New Study Determines Normal Reference Ranges for Testosterone
Researchers found harmonized reference ranges for total testosterone in men, which can be applied to cross-calibrating cohort-specific assays for diagnosing hypogonadism.
Samples of serum testosterone were obtained from 9054 men who participated in the Framingham Heart Study, European Male Aging Study, Osteoporotic Fractures in Men Study, and Male Sibling Study of Osteoporosis. Researchers sent testosterone concentrations from 100 participants in each of the 4 cohort studies to the Center of Disease Control for measurements.
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The cohort specific and CDC values were analyzed with generalized additive models and Bland-Altman-plot. The harmonized values were obtained with normalizing equations generated by Passing-Bablok regression, and were used to derive age-specific and standardized reference ranges.
Their findings showed that the harmonization procedure reduced variations within the cohort between testosterone measurements in men of similar ages. In men who were healthy, nonobese, and 19 to 39 years old, harmonized values were 2.5th, 5th, 50th, 95th and 97.5th, and percentile values were 264, 303, 531, 852 and 916 ng/dL. Researchers noted that age-specific harmonized testosterone concentrations in healthy, nonobese men were similar across cohorts.
Their findings indicated that harmonized references ranges for testosterone can be generated and applied to assays, calibrated to a reference method and calibrator, which might improve diagnostic measures for identifying hypogonadism in patients.
—Melissa Weiss
Reference:
Travison TG, Vesper HW, Orwoll E, et al. Harmonized reference ranges for circulating testosterone levels in men of four cohort studies in USA and Europe [published online January 10, 2017]. Journal of Clinical Endocrinology & Metabolism. doi:10.1210/jc.2016-2935.