Wednesday, October 20, 2021

24-Hours Before Delivering Baby, Virologist Develops India’s First Covid-19 Testing Kit

India never had a dearth of heroes. Whenever the motherland has been in need, people from various quarters of society have stepped up to the challenge to rescue India. At a time when the country is locked in a battle against coronavirus, yet another Indian has responded to the country’s call and delivered.  

India's first coronavirus testing kit is here. She made it happen

India has been amongst one of the countries with the lowest testing rates in the world against coronavirus, with just 6.8 tests per million. However, that is about to change, thanks to the efforts of one virologist, who delivered on a working test kit, just hours before delivering her baby.

Minal Dakhave Bhosale, a virologist who led a team of 10, raced against time to create the Patho Detect testing kit for coronavirus. The kit, which would have taken three to four months for completion, was developed in six weeks, the BBC report said.

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Just 24 hours before she delivered a baby, Bhosale successfully presented the kit for evaluation to the National Institute of Virology (NIV) and on the same day just an hour before she was taken to the hospital, the virologist submitted the proposal to the Indian FDA and the drugs control authority CDSCO seeking commercial approval, the report added.

“It was an emergency, so I took this on as a challenge. I have to serve my nation,” she says, adding that her team “very hard” to make the project a success. “Our kit gives the diagnosis in two and a half hours while the imported testing kits take six-seven hours,” says Bhosale, Mylab’s research and development chief.

Mylabs Discovery Solutions of Pune became the first Indian firm to received full statutory approvals from the Food and Drug Authority (FDA), the Central Drugs Standard Control Organisation (CDSCO) and the National Institute of Virology (NIV) to make and sell testing kits.

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It sent the first batch of 150 to diagnostic labs in Pune, Mumbai, Delhi, Goa and Bengaluru this week. The company which also makes testing kits for HIV and Hepatitis B and C and other diseases has said that it is capable of providing up to 100,000 Covid-19 testing kits per week from its facility at Lonavala and can produce up to 200,000 if required.

The kit can test 100 samples at a price of Rs 1,200 ($16; £13), which is almost a quarter of the Rs 4,500 which the Indian government pays to import Covid-19 testing kits from abroad.

Dr Gautam Wankhede, Mylab’s director for medical affairs, told BBC, “Our manufacturing unit is working through the weekend and the next batch will be sent out on Monday”.

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The Indian Council for Medical Research (ICMR), under which NIV operates, said that Mylab was the only Indian firm to achieve 100% results. “If you carry out 10 tests on the same sample, all 10 results should be same,” said Ms Bhosale. “And we achieved that. Our kit was perfect.”

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However, with the invention of the testing kit, the numbers of infections are expected to grow significantly. To solve this problem India recently allowed 50 private laboratories alongside the existing 118 government laboratories to test coronavirus patients and allowed private companies including MyLab and German firm Altona Diagnostics – to supply COVID-19 test kits.

Apart from the two firms, the Indian Government has also approved two South Korean firms; Seegene and SD Biosensor to supply novel coronavirus (COVID-19) diagnostic kits and overall, 16 companies to sell their test kits in the country.

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The approvals were granted to BioMednomics (USA), Getein Biotech (China), Sensing Self Ltd (Singapore), Hangzhou Biotest Biotech (China), AmonMed Biotechnology Co (China), Beijing Tigsun Diagnostics Co Ltd (China), Biomaxima (Poland), CTK Biotech (USA), Hunan Lituo Biotechnology Co (China), Vivacheck Lab (China) and Wondfo (China).

Thirteen kits have failed to get the approval of Indian Council of Medical Research (ICMR) and once these kits receive their commercial licence, India will be able to screen more number of patients effectively.

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