title: An enzyme-immunoassay for antibodies against hepatitis B core antigen: characteristics and clinical validation.
abstract: An enzyme-immunoassay (EIA) for antibodies to hepatitis B core antigen (anti-HBc) was developed. The new test uses undiluted samples, incubated directly into an HBcAg coated well. Three alternative test procedures are possible. The stability of reagents was studied and a preclinical evaluation was performed intramurally. An assay correlation study was organised. We report the results of the external evaluation performed at 4 centres. A mean analytical sensitivity of 1.1, 1.2 and 0.36 PEI units/ml anti-HBc was found for procedure I (1 h/1 h/30 min), procedure II (30 min/30 min/30 min) and procedure III (16-20 h/1 h/30 min), respectively. In total, 5288 determinations on serum or plasma from various patients and healthy individuals were performed: 10% with procedure I, 52% with procedure II and 38% with procedure III. The qualitative (positive or negative) results were compared with those found with tests used routinely at the centres--47% with Corzyme (Abbott) and 53% with Corab (Abbott)--in a first screening. A final evaluation was made taking into account the repeatability of the results. Based on all results together, the agreement between the new EIA for anti-HBc and the routine tests was 97.6% at the first screening and increased to 99.0% after further evaluation.
authors.affiliation: Organon Scientific Development Group, Oss, The Netherlands.
authors.forename: L
authors.initials: L
authors.lastname: Matthyssen
authors.forename: A
authors.initials: A
authors.lastname: Arndt-Hanser
authors.forename: W
authors.initials: W
authors.lastname: Lange
authors.forename: G
authors.initials: G
authors.lastname: Maass
authors.forename: K
authors.initials: K
authors.lastname: Schütt
authors.forename: A
authors.initials: A
authors.lastname: van Loon
authors.forename: G
authors.initials: G
authors.lastname: Wolters
mesh_terms: D001782:Blood Donors; D006509:Hepatitis B / Q000175:diagnosis / Q000276:immunology; D006510:Hepatitis B Antibodies / Q000032:analysis*; D006512:Hepatitis B Core Antigens / Q000276:immunology*; D006801:Humans; D007124:Immunoenzyme Techniques; D011237:Predictive Value of Tests
chemical_list: D006510:Hepatitis B Antibodies; D006512:Hepatitis B Core Antigens