Pune-based Mylab Discovery Solutions will launch India's first self-use rapid antigen test (RAT) kit for Covid-19 for Rs 250 per pack. The product has been cleared by the Indian Council of Medical Research (ICMR).
Test results will have to be uploaded by home users themselves through an app available on the Google Play Store and Apple Store. The data in the mobile app will be centrally captured in a secure server that is connected with the ICMR COVID-19 test portal, where all data will eventually be stored, ICMR said in an advisory.
Named CoviSelf, the self-use test can be used by symptomatic individuals and immediate contacts of confirmed cases according to ICMR guidelines without the need for a healthcare professional to collect samples. Test kits can be purchased without a prescription at local pharmacies and online channel partners. This is expected to relieve pressure on already overburdened testing laboratories and reduce test delays of more than 72 hours in some parts of the country.
The ICMR advisory says all individuals who test positive may be considered true positives and a no-repeat test is required. However, all individuals with RAT negative symptomatic individuals will be treated as suspect Covid-19 cases and are advised to follow the ICMR/ Health ministry protocol while awaiting the RTPCR test result. It also warns against indiscriminate testing.
“With CoviSelf, we are sharing the power of early testing with the citizens. It will save thousands of lives. For India, we will provide millions of kits available at a fraction of the cost of such kits in the US,” Hasmukh Rawal, Managing Director of Mylab Discovery Solutions said.
Each kit will be provided with all test materials, instructions to use (IFU) leaflet, and a biohazard bag to safely dispose of after testing. The test is designed to be performed with a nasal swab (not the deep nasopharyngeal swab) to reduce discomfort. CoviSelf will provide results in 15 minutes.
“Most Western countries have allowed self-assessment of their own citizens and considered it a powerful tool to break the chain. This easy-to-use test is integrated 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.
The company will start shipping out tests within a few days. Mylab has a current production capacity of 70,000 tests per week and plans to increase its capacity to Rs 1 crore of tests per week in 14 days.
Mylab had launched India's first locally developed RTPCR test a year ago.
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