COVID-19: NIV Pune develops India’s first indigenous IgG ELISA test, Zydus Cadila to ramp up production

In a major breakthrough, Indian Council of Medical Research (ICMR)-National Institute of Virology (NIV) at Pune has developed and validated the indigenous IgG ELISA test for antibody detection for COVID-19. ICMR has also partnered with Zydus Cadila for mass-scale production of the ELISA test kits.

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New Delhi: Having spread across 214 countries with a total of 38,55,788 confirmed cases and 2,65,862 deaths, COVID19 pandemic has wreaked havoc globally. While most countries are struggling to contain the pandemic using possible interventions, there is also an augmented demand for various types of diagnostic tests. In case of India, most of the diagnostic material for COVID19 is imported from other countries. Keeping that in view, Indian scientists are tirelessly engaged in developing indigenous diagnostics for SARS-CoV-2, the causative agent of COVID19.

In a major breakthrough, Indian Council of Medical Research (ICMR)-National Institute of Virology (NIV) at Pune has developed and validated the indigenous IgG ELISA test “COVID KAVACH ELISA” for antibody detection for COVID-19. Going forward, ICMR has now partnered with Zydus Cadila for mass-scale production of the ELISA test kits.

NIV-Pune is the apex laboratory of the country with state-of-art infrastructure and expertise for research in virology. NIV’s 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.

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 population exposed to infection.

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 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. The test is named as “COVID KAVACH ELISA”. This is a perfect example of “Make in India” in record time.

The scientists at ICMR-NIV, Pune have enthusiastically worked to develop and validate the completely indigenous IgG ELISA test for antibody detection for SARS-CoV-2. The test was validated at two sites in Mumbai and has been found to have high sensitivity and specificity. In addition, 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 the advantage of having much higher sensitivity and specificity as compared to the several rapid test kits which have recently flooded the Indian market.

Union Science and Technology Minister, Dr Harsh Vardhan expressed his happiness on the development and commented, “The robust indigenous IgG ELISA test for antibody detection developed by ICMR-NIV, Pune will play a critical role in surveillance of proportion of the population exposed to SARS-CoV-2 Coronavirus infection.”