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India’s first ‘at home’ antigen test kit developed by Pune firm to be available from next week
Pune: After the Indian Council of Medical Research (ICMR) on Wednesday approved India’s first home-based rapid antigen testing (RAT) kit for Covid, Pune-based molecular diagnostics company Mylab Discovery Solutions said it will be made available within a week
Pune: After the Indian Council of Medical Research (ICMR) on Wednesday approved India’s first home-based rapid antigen testing (RAT) kit for Covid, Pune-based molecular diagnostics company Mylab Discovery Solutions said it will be made available within a week.
The kit, advised by ICMR and to be used only on symptomatic individuals and on immediate contacts of laboratory confirmed positive cases, will be priced at ₹250. The company said it has current production capacity of one million per day with plans to augment it up to 1.5 million within two weeks.
The kit, named as CoviSelfTM, for self-use test can be used by symptomatic individuals and immediate contacts of confirmed cases as per ICMR guidelines. 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.
The country’s apex health research body stated, “all individuals who test positive using CoviSelf may be considered as true positives and no repeat testing is required”. It also said “all RAT negative symptomatic individuals may be treated as suspect Covid-19 cases and are advised to follow the ICMR/MoH&FW home isolation protocol while awaiting the RT-PCR test result”.
ICMR has advised the kit users to download a mobile app which is available for both Android and iOS operating systems, and use the same device where the app is installed to take a picture of the strip in the kit after the testing process is completed.
Each kit will have all testing materials, instructions for 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,” said Dr Gautam Wankhede, director - medical affairs, Mylab Discovery Solutions.
According to Wankhede, the kit will provide results within 15 minutes while users who test positive are advised to immediately isolate so that they do not infect others and quickly contact a healthcare provider.
“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, Mylab Discovery Solutions.
Speaking about the accuracy of the kit results, Wankhede said, the firm has made every possible step to ensure the outcome is accurate. “With ICMR also accepting it, we can say its accuracy is as much as the kit being used professionally by labs outside,” he said. The firm, which was working on the kit since last seven months, had submitted the proposal to ICMR around six weeks ago.
