Analysis of immunoassays to detect antibodies to hepatitis A virus (anti-HAV) and anti-HAV immunoglobulin M

Abstract Two newly developed anti-HAV tests were assessed, using a total of 1835 sera. These two tests are being distributed under the trademarks Enzymun-Test ® anti-HAV and Enzymun-Test ®R IgM anti-HAV. The anti-HAV test was compared to anti-HAV tests from other manufacturers and featured a high sensitivity combined with a high level of reproducibility and specificity. In terms of sensitivity, reproducibility and specificity, the IgM test proved to be comparable to other IgM anti-HAV tests used for the diagnosis of acute type A hepatitis. Combining both tests was shown to be useful to recognize an acute or past hepatitis A virus infection. In addition, the high sensitivity of the anti-HAV test makes this test extremely useful to assess the immunoresponse to the hepatitis A vaccine.