HCV antigens are immobilized on a porous immunofiltration membrane. Sample and the reagents pass through the membrane and are absorbed into the underlying absorbent pad. 2.
As the patient's sample passes through the membrane, HCV antibodies if present in serum/plasma, bind to the immobilized antigens. In the subsequent washing step, unbound serum/ plasma proteins are removed. 2.
In the next step, the protein-A conjugate is added which binds to the Fc portion of the HCV antibodies to give distinct pinkish purple dot against a white background at the test region ("T1" &/or "T2"). At the control region ("C") a "Built-in Quality Control Dot" has been devised to confirm the proper functioning of the device, reagent and correct procedural application.