Third generation Enzyme ImmunoAssay (ELISA) for the qualitative determination of IgG antibodies to Hepatitis E Virus in human plasma and sera.
The kit is intended 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 IgG are captured, if present, by the antigens.
After washing out all the other components of the sample, in the 2nd incubation bound anti-HEV IgG are detected by the addition of polyclonal specific anti hIgG 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 IgG present in the sample. A cut-off value let optical densities be interpreted into anti-HEV IgG negative and positive results.