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Cited by 113Clinical Laboratory Practices and Quality ControlHormonal and reproductive studiesScientific Measurement and Uncertainty Evaluation

Standardization of testosterone measurements in humans

Vesper, Hubert W., Botelho, Julianne Cook·2010·The Journal of Steroid Biochemistry and Molecular Biology
DOI 10.1016/j.jsbmb.2010.03.032
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Abstract

Testosterone levels are used primarily for the diagnosis of hypogonadism in men and androgen excess in women. Current studies suggest that serum testosterone measurements may be indicated in a wide range of diseases and conditions. Translation of testosterone levels outside of the reference ranges into clinical treatment, appropriate cut offs for clinical guidelines and epidemiological studies with public health impact pose challenges due to the measurement variability among assays and in assay sensitivity. While introducing mass spectrometry technology can overcome some of these challenges and help to improve measurements, it faces variability issues similar to those observed with immunoassays that need to be addressed. To overcome these problems in testosterone testing, the Centers for Disease Control and Prevention, National Center for Environmental Health, Division of Laboratory Sciences (CDC/NCEH/DLS) started a steroid hormone standardization project. Their objective was to create testosterone measurement results that are traceable to one accuracy basis, thus allowing measurements to be comparable across methods, time, and location. CDC/NCEH/DLS conducts activities to standardize and improve testosterone assays and laboratory measurements by establishing metrological traceability to a higher order reference method and material. In addition, the standardization effort includes pre- and post-analytical challenges, such as test selection, interpretation, and establishing reference ranges to improve the translation of standardized results into clinical guidelines and public health assessments. CDC is conducting these standardization activities in collaboration with the clinical, laboratory, and research communities.

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  • The clinical relevance of total versus free testosterone is controversial, with many suggesting free testosterone is more appropriate because SHBG varies with aging, acute and chronic diseases, hormonal alterations, obesity, and normal diurnal rhythms.

    “The clinical relevance of TT compared to fT is controversial, with many suggesting that fT is a more appropriate measure of hypogonadism due to SHBG variations occurring with aging, acute/chronic diseases, hormonal alterations, obesity, and normal diurnal rhythms.”

    From Challenges in Testosterone Measurement, Data Interpretation, and Methodological Appraisal of Interventional Trials (2016) · cites this paper as [95]

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Authors
Vesper, H. W., & Botelho, J. C.
Affiliations
Centers for Disease Control and Prevention (US)
Corresponding author
Vesper, Hubert W.
ORCID
Venue
The Journal of Steroid Biochemistry and Molecular Biology
Publisher
Elsevier BV
Published
2010-08
Volume
121
Issue
3-5
Pages
513-519
ISSN
0960-0760 (ISSN-L)
DOI
10.1016/j.jsbmb.2010.03.032
OpenAlex
W2036769856
Cited by
113
References
50
Citations by year
2026: 3 · 2025: 4 · 2024: 6 · 2023: 3 · 2022: 3 · 2021: 6 · 2020: 4 · 2019: 7 · 2018: 6 · 2017: 11 · 2016: 7 · 2015: 5 · 2014: 7 · 2013: 15 · 2012: 11
FWCI
1.32
Type
journal article
Language
en
Open access
closed
Licence
Locations
  • The Journal of Steroid Biochemistry and Molecular Biology (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Scientific Measurement and Uncertainty Evaluation
Keywords
testosterone measurement, assay standardization, measurement traceability, reference values, hypogonadism diagnosis, hyperandrogenism, mass spectrometry
MeSH terms
Humans, Reference Standards, Testosterone

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