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Harmonized Reference Ranges for Circulating Testosterone Levels in Men of Four Cohort Studies in the United States and Europe
Open accessAbstract
Background: Reference ranges for testosterone are essential for making a diagnosis of hypogonadism in men. Objective: To establish harmonized reference ranges for total testosterone in men that can be applied across laboratories by cross-calibrating assays to a reference method and standard. Population: The 9054 community-dwelling men in cohort studies in the United States and Europe: Framingham Heart Study; European Male Aging Study; Osteoporotic Fractures in Men Study; and Male Sibling Study of Osteoporosis. Methods: Testosterone concentrations in 100 participants in each of the four cohorts were measured using a reference method at Centers for Disease Control and Prevention (CDC). Generalized additive models and Bland-Altman analyses supported the use of normalizing equations for transformation between cohort-specific and CDC values. Normalizing equations, generated using Passing-Bablok regression, were used to generate harmonized values, which were used to derive standardized, age-specific reference ranges. Results: Harmonization procedure reduced intercohort variation between testosterone measurements in men of similar ages. In healthy nonobese men, 19 to 39 years, harmonized 2.5th, 5th, 50th, 95th, and 97.5th percentile values were 264, 303, 531, 852, and 916 ng/dL, respectively. Age-specific harmonized testosterone concentrations in nonobese men were similar across cohorts and greater than in all men. Conclusion: Harmonized normal range in a healthy nonobese population of European and American men, 19 to 39 years, is 264 to 916 ng/dL. A substantial proportion of intercohort variation in testosterone levels is due to assay differences. These data demonstrate the feasibility of generating harmonized reference ranges for testosterone that can be applied to assays, which have been calibrated to a reference method and calibrator.
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“In their effort to harmonize reference ranges, they established 264 to 916 ng/dL as a normal interval for total T in European and American non-obese men aging from 19 to 39 years.”
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 [178]
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Metadata
- Authors
- Travison, T. G., Vesper, H. W., Orwoll, E., Wu, F., Kaufman, J. M., Wang, Y., Lapauw, B., Fiers, T., Matsumoto, A. M., & Bhasin, S.
- Affiliations
- Hebrew SeniorLife (US)
- Centers for Disease Control and Prevention (US)
- Oregon Health & Science University (US)
- Manchester Academic Health Science Centre (GB)
- Ghent University Hospital (BE)
- University of Washington (US)
- Brigham and Women's Hospital (US)
- ORCID
- Venue
- The Journal of Clinical Endocrinology & Metabolism
- Publisher
- The Endocrine Society
- Published
- 2017-01-10
- Volume
- 102
- Issue
- 4
- Pages
- 1161-1173
- ISSN
- 0021-972X (ISSN-L)
- 1945-7197
- PMC
- PMC5460736
- OpenAlex
- W2604915862
- Cited by
- 326
- References
- 41
- Citations by year
- 2026: 26 · 2025: 41 · 2024: 42 · 2023: 41 · 2022: 45 · 2021: 28 · 2020: 34 · 2019: 27 · 2018: 28 · 2017: 11
- FWCI
- 21.63
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- The Journal of Clinical Endocrinology & Metabolism (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Ghent University Academic Bibliography (Ghent University) (submittedVersion)
- Research Explorer (The University of Manchester) (submittedVersion)
- Funders
- National Institutes of Health (UL1TR000128, n01hc25195-41-0-1, 5p30ag031679-15)
- Centers for Disease Control and Prevention
- National Institute on Aging (U01AG042145, R01AG031206, U01AG042168, U01AG042143, U01AG027810, P30-AG031679, U01AG042139, U01AG042124, U01AG042140)
- National Heart, Lung, and Blood Institute (N01-HC-025195)
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (U01AR066160)
- National Center for Advancing Translational Sciences
- 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
- Health Sciences › Medicine › Reproductive Medicine › Hypothalamic control of reproductive hormones
- Keywords
- total testosterone, reference values, hypogonadism, assay harmonization, age-related reference values, men, Framingham Heart Study, Osteoporotic Fractures in Men Study
- MeSH terms
- Adult, Aged, Aged, 80 and over, Aging, Blood Chemical Analysis, Diagnostic Techniques, Endocrine, Europe, Feasibility Studies, Female, Humans, Hypogonadism, Male, Middle Aged, Reference Standards, Reference Values, Testosterone, United States, Cohort Studies, Young Adult
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