12:48pm Tuesday 12 November 2019

Standardized Methods and Materials Now Available through the Centers for Disease Control and Prevention (CDC)

Atlanta, GA— On February 18 and 19, The Endocrine Society, in conjunction with the CDC, brought together the nation’s leading medical and scientific organizations to develop consensus recommendations for improving accuracy in testosterone assays.  Testosterone assays are tests that measure testosterone levels which, in turn, are used to diagnose and treat patients with a number of disorders.  These disorders may include: testicular or pituitary diseases in men potentially leading to erectile dysfunction and decreased sexual drive; polycystic ovarian syndrome which may cause menstrual disturbances and infertility in women; and early or late pubertal development in children.

“The past two days have been extremely productive and rewarding,” said William Rosner, MD of The Endocrine Society.  “We brought together the key stakeholders –professional societies, laboratories, and regulatory agencies — to identify the best communication strategies to raise awareness of inaccuracies in testosterone testing and of potential solutions to the problem.”

Many commonly used assays are particularly inaccurate in measuring the low levels of testosterone produced by women and children, but the tests are nonetheless in widespread clinical use in these populations.  The CDC’s new testosterone standardization program provides laboratories and assay manufacturers with reliable and accessible materials and methods by which to measure the accuracy of their testosterone assays.  

“Manufacturers and laboratories that meet the standards established through CDC’s testosterone standardization program will be able to assure physicians and patients of the accuracy of their products and services,” said Hubert Vesper, PhD, of the CDC.

In 2007, The Endocrine Society published a position paper in the Journal of Clinical Endocrinology & Metabolism (JCEM) summarizing the evidence of deficiencies in testosterone assays.  Specifically, the Society’s article demonstrated that assay discrepancies and inaccuracies, especially in the critical low ranges, were severely limiting the effective use of these tests in treating patients and conducting research.  

The CDC testosterone standardization program follows the principles of the successful cholesterol and glycohemoglobin standardization programs, both of which improved patient care and public health through more accurate and reliable laboratory measurements.

Participants in the February 18-19 conference formulated strategies for: informing and educating the broader medical and scientific communities about the need for accuracy in testosterone assays and about the availability of the CDC’s program; encouraging clinicians and researchers to require the use of standardized assays; and encouraging assay manufacturers and labs to follow accuracy-based standards such as those provided through the CDC standardization program.

In the coming months, a working group of conference attendees will develop a White Paper that will summarize the key recommendations of the group and describe specific steps toward improved testosterone measurements.

In addition to The Endocrine Society and CDC, other organizations participating in the conference included: American Association for Clinical Chemistry; American Association of Clinical Endocrinologists; American College of Obstetricians and Gynecologists; American Society for Bone and Mineral Research; American Society for Reproductive Medicine; American Urological Association; Androgen Excess and PCOS Society; College of American Pathologists; Eunice Kennedy Shriver National Institute of Child Health and Human Development; and Lawson Wilkins Pediatric Endocrine Society.



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Founded in 1916, The Endocrine Society is the world’s oldest, largest, and most active organization devoted to research on hormones and the clinical practice of endocrinology. Today, The Endocrine Society’s membership consists of over 14,000 scientists, physicians, educators, nurses and students in more than 80 countries. Together, these members represent all basic, applied, and clinical interests in endocrinology. The Endocrine Society is based in Chevy Chase, Md. To learn more about the Society, and the field of endocrinology, visit our web site at www.endo-society.org. 

Arlyn G. Riskind                   
Director, Media Relations                   
Phone: (301) 941-0240                   
Email: ariskind@endo-society.org

Aaron Lohr
Manager, Media Relations
Phone: (240) 482-1380
Email: alohr@endo-society.org

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