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.
Jakob
R
R
Baxter Diagnostics AG, Guin, Switzerland.
D000918:Antibody Specificity; D004797:Enzyme-Linked Immunosorbent Assay; D005455:Fluorescent Antibody Technique; D006509:Hepatitis B / Q000175:diagnosis*; D006510:Hepatitis B Antibodies / Q000097:blood*; D006512:Hepatitis B Core Antigens / Q000276:immunology*; D006514:Hepatitis B Surface Antigens / Q000097:blood*; D006801:Humans; D007124:Immunoenzyme Techniques; D007075:Immunoglobulin M / Q000097:blood*; D012680:Sensitivity and Specificity
D006510:Hepatitis B Antibodies; D006512:Hepatitis B Core Antigens; D006514:Hepatitis B Surface Antigens; D007075:Immunoglobulin M