Verification of analytical performance of cyclosporine assay on the Abbott Alinity ci® at the biochemistry laboratory of Mohammed VI university hospital Oujda

In medical laboratories, the verification of methods ensures precise measurements, complying with regulatory standards like the Moroccan Guide for Medical Laboratory Analysis (GBEA) and ISO 15189. After organ transplantation, blood levels of cyclosporine are often monitored closely, and its dosage adjusted accordingly to maintain therapeutic levels while minimizing the risk of toxicity. This study aims to verify the analytical performance of the cyclosporine assay on the Abbott Alinity ci® analyzer. Conducted at Mohammed VI university hospital’s biochemistry laboratory over 30 days, it involved two phases: evaluation of reproducibility and repeatability. Reproducibility was assessed by daily testing of the control samples at three concentration levels (low, medium, and high), and repeatability was measured by subjecting each serum sample to 30 individual assay runs. Cyclosporine determination used a dedicated reagent kit on the Abbott Alinity ci® analyzer’s immunology module, with data processing via the BYG middleware. The resulting coefficient of variation (CV) values were compared against standards set by the supplier. The investigation demonstrated a commendable repeatability across all concentration levels, with CV values of 3.59%, 3.23%, and 3.46% respectively. Intermediate fidelity examination yielded satisfactory results, with CV values of 3%, 4.83%, and 6.01% for low, medium, and high levels respectively. In conclusion, our study confirms the laboratory’s capability to provide accurate and precise cyclosporine assay results for clinical use, meeting the recommended criteria set by the suppliers.