Detection of Antibody to Hepatitis C Virus E2 Recombinant Antigen among Samples Indeterminate for Anti‐HCV after Wide Serological Testing and Correlation with Viremia

Abstract

The detection of antibody to the second envelope protein (E2) of the hepatitis C virus (HCV) has been hampered by the lack of suitable antigens. A previously described E2 recombinant antigen (CHO-E2) expressed as a non-fused, highly glycosylated protein in mammalian cells was used to detect specific antibody (anti-E2) in samples from blood donors and viraemic patients showing positive or indeterminate results for anti-HCV after a wide serological study. Anti-E2 was detected in 50-75% of the donors positive for anti-HCV, 80% of viraemic immunocompetent patients with anti-NS3 alone and 28% of non-viraemic donors with anticore alone. In donors with anti-NS3 (15 samples) or anti-NS4 (51 samples) alone, anti-E2 was found occasionally (3 cases). Moreover, two anti-E2-positive samples from viraemic patients were misidentified by some commercial assays for screening anti-HCV. These results suggest that testing for anti-E2 may be useful for improving the performance of the current assays for anti-HCV screening and confirmation.