Imprecision remains to be improved in the measurement of serum cystatin C with heterogeneous systems

Author:

Zeng Jie1,Zhang Li2,Zhang Jiangtao1,Zhou Weiyan1ORCID,Zhang Tianjiao1,Wang Jing1,Zhao Haijian1,Zhang Chuanbao1ORCID

Affiliation:

1. National Center for Clinical Laboratories, Chinese Academy of Medical Sciences, Beijing Hospital/National Center of Gerontology, Beijing Engineering Research Center of Laboratory Medicine , Institute of Geriatric Medicine , Beijing , P.R. China

2. National Center for Clinical Laboratories, Chinese Academy of Medical Sciences, Beijing Hospital/National Center of Gerontology, Beijing Engineering Research Center of Laboratory Medicine, Chinese Academy of Medical Sciences and Peking Union Medical College , Institute of Geriatric Medicine , Beijing , P.R. China

Abstract

Abstract Objectives Except for the large bias of some measurement systems for serum cystatin C (CysC) measurements, unacceptable imprecision has been observed for the heterogenous system. This study analyzed the external quality assessment (EQA) results in 2018–2021 to provide an insight into the imprecision of CysC assays. Methods Five EQA samples were sent to participating laboratories every year. Participants were divided into reagent/calibrator-based peer groups, for which the robust mean of each sample and robust coefficient of variation (CV) were calculated by Algorithm A from ISO 13528. Peers with more than 12 participants per year were selected for further analysis. The limit of CV was determined to be 4.85% based on clinical application requirements. The concentration-related effect on CVs was investigated using logarithmic curve fitting; the difference in medians and robust CVs between instrument-based subgroups was also evaluated. Results The total number of participating laboratories increased from 845 to 1,695 in four years and heterogeneous systems remained the mainstream (≥85%). Of 18 peers with ≥12 participants, those using homogeneous systems showed relatively steady and small CVs over four years, with the mean four-year CVs ranging from 3.21 to 3.68%. Some peers using heterogenous systems showed reduced CVs over four years, while 7/15 still had unacceptable CVs in 2021 (5.01–8.34%). Six peers showed larger CVs at the low or high concentrations, and some instrument-based subgroups presented greater imprecision than others. Conclusions More efforts should be made to improve the imprecision of heterogeneous systems for CysC measurement.

Funder

National Key Research and Development Program of China

Publisher

Walter de Gruyter GmbH

Subject

Biochemistry (medical),Clinical Biochemistry,General Medicine

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