Total Testosterone Assays in Women with Polycystic Ovary Syndrome: Precision and Correlation with Hirsutism
Open accessAbstract
CONTEXT: There is no standardized assay of testosterone in women. Liquid chromatography mass spectrometry (LC/MS) has been proposed as the preferable assay by an Endocrine Society Position Statement. OBJECTIVE: The aim was to compare assay results from a direct RIA with two LC/MS. DESIGN AND SETTING: We conducted a blinded laboratory study including masked duplicate samples at three laboratories--two academic (University of Virginia, RIA; and Mayo Clinic, LC/MS) and one commercial (Quest, LC/MS). PARTICIPANTS AND INTERVENTIONS: Baseline testosterone levels from 596 women with PCOS who participated in a large, multicenter, randomized controlled infertility trial performed at academic health centers in the United States were run by varying assays, and results were compared. MAIN OUTCOME MEASURE: We measured assay precision and correlation and baseline Ferriman-Gallwey hirsutism scores. RESULTS: Median testosterone levels were highest with RIA. The correlations between the blinded samples that were run in duplicate were comparable. The correlation coefficient (CC) between LC/MS at Quest and Mayo was 0.83 [95% confidence interval (CI), 0.80-0.85], between RIA and LC/MS at Mayo was 0.79 (95% CI, 0.76-0.82), and between RIA and LC/MS at Quest was 0.67 (95% CI, 0.63-0.72). Interassay variation was highest at the lower levels of total testosterone (≤50 ng/dl). The CC for Quest LC/MS was significantly different from those derived from the other assays. We found similar correlations between total testosterone levels and hirsutism score with the RIA (CC=0.24), LC/MS at Mayo (CC=0.15), or Quest (CC=0.17). CONCLUSIONS: A testosterone RIA is comparable to LC/MS assays. There is significant variability between LC/MS assays and poor precision with all assays at low testosterone levels.
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Moderate or severe comedonal acne with 10 or more facial lesions in early puberty, or moderate inflammatory acne through the perimenarcheal years, is uncommon, with a prevalence below 5%.
“While comedonal acne is common in adolescent girls, moderate or severe comedonal acne (i.e., 10 or more facial lesions) in early puberty or moderate inflammatory acne through the perimenarcheal years is uncommon (<5% prevalence) [42,43]”
From The Diagnosis of Polycystic Ovary Syndrome during Adolescence (2015) · cites this paper as [42]
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References 26 · Cited by 213
- Authors
- Legro, R. S., Schlaff, W. D., Diamond, M. P., Coutifaris, C., Casson, P. R., Brzyski, R. G., Christman, G. M., Trussell, J. C., Krawetz, S. A., Snyder, P. J., Ohl, D., Carson, S. A., Steinkampf, M. P., Carr, B. R., McGovern, P. G., Cataldo, N. A., Gosman, G. G., Nestler, J. E., Myers, E. R., Santoro, N., Eisenberg, E., Zhang, M., & Zhang, H.
- Affiliations
- Pennsylvania State University (US)
- University of Colorado Denver (US)
- Wayne State University (US)
- University of Pennsylvania (US)
- University of Vermont (US)
- The University of Texas at San Antonio (US)
- University of Michigan (US)
- Baylor College of Medicine (US)
- University of Alabama (US)
- The University of Texas at Dallas (US)
- Rutgers, The State University of New Jersey (US)
- Stanford University (US)
- University of Pittsburgh (US)
- Virginia Commonwealth University (US)
- Duke University (US)
- National Institutes of Health (US)
- Yale University (US)
- Corresponding author
- Legro, Richard S.
- ORCID
- Venue
- The Journal of Clinical Endocrinology & Metabolism
- Publisher
- The Endocrine Society
- Published
- 2010-12
- Volume
- 95
- Issue
- 12
- Pages
- 5305-5313
- ISSN
- 0021-972X (ISSN-L)
- 1945-7197
- PMC
- PMC2999971
- OpenAlex
- W2025539140
- Cited by
- 213
- References
- 26
- Citations by year
- 2026: 1 · 2025: 7 · 2024: 9 · 2023: 13 · 2022: 15 · 2021: 12 · 2020: 16 · 2019: 15 · 2018: 16 · 2017: 17 · 2016: 18 · 2015: 15 · 2014: 19 · 2013: 17 · 2012: 11
- FWCI
- 14.86
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- The Journal of Clinical Endocrinology & Metabolism (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- University of Pittsburgh (C06 RR016499)
- University of Virginia (C06 RR016499, MO1RR00056, MO1RR10732)
- Eisai
- National Institutes of Health (MO1RR10732)
- National Institute of Child Health and Human Development (U10 HD33172, U54 HD29834, U10 HD38992, U10 HD3898 8, U10 HD39005, U10 HD27049, U01 HD38997, U10 HD38998, U10 HD27011, HD055944, U10 HD38999)
- National Center for Research Resources (MO1-RR-00056, MO1 RR10732, C06RR016499, M01RR000056, M01RR010732)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (U10HD033172, U10HD038999, U54-HD29834, U10HD27049, U10HD039005, U10-HD38992, U10 HD27011, U10-HD39005, HD38992, U10HD027011, U10 HD38999, U10HD038998, U10HD055942, HD055942, U01HD038997, HD38998, HD39005, HD055936, R01HD029834, U10-HD38998, U01-HD38997, U10-HD38988, U10HD055925, U10HD038988, HD055944, U10HD027049, U10 HD33172, U10HD055944, U10HD038992, HD27049, U10HD055936)
- Topics
- Health Sciences › Medicine › Reproductive Medicine › Ovarian function and disorders
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
- Keywords
- total testosterone, polycystic ovary syndrome, radioimmunoassay, liquid chromatography-mass spectrometry, assay precision, inter-assay variability, hirsutism, Ferriman-Gallwey score
- MeSH terms
- Chromatography, Liquid, Cross Reactions, Female, Hirsutism, Humans, Male, Polycystic Ovary Syndrome, Radioimmunoassay, Regression Analysis, Sex Characteristics, Mass Spectrometry, Testosterone, United States
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