Verification of the analytical performance of the anti-cyclic citrullinated peptide assay on ALINITY ci ® experience from the biochemistry laboratory of Mohammed VI University Hospital in 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
World Journal of Biology Pharmacy and Health Sciences, 2024, 18(03), 001–008.
Article DOI: 10.30574/wjbphs.2024.18.3.0320
Publication history:
Received on 20 April 2024; revised on 27 May 2024; accepted on 30 May 2024
Abstract:
The aim of our work was to evaluate the analytical performance of the anti-cyclic citrullinated peptide determination by a two-step immunoassay using microparticle chemiluminescence immunoassay (CMIA) technology, in accordance with the Scope A criteria of the guide of the verification/validation of medical biology methods.
We evaluated the repeatability and the intermediate precision of the assay. The results obtained are very satisfactory for the two levels (low and high) both for intermediate fidelity, with coefficients of variation (CV) of CV1= 1.9% and CV2=1.8% respectively, and for repeatability, with coefficients of variation of CV1 = 1.7%, CV2= 1.61%. respectively.
The results obtained made it possible to verify the method's performance and compare it with the analytical objectives set in order to meet the regulatory and normative requirements set by the supplier and learned societies.
Keywords:
Anti-cyclic citrullinated peptide; Analytical performance; Repeatability; Reproducibility; Alinity CI analyzer; Immuno-chemiluminescence
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