Mumbai: Mylab Discovery Solutions, which has developed a do-it-yourself COVID-19 testing kit for symptomatic patients, is building a stock of one crore units of the recently-approved home test kits before a national rollout on June 1, a top official said on Friday.
The Pune-based company, which is also credited with making the first indigenous RT-PCR kit last year, is developing an integrated molecular testing product that focused on automation, as its next big project, the official said.
The home test kit branded ‘COVISELF,’ which produces a result in 15 minutes for symptomatic patients, was cleared by the Indian Council of Medical Research (ICMR) late on Wednesday evening.
The product priced at Rs 250 per unit is aimed at quick turnarounds in testing and will also ensure that a patient starts quarantining quickly and desists from spreading the virus further.
”We are manufacturing 10 lakh units a day at our facility in Lonavala. Over the next 10 days, we will be stocking up 1 crore units and then launch nationally by June 1. The purpose is to have a threshold and ensure that the product is available,” Shrikant Patole, its co-founder and director, said.
Patole said non-availability of the product in medical stores can lead to anxieties among the people and hence, it is essential to stock up adequately before the launch by deciding on a threshold to have before hitting the markets.
It helped to have a rapid antigen testing kits manufacturing set up, as some of the capacities could be utilized for the home testing kit, he said, stressing that the manufacturing facility has been certified by a lot of bodies.
The company has sufficient raw materials and the right set up to produce 10 lakh kits a day, he said, adding that in the next fortnight, it will be ramped up to 15 lakh a day as well.
Efforts to develop such a kit had gone slow because of the lull in new infections between the two waves of the pandemic, but the company redoubled its efforts after the second wave, he said, adding that if a third wave were to hit, such a product will be very useful.
Time was also taken to have the right software and mobile phone application in place, he said, pointing out that every hit has a unique QR code to identify every test.
Patole said the company has tied up with distributors to ensure that the product is available across the country from June 1 onwards, because the virus’ spread into the hinterland makes deeper penetration a necessity.
For its next research project, it is working to automate molecular diagnostic testing, which will have applications beyond COVID as well and deliver credible results on an RT-PCR test in up to 90 minutes, he said.
Patole said other applications of the product can be in diagnosing diseases or infections like cancer and tuberculosis, which also depend on RT-PCR testing.
Approving the Mylab home test kit, ICMR had said that only nasal swabs will be required for this rapid antigen testing and cautioned people against indiscriminate home testing, saying it should be used only on symptomatic individuals and on the immediate contacts of laboratory-confirmed positive cases.
All individuals who test positive through the RAT kit may be considered as true positives and no repeat testing is required, the ICMR said in the advisory.
It said the home testing mobile app is available in Google Play Store and Apple store and must be downloaded by all users.
The mobile app is a comprehensive guide of the testing procedure and will provide a positive or negative test result to the patient. All users are advised to click a picture of the test strip after completing the test procedure with the same mobile phone which has been used for downloading the mobile app and user registration.