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Chinese Journal of Clinical Laboratory Management(Electronic Edition) ›› 2026, Vol. 14 ›› Issue (02): 149-156. doi: 10.3877/cma.j.issn.2095-5820.2026.02.009

• Experience Sharing • Previous Articles    

Experience sharing in the standardization of serum C-peptide measurement

Kaiduo Xu1,2, Xuanchang Bai1,2, Yi Zhang2, Yunmiao Sun1, Jie Ma1,2, Chuanbao Zhang1,2,(), Weiyan Zhou1,2,()   

  1. 1 Beijing Hospital, National Center for Clinical Laboratories, Beijing 100730, China
    2 Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100730, China
  • Received:2026-01-08 Online:2026-05-28 Published:2026-05-28
  • Contact: Chuanbao Zhang, Weiyan Zhou

Abstract:

This article provides a systematic interpretation of two pivotal studies on the standardization of serum C-peptide measurement published in China in 2023. Addressing the significant variability in C-peptide test results across domestic laboratories, the research established an isotope-dilution liquid chromatography-tandem mass spectrometry (ID-LC-MS/MS) reference method. This method demonstrated excellent performance, with precision ≤2.2% and accuracy (recovery rate) of 99.6%~101.0%, enabling traceability to SI units. Method comparison revealed substantial biases (32.2%~81.7%) in routine immunoassays, which were significantly reduced (to -6.0%~1.2%) after recalibration using frozen human serum pools (FHSP) assigned by the reference method. Furthermore, the studies identified FHSPs as candidate reference materials with satisfactory commutability and stability, offering a solution for the commutability issues prevalent in external quality assessment (EQA) programs. Together, these two studies construct a complete "reference method - reference material - standardization application" system, providing crucial technical support for improving the consistency of C-peptide measurement in China and holding significant importance for advancing precise diagnosis and treatment of diabetes.

Key words: diabetes, serum C-peptide, standardization, reference method, reference material, commutability

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