Problems with mass spectrometry testosterone assays

Mass spectrometry (MS) assays are not commercially available in classical sense, but are to much larger extent dependent on each laboratory's own development. As mass spectrome-

try technology is capable of very high sensitivity and specificity, those assay are accepted as gold standard. But, they are more than direct commercial assays dependent on proper calibration and sample preparation[47]. Research has shown biases as high as 25.3% for testosterone values near castrate ranges [47]. Others reported up to 26% of results outside total error limit of 14% due to improper calibration and between-run calibration [48]. Although MS techniques are becoming standard assays for steroid hormones, this presents several challenges, for example affordability for smaller laboratories, high operating costs of equipment, need for standardization of MS assays and in many occasions, actually setting new reference ranges [49] and relating them to physiological and pathological conditions, as happens with testosterone, where castrate values have been moved from 50 ng/dl to 20 ng/dl.

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