The HCV Hepatitis C Virus Rapid Test Device (Serum/Plasma) is a qualitative, membrane based immunoasay for the detection of antibody to HCV in serum or plasma. The membrane is coated with recombinant HCV antigen on the test line region of the device. During testing, the serum or plasma specimen reacts with the recombinant HCV antigen coated particles. The mixture migrates upward on the membrane by capillary action to react with recombinant HCV antigen on the membrane and generate a colored line. Presence of this colored line indicates a positive result, while its absence indicates a negative aresult. To serve a procedural control, a colored line will always appear in the control line region. If the control line does not appear, the test result is not valid.