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Utility, Limitations, and Pitfalls in Measuring Testosterone: An Endocrine Society Position Statement

St. Luke’s/Roosevelt Hospital Center and Columbia University College of Physicians and Surgeons (W.R.), New York, New York 10019; Division of Endocrinology and Metabolism (R.J.A.), University of Texas Southwestern Medical Center, Dallas, Texas 75390; Center for Androgen Related Disorders and Department of Obstetrics-Gynecology (R.A.), Cedars-Sinai Medical Center and Department of Obstetrics-Gynecology and Department of Medicine, The David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, California 90048; Reproductive Endocrine Unit (Department of Medicine) and Department of Pathology (P.M.S.), Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts 02114; and Endocrine Research Laboratory (H.R.), Aurora St. Luke’s Medical Center, Division of Endocrinology, Metabolism, and Clinical Nutrition, Medical College of Wisconsin, Milwaukee, Wisconsin 53215

To whom correspondence and reprint requests should be addressed: William Rosner, M.D., Department of Medicine, St. Luke’s/Roosevelt Hospital Center, 1000 Tenth Avenue, AJA 403, New York, New York 10019. E-mail: wr7{at}columbia.edu.

Objective: The objective of the study was to evaluate the current state of clinical assays for total and free testosterone.

Participants: The five participants were appointed by the Council of The Endocrine Society and charged with attaining the objective using published data and expert opinion.

Evidence: Data were gleaned from published sources via online databases (principally PubMed, Ovid MEDLINE, Google Scholar), the College of American Pathologists, and the clinical and laboratory experiences of the participants.

Consensus Process: The statement was an effort of the committee and was reviewed in detail by each member. The Council of The Endocrine Society reviewed a late draft and made specific recommendations.

Conclusions: Laboratory proficiency testing should be based on the ability to measure accurately and precisely samples containing known concentrations of testosterone, not only on agreement with others using the same method. When such standardization is in place, normative values for total and free testosterone should be established for both genders and children, taking into account the many variables that influence serum testosterone concentration.

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