File image of union health minister Harsh Vardhan. Image credit: The Hindu
File image of Union health minister Harsh Vardhan.

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 COVID19.

This was announced by the Union Health Ministry on Sunday.

“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 ministry said in a statement.

The ministry claimed the test was validated at two sites in Mumbai and it 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,” the ministry said.

Speaking on the occasion, Union health minister 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.”

COVID19 pandemic has affected 214 countries with a total of 38,55,788 confirmed cases and 2,65,862 deaths.

Most countries in the world are struggling to contain the pandemic using possible interventions.

There is an augmented demand for various types of diagnostic tests by countries all across the globe.

Most of the diagnostic material for COVID19 is imported into India from other countries.

Indian scientists are also not leaving behind.

The scientists engaged in different institutes are developing indigenous diagnostics for SARS-CoV-2, the causative agent of COVID19.

ICMR-National Institute of Virology (NIV), Pune is the apex laboratory of the country with state-of-art infrastructure and expertise for research in virology.

“NIV’s competent scientific team successfully isolated the SARS-CoV-2 virus from laboratory confirmed patients in India,” the ministry said.

This, in turn, has paved the way for the 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 the population exposed to infection.

Moreover, ELISA based testing is easily possible even at the district level as the ELISA kit has an 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.

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 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 ministry further said.

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