Anti-HBc assays: evaluation of end-point sensitivity and performance

The performance characteristics of eight commercially available anti-HBc assays-seven ELISAs and a modified haemagglutination assay-were assessed using an eight-sample panel of sera collected from blood donors representing a cross-section of anti-HBc-positive donors that might be expected to be encountered in the course of routine screening of blood donations. End-point sensitivity was investigated with a view to choosing one anti-HBc ELISA for use in a second phase routine donor screening study in parallel with the modified haemagglutination test. The chosen anti-HBc ELISA had to be of an acceptable sensitivity level in comparison with all the other ELISAs investigated, and the ease of use and overall test time had to be taken into account. With a view to this, although the Murex assay was by far the most sensitive, the test time with the protocol available at the time was too long and therefore the Biokit ELISA was chosen for the second phase.