The Indian Council of Medical Research (ICMR) has given its approval to the country’s first home-based, self-use rapid test for Covid-19, the creators of the test, MyLab Discovery Solutions, announced on Thursday.
The self-use test kit can be used by symptomatic individuals and immediate contacts of confirmed cases as per the ICMR’s guidelines.
The test kit, named CoviSelf, will cost Rs 250, and can be bought without a prescription from pharmacies and online, the company said.
The test will require the user to download an app on their mobile phone, but will not need a healthcare professional to collect a swab sample.
“The home testing kit will soon be available at drug stores, one can download the mobile app, test yourself, click the image, and upload it on the mobile phone that gives the result,” ICMR Director General Dr Balram Bhargava said.
A year ago, Pune-based biotechnology company MyLab developed India’s first indigenous RT-PCR test kits for the novel coronavirus. Three other home test kits were in the pipeline after Mylab’s, Dr Bhargava said.
MyLab Managing Director Hasmukh Rawal said: “Each kit will be provided with all testing materials, an instructions for use (IFU) leaflet, and a biohazard bag to safely dispose of test materials afterwards. The test is designed to be done using a nasal swab (not the deep nasopharyngeal swab) to reduce the discomfort. CoviSelf will provide results in 15 minutes.”
The kits will be available in affordable packs of one, Mylab said. The company said it will start shipping out kits within a few days — Mylab’s current production capacity is 70 lakh tests per week, and it plans to ramp it up to 1 crore per week within 14 days.
Sujit Jain, Director at MyLab, said: “Most western countries have allowed self-test for their citizens, and consider it as a powerful tool to break the chain (of transmission of the virus). This easy-to-use test combines with Myab’s AI-powered mobile app so that a user can know his/her positive status, submit the result to ICMR directly for traceability, and know what to do next in case of either result. We are sure this small step will be a big leap in mitigating the second or subsequent waves of infection.”
Rawal said the Covid-19 pandemic “is the biggest crisis that our country has ever faced”. “Time and again, we have tried to observe carefully what our country needs and developed solutions with social benefit at the core,” he said.
Dr Bhargava said increasing testing was at the heart of India’s pandemic containment effort, and a massive effort was under way to bring down test positivity to under 5 per cent.
“Multiple 24/7 RAT (rapid antigen testing) booths should be set up in cities, towns and villages. We have a target of 25 lakh tests by the end of the month, and up to 45 lakh tests by next month,” Dr Bhargava said.
India has carried out more than 32 crore Covid-19 tests so far. Over 20 lakh tests were carried out across the country on Wednesday, according to Health Ministry data.
Dr Nivedita Gupta, head of ICMR’s virology unit, told The Indian Express that India’s Covid testing network now includes 2,553 laboratories, and that home testing would enable individuals to test early and isolate themselves to control transmission.
“This is especially important in high transmission settings where laboratories are overburdened and turnaround time for testing has increased. Testing is key, and more rapid antigen tests need to be done, Dr Gupta said.
Rapid antigen tests such as CoviSelf are less accurate than RT-PCR tests, considered the gold standard of testing. They are, however, cheaper and easier to administer, and provide results very quickly. Given the spread of the surge to rural areas, the Health Ministry last week recommended a massive expansion of RAT testing.
“Sometimes we have to wait for the [test] results,” Dr Bhargava said last week. Therefore, “in the second wave, we have rationalised RT-PCR tests and increased RAT testing for early detection… Earlier our recommendation was 70 per cent RT-PCR test and 30 per cent RAT, but now since the wave is raging, we have requested (states) that we have to do more RAT tests. This will result in faster tests, faster isolation and faster breaking the chain of transmission,” he had said.
Dr Gupta said 105 RAT kits have been validated so far, of which 41 have been approved. However, not all of these can be used for home testing for Covid, she said.
MyLab CEO Rahul Patil said traditional testing needs healthcare professionals whose numbers cannot increase as fast as cases. “Hence there was a need to bring a solution which can give power to the people and help them get tested faster. Particularly in villages where a smartphone has reached ahead of a laboratory, there is an option now to get tested faster and isolate and get treated,” he said.
Dr M S Chadha, a former scientist with the National Institute of Virology (NIV), said the MyLab test will prove useful in easy and quick diagnoses, especially if one person in the household is infected with Covid-19. “Early isolation will lead to limiting the household spread, which has been rampant in the current wave. If there is high sensitivity, then it indicates that there is less chance of false negatives, which is usually the problem with rapid tests,” Dr Chadha said.