Recombinant Antigens and Synthetic Peptides for Serodiagnosis of Hepatitis E Virus Infection

To detect antibodies to hepatitis E virus (HEV), two genomic regions within the second (clone SG-3) and third (clone 8-5) open reading frames (ORF) of the HEV genome were expressed as fusion proteins in E. coli, purified, and utilized in developing enzyme-linked immunosorbent assays (ELISAs). All specimens reactive via ELISAs were further tested with supplemental assays including ELISAs employing synthetic peptides and Western blots using the recombinant proteins. IgG, IgA, and/or IgM class antibodies were detected in approximately 89% of an enterically transmitted non-A, non-B hepatitis viral outbreak in Somalia. IgG class antibodies were also found in l%–2% of unselected volunteer blood donors in various geographical regions including the U.S., Europe, and the Far East. Both IgG and IgM class antibodies were detected in 2 individuals presenting with acute viral hepatitis in U.S. (travelers to endemic regions); antibodies persisted in one of these individuals for over 4.5 years after the initial illness. Both IgG and IgM class antibodies were detected in acute viral hepatitis cases in Japan, the Netherlands, and Egypt.