HCV Rapid Antibody Test is a single-use, in vitro diagnostic medical device. It is an immunoassay for the qualitative detection of immunoglobin G (IgG) antibodies to hepatitis C virus (anti-HCV) in oral fluid, fingerstick whole blood, venipuncture whole blood, plasma specimens (EDTA, sodium heparin, lithium heparin, and sodium citrate), and serum (serum separator tube (SST), and from individuals 11 years or older. OraQuick® HCV Rapid Antibody Test assay results may be used to provide presumptive evidence of infection with HCV in individuals with signs and symptoms of hepatitis and in individuals at risk for hepatitis C infection.Technical Specifications: Technology: Linear immuno-chromatographic assay Format: Cassette Sample type: Whole blood, serum, plasma, oral fluid Sensitivity: 100% Specificity: 99.7% Invalidity: 0%