Landmark Study Defines Normal Ranges for Testosterone Levels

January 11, 2017

WASHINGTON, DC -- January 11, 2017 -- A large study of more than 9,000 men has established harmonised reference ranges for total testosterone in men that when applied to assays that have been appropriately calibrated will effectively enable clinicians to make a correct diagnosis of hypogonadism.

The correct diagnosis and effective treatment and prevention of hypogonadism as well as many other diseases depend on accurate measurement of hormones, but lack of both defined reference ranges of testosterone and standardisation of hormone assays has made diagnosing hypogonadism a difficult task.

“Well-defined reference ranges are at the heart of clinical practice and without them clinicians can make erroneous diagnoses that could lead to patients receiving costly, lifelong treatments that they don't need or deny treatments to those who need them,” said Shalender Bhasin, MD, Brigham and Women’s Hospital, and Harvard Medical School, Boston, Massachusetts. “Our data establish a reference range for testosterone. These data also show that variations in assays are an important contributor to variation in testosterone levels in cohorts from different geographic regions. Clearly we need standardisation in all hormone assays.”

For the study, published in the Journal of Clinical Endocrinology & Metabolism (JCEM), the researchers obtained serum testosterone samples from men who had already had their testosterone levels assayed locally. The samples were sent to the Centers for Disease Control and Prevention's (CDC) Clinical Standardization Programs at the National Center for Environmental Health where testosterone concentrations were measured using a higher order liquid chromatography tandem mass spectrometry method.

The researchers used the results from both measurements to generate harmonised values, which were in turn used to derive standardised, age-specific reference ranges overall. The harmonised normal range for testosterone in a non-obese population of European and American Men, aged 19 to 39 years, is 264 to 916 ng/dL.

“Without harmonised reference ranges and standardised assays, tests can lead to misdiagnoses and unfortunately this happens every day around the world,” said Hubert Vesper, PhD, Partnership for the Accurate Testing of Hormones (PATH), Washington, DC. “Now we have a reference range for testosterone, and it's important that we take this into consideration in the tests that clinicians and patients depend on for accurate diagnoses.”

PATH provides technical and scientific support to the CDC Steroid Hormone Standardization Program, conducts educational activities on hormone measurement, and advocates for the universal use of standardised hormone tests, where available.

SOURCE: The Endocrine Society

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