A comprehensive verification approach of coagulation analyser, analytical performance of the sysmex CS-2500

In this study, we aimed to evaluate the precision, accuracy, linearity, reference range, hemolysis-lipemia interactions, and carryover of coagulation tests [prothrombin time (PT), activated partial prothrombin time (aPTT), fibrinogen (Fib), and D-dimer]. Precision was assessed by running normal and pathological control materials. For method comparison, 41 patients’ samples were analyzed on both Sysmex-CS-2500 (optical) and STA-Compact (mechanical) analyzers. The results were evaluated using Passing-Bablock regression and Bland-Altman plots. Linearity and carry-over were performed by serial dilution of high and low-concentration samples and alternating normal and pathological samples. Interference from hemolysis and lipemia was investigated by creating plasma pools with varying hemoglobin and lipid levels and comparing the results with the manufacturer's thresholds.