【SUMMARY】

Hepatitis C virus (HCV) now is recognized as a major agent of chronic hepatitis,transfusion acquired non-A,non-B hepatitis and liver disease throughout the world.HCV is an enveloped positive-sense,single-stranded RNA virus.Clinical diagnostic issues related to HCV is the detection of HCV antibodies in human serum,plasma or whole blood by immunoassay.We have constructed HCV genes for the expression of recombinant antigens in bacterium systems such as E.coli and focused on structural and non-structural regions of HCV-encoded polyprotein, which are definitely immunogenic.The major immunoreactive antigens of these proteins have been reported as core,NS3,NS4 and NS5 regions of HCV genome,which are known to be highly immunodominant regions. For diagnosis of HCV infection,these recombinant proteins were used as capture materials of a immunochromatographic (rapid) test.Compared to the first generation HCV test using single recombinant antigens, multiple antigens using recombinant proteins have been added in new serologic tests to avoid nonspecific cross-activity and to increase the sensitivity of the HCV antibody test.

【SENSITIVITY】

The recombinant antigen used for the HCV Rapid Test Device (Serum/Plasma/Whole blood) is encoded by genes for both structural (nucleocapsid) and non-structural proteins. The HCV Rapid Test Device (Serum/Plasma/Whole blood) has passed a seroconversion panel and compared with a leading commercial HCV EIA test using clinical specimens.The results show that the relative sensitivity of the HCV Rapid Test Device(Serum/Plasma/Whole blood) is 99.9%,and the relative specificity is 99.7%.