‘Feels good that we could serve nation’, says team that developed first COVID-19 testing kit in India

Pune-based virologists Mitali Patil, Shefali Desai and Minal Bhosle were part of the team at the Mylabs Discovery Solutions that developed India’s first RT-PCR test for COVID-19 detection in March 2020

First To Develop Covid-19 Testing Kit In India

Minal Bhosle, Shefali Desai, Mitali Patil, Pune
Virologists, Mylab Discovery Solutions

When the year 2020 started, the team of virologists at Pune's Mylab Discovery Solutions were working on research products for the lab. "We were launching the first Made in India machine for sample to PCR-ready test in February and our team was working on developing test protocols and getting the new tests for HIV, Hepatitis and cancer developed for the Indian markets," says virologist, Minal Bhosle. That changed in early January, when the team decided to meet a more urgent requirement: that of developing an RT-PCR based kit that could accurately detect COVID-19 among patients.

Developed within six weeks, even as Bhosle juggled the last stages of pregnancy - she delivered her daughter on March 19, a day after delivering the kit to the National Institute of Virology for approval - the testing kit became India's first fighting chance against the virus.

Fellow virologist at the lab, Shefali Desai, says, "The development of a test kit includes a lot of steps and parameters. Major steps include the design of the assay for accurate detection, procurement of raw material, standardisation of the test parameters followed by validation of the test for analytical sensitivity and specificity, its clinical performance, generating quality control specifications and government approvals. Our RT-PCR based kit can accurately detect COVID-19 infection in symptomatic and non-symptomatic patients, in a short period of time i.e. 2.5 hours. It is based on extraction of genetic material of the virus from the sample and then using PCR to polymerise it and make several copies and then identifying it basis of genetic signatures."

The kits have now been supplied across India, including private labs, government hospitals and Army hospitals. The Indian government has also shared kits with countries like Bhutan on humanitarian grounds.

The challenge, says colleague Mitali Patil, was in scaling this up from producing 2,000 tests per day to five lakh tests per day. "We worked day and night to increase our production and our factory worked round the clock to achieve that target," says Patil, adding that the team has "touched more than three crore lives since then, including the RT-PCR tests and rapid antigen tests".

That the team of 10 scientists is largely made up of women, is a matter for pride for all. "All of them have expertise in specific areas. As a team, we feel good
that we were able to serve the nation," says Desai. The team has also developed a rapid antigen testing kit which has received a commercial approval from ICMR.

On the juggling a newborn with work of such urgent nature, Bhosle says, "The period before delivery was definitely tough. But, I think with the support of family, and my colleagues, I was able to pull this through. Difficult as it was, it was a great experience." She adds that the last one year has been a tough time for all medical professionals. "Times like these have never been experienced by anyone so, we all had to take it one day at a time and sail through. With vaccines now being available, we will be soon out of this [pandemic]."