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Self-use Covid-19 testing kits
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- The story: Finally, you can test yourself for Covid at home. 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.
- Details: 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 pincodes (through pharmacies) soon.
- 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 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 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.
- 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.
- What change: The RT-PCR tests, 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).
- 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.
- Mylab aims to cover 95 per cent of the pincodes in India within the next few days and also plans to build in a traceability option. The firm 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. The firm claims it invested ‘millions of dollars' and five to six months to develop this self-use test kit.
- What labs say: Diagnostic laboratories, however, do not feel it would impact the demand for RT-PCR tests. 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.
- Summary: These new 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). So at least a 25-30 per cent reduction in demand for RT-PCR may happen.
- Knowledge centre:
- RT-PCR - The Reverse Transcription Polymerase Chain Reaction (RT-PCR) test is the most recommended one for tracing infection in individuals suffering from influenza-like symptoms. It has a specificity rate – it can identify individuals without disease of nearly 100 percent and a sensitivity rate – the ability to identify those with COVID-19 by 67 percent. If the sample is not collected properly by a professionally trained lab technician, the result can give a false negative. RT-PCR test uses Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panels for detecting the presence of viral RNA and is quite accurate. The swab samples are analyzed for reagents to identify the presence of the virus. This test can detect the virus even before the emergence of symptoms and aid in isolation, preventing the further spread of infection. If the test turns out positive, the patient is required to follow all COVID-19 protocols, including self-isolation, taking recommended medications, eating healthy, checking for vitals including oxygen saturation.
- Antigen test - The rapid antigen test comes in handy only while detecting patients who are quite symptomatic. It is done by collecting samples from the nose or throat with a swab. Though the results can be revealed within 30 minutes, this test is not accurate, as it may not read into vital proteins that are part of Coronavirus at the initial stages. Even if your rapid antigen test turns negative, the doctors recommend you wait for a couple of days, before confirming the presence of infection. If you happen to notice the symptoms of COVID-19, go for an RT-PCR test for better results. The rapid antigen test needs to be backed by RT-PCR to completely rule out the possibility of infection.
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