Immunodiagnosis of hepatitis B with high-affinity IgM monoclonal antibodies.

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Abstract
High-affinity monoclonal IgG and IgM antibodies to hepatitis B surface antigen (HBsAG) were prepared and their functional capabilities explored by solid-phase radioimmunoassays. 125I-labeled HBsAg binding studies indicated that monoclonal IgM antibodies against HBsAg (anti-HBs) coupled to a solid-phase support quantitatively bound more HBsAg at a faster rate than conventionally prepared anti-HBs reagents or other high-affinity IgG monoclonal anti-HBs antibodies. IgM anti-HBs was also radiolabeled, and an IgM-IgM radioimmunoassay was developed for the immunodiagnosis of hepatitis B. The lower limit of this assay was .apprxeq. 100 pg .+-. 30 (standard error of the mean) of HBsAg/ml of serum. Compared to available commercial radioassays, preliminary studies have shown the IgM-IgM assay to have increased sensitivity, which improved the detection of a HBsAg-associated determinant in acute hepatitis and post transfusion hepatitis (human). The multivalent interaction between monoclonal IgM anti-HBs and the polydeterminant HBsAg probably is important in augmenting the performance of this monoclonal assay.