INTENDED USE Bioneovan HEV-IgM ELISA is an in vitro enzyme linked immunoassay supplied for the detection of HEV-IgM in human serum or plasma. It is intended to be used as an aid in supplementary diagnosis to acute hepatitis E infection and prevalence studies among the population. Test Description This kit employs solid phase, capture ELISA method for detection of IgM antibodies to HEV (anti-HEV) in serum or plasma with two-step incubation procedure. Polystyrene microwell is pre-coated with purified activated mouse anti human IgM (μ chain) monoclonal antibody. The HRP conjugated recombinant HEV antigen serves as tracer. TMB is substrate for HRP. The enzyme reaction with substrate TMB produces a color change, and the intensity of the absorbance at 450 nm indicates the presence or absence of Anti-HEV antibodies IgM in the sample. The test is specific, sensitive, reproducible and easy to operate. It is for diagnosis of early infection and epidemic survey.