Assay Development of Diagnostic Tests for Hepatitis E

The development of convenient, sensitive, and specific diagnostic tests to investigate the serology of hepatitis E virus (HEV) infection will be crucial to the understanding of the immune response to this virus. Previously, we reported the identification of two cDNA clones from the 3′ end of open reading frame (ORF) 2 and 3 encoding specific HEV epitopes. We report here the development of an ELISA test to detect IgM and IgG antibodies to HEV based on these epitopes. Also contained within ORF2, is a broadly reactive epitope region (SG3) that has been useful in identifying previously undetected antibodies to HEV. In developing countries, serologic tests suggest that l%–2% of the population have been exposed to the virus. In countries where HEV is endemic, 7%–17% of the population have measurable antibodies to HEV. In cases of acute hepatitis E, IgM and IgG antibody responses have been confirmed by PCR amplification of the virus in the sera.