Product Name: HEPATITIS E Human IgG ELISA KIT Product Code: HEV-HG001 Two-step Incubation, Indirect Principle; 96 wells INTENDED USE This kit is an enzyme-linked immunosorbent assay for the qualitative detection of IgG-class antibodies to hepatitis E virus 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. PRINCIPLE OF THE ASSAY This kit employs solid phase, indirect ELISA method for detection of IgG-class antibodies to HEV (anti-HEV) in two-step incubation procedure. Polystyrene microwell strips are pre-coated with recombinant, highly immunoreactive antigens corresponding to the structural regions of HEV (ORF-2). During the first incubation step, anti-HEV specific antibodies, if present, will be bound to the solid phase pre-coated HEV antigens. The wells are washed to remove unbound serum proteins and than, rabbit anti-human IgG antibodies (anti-IgG) conjugated to horseradish peroxidase (HRP-Conjugate) are added. During the second incubation step, these HRP-conjugated antibodies will be bound to any antigen-antibody(IgG) complexes previously formed and the unbound HRP-conjugate is then removed by washing. Chromogen solutions containing Tetramethylbenzidine (TMB) and urea peroxide are added to the wells and in presence of the antigen-antibody-anti-IgG(HRP) immunocomplex, the colorless Chromogens are hydrolyzed by the bound HRP conjugate to a blue colored product. The blue color turns yellow after stopping the reaction with sulfuric acid. The amount of color intensity can be measured and is proportional to the amount of antibody captured in the wells, and to the sample respectively. Wells containing samples negative for anti-HEV-IgG remain colorless. Assay Procedures:
Major Components:
Figure 1: Detection of HEV infection and seroconversion in a Monkey Model.
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