Cited by 248Hormonal and reproductive studiesClinical Laboratory Practices and Quality ControlScientific Measurement and Uncertainty Evaluation

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Toward Excellence in Testosterone Testing: A Consensus Statement

Rosner, William, Vesper, Hubert·2010·The Journal of Clinical Endocrinology & Metabolism

DOI 10.1210/jc.2010-1314

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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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“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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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
DOI: 10.1210/jc.2010-1314
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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Toward Excellence in Testosterone Testing: A Consensus Statement

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