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Toward Excellence in Testosterone Testing: A Consensus Statement
Abstract
BACKGROUND: Testosterone assays are widely used. However, deficiencies in these assays limit their broad and effective implementation and threaten the health of those patients whose medical care relies upon its accurate measurement. Furthermore, the translation of research findings into information useful for patient care, such as new evidence-based clinical guidelines, is not possible unless both research and clinical assays are held to higher standards than are currently required. A group of concerned stakeholders was convened to address this problem. METHODS: Representatives of multiple professional societies, government, and industry, having a stake in ensuring that testosterone levels are measured accurately and reliably, met to identify goals, objectives, and actions necessary to bring about the standardization of assays for testosterone. RESULTS: To ensure highly accurate testosterone testing that will result in improved diagnosis, treatment, and prevention of disease through the use of standardized assays, a series of recommendations were agreed upon. The recommendations included the following: technical improvements for assay standardization; education of health care providers, patients, and all others concerned with testosterone testing; plans to encourage all concerned journals, government agencies, and health insurance companies to support this effort; and encouragement to manufacturers to develop better and more cost effective assays. CONCLUSION: A preliminary timeline was set out to implement the recommendations of the Group.
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“Mass spectrometry (MS) methods exhibit higher accuracy and lower variability than immunoassays, especially at low analyte concentrations.”
From Clinical Usefulness of Ultraperformance Liquid Chromatography-Tandem Mass Spectrometry Method for Low Serum Testosterone Measurement (2023) · cites this paper as [5]
In the citing paper
“Upper lip scores of 3-4 were found in <3% of Black and White US adolescents, though scores of 1-2 rose in prevalence from 7.3% at <2 years after menarche to 28.2% at >2 years after menarche [40,41]”
From The Diagnosis of Polycystic Ovary Syndrome during Adolescence (2015) · cites this paper as [41]
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“The Endocrine Society published a statement summarizing the evidence of these deficiencies and recommending accuracy-based testing of testosterone and calibration of all methods traceable to a single high-level reference material (1).”
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The polycystic ovary syndrome: a position statement from the European Society of
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Comas, I., Ferrer, R., Planas, J., Celma, A., Regis, L., & Moróte, J. (2018) · Actas Urológicas Españolas (English Edition) · doi:10.1016/j.acuroe.2017.12.003 · Cited by 3
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Metadata
- Authors
- Rosner, W., & Vesper, H.
- Affiliations
- St. Luke's-Roosevelt Hospital Center (US)
- Centers for Disease Control and Prevention (US)
- Corresponding author
- Rosner, William
- ORCID
- Vesper, Hubert
- Venue
- The Journal of Clinical Endocrinology & Metabolism
- Publisher
- The Endocrine Society
- Published
- 2010-10
- Volume
- 95
- Issue
- 10
- Pages
- 4542-4548
- ISSN
- 0021-972X (ISSN-L)
- 1945-7197
- OpenAlex
- W2104748844
- Cited by
- 248
- References
- 4
- Citations by year
- 2026: 6 · 2025: 7 · 2024: 7 · 2023: 10 · 2022: 17 · 2021: 14 · 2020: 11 · 2019: 13 · 2018: 19 · 2017: 22 · 2016: 20 · 2015: 16 · 2014: 25 · 2013: 18 · 2012: 24
- FWCI
- 14.51
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Journal of Clinical Endocrinology & Metabolism (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Centers for Disease Control and Prevention Foundation
- U.S. Food and Drug Administration
- National Center for Chronic Disease Prevention and Health Promotion
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
- Health Sciences › Health Professions › Medical Laboratory Technology › Clinical Laboratory Practices and Quality Control
- Physical Sciences › Physics and Astronomy › Instrumentation › Scientific Measurement and Uncertainty Evaluation
- Keywords
- testosterone testing, clinical laboratory testing, health policy recommendations, health care provider education, clinical guidelines implementation
- MeSH terms
- Cost-Benefit Analysis, Diagnostic Techniques, Endocrine, Financing, Government, Humans, Insurance, Health, Reimbursement, National Institutes of Health (U.S.), Quality Assurance, Health Care, Quality Control, Testosterone, United States, Consensus
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