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Shivani Acharya

COVID-19 Self Assessment Kit

8 July 2021

The Indian Council of Medical Research (ICMR) is one of the country’s leading research organizations that have approved the CoviSelf Rapid Antigen Test (RAT) kit for Covid-19. The kit can only be used for symptomatic patients. Individuals who have been in direct contact with a positive laboratory-confirmed case. The result was within 15 minutes. The kit manufactured by Mylab Discovery Solutions Ltd in Pune has been tested and approved. This rapid antigen test only requires a nasal swab, adding that the process should be performed according to the procedure described by the manufacturer in the user manual.

Self-tests are intended to significantly slow down the spread of Covid-19. Our goal is to form CoviSelf accessible across the country, particularly for people in rural areas and in places that have restricted testing options”, said Hasmukh Rawal, managing director of Mylab Discovery Solutions.

This kit offers an accurate and easy-to-use alternative to the current testing method. It can be used by people with or without symptoms and direct contacts of confirmed cases as per ICMR guidelines.


How to Use CoviSelf at Home?

ICMR stated that the process should be carried out in accordance with the procedures described by the manufacturer in the user manual. Each kit comes with all test materials, instructions for use (IFU), and a biohazard bag for safe disposal after the test. The test is designed to be done with a nasal swab to reduce discomfort. The following are the steps that one has to keep in mind while using Coviself at home:

  1. Each kit comes with all test materials. The kit contains a pre-filled collection tube, a sterile nasal swab, a test card, and a biohazard pouch.

  2. Nasal swab (not a deep nasopharyngeal swab) to relieve discomfort. The sterile swab set should be inserted into both nostrils (2-4 cm until resistance is achieved) and rolled about five times to ensure that the correct sample is drawn.

  3. It is then dipped into the pre-filled extraction tube and two full drops of the mixture are added to the test device's sample well.

  4. The test person must download the Mylab coviself app on their smartphone available in the Google Play Store and the Apple Store. The app has a complete guide to the test procedure and provides the patient with a positive or negative result.

  5. There are two sections on the test card one is the control section and the second is the test section. If the bar only appears in control area 'C', the result is negative. If the bar appears in both the control area and the test area (T), the test is positive.

  6. A positive test takes between 5 and 7 minutes. Individuals who test positive can be considered truly positive and no retesting is required.

  7. However, all RAT negative symptomatic individuals will be treated as suspected Covid-19 cases and it is recommended that the home isolation protocol be followed while awaiting the RTPCR test result. The agency also warns against indiscriminate testing.

Who can use the self-assessment kit and how often?

"This test is for your personal use only. If the test result is positive, you do not need to perform the ICMR-RT-PCR test. The adult in the country can use the kit by reading our manual," said Mylab Director Sujit Jain.

"At-home RAT testing is only recommended for people who are symptomatic and have direct contact with laboratory-confirmed positive cases. Multiple testing is not recommended," advises ICMR. The kit can be considered really positive and there is no need to repeat the test, he added.

Symptomatic individuals who test negative should undergo an RT-PCR test:

All RAT negative symptomatic individuals can be treated as suspected COVID-19 and it is recommended that you follow the ICMR / Department of Health's home isolation protocol while doing so wait for RT-PCR Test. Any symptomatic person who tested negative for RAT should be tested immediately by RT-PCR. This is especially important as RATs are likely to miss some positive cases with low viral loads.


Downloading the Mobile Home Test App is Mandatory

According to ICMR, mobile home test applications are available in Google Play Store and Apple Store and it should be downloaded by all users before performing the test. The mobile app is a comprehensive guide to the testing process and provides the patient with a positive one or negative test result. All users will be asked to click on an image of the test strip after completing the testing process using the same mobile phone that was used to download the mobile application and user registration.

According to the ICMR, the App is present on the Google Play Store and also the Apple Store and it should be downloaded by all users. The patient's confidentiality is fully respected.


Availability and Price of Kit

India's first Covid-19 test kit for personal use can deliver results in 20 minutes. The package costs 250 rupees and includes a cleverly designed tube filled with a virus-inactivating solution and designed to control and contain biological hazards. In addition, India's first Covid-19 test kit for personal use will be available in pharmacies and on the e-commerce website.

Biohazard pouch for safe disposal and secure single-use QR code for accurate reports. Safe Swab was intelligently designed for biological containment,” said Flipkart in the product descriptions. Mylab will reportedly be distributing a self-assessment kit to 95 percent of PIN codes in the country. The biotech company will initially manufacture one million test kits and provide 10 million units per week depending on consumer demand.

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