Inaccurate First-Generation Testosterone Assays Are Influenced by Sex Hormone–Binding Globulin Concentrations

Heijboer, Annemieke C.; Savelkoul, Edo; Kruit, Adrian; Endert, E.; Blankenstein, Marinus A.

doi:10.1373/jalm.2016.020065

Cited by 16 publications

(13 citation statements)

References 17 publications

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“…In contrast to earlier radioimmune assays, second‐generation testosterone assays suffer less from cross‐reactivity with other steroid hormones and are less influenced by SHBG levels . Strong correlation coefficients are reported between our radioimmunoassay and the gold standard ID‐LC‐MS/MS measurement in women ( R = 0.95) . Intra‐ and inter‐assay variations were between 4% and 10% at concentrations of 0.02, 2, and 20 nmol/L.…”

Section: Methodsmentioning

confidence: 69%

“…TT was measured using a second‐generation testosterone assay without extraction (Architect i2000 analyzer; Abbott Diagnostics, Abbott Park, IL). In contrast to earlier radioimmune assays, second‐generation testosterone assays suffer less from cross‐reactivity with other steroid hormones and are less influenced by SHBG levels . Strong correlation coefficients are reported between our radioimmunoassay and the gold standard ID‐LC‐MS/MS measurement in women ( R = 0.95) .…”

Section: Methodsmentioning

confidence: 75%

“…In addition, a radioimmune assay was used to determine testosterone levels, which is less reliable than liquid chromatography with tandem mass spectrometry (LC‐MS/MS) analyses, in particular at the lower concentrations generally measured in women (<5 nmol/L) . However, as stated in the method section, good correlations have been reported between this radioimmunoassay we used and the ID‐LC‐MS/MS measurement of testosterone . A strength of our study is its design with measurements of MetS components at two time points, which enabled us to study testosterone not only as a marker but also as a predictor for changes in MetS components.…”

Section: Discussionmentioning

confidence: 89%

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Associations between testosterone and metabolic syndrome in depressed and non‐depressed older men and women

Wit

Giltay

Boer

et al. 2019

Int J Geriat Psychiatry

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Objectives Older age and major depressive disorder (MDD) are both risk factors for the development of cardiovascular diseases. Testosterone has been associated with MDD and metabolic syndrome (MetS) in men, although associations in women are less clear. Therefore, we investigated whether testosterone is associated with MetS and whether this association is different for depressed and non‐depressed older men and women. Methods In this prospective cohort study, 478 participants (349 patients with MDD and 129 controls) aged between 60 and 93 years from the Netherlands Study of Depression in Older Persons were included. Total testosterone (TT) and sex‐hormone binding globulin levels were measured using a second‐generation radioimmune assay. Free testosterone (FT) was calculated based on TT. MetS was defined according to the National Cholesterol Education Program Adult Treatment Panel III criteria. Results A higher risk for MetS was found in men with low FT and TT (odds ratio [OR]: 0.67, 95% confidence interval [95%CI]: 0.47‐0.95 and OR: 0.51, 95%CI: 0.34‐0.75), and in women with high FT (OR: 1.41, 95%CI: 1.08‐1.82). Strong associations in the same direction were found with adiposity, glucose, and plasma lipid MetS components at baseline, but not with changes in these components at 2‐year follow‐up. The associations did not significantly differ between MDD patients and controls. Conclusions Independently of having MDD, low testosterone levels in men and, in contrast, high testosterone levels in women were significantly associated with MetS and its components.

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Section: Methodsmentioning

confidence: 69%

Section: Methodsmentioning

confidence: 75%

Section: Discussionmentioning

confidence: 89%

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Associations between testosterone and metabolic syndrome in depressed and non‐depressed older men and women

Wit

Giltay

Boer

et al. 2019

Int J Geriat Psychiatry

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“…The testosterone assay has been a subject of debate for many years [24]. A high rate of variation, especially at low concentrations, and cross-reactions with other steroids affect testosterone results.…”

Section: Discussionmentioning

confidence: 99%

The importance of measuring the uncertainty of Second Generation Total Testosterone Analysis

Ayyıldız¹

2017

Int J Med Biochem

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The importance of measuring the uncertainty of second-generation total testosterone analysis Objectives: Testosterone is present in both genders; however, the level is low in women, whereas it is high in men. A measurement of total testosterone (TT) is widely requested by clinicians in daily practice, and is used in both diagnosis and treatment. The aim of this study was to calculate the measurement uncertainty of TT and to make a contribution of new research to the literature. Methods: The identification of measurement, factors that can affect the measured value, laboratory reproducibility bias (uRw 2 ), laboratory and method bias measurement uncertainty (Ubias), uncertainty of calibration (uCref ), uncertainty of external quality control data (uEQA), combined measurement uncertainty (Uc), and extended measurement uncertainty (U) were evaluated and reported. Results: The results of determining the measurement uncertainty of TT measurement in this laboratory were as follows: 1) uRw 2 = (RSDlevel 1 2 + RSDlevel 2 2 + RSDlevel 3 2 ) / n: (20.90 2 + 17.48 2 + 7.00 2 ) / 3 = 263.79; 2) uCref = 0.012; Cref = 2.35; k=2. RuCref = (100 x uCref ) / (k x Cref ): (100 x 0.012) / (2 x 2.35) = 0.255; RuCref 2 = 0.065; 3) Ubias 2 = RuCref 2 + uEQA 2 : 0.065 + 105.60 = 105.67; 4) Uc=√ (uRw 2 + ubias 2 ): √ (263.79 + 105.67) = 19.22; 5) U = 2√ (uRw 2 + ubias 2 ): 2 x 19.22 = 38.44%; 6) Result report (serum TT): ± 38.44%. Conclusion:The measurement uncertainty result for TT calculated using the top-down method was ± 38.44% with a 95% confidence interval. The individual measurement uncertainty result for each test should be given to the clinician and the patient together with the test results. The TT measurement uncertainty of other methods should also be known at the international level.

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“…This topic is beyond the scope of the article by Heijboer et al (1); however, many experts recommend that free testosterone should be calculated from the measurement of sex hormone-binding globulin and total testosterone (10,11).…”

mentioning

confidence: 99%

How Should Total Testosterone Be Measured in Women?

Winter

2016

The Journal of Applied Laboratory Medicine

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The report by Heijboer et al. (1) reports that "first-generation testosterone immunoassays are influenced by SHBG (sex hormone-binding globulin) concentrations that lead to inaccurate results in samples from subjects with high or low SHBG concentrations." This conclusion is based on their finding that some testosterone immunoassays display "a statistically significant inverse relationship between SHBG concentrations and deviations in testosterone from the ID (isotope dilution) LC-MS/MS results." Other testosterone immunoassays did not display SHBG concentrationdependent biases and were deemed to be analytically satisfactory. An issue that is not addressed by this report is: "Should immunoassays be used (at all) to measure total testosterone in women?" To address this question, a PubMed search was performed under the terms "guidelines" and "testosterone" and "women" and "measurement." This search yielded 6 references. PubMed citation number 1 is the American Association for Clinical Endocrinologists' clinical review on polycystic ovarian syndrome and recommends that testosterone be measured by "LC/MS assays or by RIA with purification" (2). I am not aware of any commercially available testosterone immunoassays on automated platforms that include a routine extraction step. I suspect that the authors of the guideline refer to an "RIA" method

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Inaccurate First-Generation Testosterone Assays Are Influenced by Sex Hormone–Binding Globulin Concentrations

Cited by 16 publications

References 17 publications

Associations between testosterone and metabolic syndrome in depressed and non‐depressed older men and women

Associations between testosterone and metabolic syndrome in depressed and non‐depressed older men and women

The importance of measuring the uncertainty of Second Generation Total Testosterone Analysis

How Should Total Testosterone Be Measured in Women?

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