Competitive Enzyme ImmunoAssay (ELISA) for the determination of antibodies to Hepatitis B core Antigen in human plasma and sera. The kit is for use in screening of blood units and the follow-up of HBV-infected patients.
For “in vitro” diagnostic use only.
The assay is based on the principle of competition where the antibodies in the sample compete with a monoclonal antibody for a fixed amount of antigen on the solid phase.
A purified recombinant HBcAg is coated to the microwells. The patient’s serum/plasma is added to the microwell together with an additive able to block interferences present in the sample.
In the second incubation after washing, a monoclonal antibody, conjugated with Horseradish Peroxidase (HRP) and specific for HBcAg is added and binds to the free rec-HBcAg coated on the plastic.
After incubation, microwells are washed to remove any unbound conjugate and then the chromogen/substrate is added. In the presence of peroxidase enzyme the colorless substrate is hydrolyzed to a colored end-product.
The color intensity is inversely proportional to the amount of antibodies to HBcAg present in the sample.