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COVID-19: Here’s all you need to know about self-testing kits available online

COVID-19: Here’s all you need to know about self-testing kits available online

The Indian Council of Medical Research (ICMR) has approved seven at-home COVID test kits so far. Except one, all these tests are nasal swab-based tests.

According to an official notification dated June 18, 2020, the ICMR approves home testing kits if they have been validated in India According to an official notification dated June 18, 2020, the ICMR approves home testing kits if they have been validated in India

As the Omicron threat looms large, a self-test for coronavirus at home comes in handy. The Indian Council of Medical Research (ICMR) has approved seven at-home COVID test kits so far. Except one, all these tests are nasal swab-based tests.
 
These 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.

Graphic: Mohsin Shaikh

  
Top ICMR-approved COVID-19 self-test kits available online
 
Angstrom Biotech’s Angcard COVID-19 home test kit

Image: Angstrom Biotech website

The self-test kit is available on Flipkart at a cost of Rs 1,350. The saliva-based test kit has 25 nasal swabs and test devices. After having conducted their test, users can log into 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. Filling up all these fields is mandatory as per the ICMR guidelines.
 
Abbott Rapid’s Panbio COVID-19 antigen rapid test device

Image: Amazon.com

This nasal swab-based test kit is available on Amazon at a cost of Rs 1,250. This is a single-use, in-vitro test for self-testing in a private setting to detect coronavirus. The Panbio COVID-19 antigen rapid test device comes in four variations – 1 test, 4 tests, 10 tests and 20 tests. The one available on Amazon is a 4 tests kit version which comprises an instruction manual, 4 test devices, 4 swabs, 4 blue caps, 4 tubes, 4 buffer bottles, 4 bags and a tube rack.
 
Mylab’s Coviself COVID-19 rapid antigen self test kit

Image: Amazon.com

This self-test kit can be brought both from Amazon and the online Coviself store. The Coviself store has six variations – pack of 1, pack of 2, pack of 5, pack of 10, pack of 20 and pack of 50 (corporate pack). These packs are available at a cost of Rs 250, Rs 500, Rs 1,200, Rs 2,300, Rs 4,250 and Rs 10,500 respectively on the Coviself website. The variant available on Amazon is a pack of 1 at Rs 250. After collecting samples, people have to log into the Mylab CoviSelf app.
 
Meril Diagnostics’ CoviFind COVID-19 Rapid Antigen self test

Image: Amazon.com

This self-test kit, based on nasal swabs, is a pack of 2 available on Amazon at a cost of Rs 487. A single CoviFind pack consists of a pre-filled buffer tube with cap, a sterile nasal swab, a test device, an instructions manual and a disposal bag. After collecting samples, users are advised to open the COVIFIND app and fill in the required credentials – full name, gender, date of birth in DD/MM/YYYY format, nationality, address, state name, disrtict name and mobile number.
 
Validity of the test results
 
But, how valid are these tests? As per Angcard’s instruction for use manual, “failure to follow the test procedure and interpretation of test results may adversely affect tests performance and/or produce invalid results.”
 
Abbott also goes ahead to caution in its instructions for use manual for Panbio self-test that any confirmed diagnosis should be made only by healthcare professionals after clinical and lab findings. It further mentions that reading the test results before 15 minutes or after 20 minutes can give incorrect results.
 
ICMR’s guidelines for approving a home-test kit
 
According to an official notification dated June 18, 2020, the ICMR approves home testing kits if they have been validated in India. Test kits 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) are exempt from the domestic validation requirement.
 
Manufacturers who intend to sell these kits should ensure that the kit should comprise required material for sample collection, testing and disposal along with a usage instruction manual, interpretation and disposal of the test kit. These tests should also have an inbuilt system of data storage via mobile apps or mobile phone based softwares.
 
The guidelines further state, “All manufacturers are advised to liaise with the data entry team of ICMR to ensure compatibility of data flow into the ICMR COVID-19 testing portal. Once the compatibility is ensured, DCGI may be approached for approval,” the ICMR said in this notification.
 
When does ICMR reject a COVID-19 home-test kit?
 
ICMR rejects a COVID-19 home-test kit in case the manufacturers do not have a system or are unable to liaise the data flow with ICMR. The apex medical research body also rejects requests from those manufacturers who are likely to not be considered for marketing permission under the category of home-based testing solutions and may be considered for approvals under some other appropriate category.

(DISCLAIMER: We have listed down the most popularly available test kits on Amazon and Flipkart. This is not a recommendation for them to be used for home-testing. It is ideal to consult a doctor if one has COVID-19 symptoms)

Also read: How has COVID-19 RT-PCR testing evolved with emergence of Delta and Omicron?

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