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 Indian Council of Medical Research (ICMR).
The test results will have to be uploaded by home users themselves through an app that is available on Google play store and Apple store. The data in the app of the mobile phone will be centrally captured in a secure server which is connected with the ICMR COVID-19 testing portal, where all data will be eventually stored, ICMR said in an advisory.
Named CoviSelf, the self-use test can be used by symptomatic individuals and immediate contacts of confirmed cases as per ICMR guidelines without the need for sample collection by a healthcare professional. The test kits can be purchased without a prescription from local pharmacies and online channel partners. This is expected to ease pressure on already overburdened testing labs and reduce delays in testing, which is more than 72 hours in some parts of the country.
The ICMR advisory says that all individuals who test positive may be considered as true positives and no repeat testing is required. However, all RAT negative symptomatic individuals will be treated as suspect Covid-19 cases and are advised to follow the ICMR/ Health ministry home isolation protocol while awaiting the RTPCR test result. It also warns against indiscriminate testing.
"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," Hasmukh Rawal, Managing Director of Mylab Discovery Solutions said.
Each kit will be provided with all testing materials, instructions to use (IFU) leaflet and a biohazard bag to safely dispose after testing. The test is designed to be done using nasal swab (not the deep nasopharyngeal swab) to reduce the discomfort. CoviSelf will provide results in 15 minutes.
"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.
The company will start shipping out tests within a few days. Mylab current production capacity is 70 lakh tests per week and plans to increase its capacity to 1 crore tests per week within 14 days.
Mylab had launched India's first locally developed RTPCR test a year ago.
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