Measurement of Free Testosterone in Normal Women and Women with Androgen Deficiency: Comparison of Methods
Abstract
Androgen deficiency in women is increasingly recognized as a new clinical syndrome and has raised our awareness of the importance of accurate and well-validated measurements of serum free testosterone (T) concentrations in women. Therefore, we compared serum free T levels measured by equilibrium dialysis to those measured by a direct RIA (analog method) and to those calculated from the law of mass action (requires the measurement of total T and SHBG). We also calculated the free androgen index, 100 x T/SHBG, as a simple index known to correlate with free T. Subjects were 147 women with variable androgen and estrogen statuses. All were studied three times in 1 month and included women 1) with regular menses (estrogen positive, T positive), 2) more than 50 yr old and not receiving estrogen (estrogen negative, T positive), 3) receiving estrogen (estrogen positive, T negative), and 4) with severe androgen deficiency secondary to hypopituitarism (estrogen negative, T negative). Calculated values for free T using the laws of mass action correlated well with those obtained from equilibrium dialysis (r = 0.99; P < 0.0001). However, the agreement depended strongly on the specific assays used for total T and SHBG. In contrast, the direct RIA method had unacceptably high systematic bias and random variability and did not correlate as well with equilibrium dialysis values (r = 0.81; P < 0.0001). In addition, the lower limit of detection was higher for the direct RIA than for equilibrium…
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ED is labor intensive, technically challenging, non-automated, subject to operator-dependent errors, and has limited availability in routine clinical practice.
“Essentially obtaining accurate results, execution of this assay is, however, very labor intensive and technically challenging, resulting in limited availability of the method in everyday clinical routine [222].”
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 [222]
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- Authors
- Miller, K. K., Rosner, W., Lee, H., Hier, J., Sesmilo, G., Schoenfeld, D., Neubauer, G., & Klibanski, A.
- Affiliations
- Harvard University (US)
- St. Luke's-Roosevelt Hospital Center (US)
- Venue
- The Journal of Clinical Endocrinology & Metabolism
- Publisher
- The Endocrine Society
- Published
- 2004-02
- Volume
- 89
- Issue
- 2
- Pages
- 525-533
- ISSN
- 0021-972X (ISSN-L)
- 1945-7197
- OpenAlex
- W2157527766
- Cited by
- 301
- References
- 31
- Citations by year
- 2026: 3 · 2025: 3 · 2024: 5 · 2023: 4 · 2022: 7 · 2021: 4 · 2020: 10 · 2019: 5 · 2018: 11 · 2017: 13 · 2016: 9 · 2015: 9 · 2014: 17 · 2013: 18 · 2012: 16
- FWCI
- 18.26
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Journal of Clinical Endocrinology & Metabolism (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health (5r03dk059297-02)
- National Institute of Diabetes and Digestive and Kidney Diseases (R03-DK-59297)
- National Center for Research Resources (M01RR001066, M01 RR01066-27S1, M01-RR01066)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Adrenal Hormones and Disorders
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Keywords
- free testosterone, equilibrium dialysis, radioimmunoassay, mass action law, sex hormone-binding globulin, free androgen index, hypopituitarism, estrogen therapy, assay comparison, diagnostic accuracy
- MeSH terms
- Adult, Androgens, Dialysis, Female, Humans, Middle Aged, Radioimmunoassay, Sensitivity and Specificity, Sex Hormone-Binding Globulin, Testosterone, Reproducibility of Results, Case-Control Studies
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