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Licensed Unlicensed Requires Authentication Published by De Gruyter July 28, 2020

Evaluation of serum electrolytes measurement through the 6-year trueness verification program in China

  • Ying Yan , Yungang Pu , Jie Zeng , Tianjiao Zhang , Weiyan Zhou , Jiangtao Zhang , Jing Wang , Chao Zhang , Wenxiang Chen and Chuanbao Zhang EMAIL logo

Abstract

Objectives

The National Center for Clinical Laboratories (NCCL) in China initiated a serum electrolyte trueness verification (ETV) program in 2014 for measurement standardization.

Methods

Every year, two levels of fresh frozen commutable serum samples determined by inductively coupled plasma mass spectrometry (ICP-MS) reference methods were transported to participating clinical laboratories for the measurement of sodium, potassium, calcium and magnesium. Both samples were measured 15 times in 3 days, and the mean values and coefficient variations (CVs) were calculated from the results. The tolerance limits of trueness (bias), precision (CV) and accuracy (TE) based on the biological variation database were used as the evaluation criteria. The overall trend of the ETV program over 6 years was surveyed by calculating the pass rates of the participating laboratories. The mean bias, inter-laboratory CV, and TE of all laboratory results were analysed. Furthermore, homogeneous and heterogeneous systems were compared, and the bias and CV results of mainstream analysis systems were analysed.

Results

Pass rates of the three quality specifications increased, and the overall mean bias and inter-laboratory CVs decreased. The homogeneous system was superior to the heterogeneous system for calcium and magnesium measurements. For sodium, potassium, calcium and magnesium, the minimum bias corresponded to Hitachi, Siemens, Beckman AU and Roche, respectively. For inter-laboratory robust CVs, no obvious differences were observed between each peer group.

Conclusions

The commutable ETV materials assigned via reference methods can evaluate the accuracy and reproducibility of an individual laboratory and the calibration traceability and uniformity between laboratories for measurements.


Corresponding author: Chuanbao Zhang, Researcher, National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, 1 Dahua Road, Dongdan, Beijing, 100730, P.R. China; and Chinese Academy of Medical Sciences and Peking Union Medical College, No. 9 Dongdan, Santiao Road, Beijing, 100005, P.R. China. Phone: +86 010 5811 5059, Fax: +86 010 6513 2968, E-mail:

Funding source: National Key Technology R&D Program of China

Award Identifier / Grant number: 2011AA02A102

  1. Research funding: This work was supported by the National Key Technology R&D Program of China (Grant 2011AA02A102).

  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. Ethical approval: Residual serum samples were collected at the clinical laboratory of Beijing Hospital with approval from the Ethics Committee of Beijing Hospital.

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Received: 2020-03-20
Accepted: 2020-07-08
Published Online: 2020-07-28
Published in Print: 2021-01-26

© 2020 Walter de Gruyter GmbH, Berlin/Boston

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