Paper Title
Determination of Potential of HCV Mosaic Protein for the Diagnosis of Hepatitis C Virus Infection

HCV is considered as the most important reason for liver diseases in both developed and developing countries. For screening of HCV, different diagnostic test utilizing HCV proteins are used. The mosaic proteins are artificial composite proteins constructed from diagnostically relevant antigenic regions derived from different HCV proteins. In present study diagnostic potential of HCV mosaic protein was determined by its comparative performance study with individual recombinant proteins of HCV (i.e. Core, NS3, NS4, NS5). Performance study of proteins was carried out in the format of Immunofiltration assay. For determination of specificity total 891 Nos. of HCV antibody negative serum samples [including normal healthy donors samples (489 Nos.), other diseases positive samples (54 Nos.), interfering substances containing samples (105 Nos.), samples collected from different regions of the India (95 Nos.), clinical samples (148 Nos.)] were tested. For determination of sensitivity total 102 Nos. of HCV antibody positive serum samples were tested. All HCV antibody positive serum samples were confirmed by HCV RIBA Test (MP Diagnostics, India) and HCV ELISA (Enzyme linked immunosorbent assay) test (Ortho Diagnostic Ltd., India). In addition to above mentioned samples sero-conversion panels and performance panel from BBI [PHV911 (M), PHV913, WWHV303] were also tested. In present study 100% sensitivity and specificity was observed with HCV mosaic antigen. However 100% sensitivity and 99.55% specificity was observed with a cocktail of individual recombinant antigens hence it can be concluded from present study that HCV mosaic protein is more specific and it has good diagnostic potential. Index terms - HCV, ELISA, RIBA