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

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 meas...

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Veröffentlicht in:Annals of clinical biochemistry Jg. 62; H. 6; S. 493
Hauptverfasser: Walravens, Joeri, Adaway, Joanne, Reyns, Tim, Narinx, Nick, Nyamaah, Jennifer Afrakoma, Antonio, Leen, Kaufman, Jean-Marc, Keevil, Brian, Fiers, Tom, Lapauw, Bruno
Format: Journal Article
Sprache:Englisch
Veröffentlicht: England 01.11.2025
Schlagworte:
Adult
Aged
Chromatography, Liquid
Female
Humans
Hyperandrogenism - blood
Hyperandrogenism - diagnosis
Hypogonadism - blood
Hypogonadism - diagnosis
Immunoassay - methods
Male
Middle Aged
Sex Hormone-Binding Globulin - analysis
Sex Hormone-Binding Globulin - metabolism
Tandem Mass Spectrometry
Testosterone - blood
SHBG
free testosterone
immunoassay
ISSN:1758-1001, 1758-1001
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Zusammenfassung: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.
Bibliographie:ObjectType-Article-1
SourceType-Scholarly Journals-1
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ISSN:1758-1001
1758-1001
DOI:10.1177/00045632251350676