Predictive accuracy and sources of variability in calculated free testosterone estimates

Sartorius, Gideon; Ly, Lam P; Sikaris, Ken; McLachlan, Robert; Handelsman, David J

doi:10.1258/acb.2008.008171

Cited by 176Hormonal and reproductive studiesClinical Laboratory Practices and Quality ControlAdrenal Hormones and Disorders

Predictive accuracy and sources of variability in calculated free testosterone estimates

Sartorius, Gideon, Ly, Lam P, Sikaris, Ken, McLachlan, Robert, Handelsman, David J·2009·Annals of Clinical Biochemistry: International Journal of Laboratory Medicine

DOI 10.1258/acb.2008.008171

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Abstract

Background: Serum free testosterone (FT) concentrations are commonly requested, but because reference FT methods are too laborious various calculational algorithms for FT based on total testosterone (TT) and sex hormone-binding globulin (SHBG) are frequently used. This study provides the first large-scale evaluation of the predictive accuracy and sources of variability for different FT formulae compared with direct laboratory measurements. Methods: Using a large data-set of direct FT measurements by centrifugal ultrafiltration, the predictive accuracy of five different formulas for cFT (four existing plus a new formula) is evaluated in 3975 consecutive blood samples. In a second data-set of 124 samples from a reference panel of healthy eugonadal young men, we estimate the relative influence of the five algorithms and eight different TT and two SHBG assays including all available commercial total TT and SHBG assays together with a gas chromatography/mass spectrometry T reference method. Results: cFT formulae show wide discrepancies with equilibrium-binding algorithms showing systematic overestimation relative to direct FT measurements, whereas two empirical cFT methods were more concordant. Variations between commercially available TT immunoassays have a strong impact on calculation of FT with TT assays contributing 82.2% of overall variance compared with 13.7% for the cFT algorithms and 4.1% for the SHBG assays. Conclusions: If FT measurements are requested and direct measurement impractical, cFT formulae using TT and SHBG immunoassays provide an approximation to direct FT measurement that is strongly dependent on the TT, cFT formula used and, to a lesser extent, SHBG immunoassays.

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The third category of free T models uses empirical bootstrap regression methods on cohort datasets.
“Empirical models exploiting bootstrap regression methods on cohort datasets comprise the third and last category [214, 215].”
From Role of sex hormone-binding globulin in the free hormone hypothesis and the relevance of free testosterone in androgen physiology (2022) · cites this paper as [215]
Free T algorithms can be divided into three categories: linear mass action, non-linear allosteric, and empirical bootstrap.
“A wide spectrum of algorithms for free T exists, which can broadly be divided into three categories (Table 6).”
From Role of sex hormone-binding globulin in the free hormone hypothesis and the relevance of free testosterone in androgen physiology (2022) · cites this paper as [215]
Adult male studies confirmed similar findings, with genetic contribution to testosterone variability of 42-65%.
“Results of adult males have confirmed similar findings, with genetic contribution towards T variability of 42–65%.”
From Challenges in Testosterone Measurement, Data Interpretation, and Methodological Appraisal of Interventional Trials (2016) · cites this paper as [47]
A study of saliva-based free testosterone in 783 male twins found significant decreases in free testosterone after waking from sleep, with 32-39% of the total decline occurring within 30 minutes of waking.
“One study, which obtained saliva-based fT assessments in 783 male twins, demonstrated significant decreases in fT following waking from sleep, with 32–39% of the total decline occurring within 30 minutes of waking.”
From Challenges in Testosterone Measurement, Data Interpretation, and Methodological Appraisal of Interventional Trials (2016) · cites this paper as [47]

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ORIGINAL ARTICLE: Accuracy of calculated free testosterone formulae in men
Ly, L. P., Sartorius, G., Hull, L., Leung, A., Swerdloff, R. S., Wang, C., & Handelsman, D. J. (2010) · Clinical Endocrinology · doi:10.1111/j.1365-2265.2010.03804.x · Cited by 172 · see citing works
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Variability in SHBG assays and the effect thereof on calculated estimates of free testosterone
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Reassessing Free-Testosterone Calculation by Liquid Chromatography–Tandem Mass Spectrometry Direct Equilibrium Dialysis
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Discrepancies in Four Algorithms for the Calculation of Free and Bioavailable Testosterone
Yang, J., Hamilton, C., Robyak, K., & Zhu, Y. (2023) · Clinical Chemistry · doi:10.1093/clinchem/hvad177

Authors: Sartorius, G., Ly, L. P., Sikaris, K., McLachlan, R., & Handelsman, D. J.
Affiliations: The University of Sydney (AU)
The University of Melbourne (AU)
Prince Henry's Institute of Medical Research, Clayton, Victoria, Australia
Corresponding author: Handelsman, David J
ORCID: Sartorius, Gideon
Sikaris, Ken
McLachlan, Robert
Handelsman, David J
Venue: Annals of Clinical Biochemistry: International Journal of Laboratory Medicine
Publisher: SAGE Publications
Published: 2009-01-22
Volume: 46
Issue: 2
Pages: 137-143
ISSN: 0004-5632 (ISSN-L)
1758-1001
DOI: 10.1258/acb.2008.008171
OpenAlex: W2042309501
Cited by: 175
References: 39
Citations by year: 2025: 8 · 2024: 5 · 2023: 3 · 2022: 6 · 2021: 12 · 2020: 5 · 2019: 8 · 2018: 16 · 2017: 16 · 2016: 10 · 2015: 16 · 2014: 12 · 2013: 9 · 2012: 16
FWCI: 11.61
Type: journal article
Language: en
Open access: closed
Licence: journals.sagepub.com/page/policies/text-and-data-mining-license (tdm)
Locations: Annals of Clinical Biochemistry International Journal of Laboratory Medicine (publishedVersion)
PubMed (publishedVersion)
Funders: National Research Foundation
Johnson and Johnson
Topics: Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Adrenal Hormones and Disorders
Keywords: free testosterone, total testosterone, sex hormone-binding globulin, prediction accuracy, assay variability, centrifugal ultrafiltration, eugonadal men
MeSH terms: Humans, Male, Middle Aged, Testosterone

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Predictive accuracy and sources of variability in calculated free testosterone estimates

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Integrity signals

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