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Cited by 79Hormonal and reproductive studiesClinical Laboratory Practices and Quality ControlAdrenal Hormones and Disorders

The impact of assay quality and reference ranges on clinical decision making in the diagnosis of androgen disorders

Bhasin, Shalender, Zhang, Anqi, Coviello, Andrea, Jasuja, Ravi, Ulloor, Jagadish, Singh, Ravinder, Vesper, Hubert, Vasan, Ramachandran S.·2008·Steroids
DOI 10.1016/j.steroids.2008.07.003
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Abstract

The Endocrine Society guideline on Androgen Deficiency in Men emphasized that accurate measurement of testosterone (T) levels is central to the diagnosis of androgen deficiency. Similarly, accurate measurements of testosterone levels are important in the diagnosis of androgen disorders in women and children. However, the accuracy of direct radioimmunoassays for the measurement of total T levels has been questioned, especially in the low range prevalent in women, children, and androgen deficient men. Furthermore, reference limits for total and free T levels generated in a population-based sample of community-dwelling men, women, and children are not available. In the absence of standardized reference limits, the partitioning of total and free T levels into normal, low, or high values is fraught with substantial risk of misclassification. The recommendations for partitioning of individuals into those with low, normal, or high levels should be based on considerations of statistical distribution of total and free T values and the association of outcomes with varying degree of deviations from the reference limits. Ongoing efforts to generate population-based reference ranges for total and free testosterone levels in men and women will provide a framework for the interpretation of serum T levels and enhance the comprehensibility of circulating T values to practicing clinicians. These steps will facilitate the development of rational criteria for the diagnosis of androgen disorders in men, women, and children.

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Authors
Bhasin, S., Zhang, A., Coviello, A., Jasuja, R., Ulloor, J., Singh, R., Vesper, H., & Vasan, R. S.
Affiliations
  • Boston University (US)
  • Mayo Clinic (US)
  • Centers for Disease Control and Prevention (US)
Corresponding author
Bhasin, Shalender
ORCID
Venue
Steroids
Publisher
Elsevier BV
Published
2008-12
Volume
73
Issue
13
Pages
1311-1317
ISSN
0039-128X (ISSN-L)
DOI
10.1016/j.steroids.2008.07.003
OpenAlex
W2078674857
Cited by
79
References
59
Citations by year
2026: 1 · 2025: 2 · 2024: 2 · 2023: 3 · 2022: 1 · 2021: 2 · 2020: 3 · 2019: 2 · 2018: 3 · 2017: 7 · 2016: 5 · 2015: 5 · 2014: 6 · 2013: 8 · 2012: 7
FWCI
5.22
Type
journal article
Language
en
Open access
closed
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • Steroids (publishedVersion)
  • PubMed (publishedVersion)
Funders
National Institute on Aging (U01AG014369, 1R01AG22356)
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
androgen deficiency, testosterone measurement, total testosterone, free testosterone, reference values, misclassification, clinical decision-making, population-based reference values, women
MeSH terms
Androgens, Child, Cross-Sectional Studies, Decision Making, Endocrine System Diseases, Female, Humans, Immunoassay, Male, Reference Values, Sensitivity and Specificity, Testosterone

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