Cited by 301Hormonal and reproductive studiesAdrenal Hormones and DisordersClinical Laboratory Practices and Quality Control

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Measurement of Free Testosterone in Normal Women and Women with Androgen Deficiency: Comparison of Methods

Miller, Karen K., Rosner, William, Lee, Hang, Hier, Joan, Sesmilo, Gemma, Schoenfeld, David, Neubauer, Gregory, Klibanski, Anne·2004·The Journal of Clinical Endocrinology & Metabolism

DOI 10.1210/jc.2003-030680

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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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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)
ORCID: Miller, Karen K.
Lee, Hang
Sesmilo, Gemma
Schoenfeld, David
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
DOI: 10.1210/jc.2003-030680
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 › Health Professions › Medical Laboratory Technology › 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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Measurement of Free Testosterone in Normal Women and Women with Androgen Deficiency: Comparison of Methods

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