New Delhi: Indian Council of Medical Research (ICMR) and Pune-based National Institute of Virology (NIV) have developed Elisa based antibody testing kit for coronavirus COVID-19. The first batch of completely indigenous IgG ELISA test kit is ready and has also got ICMR clearance, said an official statement.
ELISA test has the advantage of processing 90 samples together in a single run of two-and-a-half hours, and the testing is easily possible even at the district level as the ELISA kit has an inactivated virus, said the ICMR statement.
"There are also minimal biosafety and biosecurity requirements as compared to the real-time RT-PCR test. This test has the advantage of having much higher sensitivity and specificity as compared to the several rapid test kits," it said.
It further said that while real-time RT-PCR is the frontline test for clinical diagnosis of SARS-CoV-2, robust antibody tests are critical for surveillance to understand the proportion of the population exposed to infection.
After development in the lab at ICMR-NIV, Pune, the companies like SPAN, J MITRA, Zydus-Cadila, and Cipla have been offered to take up the production. Except for Zydus-Cadila, 3 others refused to accept the offer.
Zydus-Cadila accepted to produce the ELISA, which has been named as ‘COVID KAVACH ELISA’.
ICMR has signed a ‘non-exclusive agreement’ with Zydus Cadila, which means ICMR would continue to have the right to offer to any other company (ies), which comes forward to take up the production of ELISA.
The NIV, Pune has validated the first batch of ELISA kits produced by Zydus Cadila and similar sensitivity and specificity were found, while ICMR is in the process of carrying out a national surveillance study with 24,000 individuals.
Notably, ICMR has also been approached by Cipla and NextGen Life Sciences for providing a non-exclusive license for “COVID KAVACH ELISA”, which is under process.