Enzyme ImmunoAssay (ELISA) for the determination of IgM class antibodies to Hepatitis Delta Virus or HDV in human plasma and sera with the “capture” system. The kit is intended for the classification of the viral infective agent and the follow-up of HDV infected patients. For “in vitro” diagnostic use only.
Microplates are coated with a monoclonal anti-hIgM antibody that in the 1st incubation “captures” specifically this class of antibodies.
After washing out all the other components of the sample, in the 2nd incubation bound anti HDV IgM are detected by the addition of recombinant HDV antigen immunocomplexed with a specific antibody, labeled with peroxidase (HRP).
After washing, the enzyme captured on the solid phase, acting on the substrate/chromogen mixture, generates an optical signal that is proportional to the amount of IgM antibodies present in the sample.