Sensitivity and specificity of three third-generation anti-hepatitis C virus ELISAs.
Three commercially available 3rd-generation anti-HCV ELISAs (Abbott, Murex and Ortho) were evaluated in various serum panels: (A) blood donor samples (n = 403) with 1st- or 2nd-generation anti-HCV ELISA (various manufacturers) positive test results; (B) non-A, non-B hepatitis patients (n = 212); (C) multitransfused patients (n = 253); (D) serial dilutions of HCV confirmed (RIBA and PCR) positive blood donors (n = 24), and (E) first-time blood donors (n = 1,055). All samples of panels A, B and C were tested in PCR and RIBA-2. In panels A, B and C, 398 samples were HCV PCR positive: all were detected by Abbott and Ortho, and 397 (99.7%) by Murex. The sample missed by the Murex ELISA showed an isolated anti-C33c reactivity in RIBA-2. In panels A-C, 442 samples were RIBA-2 positive and all were detected by the 3 tests. With Probit analysis on results of panel D, no significant difference in sensitivity was observed between the 3 evaluated ELISAs. Specificities of Abbott, Murex and Ortho in 1,055 blood donors were 99.7, 99.3 and 99.9%, respectively (NS, chi 2). We conclude that the sensitivity and specificity of the 3 ELISAs are comparable although the C33c antigen in the Murex VK47 test should be improved.
D001782:Blood Donors; D004797:Enzyme-Linked Immunosorbent Assay; D016174:Hepacivirus / Q000302:isolation & purification*; D018937:Hepatitis C Antibodies / Q000097:blood; D006801:Humans; D011237:Predictive Value of Tests; D012307:Risk Factors; D012680:Sensitivity and Specificity; D065227:Transfusion Reaction
D018937:Hepatitis C Antibodies