SULM – Schweizerische Union für Labormedizin | Union Suisse de Médecine de Laboratoire | Swiss Union of Laboratory Medicine

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1Departement of Laboratory Medicine (EOLAB), Ente Ospedaliero Cantonale, Lugano (Switzerland), 2Department of Gynecology and Obstetrics, Ente Ospedaliero Cantonale, Lugano (Switzerland), 3Centro di medicina di laboratorio Dr. Risch, Lugano (Switzerland), 4Departement of Nuclear Medicine and Thyroid Center, Oncology Institute of Southern Switerzland, Bellinzona (Switzerland)

Late onset hypogonadism (LOH) is a clinical and biochemical syndrome defined as the presence of three sexual symptoms (decreased frequency of morning erection, decreased frequency of sexual thoughts and erectile dysfunction) combined with a total testosterone (T) < 11 nmol/L. The etiology of LOH, is not completely understood and it is probably multifactorial.
The aim of this study was to provide age and method-specific normal ranges for total T in healthy men. We used a carefully selected group of 300 eugonadal men, with no known history of depression, diabetes, hypertension or erectile dysfunction, to measure total T. We compared reference intervals among four different assays platforms (Architect i 1000 SR-Abbot®), UniCel DxI800-Beckman Coulter®), Cobas 6000-Roche®, Immulite-Siemens® ) as well as the gold standard liquid chromatography/mass spectrometry (LC-MS 6490 Agilent Technologies®). Statistical analysis were performed with Analyse-it software. As expected, we found substantial differences in T level concentrations measured by different methods. Therefore we provided method-specific reference values. Surprisingly, all the calculated reference ranges included the cut-off of 11 nmol/L, which is currently adopted for the diagnosis of hypogonadism, and the lower limit was far below this level.
Consequently, a substantial proportion of healthy donors showed total T level below 11 nmol/L. International guidelines for the identification of LOH should consider the analytical variation among different platform. Waiting for standardization/harmonization of total testosterone assays, method-specific cut-off level must be provided and adopted to correctly identify LOH avoiding inappropriate testosterone substitution prescriptions.


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