The test kit has an advantage of having much higher sensitivity and specificity as compared to the several rapid test kits present in the Indian market

In a significant push towards producing its own diagnostic material for antibody detection for Covid-19, National Institute of Virology, a part of ICMR, has developed and validated the indigenous diagnostics for coronavirus, christened as ‘COVID KAVACH ELISA’

“NIV’s competent scientific team successfully isolated the SARS-CoV-2 virus from laboratory confirmed patients in India. This in turn has paved the way for development of indigenous diagnostics for SARS-CoV-2,” the Ministry of Health and Family Welfare said in a statement issued on Sunday.

Based on ELISA (Enzyme-linked immunoassay) test, Pune-based NIV developed antibody diagnostic testing was validated at two places in Mumbai and has been found to have high sensitive and specificity.

“The test will have the advantage of testing 90 samples together in a single run of 2.5 hours. Moreover, ELISA based testing is easily possible even at district level as the ELISA kit has inactivated virus. There are also minimal bio-safety and bio-security requirements as compared to the real-time RT-PCR test. The test has an advantage of having much higher sensitivity and specificity as compared to the several rapid test kits which have recently flooded the Indian market,” the Ministry of Health and Family Welfare said.

Speaking on the occasion, Dr. Harsh Vardhan said, “The robust indigenous IgG ELISA test for antibody detection developed by ICMR-NIV, Pune will play a critical role in surveillance of proportion of population exposed to SARS-CoV-2 Coronavirus infection.”

ICMR has partnered with Zydus Cadila for mass scale production of the ELISA test kits.

After development at ICMR-NIV, Pune, technology has been transferred for mass scale production to Zydus Cadila, which is an innovation driven global healthcare company.

Zydus has, as per the statement from the Ministry of Health and Family Welfare, proactively taken up the challenge to expedite the approvals and commercial production of the ELISA test kits so that they can be made available for use at the earliest.