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.
journal_name
J Virol Methodsjournal_title
Journal of virological methodsauthors
Matthyssen L,Arndt-Hanser A,Lange W,Maass G,Schütt K,van Loon A,Wolters Gdoi
10.1016/0166-0934(87)90072-3subject
Has Abstractpub_date
1987-08-01 00:00:00pages
95-103issue
1-2eissn
0166-0934issn
1879-0984pii
0166-0934(87)90072-3journal_volume
17pub_type
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