Commutability assessment of reference materials for homocysteine

Tongtong Xing; Jianyi Liu; Haofeng Sun; Yanhong Gao; Yi Ju; Xiaolin Liu; Dewei Song

doi:10.1515/cclm-2022-0388

Article

Commutability assessment of reference materials for homocysteine

Tongtong Xing , Jianyi Liu , Haofeng Sun , Yanhong Gao , Yi Ju , Xiaolin Liu and Dewei Song

Published/Copyright: August 18, 2022

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From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 60 Issue 10

Abstract

Objectives

Commutability of reference materials is essential for ensuring the traceability of patient measurement results and the technical basis for the use of reference materials. Commutability is only relevant for matrixed reference material; it is a prerequisite for the accuracy and authenticity of calibration methods. In this study, we evaluated the commutability of reference materials for homocysteine.

Methods

Five conventional measurement methods were applied to simultaneously measure 30 serum samples and seven homocysteine reference materials from the National Institute of Standards and Technology and the National Institute of Metrology. Liquid chromatography tandem-mass spectrometry was used as a reference method. Two methods were used to evaluate the commutability of the seven reference materials according to the Clinical and Laboratory Standards Institute EP30-A and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) commutability assessment document.

Results

Among 35 combinations of the five conventional methods and seven reference materials, after evaluation in accordance with the EP30-A, the seven reference materials passed the commutability assessment, and 34 combinations were commutable. According to the IFCC, the commutability evaluation of 28 combinations was conclusive (commutable or non-commutable), while results for the remaining seven combinations could not be determined.

Conclusions

The homocysteine reference materials showed good commutability. The sensitivity of the measurement procedure, measurement deviation and uncertainty, and differences in the “measurand” selected by different methods may affect the evaluation results. Additionally, different judgment standards for different methods may explain the observed variations in evaluation results.

Keywords: commutability; EP30-A; homocysteine; International Federation of Clinical Chemistry and Laboratory Medicine; measurand

Corresponding authors: Dewei Song, Division of Chemical Metrology and Analytical Science, National Institute of Metrology (Key Laboratory of Chemical Metrology and Applications on Nutrition and Health for State Market Regulation), Beijing 100029, P.R. China, Phone: +86 10 64524789, E-mail: songdw@nim.ac.cn; Yanhong Gao, Laboratory Department of the First Medical Center of PLA General Hospital, Beijing 100039, P.R. China, E-mail: gyh25cn@126.com; and Xiaolin Liu, School of Chemical Engineering, Beijing University of Chemical Technology, Beijing 100029, P.R. China, E-mail: liuxl@mail.buct.edu.cn

Funding source: National Key Research and Development Program of China

Award Identifier / Grant number: 2017YFF0205401

Funding source: National Institute of Metrology Fundamental Research Project

Award Identifier / Grant number: AKYZD2115-1

Research funding: This work was financially supported by the National Key Research and Development Program of China (grant no. 2017YFF0205401) and by the National Institute of Metrology Fundamental Research Project (grant no. AKYZD2115-1).
Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
Competing interests: Authors state no conflict of interest.
Informed consent: Not applicable.
Ethical approval: Not applicable.

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Supplementary Material

The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2022-0388).

Received: 2022-04-21

Accepted: 2022-07-18

Published Online: 2022-08-18

Published in Print: 2022-09-27

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Supplementary Material

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Keywords for this article

commutability; EP30-A; homocysteine; International Federation of Clinical Chemistry and Laboratory Medicine; measurand