India’s first self-use Covid-19 test kit from Mylab Discovery Solutions, which will allow people to carry out tests at home and provide results in 15 minutes, has been approved by the Indian Council for Medical Research (ICMR).
The rapid antigen test (RAT), CoviSelf, can be used by symptomatic individuals and immediate contacts of laboratory-confirmed positive cases. The test can be purchased without a prescription over the counter from local pharmacies and online.
Such home tests are available in the US, Europe and Australia for $15 to $25 per kit. Priced at Rs 250, the Mylab test kit comes at a fraction of the cost to make it affordable and accessible.
CoviSelf will help reduce the testing burden on diagnostic labs and the time taken to detect Covid-19 infections, Hasmukh Rawal, founder and managing director of Mylab Discovery Solutions, said.
The power of testing is now in the hands of people who will know if they are infected in a short time and take precautions to avoid transmission, he said. The high risk of exposure to the virus, either because of delay in testing or in getting test reports after three to four days, can be avoided, he said.
Mylab had been working for the last six months to indigenously develop the technology. Apart from the cost, the challenge for Mylab was to make the product simple to use, error-free, easy to dispose of and ensure safety, Rawal said.
The nasal swab that contains the virus has to be disposed of. A pre-filled tube in the kit contains a solution that kills the virus and does not cause any spread or contamination.
The kits come with a unique ID that has to be linked to a mobile app, which will provide a positive or negative test result to the patient. Users have to click a picture of the test strip after completing the test procedure using the app. This data is captured and connected with the ICMR Covid-19 testing portal, where the data will be stored. This provides regulators easy traceability and tracking of Covid-19 positive cases.
Mylab Discovery had launched the country’s first RT-PCR test a year ago and then developed its own RAT test kit. It now adds the home test kit to its portfolio. Mylab has a team of 125 people with the entire R&D and product development done in-house. The company currently has the capacity to make 70 lakh tests per week at its plant in Lonavala near Pune, and plans to increase it to one crore tests per week within two weeks. The company will start shipping out tests within a few days.
The CoviSelf Covid-19 antigen test kit comprises of a pre-filled extraction tube, sterile nasal swab, test card, biohazard bag and instructional manual. If the Control Line C and Test Line T appears in the cartridge it indicates presence of novel coronavirus antigen and a positive result is confirmed. If only Control Line C appears but the Test Line T does not appear, this indicates that the novel coronavirus antigen has not been detected and the result is negative. It usually takes up to 15-20 minutes to confirm the negative result.
Rawal acknowledged that a molecular test (RT-PCR) detects genetic material of the virus better and is much more sensitive than the antigen test. But a positive RAT result was highly accurate, he said.
ICMR suggests that all symptomatic individuals who test negative using an RAT should get themselves immediately tested using an RT-PCR test, as RAT is likely to miss a few positive cases with low viral load.