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COVID-19: ICMR-NIV, Pune, Develops ‘Made In India’ ELISA Test Kit For Coronavirus Antibody Detection

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PUNE (Maharashtra): National Institute of Virology, NIV, Pune has validated the first batch of ELISA kits produced by the company Zydus Cadila. ICMR-NIV have developed and validated the completely indigenous IgG ELISA test for antibody detection of Coronavirus.

Meanwhile, the Indian Council for Medical Research is in the process of carrying out a national surveillance study with 24,000 individuals.

ICMR said that the ELISA kit has been found to have a sensitivity of 98.7 per cent and specificity of 100 per cent on external validation.

Now, ICMR has also been approached by Cipla Private Limited and NextGen Life Sciences for providing a non-exclusive license for COVID-19 Kavach Elisa, which is under process.

ELISA test kits can process 90 samples together in two-and-a-half hours. Moreover, ELISA-based testing is easily possible even at the district level as the ELISA kit has an inactivated virus. 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.

While real-time RT-PCR is the frontline test for clinical diagnosis of COVID-19, robust antibody tests are critical for surveillance to understand the proportion of the population exposed to infection.

ICMR-National Institute of Virology (NIV), Pune is the apex laboratory of the country with state-of-the-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.

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.

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 the proportion of the 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.

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’.

What are antibody tests?

The antibody tests are conducted to detect coronavirus antibodies in the blood of an individual, to find out whether the person was infected with COVID-19 infection or not.

COVID-19:

The Coronavirus pandemic has currently affected over 214 countries across the world with a total of 40,97,158 confirmed cases and 2,82,495 deaths. With the unprecedented rise in cases, there is also a rise in demand for various kinds of diagnostic tests across the world. India currently imports most of the diagnostic material for COVID-19 from other countries.

Indian scientists and researchers are currently engaged in developing indigenous diagnostics for the SARS-CoV-2 virus. ICMR’s National Institute of Virology (NIV) is one of the top laboratories of the country that is equipped with state-of-art infrastructure and expertise for research in virology.

NIV’s scientists had earlier successfully isolated the SARS-CoV-2 virus from laboratory-confirmed patients in India. This development paved the way for the development of indigenous diagnostics for SARS-CoV-2.



from League of India

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