Evaluation of five hepatitis C virus screening tests and two supplemental assays: performance when testing sera from sexually transmitted diseases clinic attendees in the USA

Abstract

The performances of five screening tests (recombinant peptide-based first and second generation tests from Abbott and Ortho, and a synthetic peptide-based test from Biochem Immunosystems) and two supplemental tests: recombinant peptide- based, Abbott neutralization test and Chiron second generation recombinant immunoblot assay (RIBA 2), were evaluated for their ability to detect hepatitis C virus (HCV) antibodies in a population of 276 individuals attending a sexually transmitted diseases (STD) clinic in the USA. Although the five screening tests produced a variable number (35–62) of repeatedly reactive samples, only 13% (36/276) were classified as true positives by the supplemental tests. Thirty-four of the 36 were reactive by all screening tests and 32 of the true positives were reactive by both supplemental tests, while 2 did not neutralize but were reactive in the RIBA 2 test. Of the remaining 2 of the true positives which were discordant by several of the screening assays, 1 was confirmed by both supplemental assays but the other required a chemiluminescent enhancement technique to show positivity in RIBA 2. The sensitivities of the first and second generation Abbott and Ortho tests ranged from 97% to 100% and that of the Biochem test was 94%. The specificities of these tests ranged from 89.2% to 99.6%. The second generation Ortho test presented 9.4% (26/276) false positives. The use of second generation Ortho as a screening test would lead to an excessive number of confirmatory false positives. the positive predictive values of the screening tests ranged from 58.1% to 97.1%. Although the synthetic peptide based Biochem test exhibited the best overall indices, the presence of 2 false negative results would prevent its use as a singular screening test. Nevertheless its high specificity may lend itself to be used as a second screening test before confirmatory testing with RIBA 2.