ICMR grants approval to Pune firm’s self-use COVID-19 testing kit: How does Mylab’s CoviSelf kit work?VI

0

KEY STORY

  • The Indian Council of Medical Research, on Wednesday, approved the sale and use of a self-administered Rapid Antigen Test (RAT) for COVID-19, developed by Pune-based Mylab Discovery Solutions, and named ‘CoviSelf.’
  • The hope is that, with the self-use kit now on the market and expected to be joined by other similar products, the burden on existing laboratories as well as the manpower required for COVID-19 home testing will be reduced. According to Dr Hasmukh Rawal, managing director of Mylab, the test will retail for Rs 250 with current production of 70 lakh (per week) expected to be ramped up to one crore within the next two weeks.

    How to use the CoviSelf kit

    1. Each CoviSelf kit comes with a sterile nasal swab, a testing card (or cassette), a biohazard bag and a pre-filled extraction tube. Before opening the kit, users are required to download and open the AI-enabled Mylab CoviSelf app before inputting their relevant credentials. Once these are filled in, remove the testing cassette from the bag, and use a mobile device to scan the QR code located on the cassette to match the code with one’s credentials.
    2. Remove the pre-filled extraction tube from the pouch and hold it vertically to ensure that the extraction buffer (liquid) settles at the bottom of the tube.
    3. Carefully remove the nasal swab from the tube, before inserting it between 2 to 4 cms into one nostril (or until resistance is met). Roll the swab around to ensure that cells are collected. Repeat the same process with the other nostril using the same nasal swab.
    4. Open the nozzle at the top of the extraction tube, and insert the nasal swab into the tube. Ensure that it is the end with the nasal swab head that is being inserted and not the tail end. Also, ensure to avoid making contact with the nasal swab head.
    5. Pinch the tube at the bottom, and swirl the nasal swab around 10 times to ensure it is well immersed in the extraction buffer. Identify the breakpoint along the nasal swab, and break the swab while ensuring that the swab head remains immersed. Discard the other end of the swab.
    6. Close the extraction tube with the nozzle cap and ensure that it is well sealed. Carefully align the extraction tube with the extracted antigen buffer mixture over the testing cassette with the nozzle facing downward, and add 2 full drops of the mixture onto the testing device.
    7. Wait between 15 to 20 minutes for the results to appear. Using the CoviSelf app, take a picture of the testing cassette and wait for the app to analyse the results. If the result is COVID-19 positive, a quality control line (C) and a test line (T) will both appear on the testing cassette. In some cases, the test line may be very faint so make sure to look closely. However, if the result is COVID-19 negative, only the quality control line will appear. If the quality control line does not appear, the test must be considered invalid regardless of whether the test line appears.
    8. Once the test is complete and the results have been analysed, all components of the testing kit must be placed in the biohazard bag and disposed of safely.
    While a RAT does represent a quick way to identify whether someone is infected with COVID-19, it is important to note that such tests are notorious for showing false negatives. As such, it is only to be considered a supplementary test and is in no way as reliable as the gold standard RT-PCR test. The ICMR has advised that the test only be used for those individuals who are showing COVID-19-related symptoms or high-risk contacts of confirmed COVID-19 carriers.

LEAVE A REPLY

Please enter your comment!
Please enter your name here