Verification of the analytical performance of CA 19-9 assay on Abbott Alinity ci®: Experience of the central laboratory Mohammed VI Oujda

Sabah Mokhtari 1, 2, *, Amina Himri 1, 2, Loubna Yacoubi 1, 2, Soufiane Beyyoudh 1, 2, Dounia El Moujtahid 1, 2, El houcine Sebbar 1, 2 and Mohammed Choukri 1, 2

1 Central Laboratory, Mohammed VI University Hospital, Oujda, Morocco.
2 Mohammed First University, Faculty of Medicine and Pharmacy of Oujda, Morocco.
 
Research Article
World Journal of Biology Pharmacy and Health Sciences, 2024, 17(01), 129–135.
Article DOI: 10.30574/wjbphs.2024.17.1.0031
Publication history: 
Received on 10 December 2023; revised on 20 January 2024; accepted on 22 January 2024
 
Abstract: 
Introduction: CA19-9 is a marker used in the diagnosis and monitoring of several cancer diseases. The aim of this study is to evaluate the CA19-9 assay on the Abbott ALinity Ci automated system. This evaluation is part of an overall approach to verifying the methods used in the CHU's central laboratory, with a view to compiling an accreditation file in line with the requirements of standard NF EN ISO 15189.
Materials and methods: The aim of our study was to evaluate the scope A criteria detailed in the guide to verification/validation of methods in Medical Biology, in accordance with the recommendations of standards NF EN ISO/CEI 17025, NF EN ISO 15189 and NF EN ISO 22870. Verification was carried out on the CA19-9 assay on Alinity® Ci, which uses the immunoassay technique Criteria (repeatability, reproducibility) were verified.
Results:  The results obtained show good repeatability for the 3 levels with respectively CV1=2,61% , CV2=2,78% , and CV3 =3,26% % and intra-laboratory reproducibility with CV1=3,98% , CV2= 3,16% and CV3 = 3,61%.
Discussion and Conclusion: The central laboratory of our University Hospital is committed to a quality policy which includes a control approach for the various analytical systems used. The results obtained for the various CA19-9 assay verification criteria on our Alinity® Ci system, compared with data from the supplier, RICOS and learned societies, are satisfactory and verify analytical performance.
 
Keywords: 
CA 19-9(carbohydrate antigen); Verification; Repeatability; Reproducibility; Alinity ci®
 
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Copyright information: 
Copyright © 2024 Author(s) retain the copyright of this article. This article is published under the terms of the Creative Commons Attribution Liscense 4.0