Annals of Laboratory Medicine

Korean Society for Laboratory Medicine (대한진단검사의학회)
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Evaluation of Coefficients of Variation for Clinical Chemistry Tests Based on Internal Quality Control Data Across 5,425 Laboratories in China From 2013 to 2022

  • Wei Wang (National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital, National Center of Gerontology) ;
  • Zhixin Zhang (National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital, National Center of Gerontology) ;
  • Chuanbao Zhang (National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital, National Center of Gerontology) ;
  • Haijian Zhao (National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital, National Center of Gerontology) ;
  • Shuai Yuan (National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital, National Center of Gerontology) ;
  • Jiali Liu (National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital, National Center of Gerontology) ;
  • Na Dong (National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital, National Center of Gerontology) ;
  • Zhiguo Wang (National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital, National Center of Gerontology) ;
  • Fengfeng Kang (Laboratory Medicine Center, Zhejiang Center for Clinical Laboratory, Zhejiang Provincial People's Hospital (Affiliated People's Hospital), Hangzhou Medical College)
  • Received : 2023.06.05
  • Accepted : 2023.11.07
  • Published : 2024.05.01
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Abstract

Background: Clinical chemistry tests are most widely used in clinical laboratories, and diverse measurement systems for these analyses are available in China. We evaluated the imprecision of clinical chemistry measurement systems based on internal QC (IQC) data. Methods: IQC data for 27 general chemistry analytes were collected in February each year from 2013 to 2022. Four performance specifications were used to calculate pass rates for CVs of IQC data in 2022. Boxplots were drawn to analyze trends of CVs, and differences in CVs among different groups were assessed using the Mann-Whitney U-test or Kruskal-Wallis test. Results: The number of participating laboratories increased significantly from 1,777 in 2013 to 5,425 in 2022. CVs significantly decreased for all 27 analytes, except creatine kinase and lipase. Triglycerides, total bilirubin, direct bilirubin, iron, and γ-glutamyl transferase achieved pass rates >80% for all goals. Nine analytes with pass rates <80% based on 1/3 allowable total error were further analyzed; the results indicated that closed systems exhibited lower CVs than open systems for all analytes, except total protein. For all nine analytes, differences were significant between tertiary hospitals and non-tertiary hospitals and between accredited and non-accredited laboratories. Conclusions: The CVs of IQC data for clinical chemistry have seen a continuous overall improvement in China. However, there is ample room for imprecision improvement for several analytes, with stricter performance specifications.

Keywords

Acknowledgement

This work was supported by the National Natural Science Foundation of China (Grant No. 81871737), Project for Science Technology Department of Zhejiang Province (Grant No. 2020C35057), and Zhejiang Provincial Project for Medical and Health Science and Technology (Grant No. 2022KY526).

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