Abstract
Objectives
To find suitable external quality assessment (EQA) materials for serum C-peptide, we evaluated the commutability of five types of processed materials.
Methods
Seventy-four individual serum samples and 12 processed samples including three EQA samples currently in use, frozen human serum pools (FHSP), and three other kinds of processed samples were prepared by dissolving WHO International Standard Reagent for C-peptide (WHO ISR 13/146) in three different matrixes: 0.05 % bovine serum albumin, fetal bovine serum and human serum pools. Samples were analyzed using the isotope dilution liquid chromatography-tandem mass spectrometry (ID-LC-MS/MS) method and six widely used immunoassays. The commutabilities of processed materials were assessed according to the difference in bias approach recommended by the IFCC. And the short- and long-term stability of FHSP samples at different temperatures were also evaluated.
Results
Out of the five kinds of processed materials, FHSP samples were commutable on most assays. In contrast, the EQA materials currently in use were only commutable on a few immunoassays. Additionally, processed materials derived from WHO ISR 13/146 were found to be un-commutable on over half of immunoassays. The FHSP samples could be stably stored at 4 and −20 °C for at least 16 days, and at −80 °C for at least 1 year, but at room temperature only for 12 h.
Conclusions
With clarified commutability and stability information, the human serum pool samples along with the developed ID-LC-MS/MS method could be used in the EQA program to promote the comparability among laboratories for C-peptide measurement in China.
Funding source: Beijing Natural Science Foundation
Award Identifier / Grant number: 7212087
Funding source: National Key Research and Development Program of China
Award Identifier / Grant number: 2022YFF0710301
Acknowledgments
The authors gratefully acknowledge the 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 kind assistance in testing samples during this study.
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Research funding: Beijing Natural Science Foundation: No. 7212087. National Key Research and Development Program of China, Grant Number: No. 2022YFF0710301.
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Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Competing interests: Authors state no conflict of interest.
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Informed consent: Informed consent was obtained from all individuals included in this study.
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Ethical approval: The Ethics Committee of Beijing Hospital approved this study and exempted the need for obtaining informed consent (2018BJYYEC-019-01).
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Supplementary Material
This article contains supplementary material (https://doi.org/10.1515/cclm-2023-0215).
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