Comparison of serum testosterone and estradiol measurements in 3174 European men using platform immunoassay and mass spectrometry; relevance for the diagnostics in aging men

Abstract

Background: The limitations of serum testosterone and estradiol (E 2 ) measurements using nonextraction platform immunoassays (IAs) are widely recognized. Switching to more specific mass spectrometry (MS)-based methods has been advocated, but directly comparative data on the two methods are scarce. Methods: We compared serum testosterone and E 2 measurements in a large sample of middle-aged/elderly men using a common platform IA and a gas chromatography (GC)-MS method, in order to assess their limitations and advantages, and to diagnose male hypogonadism. Of subjects from the European Male Aging Study (nZ3174; age 40-79 years), peripheral serum testosterone and E 2 were analyzed using established commercial platform IAs (Roche Diagnostics E170) and in-house GC-MS methods. Results: Over a broad concentration range, serum testosterone concentration measured by IA and MS showed high correlation (RZ0.93, P!0.001), which was less robust in the hypogonadal range (!11 nmol/l; RZ0.72, P!0.001). The IA/MS correlation was weaker in E 2 measurements (RZ0.32, P!0.001, at E 2 !40.8 pmol/l, and RZ0.74, P!0.001, at E 2 O40.8 pmol/l). Using MS as the comparator method, IA ascertained low testosterone compatible with hypogonadism (!11 nmol/l), with 75% sensitivity and 96.3% specificity. The same parameters with IA for the detection of low E 2 (!40.7 pmol/l) were 13.3 and 99.3%, and for high E 2 (O120 pmol/l) 88.4 and 88.6%. Conclusion: A validated platform IA is sufficient to detect subnormal testosterone concentrations in the diagnosis of male hypogonadism. The IA used for E 2 measurements showed poor correlation with MS and may only be suitable for the detection of high E 2 in men.

Age-specific population centiles for androgen status in men

“…Furthermore, serum DHT was rarely measured in population-based studies as few in-house DHT immunoassays were available and none in multiplex or valid single-tube formats (23). Similarly, serum E 2 was usually measured by direct immunoassays, which are inaccurate at the low circulating E 2 levels prevailing in men of all ages (24,25,26). Finally, few studies reported measuring serum testosterone, DHT, and E 2 in studies of thousands of participants (21,22).…”

Adaptation to acute coronary syndrome-induced stress with lowering of testosterone: a possible survival factor

“…A good quality immunoassay was used for testosterone measurements; therefore, the hormone data can be considered reliable, although mass spectrometry was not used (28,29). Only total testosterone was measured, because sex hormone-binding globulin (SHBG) levels were not available.…”

Hypogonadism as an additional indication for bariatric surgery in male morbid obesity?

“…The analytical sensitivity of the assays was 0.5 nmol/l for TT, 55 pmol/l for E 2 , 0.1 mIU/ml for FSH, 0.05 mIU/ml for LH, and 0.02 nmol/l for SHBG. TT measurement by immunoassay has been validated by isotopic dilution-liquid chromatography-tandem mass spectrometry method for values higher than nanomolar (12). Calculated free testosterone (cFT) was calculated as demonstrated previously (13).…”