Evaluating the performance of two different chemiluminescence analyzers systems in screening donors’ samples for HCV infection

Abstract

The approved screening test for HCV infection among blood donors is the HCV antibody test. The diagnostic performances of the available immunoassays in the market that target different HCV antigens have not yet been thoroughly analyzed. Our study aimed to assess the diagnostic performances of two different chemiluminescence immunoassay (CLIA) assays. We analyzed 1909 samples using two assay systems (COBAS e601 ROCHE® & Vitros 3600 ORTHO®) and evaluated the agreement of each with the gold standard method ELISA, as well as studying their diagnostic performances. The Cohen’s Kappa statistics revealed excellent agreement between ELISA and both CLIA methods performed on Cobas e 601 ROCHE and Vitrous 3600 ORTHO (0.81 & 0.994 respectively). The sensitivities and positive predictive values were 95.05% and 73.85% for Cobas e 601 ROCHE, 100.00%, and 98.97% for Vitrous 3600 ORTHO, respectively. Excellent diagnostic performance was detected by both assays; however, Vitros 3600 ORTHO outperformed Cobas e 601 ROCHE in terms of sensitivity and specificity.