ICMR in talks with two more pharma companies for production of desi antibody kits

Indian Council of Medical Research (ICMR) is in talks with two more pharma companies for mass production of the antibody test kit for COVID-19 developed by Pune-based National Institute of Virology.

The Covid Kavach Elisa, developed by ICMR-NIV, already has a “non-exclusive agreement” with Zydus Cadila, a Gujarat-based pharma major that exports medicines to European and US markets.

“ICMR has also been approached by Cipla Pvt. Ltd. and NextGen Life Sciences for providing non-exclusive license for ‘COVID KAVACH ELISA’, which is under process,” the ICMR statement said.

After the test was developed at NIV, the ICMR had approached companies such as SPAN, J-MITRA, Zydus-Cadila and Cipla with an offer to take up production.

“Except Zydus-Cadila, three others refused to accept the offer,” the ICMR said.

The ELISA test has the advantage of processing 90 samples together in a single run of two-and-a-half hours and can be deployed easily at the district-level as the kit has inactivated virus.

“On external validation, the IgG test kit produced by ICMR-NIV, Pune has been found to have sensitivity and specificity of 98.7% and 100% respectively,” a statement from the ICMR said.

The first batch of kits produced by Zydus Cadila have been validated by the NIV and it was found that they have similar sensitivity and specificity.

The kits will be deployed in the to carry out the sero survey among 24,000 individuals across 69 districts to assess the prevalence of the Covid-19 infection in the country.

Sero survey involves collection and analyses of blood samples to find out the extent to which Covid-19 has spread in the country and provide insights into which communities and populations are most affected by it.

“The survey will involve collection of venous blood samples from 400 randomly selected individuals (one per household) from 10 clusters in each district. Sera from these individuals will be tested for presence of IgG antibodies using ELISA test developed by ICMR-National Institute of Virology (NIV), Pune,” the ICMR had said on Tuesday.