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

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.