POSSIBILITIES AND LIMITATIONS OF HEPATITIS-C ANTIBODY SCREENING IN BLOOD-DONORS

Background: Hepatitis C virus (HCV) is responsible for the majority of post-transfusion hepatitis cases. We compared the correlation and rep roducibility of different screening and confirmatory tests. Material a nd Methods: 1,406 samples of voluntary blood donors were tested in par allel using 3 enzyme-linked immune sorbent assays (ELISA) for HCV anti bodies. Those samples that were positive in at least 1 of the 3 tests were additionally tested in a 3rd-generation ELISA as well as in 3 dif ferent confirmatory tests. Results: 13 samples (0.92%) were repeat rea ctive in at least 1 of the ELISAs with different results in the confir matory tests. Only 3 samples (0.21%) with high sample/cutoff ratios in the ELISAs were positive in all 3 confirmatory tests. Conclusions: Th e reproducibility of the tested ELISAs and the correlation with confir matory tests were good only in samples with a high signal to cutoff ra tio. Two different high-positive ELISA results can be regarded as conf irmation.