A multiple centre clinical study of third-generation enzyme immunoassays for hepatitis B surface antigen and hepatitis B core IgM class antibody.

Two new monoclonal antibody-based automated enzyme immunoassays for hepatitis B markers were tested for their clinical performance. The assays specifically detect hepatitis B surface antigen (HBsAg) and hepatitis B core (HBc) IgM antibodies by radial partition fluorescence enzyme immunoassay. Taken together, the HBsAg and IgM anti-HBc assay show clinical sensitivities of 99.5% and 95.6% and respective clinical specificities of 99.8% and 99.5%, compared with standard ELISAs. The detection limit goes down to 50 PEI units per litre for HBsAg ad subtype and 70 PEI units per litre for ay subtype.