Verification of analytical performance of the C- peptide assay on the Abbott Alinity ci®: Experience of the central laboratory of Mohammed VI University Hospital of Oujda
1 Mohammed First University, Faculty of Medicine and Pharmacy of Oujda, Morocco.
2 Biochemistry laboratory of Mohammed VI University Hospital, Oujda, Morocco.
Research Article
GSC Biological and Pharmaceutical Sciences, 2024, 28(02), 153–161.
Article DOI: 10.30574/gscbps.2024.28.2.0300
Publication history:
Received on 02 July 2024; revised on 09 August 2024; accepted on 12 August 2024
Abstract:
The objective of our study was to assess the analytical performance of C- peptide determination using a two-step immunoassay with microparticle chemiluminescence immunoassay (CMIA) technology, adhering to Scope A criteria outlined in the guide for the verification/validation of medical biology methods.
We analyzed the C- peptide assay's intermediate precision and reproducibility. For the three levels (low, medium, and high), the obtained results are very satisfactory. For intermediate fidelity, the coefficients of variation are 2.52%, CV2 = 3.70%, and CV3 = 4.37%, respectively. For repeatability, the results): CV1 = 3.15%, CV2 = 1.65%, and CV3 = 1.55%, respectively.
The obtained results enabled verification of method performance and comparison with predefined analytical objectives to ensure compliance with regulatory and normative standards. The central laboratory at University Hospital Mohammed VI of Oujda adheres to a quality policy focused on mastering various analytical systems.
Keywords:
C- peptide assay; Analytical performance; Repeatability; Reproducibility Biochemistry laboratory; Abbott Alinity CI analyzer; Chemiluminescent microparticle immunoassay method
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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
