Annals of Laboratory Medicine

Korean Society for Laboratory Medicine (대한진단검사의학회)
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An Accurate Isotope Dilution Liquid Chromatography-Tandem Mass Spectrometry Method for Serum C-Peptide and Its Use in Harmonization in China

  • Yuhang Deng (National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Chinese Academy of Medical Sciences and Peking Union Medical College) ;
  • Chao Zhang (National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences) ;
  • Jing Wang (National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences) ;
  • Jie Zeng (National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences) ;
  • Jiangtao Zhang (National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences) ;
  • Tianjiao Zhang (National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences) ;
  • Haijian Zhao (National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences) ;
  • Weiyan Zhou (National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences) ;
  • Chuanbao Zhang (National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences)
  • Received : 2022.11.13
  • Accepted : 2023.01.25
  • Published : 2023.07.01
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Abstract

Background: Serum C-peptide results from various routine methods used in China are highly variable, warranting well-performing methods to serve as an accuracy base to improve the harmonization of C-peptide measurements in China. We developed an accurate isotope dilution liquid chromatography-tandem mass spectrometry (ID-LC-MS/MS) method for serum C-peptide measurement and explored its use in harmonization. Methods: After protein precipitation with ZnSO4 solution, C-peptide was extracted from serum samples by anion-exchange solid-phase extraction and quantified by ID-LC-MS/MS in positive ion mode. The precision and analytical recovery of the ID-LC-MS/MS method were assessed. Seventy-six serum samples were analyzed using the ID-LC-MS/MS method and six routine immunoassays. Ordinary linear regression (OLR) and Bland-Altman (BA) analyses were conducted to evaluate the relationship between the ID-LC-MS/MS method and routine immunoassays. Five serum pool samples assigned using the ID-LC-MS/MS method were used to recalibrate the routine assays. OLR and BA analyses were re-conducted after recalibration. Results: The within-run, between-run, and total precision for the ID-LC-MS/MS method at four concentrations were 1.0%-2.1%, 0.6%-1.2%, and 1.3%-2.2%, respectively. The analytical recoveries for the ID-LC-MS/MS method at three concentrations were 100.3%-100.7%, 100.4%-101.0%, and 99.6%-100.7%. The developed method and the immunoassays were strongly correlated, with all R2>0.98. The comparability among the immunoassays was substantially improved after recalibration. Conclusions: The performance of the ID-LC-MS/MS method was carefully validated, and this method can be used to improve the harmonization of serum C-peptide measurements in China.

Keywords

Acknowledgement

The authors gratefully acknowledge their colleagues at West China Hospital, Sichuan University Department of Laboratory Medicine, Beijing Aerospace General Hospital Department of Laboratory Medicine, Snibe Diagnostic Co. Ltd. (Shenzhen, China), and Mindray Co. Ltd. (Shenzhen, China) for their assistance in sample testing during this study.

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