Cited by 383Clinical Laboratory Practices and Quality ControlScientific Measurement and Uncertainty EvaluationDiabetes and associated disorders

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Implementing a Reference Measurement System for C-Peptide: Successes and Lessons Learned

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Little, Randie R, Wielgosz, Robert I, Josephs, Ralf, Kinumi, Tomoya, Takatsu, Akiko, Li, Hongmei, Stein, Daniel, Burns, Chris·2017·Clinical Chemistry

DOI 10.1373/clinchem.2016.269274PMC PMC5575958

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Abstract

BACKGROUND: Assessment of endogenous insulin secretion by measuring C-peptide concentrations is widely accepted. Recent studies have shown that preservation of even small amounts of endogenous C-peptide production in patients with type 1 diabetes reduces risks for diabetic complications. Harmonization of C-peptide results will facilitate comparison of data from different research studies and later among clinical laboratory results at different sites using different assay methods. CONTENT: This review provides an overview of the general process of harmonization and standardization and the challenges encountered with implementing a reference measurement system for C-peptide. SUMMARY: Efforts to harmonize C-peptide results are described, including those by the National Institute of Diabetes and Digestive and Kidney Diseases–led C-peptide Standardization Committee in the US, activities in Japan, efforts by the National Institute for Biological Standards and Control in the UK, as well as activities led by the Bureau International des Poids et Mesures and the National Metrology Institute in China. A traceability scheme is proposed along with the next steps for implementation. Suggestions are made for better collaboration to optimize the harmonization process for other measurands.

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C-Peptide Is the Appropriate Outcome Measure for Type 1 Diabetes Clinical Trials to Preserve β-Cell Function
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Self-citation
Verification of in vitro medical diagnostics (IVD) metrological traceability: Responsibilities and strategies
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Authors: Little, R. R., Wielgosz, R. I., Josephs, R., Kinumi, T., Takatsu, A., Li, H., Stein, D., & Burns, C.
Affiliations: University of Missouri (US)
Bureau international des poids et mesures (FR)
National Metrology Institute of Japan (JP)
National Institute of Metrology (CN)
Albert Einstein College of Medicine (US)
National Institute for Biological Standards and Control (GB)
Corresponding author: Little, Randie R
ORCID: Little, Randie R
Wielgosz, Robert I
Josephs, Ralf
Kinumi, Tomoya
Takatsu, Akiko
Li, Hongmei
Burns, Chris
Venue: Clinical Chemistry
Publisher: Oxford University Press (OUP)
Published: 2017-09-01
Volume: 63
Issue: 9
Pages: 1447-1456
ISSN: 0009-9147 (ISSN-L)
1530-8561
DOI: 10.1373/clinchem.2016.269274
PMC: PMC5575958
OpenAlex: W2696753613
Semantic Scholar: 909dfba036768bf9c9b2a61af2b3182361e08901
Cited by: 383
References: 23
Citations by year: 2026: 9 · 2025: 6 · 2024: 5 · 2023: 6 · 2022: 6 · 2021: 3 · 2020: 3 · 2019: 336 · 2018: 7 · 2017: 2
FWCI: 11.68
Type: journal article
Language: en
Open access: green
europepmc.org
Licence: academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model (vor)
Locations: Clinical Chemistry (publishedVersion)
PubMed (publishedVersion)
Europe PMC (PubMed Central) (acceptedVersion)
PubMed Central (acceptedVersion)
Funders: National Institute of Diabetes and Digestive and Kidney Diseases (1UC4DK096587–01)
National Institute of Mental Health (2014DFA31810, K115/P55.2)
Topics: Health Sciences › Health Professions › Medical Laboratory Technology › Clinical Laboratory Practices and Quality Control
Physical Sciences › Physics and Astronomy › Instrumentation › Scientific Measurement and Uncertainty Evaluation
Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
Keywords: C-peptide, reference measurement system, assay harmonization, standardization, traceability, type 1 diabetes, endogenous insulin secretion, metrology, international cooperation
MeSH terms: C-Peptide, Diabetes Mellitus, Type 1, Humans, Reference Standards, Observer Variation, Clinical Laboratory Services

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Implementing a Reference Measurement System for C-Peptide: Successes and Lessons Learned

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