Standardization of testosterone measurements in humans

Abstract

Testosterone levels are used primarily for the diagnosis of hypogonadism in men and androgen excess in women. Current studies suggest that serum testosterone measurements may be indicated in a wide range of diseases and conditions. Translation of testosterone levels outside of the reference ranges into clinical treatment, appropriate cut offs for clinical guidelines and epidemiological studies with public health impact pose challenges due to the measurement variability among assays and in assay sensitivity. While introducing mass spectrometry technology can overcome some of these challenges and help to improve measurements, it faces variability issues similar to those observed with immunoassays that need to be addressed. To overcome these problems in testosterone testing, the Centers for Disease Control and Prevention, National Center for Environmental Health, Division of Laboratory Sciences (CDC/NCEH/DLS) started a steroid hormone standardization project. Their objective was to create testosterone measurement results that are traceable to one accuracy basis, thus allowing measurements to be comparable across methods, time, and location. CDC/NCEH/DLS conducts activities to standardize and improve testosterone assays and laboratory measurements by establishing metrological traceability to a higher order reference method and material. In addition, the standardization effort includes pre- and post-analytical challenges, such as test selection, interpretation, and establishing reference ranges to improve the translation of standardized results into clinical guidelines and public health assessments. CDC is conducting these standardization activities in collaboration with the clinical, laboratory, and research communities.