An epitope chimeric antigen for the hepatitis C virus serological screening test

Area of Science:

• Virology
• Immunology
• Biotechnology

Background:

• Hepatitis C virus (HCV) infection remains a significant global health concern.
• Accurate and sensitive diagnostic tools are crucial for effective HCV screening and management.
• Current diagnostic kits may have limitations in detecting early or low-level HCV infections.

Purpose of the Study:

• To develop and evaluate a novel epitope chimeric antigen, CepCM, for HCV diagnostics.
• To assess the diagnostic performance of CepCM compared to existing second-generation HCV screening kits.
• To investigate the reactivity of CepCM with various patient sera, including seroconversion panels.

Main Methods:

• An epitope chimeric antigen (CepCM) was constructed using 9 major epitope regions from different HCV proteins and genotypes.
• CepCM was expressed as a fusion protein with trpE in E. coli.
• An Enzyme-Linked Immunosorbent Assay (ELISA) was developed using CepCM for testing patient sera.
• Results were compared with a second-generation HCV screening kit and confirmed with immunoblot tests.

Main Results:

• The ELISA test using CepCM demonstrated comparable performance to a second-generation HCV screening kit for most samples.
• Discrepancies in 12 samples (5%) were largely resolved by immunoblot testing, identifying 11 indeterminate sera.
• CepCM exhibited superior reactivity with seroconversion series sera, suggesting enhanced sensitivity.
• The engineered antigen showed high reactivity with HCV-infected sera.

Conclusions:

• The epitope chimeric antigen CepCM is a promising tool for developing improved HCV diagnostic test kits.
• Engineered antigens with synthetic sequences offer potential for enhanced diagnostic performance in viral infections.
• CepCM's superior reactivity indicates its potential to improve HCV detection rates and accuracy.