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Without reliability, testosterone testing may fall short



Exclusive use of labs that have been accredited by the Centers for Disease Control and Prevention in performing free testosterone assays is one addition to the evaluation of men with suspected hypogonadism that is included in the revised clinical practice guideline on testosterone therapy in men with hypogonadism, issued March 17 by the Endocrine Society. The previous guideline was issued in 2010.

“Since 2010, the CDC has provided an accuracy-based standardization program for T (CDC Hormone Standardization Program for Testosterone). Although several commercial laboratories, some assay manufacturers, and some academic laboratories are now CDC certified, most T immunoassay kit manufacturers and local hospital-based laboratories have not been certified. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) assays for TT generally offer higher concentrations of specificity, sensitivity, and precision (especially in the low range) than do most immunoassays. Clinicians should ideally measure TT using a CDC-certified assay or an assay verified by an accuracy-based external quality control program,” according to the guideline.

Diagnosis, treatment, and follow-up of men with suspected hypogonadism often involve nuanced decisions, according to guideline panel chair Shalender Bhasin, MB, an endocrinologist who is professor of medicine at both Harvard Medical School and Brigham and Women’s Hospital, in Boston. The guideline will be published in its entirety in the May 2018 print issue of The Journal of Clinical Endocrinology & Metabolism.


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