Selective detection of IgM-antibody against core antigen of the hepatitis B virus by a modified enzyme immune assay.

IgM antibody against core antigen of the hepatitis B virus (anti-HBc IgM) was selectively determined by a new enzyme immunoassay (EIA). Microtiter plates were coated with anti-human micro chain immunoglobulin. On addition of serum IgM is bound by a factor of about 4,000 more than IgG. After removing the sample, HBcAg is added to the IgM-coated surface. Binding takes place if the IgM contained anti-HBc and was demonstrated by the aid of a conjugate made from anti-HBc IgG and horse radish peroxidase. Quantitation may be achieved without testing a dilution series. The assay was not disturbed by a large excess of anti-HBc IgG in the sample and rheumatoid factor did not produce false-positive results, provided the sample was diluted in an excess of aggregated IgG. The diagnostic relevance of the assay was demonstrated in selected cases of acute hepatitis B. Rapid diagnosis of acute hepatitis B infection is therefore now possible in those cases whihc are HBsAg-negative but anti-HBc-positive.