BACKGROUND: This study was undertaken to assess the prevalence of hepatitis C virus (HCV) antibody and RNA in first-time blood donors and to examine the HCV genotype distribution.
STUDY DESIGN AND METHODS: A third-generation enzyme-linked immunosorbent assay (ELISA) was used to screen 34,725 donors for HCV antibodies. Donors who were repeatably reactive were tested in two immunoblot assays—a second-generation and a third-generation recombinant immunoblot assay—as well as by a polymerase chain reaction (PCR) assay. PCR-positive donors were genotyped. All samples were screened for alanine aminotransferase levels.
RESULTS: The ELISA repeat reactivity rate was 0.55 percent. PCR testing showed that 69 (38%) of the 183 ELISA-reactive samples contained HCV RNA. The third-generation recombinant immunoblot assay identified all 69 viremic samples as antibody positive; however, only 63 tested positive on the second-generation immunoblot. The remaining six PCR-positive donors tested antibody-indeterminate to the core peptide. All six of these donors had HCV subtype 3a infections. Genotype distribution among 58 samples showed that 34 were type 1, of which 22 could be further subtyped as 1a (16) and 1b (6); 2 were 2a; 5 were 2b; and 17 were subtyped as 3a. Donors infected with 2b and 3a had reduced antibody reactivity to the NS4 and NS3 peptides only on the second-generation immunoblot.
CONCLUSION: The prevalence of confirmed anti-HCV and viral RNA in new donors is 0.29 and 0.2 percent, respectively. The third-generation recombinant immunoblot assay was more sensitive than the second-generation immunoblot assay in detecting 2b and 3a HCV subtypes. The inclusion of the NS5 peptide in the third- generation recombinant immunoblot did not result in positive tests in any additional donors. Rather, the improvement was due to the increased detection of NS3 and, to a lesser extent, NS4 antibodies. Subtypes 1a and 3a were most prevalent in this population.