Rapid Anti-HCV Test is for the qualitative detection of antibodies to Hepatitis C Virus (HCV)
INTENDED USE
Rapid Anti-HCV Test is a colloidal gold enhanced, rapid immunochromatographic assay for the qualitative detection of antibodies to Hepatitis C Virus (HCV) in human serum or plasma. This test is a screening test and all positives must be confirmed using an alternate test such as Western Blot. The test is intended for healthcare professional use only.
PERFORMANCE CHARATERISTICS
Specificity:
The specificity of the Rapid Anti-HCV Test is based on clinical studies using confirmed negative serum samples from blood bank and hospital patients in USA (66 samples) and China (90 samples). The studies were performed comparing the results from Rapid Anti-HCV test and that from Abbott’s ELISA as a reference test. The overall specificity was found to be 97 - 99%.
Sensitivity:
In the same studies mentioned above, Rapid Anti-HCV Test was evaluated with 61 confirmed positive serum samples (USA: 31 samples and China: 30 samples). All 61 samples were found reactive.
Rapid anti hcv test kit
