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Licensed Unlicensed Requires Authentication Published by De Gruyter July 19, 2022

Performance of HDL-C measurements assessed by a 4-year trueness-based EQA/PT program in China

  • Weiyan Zhou , Wenbo Luo , Songlin Yu , Hongxia Li , Donghuan Wang , Jiangtao Zhang , Siming Wang , Jie Zeng , Chao Zhang , Haijian Zhao , Hao Zheng , Jun Dong , Wenxiang Chen EMAIL logo and Chuanbao Zhang ORCID logo EMAIL logo



A trueness-based EQA/PT program for high density lipoprotein cholesterol (HDL-C) was initiated. We analyzed the 4 year EQA/PT program to overview the measurement standardization for HDL-C in China.


Two levels of freshly frozen, commutable serum external quality assessment/proficiency testing (EQA/PT) materials were prepared and determined by reference measurement procedure each year. The samples were delivered to clinical laboratories and measured 15 times in 3 days. The precision [coefficient of variation (CV)], trueness (bias), and accuracy [total error (TE)] were calculated and used to evaluate measurement performance. The pass rates of individual laboratories and peer groups were analyzed using the acceptable performance from the National Cholesterol Education Program (NCEP) and biological variation as the evaluation criteria.


More than 60% of laboratories use heterogeneous systems, and there was a decrease in the percentage from 2016 to 2019. About 95, 78, and 33% of laboratories met the minimum, desirable and optimum TE criteria derived from biological variation. The pass rates were 87.0% (84.7–88.8%), 58.7% (55.3–62.4%), and 97.3% (95.6–98.3%) that met the acceptable performance of TE, bias, and CV of NCEP. The homogeneous systems had higher pass rates of TE, bias, and CV than the heterogeneous groups in 2016, but they did not show apparent advantages in 2017–2019.


The trueness-based EQA/PT program can be used to evaluate the accuracy, reproducibility, and trueness of results. For some IVD manufacturers and individual laboratories, accuracy, especially trueness, are still problems. Efforts should be made to improve the situation and achieve better HDL-C measurement standardization.

Corresponding authors: Wenxiang Chen and Chuanbao Zhang, National Center for Clinical Laboratories, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital/National Center of Gerontology, No 1, Dahua Road, Dongcheng District, Beijing, P.R. China, Fax: +86 10 58115059, E-mail: and

Funding source: Beijing Natural Science Found

Award Identifier / Grant number: 7212087

Funding source: CAMS Innovation Fund for Medical Sciences

Award Identifier / Grant number: 2021-I2M-1-050

Funding source: Beijing’s Golden Bridge Seed Fund Project

  1. Research funding: This work was supported by the Beijing Natural Science Found (N0. 7212087), CAMS Innovation Fund for Medical Sciences (No. 2018-I2M-1-002), and Excellent training project of Beijing Dongcheng district.

  2. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  3. Competing interests: Authors state no conflict of interest.

  4. Informed consent: Informed consent was obtained from all individuals included in this study.

  5. Ethical approval: The local Institutional Review Board deemed the study exempt from review.


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Supplementary Material

The online version of this article offers supplementary material (

Received: 2020-05-06
Accepted: 2022-07-01
Published Online: 2022-07-19
Published in Print: 2022-09-27

© 2022 Walter de Gruyter GmbH, Berlin/Boston

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