INTENDED USE

The HCV Ab Rapid Test is a double antigen lateral flow chromatographic immunoassay for the qualitative detection of anti-hepatitis C virus antibodies in human serum, plasma or whole blood. It is intended to be used as a screening test and as an aid in the diagnosis of infection with HCV. Any reactive specimen with the HCV Ab Rapid Test must be confirmed with alternative testing method(s) and clinical findings.

SUMMARY AND EXPLANATION
HCV represents the hepatitis C virus, hepatitis C virus is one of the chronic hepatitis, after the infection may make the patient in a chronic hepatitis state, long-term failure can lead to liver cirrhosis, and even liver cancer. Its harm and hepatitis B are similar, so after finding hepatitis C virus positive, should further check hepatitis C virus antibody. In addition, to check the hepatitis C virus HCV-RNA, its positive result indicates that HCV is replicating and requires antiviral therapy. Hepatitis C is caused by hepatitis C virus (HCV) infection and is mainly transmitted by blood / body fluids. The World Health Organization estimates that 170 million people are infected with HCV worldwide. The anti-HCV positive rate in the healthy population in China is 0.7%~3.1%, with about 38 million hcv patients. Due to the biological characteristics of the virus and the host immune function and other factors, the body immunity is often difficult to effectively remove the virus, resulting in about 50% ~ 80% of H C V infected people developing chronic hepatitis, of which 20%~30% will develop into cirrhosis. 1-4% of patients with liver cirrhosis develop hepatocellular cancer every year.Hepatitis C virus (HCV), which was formerly described as the parentally transmitted form of non-A, non-B hepatitis (NANBH)1 , causes chronic disease in 50% of patients2. HCV can also be transmitted through intravenous drug abuse and sexual contact3 . Hepatitis C virus is a single-stranded RNA virus with structural similarities to the flavivirus family. Nucleic acid sequences of HCV cDNA clones provide the basis for the construction of recombinant peptides representing putative hepatitis C virus proteins4,5. Anti-hepatitis C virus antibody screening of blood using synthetic or recombinant proteins to identify apparently healthy blood donors with anti-HCV antibodies who otherwise might have transmitted the virus6 . Therefore,HCV Ab Cassette Rapid Test is a useful tool for blood bank screening safety. HCV Ab Cassette Rapid Test was developed to detect anti-HCV antibodies (IgG, IgM, IgA) in human serum or plasma. The test can be performed by minimally trained personnel and without cumbersome laboratory equipment.