MyLab Discovery Solutions’ Covid-19 antigen testing kits get ICMR nod

Molecular diagnostics company, Mylab Discovery Solutions, which launched the first indigenous RT-PCR testing kit, has received the approval to commercially manufacture antigen testing kits for Covid-19. It is the first Indian company to get the go ahead from the Indian Council of Medical Research (ICMR) that has developed the kit in India and will be making it here too.

MyLab’s kit named ‘Pathocatch’ will be available for orders immediately and will be priced at around Rs 450.

At present, Korean company SD Biosensor makes the antigen kits in use and was the only company approved by ICMR for these kits. It has a plant in Manesar.

Another company called Vishat Diagnostics that supplies an antigen kit from Belgium’s Coris Bioconcept also got the ICMR approval.

“The launch of antigen testing kit is in line with the government’s expectations to increase rapid testing which is the point-of-care method and complements the more rigorous RT-PCR (Reverse transcription polymerase chain reaction) test to detect coronavirus,” the company said.

As infections surge across the country, more states are now allowing antigen-based rapid testing in India.

Hasmukh Rawal, MD, Mylab Discovery Solutions said, “Mylab team is working really hard to fight this pandemic in every possible way. Now, with the approval for an antigen testing kit, we will cover the whole spectrum of Covid-19 testing and leave no stone unturned to fight this pandemic”

India is using a combination of both antigen and RT-PCR testing as its testing strategy.

Those who are found positive in the antigen test are considered positive, while those who get a negative result in antigen test may be then tested with RT-PCR test for confirmation.

This will save time and cost, thereby speeding up the process of testing and isolation.

How is an antigen test done?

• Each kit has an inbuilt Covid antigen test device, Viral extraction tube and a sterile swab for sample collection
• A Nasal swab is collected and immersed into viral extraction buffer.
• The buffer inactivates the virus
• Sample is then placed in a well of the test strip. Results in 15-20 mins
• It is a point of care test as sample is stable for only one hour after collection
• Antigen tests (SD Biosensor) have high specificity -99.3% but sensitivity ranges between 50.6% to 84%