The innovation aims to address delayed testing and to help mitigate the impact of the ongoing second wave by giving quick results at home.
Since the rise of COVID-19 cases in April-May, India has been testing samples in the range of 18-19 lakhs a day. The numbers, however, indicate that testing in the country is not being done at full capacity because we have a capacity of conducting 33 lakh tests a day. This implies that around 45 per cent of the country’s
testing capacity is not being utilised.
Many complain that getting tested for COVID-19 by a lab is not easy. In the first week of May, it was almost impossible to get an appointment for home collection of samples, especially in cities with a high caseload of coronavirus infections. To take some pressure off from the already overburdened testing labs and reduce delays in testing, which is more than 72 hours in some parts of the country, the Indian Council of Medical Research (ICMR) has approved a home-based rapid antigen testing (RAT) kit for COVID-19.
The home-based rapid antigen testing kit CoviSelf (PathoCatch) COVID-19 OTC Antigen LF device has been created by Pune-based Mylab Discovery Solutions Ltd. It is the same company that gave India its first RT-PCR test a year ago.
Any person with coronavirus symptoms can use this kit to test
COVID-19 positivity at home. There is no requirement to visit an earmarked pathological laboratory to get one’s sample tested. Only nasal swabs are required for this rapid antigen testing and
the procedure described by the manufacturer in the user manual has to be followed. The concept of home testing is not new and several countries have already allowed the use of such kits.
However, the country’s apex health research body — ICMR — has cautioned people against indiscriminate home testing using Rapid Antigen Tests (RATs), saying it should be used only on symptomatic individuals and on the immediate contacts of laboratory-confirmed positive cases. The advisory states that all
individuals who test positive through the RAT kit may be considered as true positives and no-repeat testing is required. But all RAT negative symptomatic individuals may be treated as suspect COVID-19 cases and are advised to follow the ICMR Ministry of Health home isolation protocol while awaiting the RT-PCR test result.
The home testing mobile app is available in Google Play Store and Apple Store and has to be downloaded by all users.
Hasmukh Rawal, Managing Director of Mylab Discovery Solutions said: “This is the biggest crisis our country has ever faced. Time and again, we have tried to observe carefully what our country needs and developed solutions with social benefit at the core. 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 a fraction of the cost of such kits in the US.” The Coviself kit is available at Rs 250 per pack.
The mobile app is a comprehensive guide of the testing procedure and provides a positive or negative test result to the patient. Users need 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. The data from the phone is centrally captured in a secure server which is connected with the ICMR COVID-19 testing portal, where all data will be eventually stored. The medical body has assured that patient confidentiality will be fully maintained.
With CoviSelf, Mylab aims to make testing reach the doorstep of every Indian to help them fight the second and any subsequent
waves of the pandemic. Now, any citizen can test for COVID-19 themselves, isolate and seek treatment quickly. Early detection can help save thousands of lives and significantly reduce the burden on hospitals. The test kit can be purchased without a prescription from local pharmacies and online channel partners.
“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 positivity 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 of Mylab Discovery Solutions.
The ICMR, the nodal body in the fight against the virus, has issued detailed guidelines on who can use the kit and how. Each kit will be provided with all testing materials, instructions to use (IFU) leaflet, and a biohazard bag to safely dispose of the testing material after testing. The test is designed to be done using a nasal swab (not the deep nasopharyngeal swab) to reduce discomfort. CoviSelf will provide results in 20 mins. The kit will be available in an affordable pack of one. It will also be available for online purchase. Mylab’s current production capacity is 70 lakh test kits per week and it plans to increase its capacity to one Crore test kits per week within 14 days.
Here’s how one can use the CoviSelf kit:
* The kit contains a manual which describes how to use it. Also, a video has been uploaded on the CoviSelf website, explaining how to use the kit. Users should refer to that while taking the test.
* Users need to install Mylab app on their smartphones before the taking the test and will have to fill out all the credentials.
* The kit contains a nasal swab and a pre-filled extraction tube and one testing card. The tube is intelligently designed, it is filled with a solution that inactivates the virus and is designed to control and contain biohazard.
* Without touching the head of the swab, it is to be inserted slowly inside both the nostrils upto 2-3 centimetres and rolled at least five times inside each nostril.
* The swab is to be dipped in the tube, and then the tube is to be pinched from bottom. The nasal swab is then stirred at least 10 times so that the swab is immersed properly in the tube.
* The swab is to be broken from the breakpoint and then while covering the tube, 2-3 drops are added to the test kit by pressing. A wait time of 20 minutes is required for the results to appear.
* Result appearing before 20 minutes will be considered invalid. It has a Unique QR Code for accurate report generation.
* After 20 minutes, the app will ring and show the result. A picture of the test device is then to be taken.
* If both the quality control line “C” and the detection/ test line “T” appear, then the novel coronavirus antigen has been detected and the result is positive.
* If there is only a quality control line “C” and no test line “T”, it indicates that the result is negative.
