ICMR approves Coviself, Mylab’s Self-use Test Kit for Covid-19

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Mylab Discovery Solutions, a Pune-based Indian molecular and biology Company today received  approval from the Central Drugs Standard Control Organisation (CDSCO) for the commercial Covid-19 PCR Kit, Coviself. Cleared by the Indian Council of Medical Research (ICMR), Mylab became the first Indian Company to launch the country’s first Covid-19 self-use rapid antigen test (RAT) kit for Rs 250 per pack.

With the sudden outbreak of the second wave of Covid-19, the limited testing facilities became a major concern for the authorities. In view of the recent pressure on testing facilities, the approval to CoviSelf is a major relief.

The test kits can be purchased without a prescription from local pharmacies and online partners. Providing results in 15 minutes, CoviSelf is expected to ease pressure on already overburdened Covid 19 testing labs.

The test results will be uploaded by users through Mylab’s Artificial Intelligence (AI)-powered mobile app available on Google play store and Apple store. The data will be centrally captured in a secure server directly connected to the ICMR COVID-19 testing portal, where all data will be eventually stored.

The ICMR advisory reports that all individuals who test positive may be considered as genuinely positive, thereby no repeat testing will be required. However, all RAT negative symptomatic individuals will be treated as suspect Covid-19 cases, advised to follow the ICMR / Health Ministry home isolation protocol while awaiting the RT-PCR test result. Coviself has also warned against indiscriminate testing.

These kits will be provided with all testing materials, instructions to use  leaflet and a biohazard bag to safely dispose the kit after testing. The test is designed to be done using nasal swab (not the deep nasopharyngeal swab) to reduce the discomfort. Mylab will commence shipping within a few days. With a current production capacity of 70 lakh tests per week, it is also planning to increase production to 1 crore tests per week within 14 days time.

“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.

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