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Variability in SHBG assays and the effect thereof on calculated estimates of free testosterone

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Τίτλος: Variability in SHBG assays and the effect thereof on calculated estimates of free testosterone
Συγγραφείς: Walravens, Joeri, Adaway, Joanne, Reyns, Tim, Narinx, Nick, Nyamaah, Jennifer Afrakoma, Antonio, Leen, Kaufman, Jean-Marc, Keevil, Brian, Fiers, Tom, Lapauw, Bruno
Πηγή: ISSN:0004-5632 ; ISSN:1758-1001 ; Annals Of Clinical Biochemistry, vol. 62 (6.
Στοιχεία εκδότη: SAGE Publications
Έτος έκδοσης: 2025
Θεματικοί όροι: Science & Technology, Life Sciences & Biomedicine, Medical Laboratory Technology, SHBG, free testosterone, immunoassay, BINDING GLOBULIN, ACCURACY, Humans, Testosterone, Sex Hormone-Binding Globulin, Male, Female, Middle Aged, Adult, Hypogonadism, Tandem Mass Spectrometry, Chromatography, Liquid, Hyperandrogenism, Aged, 1101 Medical Biochemistry and Metabolomics, 1103 Clinical Sciences, General Clinical Medicine, 3202 Clinical sciences, 3205 Medical biochemistry and metabolomics
Περιγραφή: BackgroundSerum free testosterone is commonly used as a parameter to evaluate testosterone exposure and is mostly calculated using mathematical approximations. As the principal testosterone-binding protein, SHBG concentration is always included in such calculations. However, variability in SHBG measurements may affect reported SHBG levels and consequently free testosterone calculations. In this study, we re-evaluate the effects of SHBG assay choice and interlaboratory variability on calculated free testosterone (cFT).MethodsSerum samples from 113 men and 106 women were collected. SHBG levels were measured using three different SHBG immunoassays (Roche, Abbott and Siemens). Testosterone levels were measured using LC-MS/MS. Afterwards, cFT was calculated using the Vermeulen formula and measured directly. SHBG concentrations, and derived cFT concentrations, from different assays were compared. To simulate interlaboratory SHBG variability, measured levels were modified by 15% after which cFT was recalculated using the Vermeulen, Ly, Sartorius and Södergard formulae. The proportions of diagnoses of hypogonadism or hyperandrogenism were compared.ResultsAssessed SHBG assays showed very good conformity. The largest difference was 7%, between the Abbott and Siemens assay. The difference in cFT levels was at most 3% between the Abbott and Siemens assay. Interlaboratory variability affected the proportion of diagnoses depending on the used formula.ConclusionsOur results do not show large differences between SHBG assays and only minor effects on cFT levels. Therefore, SHBG assay choice is not expected to greatly influence clinical decision making. In contrast, interlaboratory variation in SHBG measurements and choice of formula might considerably affect cFT results and their interpretation. ; sponsorship: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This research was funded by the Flemish FWO-TBM program (grant number: T004321N). ...
Τύπος εγγράφου: article in journal/newspaper
Περιγραφή αρχείου: application/pdf
Γλώσσα: English
Relation: https://lirias.kuleuven.be/handle/20.500.12942/773022; https://doi.org/10.1177/00045632251350676; https://pubmed.ncbi.nlm.nih.gov/40500910
DOI: 10.1177/00045632251350676
Διαθεσιμότητα: https://lirias.kuleuven.be/handle/20.500.12942/773022
https://hdl.handle.net/20.500.12942/773022
https://lirias.kuleuven.be/retrieve/751df2b4-2c66-4d3e-9a7d-b23dc1db30af
https://doi.org/10.1177/00045632251350676
https://pubmed.ncbi.nlm.nih.gov/40500910
Rights: info:eu-repo/semantics/openAccess ; public
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  Data: Variability in SHBG assays and the effect thereof on calculated estimates of free testosterone
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  Data: <i>ISSN:0004-5632 ; ISSN:1758-1001 ; Annals Of Clinical Biochemistry, vol. 62 (6</i>.
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  Data: 2025
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  Data: <searchLink fieldCode="DE" term="%22Science+%26+Technology%22">Science & Technology</searchLink><br /><searchLink fieldCode="DE" term="%22Life+Sciences+%26+Biomedicine%22">Life Sciences & Biomedicine</searchLink><br /><searchLink fieldCode="DE" term="%22Medical+Laboratory+Technology%22">Medical Laboratory Technology</searchLink><br /><searchLink fieldCode="DE" term="%22SHBG%22">SHBG</searchLink><br /><searchLink fieldCode="DE" term="%22free+testosterone%22">free testosterone</searchLink><br /><searchLink fieldCode="DE" term="%22immunoassay%22">immunoassay</searchLink><br /><searchLink fieldCode="DE" term="%22BINDING+GLOBULIN%22">BINDING GLOBULIN</searchLink><br /><searchLink fieldCode="DE" term="%22ACCURACY%22">ACCURACY</searchLink><br /><searchLink fieldCode="DE" term="%22Humans%22">Humans</searchLink><br /><searchLink fieldCode="DE" term="%22Testosterone%22">Testosterone</searchLink><br /><searchLink fieldCode="DE" term="%22Sex+Hormone-Binding+Globulin%22">Sex Hormone-Binding Globulin</searchLink><br /><searchLink fieldCode="DE" term="%22Male%22">Male</searchLink><br /><searchLink fieldCode="DE" term="%22Female%22">Female</searchLink><br /><searchLink fieldCode="DE" term="%22Middle+Aged%22">Middle Aged</searchLink><br /><searchLink fieldCode="DE" term="%22Adult%22">Adult</searchLink><br /><searchLink fieldCode="DE" term="%22Hypogonadism%22">Hypogonadism</searchLink><br /><searchLink fieldCode="DE" term="%22Tandem+Mass+Spectrometry%22">Tandem Mass Spectrometry</searchLink><br /><searchLink fieldCode="DE" term="%22Chromatography%22">Chromatography</searchLink><br /><searchLink fieldCode="DE" term="%22Liquid%22">Liquid</searchLink><br /><searchLink fieldCode="DE" term="%22Hyperandrogenism%22">Hyperandrogenism</searchLink><br /><searchLink fieldCode="DE" term="%22Aged%22">Aged</searchLink><br /><searchLink fieldCode="DE" term="%221101+Medical+Biochemistry+and+Metabolomics%22">1101 Medical Biochemistry and Metabolomics</searchLink><br /><searchLink fieldCode="DE" term="%221103+Clinical+Sciences%22">1103 Clinical Sciences</searchLink><br /><searchLink fieldCode="DE" term="%22General+Clinical+Medicine%22">General Clinical Medicine</searchLink><br /><searchLink fieldCode="DE" term="%223202+Clinical+sciences%22">3202 Clinical sciences</searchLink><br /><searchLink fieldCode="DE" term="%223205+Medical+biochemistry+and+metabolomics%22">3205 Medical biochemistry and metabolomics</searchLink>
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  Data: BackgroundSerum free testosterone is commonly used as a parameter to evaluate testosterone exposure and is mostly calculated using mathematical approximations. As the principal testosterone-binding protein, SHBG concentration is always included in such calculations. However, variability in SHBG measurements may affect reported SHBG levels and consequently free testosterone calculations. In this study, we re-evaluate the effects of SHBG assay choice and interlaboratory variability on calculated free testosterone (cFT).MethodsSerum samples from 113 men and 106 women were collected. SHBG levels were measured using three different SHBG immunoassays (Roche, Abbott and Siemens). Testosterone levels were measured using LC-MS/MS. Afterwards, cFT was calculated using the Vermeulen formula and measured directly. SHBG concentrations, and derived cFT concentrations, from different assays were compared. To simulate interlaboratory SHBG variability, measured levels were modified by 15% after which cFT was recalculated using the Vermeulen, Ly, Sartorius and Södergard formulae. The proportions of diagnoses of hypogonadism or hyperandrogenism were compared.ResultsAssessed SHBG assays showed very good conformity. The largest difference was 7%, between the Abbott and Siemens assay. The difference in cFT levels was at most 3% between the Abbott and Siemens assay. Interlaboratory variability affected the proportion of diagnoses depending on the used formula.ConclusionsOur results do not show large differences between SHBG assays and only minor effects on cFT levels. Therefore, SHBG assay choice is not expected to greatly influence clinical decision making. In contrast, interlaboratory variation in SHBG measurements and choice of formula might considerably affect cFT results and their interpretation. ; sponsorship: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This research was funded by the Flemish FWO-TBM program (grant number: T004321N). ...
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  Data: https://lirias.kuleuven.be/handle/20.500.12942/773022; https://doi.org/10.1177/00045632251350676; https://pubmed.ncbi.nlm.nih.gov/40500910
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