Verification of the analytical performance of the serum CA 125 assay on the Abbott Alinity ci®: Experience of the biochemistry laboratory of the Mohammed VI university hospital of Oujda

Abstract

The aim of our work was to evaluate the analytical performance of CA 125 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 CA 125 assay.The results obtained are very satisfactory for the three levels (low, medium and high), both for intermediate fidelity, with coefficients of variation (CV) of 2.68%, 1.62% and 2.11% respectively, and for repeatability, with coefficients of variation of CV1 = 2.17%, CV2 = 2.04%, and CV3 = 1.38% 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. The achieved results facilitated the verification of the method's performance and its comparison with the analytical objectives established, aligning with regulatory and normative requirements outlined by the supplier and relevant professional learned societies.