Warning on Serum Testosterone Measurement

Wheeler, Michael J.

doi:10.1016/s0140-6736(87)91828-9

Cited by 16 publications

(10 citation statements)

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“…Commercially available direct testosterone assays generally overestimate the steroid concentration (27 ). This is true for samples from children (particularly newborns and young infants) and for samples from women (22,27,39 ). Differences among RIAs using iodinated testosterone have also been described, to a lesser extent, for samples from men (31 ).…”

Section: Discussionmentioning

confidence: 99%

Testosterone Measured by 10 Immunoassays and by Isotope-Dilution Gas Chromatography–Mass Spectrometry in Sera from 116 Men, Women, and Children

et al. 2003

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Background: Commercially available testosterone immunoassays give divergent results, especially at the low concentrations seen in women. We compared immunoassays and a nonimmunochemical method that could quantify low testosterone concentrations. Methods: We measured serum testosterone in 50 men, 55 women, and 11 children with use of eight nonisotopic immunoassays, two isotopic immunoassays, and isotope-dilution gas chromatography-mass spectrometry (ID/GC-MS).

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Section: Discussionmentioning

confidence: 99%

Testosterone Measured by 10 Immunoassays and by Isotope-Dilution Gas Chromatography–Mass Spectrometry in Sera from 116 Men, Women, and Children

et al. 2003

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“…The results of the comparison were consistent with observations by Fitzgerald and Herold (27 ) and Taieb et al (18 ): Immunoassay results agreed with an MS-based method for samples from healthy men, but in samples from women, the methods correlated poorly with each other. Possible reasons for the lack of agreement between the results obtained with the immunoassays are matrix effects and cross-reactivity of the antibody with structurally related steroids (17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27). Low physiologic concentrations of Te in women and children and limited sample size for pediatric samples challenge method sensitivity.…”

Section: Methods Performancementioning

confidence: 99%

“…Taieb and coworkers (17,18 ) reported that none of the commercially available automated assays for Te has adequate specificity for the analysis of Te in the serum of children and women. In addition, there is often very poor agreement among the results obtained by different immunoassays, even assays from the same manufacturer (17)(18)(19)(20)(21)(22)(23)(24)(25)(26).…”

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confidence: 99%

“…Numerous studies found acceptable concordance between immunoassay results for samples from men (27)(28)(29) but significant overestimation of the Te concentration in samples from women and children (19,25,(30)(31)(32)(33)(34). To eliminate interference from binding globulins and structurally related molecules, RIAs have been combined with extraction and chromatographic separation, but these assays do not compare well with isotope-dilution mass spectrometry (MS) (18,32 ).…”

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confidence: 99%

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Performance Characteristics of a Novel Tandem Mass Spectrometry Assay For Serum Testosterone

et al. 2006

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Background: Commercial immunoassays for testosterone (Te) may give inaccurate results for samples from women and children, leading to misdiagnosis and inappropriate treatment. We developed a sensitive and specific tandem mass spectrometric assay for measurement of Te at the concentrations encountered in women and children. Methods: Te was extracted with methyl tert-butyl ether from 100 L of serum or plasma, derivatized to form an oxime, and reextracted by solid-phase extraction. Instrumental analysis was performed on an API 4000 HPLC tandem mass spectrometer in the multiple-reaction monitoring (MRM) mode. The MRM transitions (m/z) were 3043124 and 3043112 for Te and 3073124 and 3073112 for d 3 -Te. Results: Within-and between-run CVs were <12% and 7.9%, respectively. The limit of quantification was 0.0346 nmol/L (1 ng/dL). Reference intervals for sex hormone-binding globulin and total, free, and bioavailable Te were established for children of Tanner stages 1 through 5 and adult males and females. Conclusions: The sensitivity and specificity of the method are adequate for analysis of Te in samples from women and children. The method requires small sample volumes, has adequate precision, and is not subject to interferences.

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“…Even high-sensitivity Te immunoassays are inadequate for testing samples from women and children because physiologic serum concentrations are typically Ͻ1.73 nmol/L (Ͻ50 ng/dL) in adult women and Ͻ0.346 nmol/L (Ͻ10 ng/dL) in infants and children of both sexes. In addition, there is often very poor agreement among the results obtained by different immunoassays, even assays from the same manufacturer (17)(18)(19)(20)(21)(22)(23)(24)(25)(26). In addition, there is often very poor agreement among the results obtained by different immunoassays, even assays from the same manufacturer (17)(18)(19)(20)(21)(22)(23)(24)(25)(26).…”

mentioning

confidence: 99%