It simultaneously detects HCV core antigen and anti-HCV antibodies for more accurate screening
Transasia Bio-Medicals has announced the launch of India’s first, high sensitivity testing kit for hepatitis C virus. Based on the latest method, the ErbaLisa HCV Gen 4 Ag+Ab kit, is India’s first and only indigenously developed 4th gen ELISA kit and has been evaluated by the National Institute of Biologicals (NIB).
Hepatitis is a term used to describe inflammation (swelling) of the liver. It can be caused due to a viral infection, often shows no symptoms, and leads to jaundice and other conditions. Hepatitis C is caused by the Hepatitis C virus and is transmitted through blood-to-blood contact. As a result, it is imperative for blood banks to check for HCV among other Transfusion Transmitted Infections (TTIs) before blood transfusion.
Currently majority of pathology labs in India perform HCV Elisa testing based on 3rd generation assays that detect antibodies against the infection only. Though this has been the current method, 4th generation assay offers additional advantages that result in early and more accurate detection of the HCV infection.
ErbaLisa HCV Gen4 Ag+Ab kit is intended for the detection of HCV core antigen (viral protein) and anti-HCV antibodies, simultaneously, in human serum and plasma. It has a sensitivity of 100% and specificity of 99.67%.
| Features | HCV 4th Generation ELISA | HCV 3rd generation ELISA |
| Detects HCV Antigen | ✓ | ✕ |
| Detects Anti-HCV IgG Antibody | ✓ | ✓ |
| Detects Anti-HCV IgM Antibody | ✓ | ✕ |
| Window period | < 28 days | > 66 days |
| Accuracy | Highly accurate due to antigen detection | Accurate |
A window period is the time between the first infection and when the test can reliably detect the infection. Any third generation kit usually offers a window period in the reported range of 15 – 180 days. The simultaneous detection of antigen and antibodies with ErbaLisa HCV Gen4 Ag+Ab will greatly aid in screening HCV more accurately, as the window period for HCV detection will be reduced to less than 28 days.
Suresh Vazirani, Founder Chairman & Managing Director, Transasia-Erba International Group of Companies said, “In the last two years, the focus has been on COVID-19. Needless to say, there are other infectious diseases too, that need immediate attention. Viral hepatitis continues to be a growing concern in India, and is equated as a threat comparable to the big three communicable diseases – HIV/AIDS, Malaria and TB. It is crucial to screen blood donors for HCV. ErbaLisa HCV Gen4 Ag+Ab kit on one hand offers better and reliable screening of blood in blood banks prior to transfusion and on the other hand for the labs and patients, it allows an opportunity for early detection and better management of infection.”
As per WHO, in India, as of 2020, about 60 lakh to 1.2 crore people are infected with hepatitis C, primarily a result of blood transfusions. With international organizations such as WHO running campaigns such as ‘Hep Can’t Wait’ and the Indian government aiming at a nationwide eradication of hepatitis by 2030, accurate screening along with the screening of reduced window period samples with a product such as ErbaLisa HCV Gen4 Ag+Ab is the need of the hour.
The ErbaLisa HCV Gen4 Ag+Ab kit is fully adaptable on reputed automated ELISA processors. The assay can be run in 150 mins only and is pre-programmed on Transasia’s Elan 30s, a fully automated ELISA system and Lisa XL, a fully automated, six plate microprocessor.
Dr Anusha Rohit, Sr. Consultant & Head of Department – Microbiology, and Chair – Infection Control, Madras Medical Mission, Chennai, quoted, “If we do not keep up with newer technologies, we cease to progress and grow in our fields and quality. The newer technology of using a 4th generation test that can simultaneously detect antigen and antibodies has been successfully used in HIV and dengue to greatly improve the sensitivity and enhance early detection and diagnosis. Now Transasia has come up with the first Made in India 4th Gen HCV kit, the ErbaLisa HCV Gen4 Ag+Ab ELISA kit that will ensure early detection of cases of HCV. This will be a game-changer for many hospitals, labs and blood banks.”