Know All About Testing Yourself For COVID-19 At Home Using The Kit Approved By ICMR

New Delhi: The Indian Council of Medical Research (ICMR) has approved 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.

To decipher the self-use kit, ICMR has issued detailed guidelines on who can use it and how. The ICMR has emphasised that indiscriminate testing is not advised in order to avoid shortage. To decode the results of the test, ICMR said in the guidelines,

All individuals who test positive may be considered as true positives and no repeat testing is required. However, all RAT (Rapid Antigen Test) negative symptomatic individuals will be treated as suspect COVID-19 cases and are advised to follow the ICMR/ Health ministry home isolation protocol while awaiting the real-time reverse transcription polymerase chain reaction (RT-PCR) test result.

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— ICMR (@ICMRDELHI) May 19, 2021

Also Read: COVID-19 In India: Experts Say Pregnant Women At Greater Risk In The Second Wave Of COVID-19

As of now, the self-test kit can be used by symptomatic individuals and immediate contacts of confirmed cases only, in order to avoid overuse.

According to the company,

This test is authorized for non-prescription home use with self-collected nasal swab specimens from individuals aged 18 years and older or with adult-collected nasal swab samples from individuals aged 2 years or older.

The self-use rapid antigen test kit will become available in markets across the country by the end of May at Rs. 250 per pack, according to the spokesperson of Mylab Discovery Solutions Limited. He further said that this is expected to ease pressure on already overburdened testing labs and reduce delays in testing, which is more than 72 hours in some parts of the country.

How To Use The COVID-19 Self-Test Kit

Each kit will be provided with testing materials in a pouch containing a nasal swab and a pre-filled extraction tube and one test card, a manual describing the entire process and a biohazard waste bag to safely dispose of the items after testing.

It is important to wash and dry hands properly before starting the test. The home test should be conducted according to Mylab CoviSelf app that can be downloaded from the Google play store and Apple App Store. It is important to fill in the individual credentials before proceeding with the test. Scan the QR Code on the test card to link the code with credentials on the app.

The test is designed to be done using a nasal swab. Without touching the swab head, insert the swab inside both the nostrils up to 2 to 3 centimetres and roll the swab five times inside each nostril.
Now, dip the swab in the tube, pinch the tube at the bottom and swirl the nasal swab 10 times to ensure that the swab is immersed well in the tube.

After this, the swab has to be broken from the breakpoint.

By pressing, two drops have to be added to the test kit from the tube.

The result will appear in 20 minutes and the report with become visible on the app. The software communicates with the testing card through specifically designed Artificial Intelligence (AI). Any result appearing after 20 minutes is considered invalid. If both Control Line C and the Test Line T appears in the test card, presence of novel coronavirus antigen is confirmed and the result is positive.

The user is required to click a picture of the test card after completing the test procedure with the same mobile phone on which the app has been installed.

The data from the 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. There is no threat to patient confidentiality, said ICMR in its guidelines.

According to Sujit Jain, Director, Mylab Discovery Solutions Limited, most western countries have allowed self-test for citizens and consider it as a powerful tool to break the chain of transmission. He said,

Self-tests are easy-to-use. A user can know his/her positive status, submit the result to ICMR directly for traceability, and know what to do next in either case of result. We are sure this small step will be a big leap in mitigating the second and subsequent waves.

Also Read: COVID-19 Could Become Like Common Cold In Future, Study Suggests

RAT, Not As Sensitive As RT-PCR, Can Help In Early Detection Of COVID-19: Expert

Commenting on CoviSelf home test, Dr Preeti Kumar is the Vice President- Public Health System Support at the Public Health Foundation of India said that early testing is one of the key strategies in an epidemic/pandemic.

It is good that there is now a self-testing kit for early diagnosis of COVID-19 and early intervention.

However, Dr Kumar stressed that even though people will get access to self-test, it does not mean that the government’s responsibility is over. She added,

In fact, it becomes all the more important to ensure that the use is correct, appropriate and that supportive systems are in place when a person detects positive. So, this requires higher engagement on dissemination of correct messaging on who can use, how to use (to ensure optimal results of testing by correct use), and most importantly, to enable COVID positive people to reach out promptly to health worker or doctor and come under the umbrella of care. In the context of India, the testing will be uneven, based on the supply side, on availability and on the demand side- affordability, awareness and accessibility to the kit, and smartphone among other things. Thus, it’s use is likely to be limited to urban areas.

On the effectiveness of RAT against RT-PCR and reasons to push for RAT test, Dr Kumar said,

Definitely RT-PCR is the gold standard. However, there are capacity limitations in availability of kits and of testing laboratories. Also, the RT-PCR tests are less affordable (may cost between Rs. 700-1,800). Even in the testing by health system, a fair per cent is RAT. The advantage of RAT is that if done at more frequent intervals, we can still detect many cases early. RT-PCR is more sensitive, but in a high case load, we want to catch as many people as possible early.

Talking about the limitations of RAT test, Dr Kumar highlighted that these are lower in sensitivity and while positive are surely positive, negatives are mostly false negatives. She said,

If you increase frequency, then it will detect more cases. For example, a person using the test today might have low viral load and the test may fail to detect, which RT-PCR would catch. But if the user does the test again the next day, then perhaps the viral load may have sufficiently increased to detect positive. RT-PCR cannot be done so frequently.

Also Read: Union Ministry Invites Applications From Startups, Companies For Developing New Tech To Tackle COVID-19 Wave

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