Verification of analytical performance of Creatine Kinase isoenzyme MB (CK-MB) on the Alinity c® Experience from the Biochemistry Laboratory of Mohammed VI University Hospital in Oujda
1 Central Laboratory, Mohammed VI University Hospital, Oujda, Morocco.
2 Mohammed First University, Faculty of Medicine and Pharmacy of Oujda, Morocco.
Research Article
GSC Biological and Pharmaceutical Sciences, 2025, 30(01), 201-205
Article DOI: 10.30574/gscbps.2025.30.1.0026
Publication history:
Received on 08 December 2024; revised on 17 January 2025; accepted on 20 January 2025
Abstract:
The verification of analytical methods is a requirement of the NF EN ISO 15189 standard. It involves evaluating the performance of an analytical method according to a well-defined protocol and comparing it to pre-established analytical objectives. In this study, we present the results of the verification protocol for the measurement method of creatine kinase isoenzyme MB (CK-MB) on the Alinity c® analyzer, which is employed for functional exploration of the heart.
Our study is conducted according to the criteria of Scope A detailed in the Verification/Validation Guide for Methods in Medical Biology, following the SH GTA 04 recommendations from COFRAC. The verification focused on the CK-MB assay on the Alinity c® analyzer using International Federation of Clinical Chemistry (IFCC) method based on immunoinhibition principle for an assessment of analytical performance in terms of repeatability and intermediate precision. these results were aligned with the manufacturer's specifications.
The results obtained for various CK-MB assay verification criteria on the Alinity c® analyzer demonstrate satisfactory repeatability across one level with CV = 1.29%. Intra-laboratory reproducibility was satisfactory for one level with CV = 2.58%. The coefficient of variation (CV) values obtained in our study were compared with manufacturer's specifications, no CV reference values were established by French Society of Clinical Biology SFBC.
The findings from this study have allowed us to verify the performance of the CK-MB assay method and to compare them with the objectives set in the accreditation process to which our laboratory is committed.
Keywords:
Method verification/validation; Repeatability; Reproducibility; Coefficient of variation; Alinity c®
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Copyright © 2025 Author(s) retain the copyright of this article. This article is published under the terms of the Creative Commons Attribution Liscense 4.0
