased interest in testosterone therapy for a number of clinical applications.  Additionally, methodologies for measuring testosterone in blood have improved, resulting in a greater accessibility to accurate methods.  However, there is no accuracy-based standard to which testosterone assays are held, and consequently, many widely used tests do not provide accurate results across the range of expected testosterone concentrations.

The Society has been leading efforts to improve testosterone assays for the past several years, beginning with a September 2007 article in the Journal of Clinical Endocrinology and Metabolism identifying pitfalls in commercially available assays.  Since 2007, the Society has worked closely with the CDC to disseminate information about the agency’s testosterone standardization program, which is now available to assay manufacturers wishing to validate/improve the accuracy of their tests.

A consensus document will be developed in the coming months that will summarize the conference proceedings and present recommendations for moving forward.  Progress of the overall initiative will require ongoing engagement by the entire stakeholder community, and the Society will continue to work with its partners toward the realization of excellence in testosterone testing.

Hubert Vesper of CDC consults with meeting facilitator Elaine Kuttner of Cambridge Concord Associates

Conference participants engage in discussions on day 2