Consensus group calls for standardization of testosterone testing

Issue: November 2010

The use of testosterone assays for patient care and research is on the rise as new research links testosterone to a variety of diseases and conditions. Testosterone assays are heavily used; however, discrepancies and inaccuracies in measurements resulting from the various assays are widespread.

To address this critical health issue, a multidisciplinary group of experts convened by the Endocrine Society and the CDC issued new recommendations for improving and standardizing testosterone testing.

The consensus statement was published in the October issue of the Journal of Endocrinology & Metabolism.

“The development of this consensus statement has been a collaborative effort among key stakeholders, including professional societies, laboratories and regulatory agencies,” William Rosner, MD, lead author of the consensus statement, said in a press release. “Not only does this entire group benefit from better assays, but all bear some responsibility in working to improve accuracy.”

The consensus statement aims to improve the quality of research, patient care and public health through broad implementation of standardized accurate and reliable testosterone assays. Recommendations in the statement include:

Stakeholders should acknowledge the importance of testosterone assay standardization and work closely with the CDC to formulate plans to implement accuracy-based calibrated testing across the community of assay providers and users.
Expert scientific and medical communities should work to define performance criteria that cover the full range of expected values, from children to adult men and women; define reference intervals for testosterone in adults and children of both sexes; and develop guidelines and protocols to ensure uniform patient preparation and handling of samples before they are assayed.
Third-party payers and health care organizations should promote the use of and enable payment for assays that have been standardized through the above mentioned efforts;
Funding entities, journals and others involved in research should support the standardization of assays; and
Manufacturers and laboratories should continue to develop new methodological approaches ensuring the sensitive, specific, accurate and cost-effective measurement of testosterone.

Need for standardization

Testosterone assays are used to diagnose and treat patients with a number of disorders, including testicular or pituitary diseases in men, potentially leading to erectile dysfunction and decreased sexual drive; polycystic ovary syndrome, which may cause menstrual disturbances and infertility in women; and early or late pubertal development in children, according to the release.

“The recommendations in this consensus statement emphasize the need for the research, medical and industry communities to each play their part in improving testosterone assays,” Rosner said in the release. “High-quality testosterone testing will not only provide for better patient care outcomes, but will rein in the cost of health care as it will lessen the need for frequent retesting.”

In addition to the Endocrine Society, the consensus statement has been endorsed by the American Association for Clinical Chemistry, American Association of Clinical Endocrinologists, Androgen Excess/PCOS Society, American Society for Bone and Mineral Research, American Society for Reproductive Medicine, and other organizations.

Rosner W. J Clin Endocrinol Metab. 2010;95:4542-4548.

Ronald Tamler, MD, PhD, MBA
Ronald Tamler

As a clinician and a researcher, I am relieved that scientists, organizations and major labs have recognized that it is time to act. Today, a patient may have widely disparate testosterone levels when seen at different facilities. The standardization of the assay is a much-needed development to ensure valid data from our studies and appropriate diagnosis and treatment for our patients.

– Ronald Tamler, MD, PhD, MBA

Endocrine Today Editorial Board member