(063) VARIABILITY IN THE REFERENCE VALUES OF TESTOSTERONE, ITS MEASUREMENT METHODOLOGY, AND THE ASSOCIATED COSTS ACROSS LABORATORIES

Abstract Introduction Hypogonadism is defined as the gonadal failure resulting in an impaired steroid hormone production. The classic causes of male androgen deficiency are hyperprolactinemia, pituitary macroadenoma, endogenous Cushing syndrome and iron overload syndrome. Klinefelter syndrome and mild traumatic injury might also be a common cause of androgen deficiency. According to EAA guidelines, the diagnosis of hypogonadism should be based on both the presence of clinical symptoms and a low serum total testosterone. The diagnosis of hypogonadism can be complicated by the limited availability of laboratories capable of measuring testosterone, the variable reference ranges, and the costs of the test. Objective Investigate the variations in the normal range of testosterone levels reported by laboratories, as well as elucidate their corresponding methodologies of measurement and costs. Methods Telephone interviews were conducted with two hundred laboratories regarding the method they use for testosterone measurement, their reference parameters, and the cost of the assay. Results From the total of laboratories interviewed, only one hundred sixty of them measured total testosterone. One hundred sixteen were private laboratories, thirty-four laboratories were part of public hospitals and ten belonged to private hospitals. Sixty-six laboratories used chemiluminescence to determine testosterone, twenty-five used electrochemiluminescence, thirty-eight laboratories were unable to describe the method they use. The low reference value for total testosterone ranged from 84 to 668 ng/dL (795% difference), and the upper value ranged from 400 to 2562 ng/dL (640% difference). The average cost of testosterone testing is $35, with a maximum of $160 and a minimum of $9. Conclusions The great variability in testosterone measurement methods, the reference ranges of each laboratory and their costs mean greater difficulty in establishing the diagnosis of hypogonadism. Disclosure No.