Clinical Significance

The hepatitis C virus (HCV) is now known to be the causative agent for most, if not all, blood-borne non-A, non-B hepatitis (NANBH). Studies throughout the world indicate that HCV is transmitted through contaminated blood and blood products, through blood transfusions or through other close, personal contacts. The presence of anti-HCV indicates that an individual may have been infected with HCV and may be capable of transmitting HCV infection.

Three recombinant hepatitis C virus encoded antigens (c22-3, c200 and NS5) are used in the VITROS Anti-HCV test. The recombinant protein c22-3 in encoded by the putative core region of the HCV genome. HCV recombinant protein c200 is encoded by the putative NS5 and NS4 regions of the HCV genome. The c200 protein contains the c33c protein sequence which is genetically linked to the c100-3 protein sequence. Studies have indicated that antibodies which develop after infection with HCV are often reactive with c22-3 and/or c33c. HCV recombinant protein NS5 is encoded by the putative NS5 region of the HCV genome. A significant proportion of persons infected with HCV develop antibodies to NS5. The host organism for all three HCV recombinant antigens is S. cerevisiae (yeast).

_{Source: Vitros ECiQ, aHCV IFU. Pub. No. GEM1243 Version 13.0}