Method Description

This test is performed using a competitive enzyme immunoassay in which hepatitis delta virus-specific antibodies (anti-HDV) compete with virus-specific polyclonal IgG antibody that is labeled with horseradish peroxidase (HRP) for a fixed amount of recombinant HDV protein coated on the microplate wells. Patient serum sample is added first to the microplate well, in which anti-HDV IgG and IgM antibodies will bind to the recombinant HDV protein coated in the well. After washing, a polyclonal anti-HDV-enzyme conjugate is added and allowed to bind to unbound recombinant HDV protein coated in the well. After another wash, a chromogenic mixture is added as a substrate for the HRP enzymatic reaction. Concentration of the enzyme conjugate bound to the coated well is inversely proportional to the amount of anti-HDV total antibodies present in the patient sample. The concentration of anti-HDV total antibodies present is determined by comparing the calorimetric reaction signal to a calibrated cut-off signal value.