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

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

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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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
Venue
Clinical Chemistry
Published
2017-09-01
Volume
63
Issue
9
Pages
1447-1456
ISSN
  • 0009-9147 (ISSN-L)
  • 1530-8561
OpenAlex
W2696753613
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
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 › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › 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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