Evaluation of the performance of 44 assays used in countries with limited resources for the detection of antibodies to hepatitis C virus

BACKGROUND: This study was conducted by the International Consortium for Blood Safety (ICBS) and its Collaborating Center, the Paul Ehrlich Institute, to identify high-quality, affordable assays for the detection of hepatitis C virus (HCV) antibodies and make available information on their performance for the benefit of developing countries. STUDY DESIGN AND METHODS: Forty-four assays were evaluated for their sensitivity and specificity. The assays' sensitivity was evaluated on a characterized panel of 200 anti-HCV-positive samples comprising major HCV genotypes 1 through 6. Three seroconversion panels were used to estimate sensitivity in the early infectious phase. Specificity was evaluated with a characterized ICBS-negative panel of 181 verified negative samples. RESULTS: Sensitivity was 100 percent for 15 assays, 99.5 percent for 11 assays, 99.0 percent for 6 assays, and less than 99.0 percent for 12 assays. The false-negative results found were not linked to the genotype. Anti-HCV detection in the early infectious phase was, on average, 16.7 days later than for tests licensed in the European Union. Specificity in 25 tests was 100 percent, whereas 11 assays showed 1 false-positive result (99.45%) and the other assays were nonspecific in 2 or more samples. Two assays were not supplied in sufficient quantity to test for specificity. CONCLUSIONS: On applying criteria for highest sensitivity (100%) and high specificity (>= 99.5%), 11 tests met the criteria. An additional 19 tests reached a performance comparable to WHO's criteria for human immunodeficiency virus antibody assays. The genotype diversity of HCV was found not to influence sensitivity of the assays.