Third generation Enzyme ImmunoAssay (ELISA) for the determination of Hepatitis Delta Virus or HDV in human plasma and sera. The kit is intended for the follow-up of HDV infected patients. For “in vitro” diagnostic use only.
HDV Ag, if present in the sample, is captured by a specific monoclonal antibody, in the 1st incubation. A detergent is added to the sample in order to dissolve the specific antigen from HDV particles.
In the 2nd incubation, after washing, a tracer, composed of a second anti HDV Ag antibody, labeled with peroxidase (HRP), is added to the microplate and binds to the captured HDV Ag.
The concentration of the bound enzyme on the solid phase is proportional to the amount of HDV Ag in the sample and its activity is detected by adding the chromogen/substrate in the 3rd incubation.
The presence of HDV Ag in the sample is determined by means of a cut-off value that allows for the semi quantitative detection of the antigen.