Competitive Enzyme ImmunoAssay (ELISA) for the determination of antibodies to Hepatitis Delta Virus or HDV in human plasma and sera with a “two-steps” methodology. The kit is used for the follow-up of patients infected by HDV. For “in vitro” diagnostic use only.
Anti-HDV antibodies, if present in the sample, compete with a virus-specific polyclonal IgG, labeled with peroxidase (HRP), for a fixed amount of rec-HDV coated on the microplate.
The test is carried out with a two steps incubation competitive system. First the sample is added to the plate and specific anti HDV antibodies bind to the adsorbed antigen. After washing, an enzyme conjugated polyclonal antibody to HDV is added and binds to the free portion of the antigen coated.
After washing a chromogen/substrate mixture is dispensed. The concentration of the bound enzyme on the solid phase becomes inversely proportional to the amount of anti-HDV antibodies in the sample and its activity is detected by the added chromogen/substrate.
The concentration of HDV-specific antibodies in the sample is determined by means of a cut-off value that allows for the semi quantitative detection of anti-HDV antibodies.