These Rapid Antigen Testing (RAT) kits can add more to the pandemic than resolve it. As it leaves a huge margin of being undetected, it’s impending danger as the government is asking for trouble.
Many doctors and civil society members gave their mixed reactions when, The Indian Council of Medical Research (ICMR) has permitted a home-based Rapid Antigen Testing (RAT) kit for COVID-19, which will allow people to test themselves within 20 minutes without the need for going to a lab or sample collection by a healthcare professional.
Manufactured by Pune-based Mylab Discovery Solutions Limited, CoviSelf is the first home test that has got the regulatory nod in the country. These Rapid Antigen Testing kits which have been approved by ICMR right now, will they be guaranteeing accuracy?
Dr Deepak Sawant, former Minister of Public Health and Family Welfare said, “Firstly, the testing should be done under medical supervision. Second thing is that how the swab is taken from the nose and throat is a very important aspect of this test, as it influences the positivity and negativity rate of taking the swab. The apprehension of hurting yourself will always prevent the person from taking the sample correctly from the nose and throat, and eventually correct results will be uncertain. Also, people will do the test and remain at home and have home-based treatment which may result in health matters getting worse and this will result in affecting more people around in the society. Thus, real information of the Covid patient’s numbers if increasing or decreasing will be compromised by causing bigger issues down the line.”
Dr Samir Dalwai, Developmental and Behavioral Pediatrician, National Jt Sec-Indian Academy of Pediatrics said, “We don’t know how well it can be practically used by the persons taking the test. The test comprises chemical or technological parts which must be appropriate, but the second aspect, which is the method of doing the test, may not be appropriate. Since this test requires a nasal swab, one cannot guarantee the trustworthiness of the nasal swab derivation. If it is not done correctly and under expert check, this may cause concern. So let us not say that it cannot be done and be more objective and say we do not know the reliability of procuring the sample for the test.”
“Also, COVID-19 is a notifiable disease, so it is important to know if the reporting is happening properly. Data is very important as we are in a pandemic. We need to see how competently the self-testing can be done. To deal with this concern, what we are suggesting is that these self-testing kits be placed at the PHC centre, maybe Gram Panchayat level and appoint a trained person to take the test samples. Appointing a rightly trained person who takes accountability and responsibility for carrying out the test must be placed there and report correct data. Thus, the health and treatment of the COVID-positive person along with his relatives must be addressed plus overall statistical information reporting on pandemic level, both should be balanced. Mainly doubts on whether testing will be performed correctly and reported properly are the key concerns,” Dr Dalwai further stated.
Mahesh Zagade, former Principal Secretary to Government of Maharashtra said, “Generally, RT-PCR test is considered as most reliable except for occasional false negative or positive. But, as it takes a longer time of 1-2 days, it can’t be used for mass detection. For mass detection, an antigen test is used on a large scale which gives results in half an hour. However, it’s at best a preliminary test. The CoviSelf could be used as the third layer testing technique just to give a very raw idea and subsequently, it should be followed by RT-PCR. As CoviSelf is a new entrant in the market, its efficacy would be known only after statistical studies are carried out and analysis of its accuracy is proven beyond doubt.”
Vivek Parab, M.SC Microbiology said, “Rapid antigen tests like CoviSelf are a simple and faster alternative for antigen testing, but can be inaccurate and may give a false positive or a false negative test if the samples are not tested at a right time. So, if the test comes as positive, then it’s better to go ahead with isolation or consider contacting a medical doctor.”
Dr Parag Telang, Plastic surgeon said, “If it is approved by ICMR and seems to be promising. It will be especially useful for elderly people who cannot visit a lab to get tested. Also, you can get the result in 15 mins as against RT-PCR which takes 1-2 days.”
The Indian Council of Medical Research issued an advisory for COVID-19 home testing where an individual will be able to test himself or herself without the presence of any medical professional. Giving details of how to conduct this test, the ICMR said that it has approved one kit called CoviSelf for home testing. Only nasal swabs will be required for this rapid antigen testing.
Indian diagnostics company said, “Mylab Discovery Solutions has the ability to increase their production of the self-test COVID-19 kits to 100 million units per week over the next few months based on demand.”
As the uncertainty created by the global pandemic rumbles on, one thing there is widespread agreement on is the need for more testing. Increased testing and quicker identification of COVID-19 cases can help to prevent spread by isolating infected people.
Health authorities can then start to identify close contacts of infected people and respond appropriately as more positive cases emerge. Increased testing also provides investigators with more data on the level of contagiousness of COVID-19 and the true scope of the outbreak.
Mylab Chief Executive Officer Rahul Patil said, “The government agencies have shown interest in our test kits. Each individual without any technical expertise can perform the test. And our motive is to make sure it reaches rural India as well.”
“Mylab which is backed by Adar Poonawalla, CEO of vaccine maker Serum Institute of India, plans to start shipping the product within a few days, with the aim of producing 7-million kits next week. The company can raise the weekly production to 10 million in the next two weeks and has the capacity to hit the 100 million mark, depending on demand over the following four to six weeks,” Patil further said.
Things you need to follow with the self-testing kit
Users can follow these simple steps to use CoviSelf:
- Download the Mylab CoviSelf app.
- Wash your hands and let them dry. Now, open the CoviSelf kit.
- Open the Mylab CoviSelf app and enter your credentials. Now, scan the QR code on the test device to link the code with the credentials filled in.
- Tap the pre-filled buffer tube vertically and ensure that the extraction buffer solution settles at the bottom of the tube.
- Remove the cap and keep it upright so that there is no spillage.
- Take the nostril swab and insert it into the nose till you face some resistance. Roll it inside your nose at least five times so that enough cells are extracted. Repeat the process with the other nostril with the same swab.
- Now, dip this nasal swab into the pre-filled extraction tube and pinch its bottom. Swirl the swab 10 times before breaking it at its “breakpoint”. Now, cover the tube with its attached nozzle cap.
- Add two drops of extracted antigen buffer mixture into the sample of the test device by pressing the tube.
- Wait for a few minutes. The result will be available on the app within 10-15 minutes. If results don’t appear within 20 minutes, your report must be negative. The result will be considered invalid if it appears after 20 minutes. Click a picture of the device with the phone app and wait for it to analyze the result.
- Dispose of the kit in the biohazard bag provided. If your result is positive, isolate yourself as per ICMR guidelines.