ICMR Approves Antigen Testing Kit By Mylab Discovery

Mylab Discovery has become the first Indian firm to get approval from the Indian Council of Medical Research (ICMR) to commercially make antigen RT-PCR testing kits for COVID-19.

The kit, ‘Pathocatch’ will be available immediately at Rs 450 each, reported Business Standard. The Korean company SD Biosensor, which has a plant in Manesar was the only firm approved by ICMR for these kits, the report added. Maharashtra-based Vishat Diagnostic that supplies an antigen kit from Belgium’s Coris BioConcept also got ICMR approval.

“The launch of the antigen testing kit is in line with the government’s expectation to increase rapid testing, which is the point-of-care method and complements the more rigorous RT-PCR test to detect coronavirus,” Business Standard reported the company as saying.

Managing Director Hasmukh Rawal, Mylab Discovery Solutions told Business Standard, “With the approval for an antigen testing kit, we will cover the whole spectrum of COVID-19 testing.”

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 a viral extraction buffer.
• The buffer inactivates the virus
• The sample is then placed in a well of the test strip. Results in 15-20 mins
• It is a point of care test as the 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%SD Biosensor) have high specificity -99.3% but sensitivity ranges between 50.6% to 84 (Source: Business Standard)