This HEV IgM kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative determination of IgM-class antibodies to hepatitis E virus in human serum or plasma. It is intended for use in clinical laboratories for diagnosis and management of patients related to infection with hepatitis E virus.
Principle of the assay
This kit is a two-steps incubation, solid phase antibody capture ELISA assay in which polystyrene microwell strips are pre-coated with antibodies directed to human immunoglobulin M proteins (anti-μ chain). The patient’s serum/plasma sample is added and during the first incubation step, any IgM-class antibodies will be captured in the wells. After washing out all the other components of the sample and in particular IgG-class antibodies, the specific HEV IgM captured on the solid phase is detected by the addition of recombinant HEV ORF2 antigens conjugated to horseradish peroxidase (HRP-Conjugate). During the second incubation, the HRP-conjugated antigens will specifically react only with HEV IgM antibodies and after washing to remove the unbound HRP-Conjugate, Chromogen solutions are added into the wells. In presence of (anti-μ) - (anti-HEV-IgM) - (HEV Ag-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 HEV IgM remain colorless.