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KMID : 1100720230430040345
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Annals of Laboratory Medicine
2023 Volume.43 No. 4 p.345 ~ p.354
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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
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Deng Yuhang
Zhang Chao
Wang Jing
Zeng Jie
Zhang Jiangtao
Zhang Tianjiao
Zhao Haijian
Zhou Weiyan
Zhang Chuanbao
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Abstract
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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.
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KEYWORD
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Serum C-peptide, Liquid chromatography-tandem mass spectrometry, Method comparison, Diabetes mellitus, Harmonization
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