PharmEasy Blog

ICMR Guidelines | COVID-19 Home Testing Kits Approved

Introduction

Recently there has been another medical breakthrough in the fight against COVID-19. The Indian Council of Medical Research (ICMR) has approved a home Rapid Antigen testing (RAT) kit for COVID-19. According to the ICMR, the COVID-19 home test kit manufactured by Mylab Discovery Solutions Ltd, Pune, has been validated and approved. The ICMR has clearly stated that since the COVID-19 home test is a nasal swab test it should be conducted as per the instructions given by the manufacturer in the user manual.

How does the COVID-19 home test work?

The COVID-19 RAT test enables people to collect their nasal sample and test if they are COVID-19 positive. With the pandemic spreading like wildfire in many states of India, there is immense pressure on diagnostic labs conducting RT-PCR tests. Moreover, the RT-PCR test takes two to three days to give results which delay the start of treatment for positive patients. The ICMR has now approved the COVID-19 home test kit as it gives quick results in fifteen minutes. The guidelines that need to be followed while conducting the COVID-19 RAT test are given below.

COVID-19 home test guidelines:

The visible protrusions on the surface of the coronavirus are the known antigens present in the SARS-CoV-2, which includes nucleocapsid phosphoprotein and spike glycoprotein.
The COVID-19 RAT test works by picking out specific proteins only found in the virus, which the body’s immune system recognizes as ‘foreign’. Most COVID-19 antigen tests target the ‘spike protein’ that is found on the surface of the coronavirus. An oropharyngeal swab from the nose is collected for this test, where there’s a high chance of virus particles being present.
The COVID-19 home test kit is known as CoviSelf, which costs merely INR 250, much cheaper than RT-PCR.
The kit contains an extraction tube, a testing card, a biohazard bag and a sterile nasal swab.
After acquiring the COVID-19 home test kit you should sanitise your hands properly before inserting the swab inside your nose. The swab should touch the back of your nasal tract. Then you should rub the swab well inside the nose for proper collection of the nasal sample.
The extraction tube contains a liquid and you need to place the swab inside the tube so that it mixes with the liquid.
The tube should be closed tightly allowing two drops of the liquid to fall on the testing card from the tube’s outlet.
The testing card has two markers, ”t” for the testing line and ”c” for the quality control line. If a person is COVID-19 positive, two lines appear on the card. If a person is negative only one line will appear on the marker ”c”.
The test will be considered invalid if the COVID-19 home test kit shows no results after 20 minutes or if there is no line on the marker ”c”.
The last step which is essential for all is the safe disposal of the home testing kit. You should seal the tube and swab in the biohazard bag and then dispose of it safely as biomedical waste.

COVID-19 home test – Do’s and Don’ts

The ICMR advised that the COVID-19 home test should be used only on symptomatic individuals and on people who were in contact with laboratory-confirmed COVID-19 positive patients.
The Indian Council of Medical Research declared in its advisory that all individuals who test positive through the COVID-19 RAT test can be considered as COVID-19 positives and no re-testing is required.
All symptomatic individuals who test negative by COVID-19 home test should get themselves immediately tested by RT-PCR. This is especially important as the COVID-19 RAT test is likely to miss few positive cases that have a low viral load.
All COVID RAT test negative symptomatic people may be treated as suspect COVID-19 cases. They are advised to follow the ICMR/Ministry of Health home isolation rules while awaiting the RT-PCR test result.
Technical error through the mobile app can result in faulty reports. Therefore, over-dependence on Rapid antigen tests is not advisable.
Moreover, the authenticity of the RAT test depends on how well the self-assessing person had collected his sample. Therefore, a re-test in case of a negative result is essential because the viral load at the time of sample collection might have differed.

Tracking cases across India

The company manufacturing the COVID-19 home test kits promises to make millions of kits for India and that too at an inexpensive price. India has a huge population and regular testing through RT-PCR is not only impossible but also expensive. As a result, many avoid getting tested despite having symptoms. The self-testing kit being cheaper is accessible to a huge portion of the population who earlier refrained from getting tested.

The person using the COVID-19 home test kit must download MyLab’s AI-powered mobile app to get their reports as soon as possible. The home testing mobile app is available in the Google Play store and Apple store and must be downloaded by all users. The mobile app submits the result to ICMR immediately so that patients can get their reports and start treatment if found COVID-19 positive.

The mobile app is a comprehensive guide of the testing procedure and will provide a positive or negative test result to the patient. All users ‘MUST’ click a picture of the test strip after completing the test procedure with the same mobile phone which has been used for downloading the mobile app and user registration.

Conclusion

The home RAT test for COVID-19 is a significant step in our fight against COVID-19. Although less sensitive, it gives patients a sense of direction to start isolation and treatment as soon as found positive. Rapid antigen tests are also cheaper compared to RT-PCR and reduce the excessive pressure and the dependence on RT-PCR tests. But you should consciously follow the instructions given by both ICMR and the home testing kit company before conducting the test at home.

Disclaimer: The information provided here is for educational/awareness purposes only and is not intended to be a substitute for medical treatment by a healthcare professional and should not be relied upon to diagnose or treat any medical condition. The reader should consult a registered medical practitioner to determine the appropriateness of the information and before consuming any medication. PharmEasy does not provide any guarantee or warranty (express or implied) regarding the accuracy, adequacy, completeness, legality, reliability or usefulness of the information; and disclaims any liability arising thereof.

Links and product recommendations in the information provided here are advertisements of third-party products available on the website. PharmEasy does not make any representation on the accuracy or suitability of such products/services. Advertisements do not influence the editorial decisions or content. The information in this blog is subject to change without notice. The authors and administrators reserve the right to modify, add, or remove content without notification. It is your responsibility to review this disclaimer regularly for any changes.