Highlights:
- Self-use Rapid Antigen Test (RAT) kit CoviSelf is developed by Pune-based Mylab Discovery Solutions.
- The Indian Council of Medical Research (ICMR) approved the test kit on Wednesday (May 19).
- The test kit will be available in over seven lakh pharmacies by next week.
On Wednesday, the first coronavirus self-use Rapid Antigen Test (RAT) kit for use at home has been approved by the Indian Council of Medical Research (ICMR). That means anybody can collect a nasal sample and get it tested for SARS-CoV-2.
How does a self-test kit help?
A second wave of infections has hit several states, putting strain on diagnostic laboratories. The gold standard for Covid-19 testing, the RT-PCR test, takes 3-4 days to produce results, delaying hospitalisation and treatment.
Self-test kits have the ability to change Covid-19 management in India. This can shorten lab lines, save money, relieve current manpower from collecting samples from homes, and provide rapid results (within 15 minutes), allowing for faster treatment and isolation.
The FDA (Food and Drug Administration) approved the first self-test kit in the United States in November of last year. The rapid-result all-in-one test kit from Lucira Health has been licenced for emergency use. Kits of this kind have also been accepted in Europe and South Korea.
What is this ICMR approved kit?
The kit is called CoviSelf, and it was created by MyLab Discovery Solutions, a molecular firm based in Pune. It uses a rapid antigen test, which analyses a nasal swab sample for the virus and provides results in 15 minutes. The test can be completed within two minutes.
An RT-PCR test costs between Rs 400 and Rs 1,500, while a rapid antigen test in a lab costs between Rs 300 and Rs 900, depending on the states and this testing kit costs Rs 250.
MyLab Discovery Solutions managing director Dr Hasmukh Rawal. “For India, we will make millions of kits available at a fraction of the cost of similar kits in the United States.” By the end of next week, the kit will be available in the market. MyLab’s total weekly production capacity is 70 lakh kits, with plans to increase to one crore kits in the next two weeks. According to the company, the kits will be available in at least seven lakh chemists and e-pharmacy portals across India.
“This easy RAT test can be used in combination with MyLab’s AI-powered mobile app to decide whether a user is positive and send the results directly to the ICMR for traceability, and know what to do next in either situation. We are confident that this small move will pave the way for the second and subsequent waves to be mitigated,” said Sujit Jain, director of MyLab Discovery Solutions.
Who can use this test?
This test is only recommended by the ICMR for those who have symptoms or are high-risk contacts with positive patients and need a home test. If the result is positive, the individual is considered Covid-19 positive, and RT-PCR is not needed as a confirmatory test. Both government isolation and high-risk contact tracing protocols will be followed. This test is linked to CoviSelf, a mobile app that will help feed the positive case’s report directly into the ICMR portal. This test is not recommended for general screening of hawkers, display owners, or commuters in public places.
If a person tests negative but has symptoms, an RT-PCR test is needed.
How to test yourself?
A pre-filled extraction tube, sterile nasal swab, testing card, and biohazard bag are included in the pack. To begin, download the CoviSelf app and fill in all of your personal information. The app will collect data and store it on a secure server linked to the ICMR portal, which makes all test results accessible to the government.
Clean the surface on which the kit will be put and sanitise your hands before taking the test. To extract the specimen, insert the swab 2-4 cm within your nose, or until it reaches the back of your nasal tract, and rub it well. The swab is swirled inside the extraction tube to blend with the liquid inside, and two drops from the extraction tube’s outlet are spilled onto the measuring card.
The result is visible in 15 minutes. A person is coronavirus positive if two lines appear on the testing kit card — on marker ‘t’ for testing line and ‘c’ for quality control line. A single line appears on marker ‘c’ if the individual is negative. The test is invalid if the outcome takes longer than 20 minutes to appear or if a line does not flash across marker ‘c’.
Place the tube and swab in a biohazard bag and throw it away with the biomedical waste.
What are the advantages and disadvantages of self-testing?
The risk of transmission to others is reduced when a person tests himself at home rather than going to a hospital or lab or calling a technician at home. In current situation, swab extraction is simple and convenient, lowering overall testing costs and eliminating the hassle of making appointments in laboratories. Self-testing would relieve the strain on laboratories that are already overburdened by running 24 hours a day, 7 days a week at maximum capacity.
On the other hand, the accuracy of the findings remains a major concern. It’s very likely that the sample won’t be obtained properly or that the swab stick may become contaminated.
Rapid antigen tests, on the other hand, have a high rate of false negatives. The test can offer a false sense of security if a Covid-infected individual is asymptomatic and tests negative. The difficulty in tracing positive patients, however, is by far the most serious problem. An individual may enter the wrong address and information into the mobile app, rendering contact tracking difficult for health workers. Technical errors in the mobile app, on the other hand, can sabotage the entire testing and reporting process.
Although a rapid antigen test is useful for mass surveillance, relying on it for testing is not recommended. It can only be used to complement, not replace, the bulk of testing.
What is the efficacy of self-testing?
Self-tests can be useful if the patient adheres to isolation guidelines, provides reliable data, and interprets the findings correctly.
According to the European Centre for Disease Prevention and Control, “The test’s result is determined by a number of factors, the willingness of the person taking the sample and performing the test to follow directions, the viral load at the time of sampling, and the disease prevalence in the population at the time the test is taken are all factors to consider.”
Self-testing should complement but not replace conventional testing methods, according to a document published by the European CDC in March. According to research, “Shifting responsibility for reporting test results from health practitioners and labs to individuals can lead to underreporting, making contract tracing and contact quarantine more difficult.”
However, a preprint published in MedRxiv by three Harvard and Yale researchers argued that home testing could potentially aid in pandemic control and should be seen as part of a national containment strategy. Another article published in The New England Journal of Medicine in September stated that quick, inexpensive rapid tests would achieve the goal of mass surveillance even if their sensitivity to capture accurate results is lower than other tests.
