Hepatitis C Virus (HCV) is a small, enveloped, single-stranded, positive-sense RNA virus belonging to the family Flaviviridae. It is a significant global health concern, affecting millions of people worldwide. HCV is known for its high replication rate, producing approximately one trillion particles daily in an infected individual . The virus’s RNA polymerase lacks proofreading ability, leading to a high mutation rate, which helps it evade the host’s immune response .
HCV is classified into six major genotypes (1-6), each with several subtypes. The distribution of these genotypes varies globally and is clinically significant in determining the response to interferon-based therapy and the duration of such treatment . Genotypes 1 and 4 are less responsive to interferon-based treatment compared to genotypes 2, 3, 5, and 6 .
The recombinant HCV 4th Generation 65 kDa antigen is a large fusion protein derived from Escherichia coli (E. coli). This recombinant protein includes core NS3, NS4, and NS5 regions of the HCV . The protein migrates at 65 kDa and is used in the development of HCV rapid test products. It is utilized for both gold conjugation and membrane coating, providing good performance in terms of sensitivity and specificity .