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, χ2). 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.

[1]  M. Houghton,et al.  Isolation of a cDNA clone derived from a blood-borne non-A, non-B viral hepatitis genome. , 1989, Science.

[2]  G. Nemo,et al.  Hepatitis C virus infection in post-transfusion hepatitis. An analysis with first- and second-generation assays. , 1992, The New England journal of medicine.

[3]  M. Houghton,et al.  Storage conditions of blood samples and primer selection affect the yield of cDNA polymerase chain reaction products of hepatitis C virus , 1992, Journal of clinical microbiology.

[4]  M. Houghton,et al.  Early Antihepatitis C Virus Response with Second—Generation C200/C22 ELISA , 1992, Vox sanguinis.

[5]  E. Holmes,et al.  Sequence variability in the 5' non-coding region of hepatitis C virus: identification of a new virus type and restrictions on sequence diversity. , 1993, The Journal of general virology.

[6]  G. Gerken,et al.  Reliability of polymerase chain reaction for detection of hepatitis C virus , 1993, The Lancet.

[7]  P. Simmonds,et al.  Testing of blood donations for hepatitis C virus , 1994, The Lancet.

[8]  M. Jadoul,et al.  Significance of NS3 and NS5 antigens in screening for HCV antibody , 1994, The Lancet.

[9]  H. Claeys,et al.  Evaluation of Third‐Generation Screening and Confirmatory Assays for HCV Antibodies , 1994, Vox sanguinis.

[10]  H. Reesink,et al.  E2 and NS5: New antigens for detection of hepatitis C virus antibodies , 1994, Journal of medical virology.

[11]  C. L. van der Poel,et al.  Hepatitis C virus infection from blood and blood products. , 1994, FEMS microbiology reviews.

[12]  H. Vrielink,et al.  Confirmation of hepatitis C infection: a comparison of five immunoblot assays , 1994, Transfusion.

[13]  H. Vrielink,et al.  Look-back study of infectivity of anti-HCV ELISA-positive blood components , 1995, The Lancet.

[14]  H. M. van den Berg,et al.  Hepatitis E virus antibodies among patients with hemophilia, blood donors, and hepatitis patients , 1995, Journal of medical virology.