Company Gets Approval for India’s First Self-Use Test Kit for Covid-19

Mylab Discovery Solutions has won approval for India’s first self-use rapid test for Covid-19 a year after it was allowed to develop an indigenous RT PCR test.

The Pune-based company’s CoviSelf test can be used by symptomatic individuals and immediate contacts. It costs Rs 250 per kit and gives results in 15 minutes. “Users of this test will not need sample collection by a healthcare professional. This will ease pressure on already overburdened testing labs and reduce delays in testing, which is more than 72 hours in some parts of the country,” Mylab said.

The test will be available at pharmacies for purchase without a prescription.

“This (Covid-19) is the biggest crisis 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,” said Hasmukh Rawal, managing director of Mylab Discovery Solutions.

“With CoviSelf, we are sharing the power of testing early with the citizens. It will save thousands of lives. For India, we will make millions of kits available at fraction of the cost of such kits in the US,” said Rawal.

Each kit will be provided with all testing materials, instructions to use (IFU) leaflet and a biohazard bag to safely dispose of after testing. The test is designed to be done using nasal swab (not the deep nasopharyngeal swab) to reduce the discomfort.

“Most western countries have allowed self-test for their citizens and consider it as a powerful tool to break the chain. 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 either case of result. We are sure this small step will be a big leap in mitigating the second and subsequent waves,” said Sujit Jain, director at Mylab Discovery Solutions.

People who test negative and continue to experience Covid-like symptoms should seek follow up care from their healthcare provider, Mylab said.

The company’s indigenous RT PCR test—regarded as the most reliable to detect Covid-19—was the first to win approval in India.

Source: Business Standard