First-Ever Covid Self-Test Kit Approved By ICMR, Priced At Rs 250

The Indian Council of Medical Research (ICMR) has given a heads up to a country's first ever self-use rapid antigen test (RAT) kit called CoviSelf.

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, the country's first self-use kit for at-home testing, will cost Rs 250 and provide results in 15 minutes. Over the next few weeks, the company hopes to produce 40-60 million kits each month and cover 95 per cent of India's pin codes with the help of pharmacies.

"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.

The strip (which resembles a traditional home pregnancy test) is coated with a mixture of antibodies unique to the Sars-CoV-2 antigen, according to Gautam Wankhede, clinical director of Mylab."Presence of the antigen (a type of protein) will react with the antibodies on the strip and produce a change of colour," he said.

Covid Self-Test Kit Provides Result In Just 15 Minutes

A nasal swab must be used, and the sample must be mixed in the pre-filled extraction tube before being poured onto the test strip. Within 15 minutes, a single or two lines will appear on the test strip, showing whether or not the sample contains the Sars-CoV-2 antigen. The gene sequence of the Sars-CoV-2 virus is tested using RT-PCR scans, which are being used to test Covid. Most RT-PCR kits make copies of the DNA (amplify it) to diagnose the virus.

"This will ease pressure on overburdened testing labs and reduce the time taken for results, which can be as long as 72 hours in some parts of the country. 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" a Mylab statement said.

The company will begin shipping the kits out in a few days at a cost of Rs 250 per test. Mylab's total weekly manufacturing volume is 70 lakh kits, with plans to expand to 1 crore kits in the next two weeks.

ICMR Advisory

With the approval of CoviSelf, the International Committee on Medical Research (ICMR) has released an advisory on the use of these self-test kits. "Home testing by rapid antigen tests (RAT) is advised only in symptomatic individuals and immediate contacts of laboratory-confirmed positive cases. Indiscriminate testing is not advised. Home testing should be conducted as per the procedure described by the manufacturer in the user manual," the ICMR stated.

Each user must download a smartphone application (CoviSelf), and users are instructed to take a photo of the test strip after completing the test process using the same phone that was used to download the software and register.