title: Specific detection of anti-HBc antibodies with an enzyme immunoassay using recombinant HBcAg and monoclonal antibodies.
abstract: An enzyme immunoassay for the detection of total anti-HBc antibodies in undiluted serum samples was developed. This assay utilizes an anti-HBc monoclonal antibody and a recombinant HBc antigen. The results of the clinical validation are now reported. A total of 1,301 sera were tested using both the Recombinant TOTAL HBc Ab EIA and a reference assay. The specificity was evaluated on a panel of 573 normal human sera and human sera from subjects with pathological findings unrelated to a hepatitis B virus infection. The sensitivity was studied on a total of 455 sera from HBV infected patients at different stages of infection. The final results indicate 99.8% sensitivity and 99.8% specificity. In addition, 273 sera with either isolated anti-HBc antibodies or with anti-HCV antibodies were tested. The agreement between the Recombinant and the reference assay for these two populations, 96.6 and 90.1%, respectively, is discussed.
authors.affiliation: Clonatec, Paris, France.
authors.forename: M
authors.initials: M
authors.lastname: Tordjeman
authors.forename: V
authors.initials: V
authors.lastname: Rabillon
authors.forename: D
authors.initials: D
authors.lastname: Abouth
authors.forename: C
authors.initials: C
authors.lastname: Trepo
authors.forename: A
authors.initials: A
authors.lastname: Hoffenbach
authors.forename: G
authors.initials: G
authors.lastname: Somme
mesh_terms: D000208:Acute Disease; D000818:Animals; D000911:Antibodies, Monoclonal / Q000276:immunology*; D001327:Autoimmune Diseases / Q000097:blood; D015415:Biomarkers; D006509:Hepatitis B / Q000097:blood* / Q000175:diagnosis; D006510:Hepatitis B Antibodies / Q000097:blood* / Q000276:immunology; D006512:Hepatitis B Core Antigens / Q000276:immunology*; D006521:Hepatitis, Chronic / Q000097:blood; D006525:Hepatitis, Viral, Human / Q000097:blood; D006801:Humans; D007124:Immunoenzyme Techniques; D007075:Immunoglobulin M / Q000276:immunology; D007239:Infections / Q000097:blood; D051379:Mice; D008807:Mice, Inbred BALB C / Q000276:immunology; D011994:Recombinant Proteins / Q000276:immunology; D012015:Reference Standards; D012680:Sensitivity and Specificity
chemical_list: D000911:Antibodies, Monoclonal; D015415:Biomarkers; D006510:Hepatitis B Antibodies; D006512:Hepatitis B Core Antigens; D007075:Immunoglobulin M; D011994:Recombinant Proteins