Safety and efficacy of hepatitis C virus antibody screening of blood donors with two sequential screening assays

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Abstract
BACKGROUND: Reactive samples in hepatitis C virus (HCV) antibody screening of blood donors are currently referred for a confirmatory assay. This scheme is not optimally efficient and is expensive because of the lack of specificity and cost of confirmatory tests, as well as the need to discard false‐positive donations. As in some human immunodeficiency virus antibody‐confirmatory schemes, the safety and efficacy of confirming anti‐HCV with two sequential screening assays were evaluated.STUDY DESIGN AND METHODS: Three combinations of two anti‐HCV screening assays were used to test 75,874 blood donors. Results were compared with the routine testing scheme and HCV RNA detection in any enzyme immunoassay‐repeatably reactive samples.RESULTS: The use of an alternative screening assay for repeat testing decreased the proportion of enzyme immunoassay‐positive donors from 0.28 to 0.05 percent. All samples that were “confirmed” as positive by the standard combination of immunoassays and all HCV RNA‐positive samples were detected by the sequential screening assays. No samples that had discordant results on primary and secondary screening assays were confirmed by recombinant immunoblot assay or were found to contain detectable HCV RNA.CONCLUSION: The combination of screening assays for anti‐HCV confirmation was as safe as, cheaper than, and nearly as efficient as the standard testing scheme.