Standardization of testosterone measurements in humans

Vesper, Hubert W.; Botelho, Julianne Cook

doi:10.1016/j.jsbmb.2010.03.032

Cited by 95 publications

(67 citation statements)

References 44 publications

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“…Most of the time they provide rapid and economical information about circulating hormone concentrations. However, the accuracy and precision of testosterone IAs, especially at the low concentrations found in children, women, and hypogonadal men, remain a concern (1,2,3,4). While the majority of IAs estimate high (adult male) concentrations sufficiently well, they usually overestimate low (female) concentrations (5), thus reducing the specificity and sensitivity of diagnosis of female hyperadrogenism and male hypogonadism.…”

Section: Introductionmentioning

confidence: 99%

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

Huhtaniemi

Tajar

Lee

et al. 2012

European Journal of Endocrinology

175

120

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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.

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Section: Introductionmentioning

confidence: 99%

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

Huhtaniemi

Tajar

Lee

et al. 2012

European Journal of Endocrinology

175

120

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“…By contrast, the advent of lower-cost, benchtop MS equipment that retains reference concentration specificity but now features analytical sensitivity matching the best steroid immunoassays renders MS-based E 2 assays more widely accessible. Although MS-based E 2 assays provide a durable chemical analysis free from methoddependent bias of immunoassays, like all biochemical measurements, MS-based assays may be subject to different features such as those involving matrix effects, chromatography, and differences in monitored transitions, all of which require rigorous standardization and ongoing quality control (16,28,40 ), an essential but challenging process that remains to be completed. …”

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confidence: 99%

Performance of Direct Estradiol Immunoassays with Human Male Serum Samples

Handelsman

Newman²,

Jimenez

et al. 2014

Clinical Chemistry

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BACKGROUND:Steroid immunoassays originally required solvent extraction, chromatography, and structurally authentic tracers to avoid interference from steroid cross-reactivity and matrix effects. The demand for steroid assays has driven assay simplification, bypassing this triplet of validity criteria to allow use of unextracted serum, which has introduced bias and nonspecificity at low steroid concentrations. We aimed to evaluate the performance of commercial direct estradiol (E 2 ) immunoassays relative to the reference method of LC-MS and compared serum E 2 measurements from each assay with biomarkers of estrogen action.

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“…To overcome this problem, the CDC established a testosterone standardization program (19,20 ). The key component in this program is the reference measurement procedure (RMP) 4 for testosterone, which is used to assign target values to the serum materials used by laboratories and assay manufacturers to verify and ad-just calibration.…”

mentioning

confidence: 99%