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Ahmedabad-based Cadila Healthcare Ltd has said in a regulatory filing that it has been provided with technology to make and market the country’s first anti-SARS-Cov-2 human IgG Elisa test kit.
The kit will be used for antibody detection of Covid-19, a disease caused by the coronavirus infection.
Zydus Cadila said it will manufacture ‘Covid Kavach Elisa’, claimed to be the first indigenously developed IgG Elisa test for antibody detection by the Indian Council of Medical Research (ICMR), National Institute of Virology (NIV), Pune.
“The kits will be manufactured through a tech transfer by Cadila Healthcare Ltd at Moraiya, Ahmedabad,” the company said.
Earlier, Union Health Minister Harsh Vardhan, in a social media post, had said: “National Institute of Virology, Pune, has successfully developed the first indigenous anti-SARS-Cov-2 human IgG Elisa test kit for antibody detection of Covid-19. This robust test will play a critical role in surveillance of proportion of population exposed to SARSCoV2 infection.”
ICMR-NIV’s test kit was validated at two sites in Mumbai and has been found to have high sensitivity and specificity, said Cadila. In addition, the kit will have the advantage of testing 90 samples together in a single run of 2.5 hours, it added. Moreover, Elisa-based testing is easily possible even at the district level.
Technology transfer
After development at ICMR-NIV, technology has been transferred to Zydus Cadila for mass scale production.
Initial reports had suggested that ICMR had granted approvals for two types of test kits. The first is a real-time polymerase chain reaction test, which is conducted in a laboratory and requires nasal and throat swabs. The test takes up to eight hours to give results and is stated to be a confirmatory molecular test.
The second type of test is rapid antibody test, which is primarily testing blood to detect Covid-19 antibodies. The results can be obtained in 30 minutes.
However, India had a bad experience in the rapid anti-body test kits that were imported from China, which were found to have an accuracy rate of 6-30 per cent. The tests showed false positive and false negative results with multiple instances of failure.
Meanwhile, Zydus Cadila is already working on developing a vaccine for Covid-19. The development is currently at the animal trial phase and is expected to soon progress towards clinical trials in a few months.
On Monday, Cadila Healthcare shares gained over 2 per cent to trade at Rs 328.25 in early trade.
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