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This version published online on November 7, 2006
Journal of Clinical Endocrinology & Metabolism, doi:10.1210/jc.2006-1864
A more recent version of this article appeared on February 1, 2007
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Submitted on August 24, 2006
Accepted on October 30, 2006

UTILITY, LIMITATIONS AND PITFALLS IN MEASURING TESTOSTERONE: An Endocrine Society Position Statement

William Rosner*, Richard J. Auchus, Ricardo Azziz, Patrick M. Sluss, and Hershel Raff

St Luke's/Roosevelt Hospital Center and Columbia University College of Physicians and Surgeons, New York, NY 10019; Division of Endocrinology and Metabolism, UT Southwestern Medical Center, Dallas, TX 75390; Center for Androgen Related Disorders and Dept. of Ob/Gyn, Cedars-Sinai Medical Center and Dept. of Ob/Gyn and Dept. of Medicine, The David Geffen School of Medicine at UCLA, Los Angeles, CA 90048; Reproductive Endocrine Unit (Department of Medicine) and Department of Pathology, Massachusetts General Hospital and Harvard Medical School, Boston, MA 02114; Endocrine Research Laboratory, Aurora St. Luke's Medical Center, Division of Endocrinology, Metabolism and Clinical Nutrition, Medical College of Wisconsin, Milwaukee, WI 53215

* To whom correspondence should be addressed. E-mail: wr7{at}columbia.edu.

Objective: 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 upon 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 for children taking into account the many variables that influence serum testosterone concentration.
Key words: testosterone • free testosterone • assay • hypogonadism • sex hormone binding globulin • polycystic ovary syndrome




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