Method Description

This is a qualitative, in vitro test for the detection and identification of IgG antibodies specifically against to hepatitis E virus (HEV) in human serum. This assay is a screening test based on the principle of an indirect sandwich enzyme-linked immunosorbent assay.

Highly purified recombinant HEV-ORF2 viral antigens (specific for HEV genotypes 1 and 3) are fixed to microplate wells. Diluted patient serum specimens are incubated in the wells, in which antibodies bind specifically to the HEV recombinant antigens coating the surface of the wells. Unbound antibodies are then washed away. Anti-human immunoglobulin antibodies (IgG), which are coupled to horseradish peroxidase, are then added to the wells and incubated. Unbound conjugate antibodies are then washed away. Specifically, bound antibodies are detected by a peroxidase-catalyzed color reaction. Intensity of the color, as measured with a photometric analyzer, is proportionate to the quantity of bound HEV IgG antibodies present in the serum specimen.(Unpublished Mayo method)