India’s top health research body, the Indian Council of Medical Research (ICMR), Wednesday gave its approval for a self-use rapid antigen testing (RAT) kit, CoviSelf, for testing Covid-19; country’s first self-testing kit for home use for suspected Covid-19 patients. The medical body has issued an advisory wherein it approved the use of this home-based kit. However, it has warned against indiscriminate testing.
Its efficacy, however, is not 100 per cent and has chances of false negatives even if a person has Covid-19.
All you need to know about ‘Coviself’
As the name suggests, Coviself is a do-it-yourself kit for Covid-19 testing, manufactured by Pune-based Mylab Discovery Solutions Ltd. According to ICMR, the kit will be priced at Rs 250 per pack and available in the markets in a week.
“The company will start shipping out tests within a few days. Mylab’s current production capacity is 7 million tests per week and plans to increase its capacity to 10 million tests per week within 14 days,” the company said.
“These kits will be available in pharmacies across the country by early next week. We have a channel partner we have tied up intending to reach as many as 95 percent pin codes in the country,” says Dr. Gautam Wankhede, Medical Affairs Director at Mylab.
He adds, “In countries like the UK and US, where these tests were made available to the general public about four months ago, the benefits have been immense. For example, children going to school in the UK have to take this test twice a week. That is perhaps the only way to break the chain and curtain this pandemic.”
This self-use test kit can be used by symptomatic patients and immediate contacts of confirmed cases as per ICMR guidelines. Patients will require only a nasal swab for this rapid antigen testing. The test results will then have to be uploaded by the home users themselves through an app that is available on the Google play store and Apple store. Mylab will centrally capture the data in the app of the mobile phone in a secure server that is connected with the ICMR COVID-19 testing portal. Here all data will be eventually stored, ICMR said in an advisory.
Each self-testing kit will be provided with all testing materials, instructions to use (IFU) leaflet, and a biohazard bag to safely dispose of it after testing. The test is designed to be done using a nasal swab (not the deep nasopharyngeal swab) to reduce the discomfort. CoviSelf will provide results in 15 min. Those who test negative and continue to experience COVID-like symptoms should seek follow-up care from their healthcare provider.
While this test kit cost Rs 250, RT-PCR cost between Rs 500 to 1500 and a rapid antigen test in laboratory cost Rs 300-900 in different states.
Who can use CoviSelf, the Covid home test kit?
ICMR has advised this test for only those who have symptoms or are high-risk contacts of positive patients and need to conduct a test at home. If positive, the person will be considered Covid-19 positive and will not require RT-PCR as a confirmatory test. This test is synced with a mobile app which will help directly feed data on the ICMR portal for contact tracing. This test is not advised for general screening in public places of hawkers, show owners, or commuters.
If a person has symptoms and tests negative on this kit, he has to undergo RT-PCR test.
Process of using Covid-19 home test kit
The kit comes with a pre-filled extraction tube, sterile nasal swab, a testing card, and a biohazard bag. The person taking the test has to first download and feed all details on a mobile app of Coviself. The person has to sanitize his hands, clean the surface on which he will place the kit. He has to insert the swab into his nose 2-4 cms inside or until it touches the back of the nasal tract. The swab is then swirled inside the extraction tube to mix with the liquid inside, the tube is tightly closed, and two drops from the extraction tube’s outlet are spilled onto the testing card. The result comes within 15 minutes. A person is positive for Covid-19 if two lines appear on the testing card on marker ‘T’ for testing line and ‘C’ for quality control line, negative if a single line appears on marker ‘C’.
The tube and swab have to be sealed in bio hazard bag and disposed as biomedical waste.
When is the test considered invalid?
If it takes more than 20 minutes to show results or if a line does not flash across marker ‘c’ then the test is invalid.
Drawbacks of Covid-19 home test kit
If a Covid-19 infected person is asymptomatic and tests negative, this test may give a false sense of security. While rapid antigen testing serves as a quick mass surveillance tool, over-dependence on testing is not advisable. It should only supplement, not form the bulk of testing. The test has a high chance of false negatives. RT-PCR is considered the gold standard for Covid-19 testing. If a symptomatic person tests negative for Covid-19 through rapid antigen, a RT-PCR is highly recommended.
Also, if the sample is not collected properly or the swab is contaminated, the test is a futile exercise. Nasal swab collection requires proper insertion and extraction, which requires basic training that common people do not have.
Over the last two months, India has seen a rapid surge in the number of covid-19 cases, which has been called the second wave, with daily new cases at till about earlier this month crossing 400,000 regularly. On Wednesday, over 276,000 new cases were reported in India, while nearly 3,900 patients died.