J Mitra & Company, the global leader in the IVD space, has launched India’s first Covid-19 Neutralizing Antibody Microlisa Elisa Test in its ongoing fight against the corona pandemic. The test kit has cleared all government parameters and received all necessary approvals, including Drug Controller General of India (DCGI) & successful product validation, the company said.
Virus neutralization remains the gold standard for determining antibody efficacy. The Covid-19 Neutralizing Antibody Microlisa Elisa Test is the first commercial laboratory test to detect neutralizing antibodies against SARS-CoV-2, the virus that causes Covid-19. The test kit will help highlight the efficacy of the vaccines on the human body and the development of the antibodies to fight the virus and help identify potential plasma donors. The test kit has high sensitivity (> 95%) and Specificity (100%).
The test identifies individuals who have had recent or prior infection with SARS-CoV-2. Detection of neutralizing antibodies helps us identify its significance for patients as we continue the fight against Covid-19.
“The Covid-19 Neutralizing Antibody Microlisa test is critical to our fight against the corona pandemic because it not only showcases how effective the vaccination has been against the SARS-CoV-2 virus but also helps in identifying possible plasma donors,” the company’s chairman Lalit Mahajan said.
Focusing on the performance of the test, Mahajan, shared, “The test kit has high sensitivity (> 95%) and Specificity (100%). It has a shelf life of 12-months; is easy to use, and provides high throughput of 92 tests in 75 minutes.”
He further added, “We already have four other products in the global fight against Covid-19 – our Covid-19 [IgM, IgG, IgA] Microlisa Elisa test kit is one of the best kits available in the Indian market. We also manufacture the ICMR-NIV developed COVID KAWACH IgG Microlisa Covid-19 test kit. To go with these two test kits, we also developed two Covid Test readers to make India self-reliant and empowered to fight against Corona. We will continue our aggressive R&D against the SARS-CoV-2 virus and help in the global fight against the pandemic.”
The test kit is based on the blocking Elisa Principle and designed for in-vitro semi-quantitative detection of neutralizing antibodies developed against SARS-CoV-2 in human serum/ plasma that prevents the interaction between receptor binding domain viral spike glycoprotein (RBD) and cell surface receptor angiotensin-converting enzyme-2 (ACE2), he informed.
Neutralizing antibodies are produced within the human immune system and stop infections through incapacitation of the invading pathogen. Virus neutralizing antibodies directly inactivate a virus by Blocking cell entry, replication, or other vital function.
- Assist in the tracking of infection chains
- Answer epidemiological, virological, and clinic questions, including, but not limited to, whether a robust antibody response has occurred.
- Answer how many infected individuals have remained asymptomatic
- The presence of neutralizing antibodies highlights protective immunity against viral infections
- Identify individuals with high levels of neutralizing antibodies as potential candidates for plasma donation to severely infected Covid patients.