Hepatitis C Virus (HCV), causes acute and chronic liver inflammation, sometimes leading to permanent damage. HCV mainly transmits through infected blood transfusion; hence it is crucial to screen blood donors for HCV to avoid its spread. The incubation period for HCV ranges from 2 weeks to 6 months. Because new infections are usually asymptomatic, only a few people are diagnosed when it is recent. Chronic infection too, is often undiagnosed as it may remain asymptomatic until decades after infection leads to permanent liver damage. It is thus crucial to detect HCV during the early stages, with minimum window period.

HCV core Antigen (HCV-cAg)

HCV-cAg is the first serological marker, a highly conserved, antigenic protein which can be detected as early as 1 week or as late as 9 weeks, well before the antibodies against the virus. However, after sero-conversion, HCV RNA and HCV antigen become undetectable because of a progressive decline in viremia thereby making NAT and HCV Ag specific assays ineffective for the diagnosis. Hence, simultaneous detection of HCV core antigen and anti-HCV antibodies improves the early detection of HCV infection.

ErbaLisa HCV Gen4 Ag+Ab - India’s first and only high sensitivity Hepatitis C testing kit

Transasia offers India’s first and only indigenously developed 4^th generation ELISA kit for HCV, evaluated by the National Institute of Biologicals. ErbaLisa® HCV Gen4 Ag+Ab, an ELISA for the qualitative detection of HCVcAg and anti-HCV antibodies in human serum and plasma, together in same well. It uses monoclonal antibodies to HCV-cAg and a mixture of Core, NS3, NS4 and NS5 recombinant proteins of Hepatitis C virus for detection of HCV-cAg and anti-HCV antibodies.

Key features include:

• Window period reduced by minimum 24 days compared to the HCV-Ab detection assays
• Assay time: 150 minutes
• Sensitivity: 100%
• Specificity: 99.67%
• Adaptable on fully automated analyzers

Advantage of 4^th gen assays over 3^rd gen assays

Currently majority of Indian pathology labs perform HCV Elisa testing based on 3^rd generation assays to detect only antibodies with a window period of approximately 70 days. In contrast, 4^th generation assays offers additional advantage for early and more accurate detection of HCV infection. The simultaneous detection of antigen and antibodies with ErbaLisa HCV Gen4 Ag+Ab aids in screening HCV more accurately, as it detects HCV infection approximately 24 -28 days earlier than the HCV-Ab detection assays.

“Post infection, HCV RNA can be detected in the infected individual. But antibodies against viral proteins may take up to 6 months to develop, during which time the individual may spread the disease. Detection of HCV core antigen can happen before antibody detection, thus reducing the window period of infection.”

• Dr. Manoj Chugh, Vice President, R&D (Reagents), Transasia BioMedicals.