New Delhi: When the Covid-19 pandemic hit the world, getting to know if you are carrying the virus was a long process. The available test methods were all regulated by the government authorities, before private labs were allowed to do the tests. As the world grapples with the latest wave of the pandemic, it is now much easier to get an antigen test done — sitting at home, without even having to call anyone from a lab.
Covid-19 self-testing kits have become handy, and there are at least seven brands that have received approval from the Indian Council of Medical Research. Six of these are nasal swab tests.
The test kits are: Mylab Discovery’s Coviself (Pathocatch) COVID-19 OTC Antigen LF device, Abbott Rapid’s Panbio COVID-19 Antigen rapid test device, Meril Diagnostics’ CoviFind COVID-19 Rapid Antigen self test, Angstrom Biotech’s Angtech COVID-19 home test kit, Healgen Scientific Limited’s CliniTest COVID-19 Antigen self test, SD Biosensor Healthcare’s ULTRA Covi-Catch SARS-CoV-2 home test and Nulife Care’s AbCheck Rapid Antigen self test.
A positive test result by the devices is considered accurate. But if symptomatic people get a negative result, ICMR advises them to get a RT-PCR test done. ICMR says RATs could miss a positive case presenting with a low viral load.
What ICMR Guidelines Say For Home-Test Kits
The ICMR approves home testing kits if they have been validated in India, according to an official notification dated June 18, 2020.
Moreover, domestic validation requirement of an ICMR test kit is not needed if it has been approved by the US Food and Drug Administration (USFDA), WHO Emergency Use Listing (EUL) procedure, Japan’s Pharmaceutical and Medical Devices Agency (PMDA) and Australia’s Therapeutic Goods Administration (TGA).
Manufacturers of these kits must make sure that each kit consists of the required material for sample collection, testing and disposal along with a usage instruction manual, interpretation and disposal of the test kit. The tests should be equipped with an inbuilt system of data storage using mobile apps or mobile phone-based softwares.
The ICMR said in its notification that the Drugs Controller General of India (DCGI) may be approached for approval once the compatibility is ensured. In case the manufacturers do not have a system or are are unable to liase the data flow with ICMR, their test kits will be rejected by the apex medical research body.
The requests from manufacturers who are not likely to be considered for marketing permission under the category of home-based testing solutions are also rejected.
How To Use Meril Diagnostics’ CoviFind Rapid Antigen Self-Test Kit
This self-test kit is based on nasal swabs. Avalable in two and three-pack sets, each kit contains a pre-filled buffer tube with cap, a sterile swab, a test device, an instructions manual and a disposal bag.
User need to download the COVIFIND app, as mandated by ICMR, and fill in the required credentials after collecting samples.
The credentials asked are full name, gender, date of birth in DD/MM/YYYY format, nationality, address, state name, disrtict name and mobile number.
Price: A 2-pack set is available for Rs 487 on Amazon.
Step-By-Step Guide
- Take out the buffer tube and put it on the perforsted section of the box
- Keep the test device on a flat surface and scan the code on your app
- Take out the sterile swab holding the tail end and carefully insert in one nostril until resistence is met
- Roll the swab 5 times inside the nasal passage
- Repeat the process in the other nostril
- Dip the swab in the buffer tube and swirl it 8-10 times in the fluid and close the tube as per instruction manual
- Now squeeze 4 drops of the fluid into the sample well of the test device
- Now open the app and start a 15-minute timer
- Read the result at 15 minutes
How To Use Mylab’s Coviself COVID-19 Rapid Antigen Self-Test Kit
This kit can be purchased from both Amazon or online Coviself store. Six variations of the self-test kit are available on the Coviself website. These variations are: Pack of 1, Pack of 2, Pack of 5, Pack of 10, Pack of 20, and Pack of 50, which is a corporate pack.
Only the Pack of 1 variant is available on Amazon. Users will have to log into the Mylab Coviself app after collecting their own samples.
Price: Starting from Rs 250 on Coviself website.
Step-By-Step-Guide
- Register in the app and take sample with a safe swab
- Put the sample in a tube, break swab, and close the nozzle cap
- Add two drops
- Wait for 15 minutes, and get the report on the app
- Put the kit contents in the disposal bag and discard
How To Do A Covid Test At Home Using Abbott Panbio Kit
This is a nasal swab-based test kit. It is a single-use, in-vitro kit for self-testing in a private setting to detect SARS-CoV-2. You can buy it from a chemist shop or order online.
The rapid-antigen test device comes in four variations – one test, four tests, 10 tests, and 20 tests.
Each single-test kit comes with a test device, a swab, a blue cap, a tube, a buffer bottle, a bag, a tube rack, and an instruction manual.
Price: A four-test kit is available on Amazon for Rs 1,250. On Flipkart, a two-test kit costs Rs 598.
Step-By-Step-Guide
- Perform hand hygiene.
- Put the buffer fluid in the tube to the marked line (300 μl).
- Place it in the tube rack. Perform hand hygeine.
- Remove mask/respirator. Perform hand hygeine. Start by blowing your nose or removing any mucous with a tissue or cotton tipped swab.
- Collect sample with one of the smaller nasal swabs.
- Insert one swab - the same swab - into each nostril about 2 cm deep.
- Gently rub and roll the swab 3-4 times then remove slowly.
- Swirl the swab stick in the buffer fluid, making sure to push the stick into the side of the tube at least 5 times.
- Squeeze the tube with your fingers where arrows show.
- Break the swab as shown and close the cap on the tube. Use caution as to not contaminate the swab stick during process of inserting into tube.
- Open the dropper nozzle and add 5 drops of the sample onto the test device. Close cap on the tube and dispose.
- Disinfect buffer bottle with disinfectant wipes.
- Perform hand hygiene. Reapply mask/respirator, or apply new mask if the other mask is soiled, damaged, wet or if you are applying a new respirator.
- Start a 15 minute timer and wait for the result.
- Check results after 15 minutes.
- Dispose of test device. Perform hand hygiene.
(Note: Results must be read within 20 minutes)
Two lines indicate a positive result. One line at the C mark indicates a negative result
How To Use Angstrom Biotech’s Angcard COVID-19 Home Test Kit
This is a saliva-based test kit that consists of 25 nasal swabs and test devices.
Users can log in to the EONMED app and start the Covid-19 self-test by filling in fields like first name, last name, gender, nationality, occupation, and vaccination status. This is mandatory, according to ICMR guidelines.
Price: Available on Flipkart for Rs 1,350
Steps: All one needs to do is spittle and scan, and within 20 minutes, the results will be known.
Tested Positive In Home Test. Now What?
ICMR says on its website all symptomatic individuals who test negative in a rapid antigent test should immediately get themselves tested by RT-PCR, since RATs are known to miss positive cases if the viral load is low.
Such individuals, it says, may be treated as suspect Covid-19 cases, and they are advised to follow the government's home isolation protocol as they await the RT PCR test result.
All those who test positive should be considered true positives, and there is no need for repeat testing, the ICMR guidelines say.
Such individuals are advised to follow isolation and care depending on the severity of the symptoms as per the ICMR and Ministry of Health & Family Welfare protocol.