Enzyme ImmunoAssay (ELISA) for the determination of IgM antibodies to Hepatitis E Virus in human plasma and sera.
The kit may be used for the determination of the acute phase of infection where IgM antibodies are generated before the other immunoglobulins and for the follow-up of HEV-infected patients.
For “in vitro” diagnostic use only.

Microplates are coated with HEV-specific recombinant antigens encoding for conservative and immunodominant determinants of all the 4 subtypes.
The solid phase is first treated with the diluted sample and anti HEV IgM are captured, if present, by the antigens.
After washing out all the other components of the sample, in the 2nd incubation bound anti-HEV IgM are detected by the addition of polyclonal specific anti hIgM antibodies, labelled with peroxidase (HRP).
The enzyme captured on the solid phase, acting on the substrate/chromogen mixture, generates an optical signal that is proportional to the amount of anti HEV IgM present in the sample. A cut-off value let optical densities be interpreted into anti-HEV IgM negative and positive results.
Neutralization of IgG anti-HEV and Rheumatoid Factor, carried out directly in the well, is performed in the assay in order to block such kind of interferences.