In what can be a paradigm shift in the way Indians test themselves for Covid-19, the Indian Council of Medical Research (ICMR) has approved a self-use rapid antigen test (RAT) kit developed by Pune-based Mylab Discovery Solutions. CoviSelf would be the country’s first self-use kit for testing at home that will give results in 15 minutes and would cost Rs 250.
The company aims to make 40-60 million kits per month and cover 95 per cent of India’s pin codes (through pharmacies) within the next few weeks.
The ICMR has issued an advisory on the use of these self-test kits. A mobile application (CoviSelf) has to be downloaded by each user, and 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 app and user registration.
“The data in the app of your 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. Patient confidentiality will be fully maintained. All individuals who test positive may be considered as true positives and no-repeat testing is required,” the advisory read.
Explaining how the kit works, Gautam Wankhede, clinical director of Mylab, said the strip (it looks like a typical home pregnancy test) is coated with a combination of antibodies specific to the Sars-CoV-2 antigen. “Presence of the antigen (a type of protein) will react with the antibodies on the strip and produce a change of colour,” he said.
One has to take a nasal swab, then mix it in the pre-filled extraction tube before pouring the sample on the test strip. Either a single line or two lines will appear on the test strip within 15 minutes indicating if the sample has the presence of the Sars-CoV-2 antigen or not.
RT-PCR tests, which are considered the gold standard in Covid testing, test for the gene sequence of the Sars-CoV-2 virus. Most RT-PCR kits make copies of the DNA (amplify it) to be able to detect the virus.
RATs do not have this option of amplifying the presence of any genetic material in the swab sample. There is a high specificity of these tests (a positive test report does not need to be re-confirmed through other tests), but a slightly lower sensitivity (about 20-30 per cent of the tests can come as false negatives).
Hasmukh Rawal, managing director of Mylab, felt this would give citizens an option and access to early detection as compared to laboratory testing at a time when there was a huge burden on the diagnostic laboratories.
He said the company can now make 7-8 million CoviSelf kits per week, which is ramping up to 1.5 times within the next 20 days. Mylab aims to cover 95 per cent of the pin codes in India within the next few days and also plans to build in a traceability option.
“We would know pincode wise how many kits we have sold as the kits up to the end user,” Rawal said, adding there would be awareness campaigns for the users and pharmacies etc on how to use the kit.
He also expects sales of the CoviSelf kit may affect the sales of their RT-PCR test kits as demand for laboratory testing is likely to go down. Rawal claimed they invested ‘millions of dollars' and five to six months to develop this self-use test kit. “We had to get the potency of the antibodies right so that non-professional users can also easily get the right results. We have been working on it since last year,” Wankhede said.
Diagnostic laboratories, however, do not feel it would impact the demand for RT-PCR tests. The promoter of a Mumbai-based laboratory chain on the grounds of anonymity said: “We do not think the demand for RT-PCR tests would go down. Demand for RATs would fall significantly. However, there will be an issue of compliance. There was so much pressure on private laboratories to report test results within a stipulated time, etc.”
Analysts, however, feel there would be some impact on laboratory test demand as the turnaround time is now high. “These tests would come for one-third the cost of a lab test, and within the convenience of one’s home. Now turnaround time for lab tests is high (not less than 72 hours). We feel at least a 25-30 per cent reduction in demand for RT-PCR,” a Mumbai-based analyst said. He said the availability of the self-test kits will be a determining factor on demand for RT-PCR tests.
Reference: Business Standard | May 21, 2021