INTENDED USE The HCV Gold Rapid Screen Test (RST) is a Chromatographic immunoassay (CIA) for direct qualitative detection of antibodies to Hepatitis C type virus (HCV) in human serum/ plasma and whole blood. PRINCIPLE HCV RST is a chromatographic immunoassay (CIA) for the detection of antibodies to HCV in human serum/plasma and whole blood. HCV recombinant antigens are precoated onto membrane as a capture reagent on the test region. During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with HCV recombinant antigens. If antibodies to HCV present, a pink colored band will develop on the membrane in proportion to the amount of HCV antibodies present in the specimen .Absence of this pink colored band in the test region suggests a negative result. To serve as a procedural control, a purple colored band in the control region will always appear regardless the presence of antibodies to HCV. REAGENTS AND MATERIALS PROVIDED 1. One pouched cassette with desiccant. 2. Blood diluent in a dropper bottle, stored at 4-30°C. 3. One piece of operating instruction. WARNING AND PRECAUTIONS 1. For in vitro diagnostic uses only. 2. All patient samples should be treated as if capable of transmitting diseases. 3. Do not interchange reagents from different lots or use test kit beyond expiration date. 4. Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results. STORAGE The kits should be stored at temperature 4-30°C, the sealed pouch for the duration of the shelf life (24 months).
