New kit to detect Omicron variant in RT-PCR tests developed

Mumbai: The Tata Medical and Diagnostics has developed a kit ‘OmiSure’ which can detect the Omicron variant of SARS-CoV2 in nasopharyngeal/oropharyngeal specimens during the RT-PCR tests, a senior company executive said Tuesday. The test kit is compatible with all standard Real-Time PCR machines. The first target is based on S-gene dropout or S-gene target failure (SGTF), and the second target is based on S-gene mutation amplification (SGMA), said Ravi Vasanthapuram, the head of the research and development of TATA MD.

“This kit can detect the Omicron variant as well as other variants of SARS-CoV2 reported so far. Currently, Omicron patients are detected only after genome sequencing. But this test can help eliminate that step and detection can be done during the testing,” Vasanthapuram informed Tuesday.

According to the Indian Medical Research Council (IMRC), it approved the ‘OmiSure’ kit December 30.

Also read: Mutant variant of Omicron found; likely to be more dangerous

The kit has been developed for ‘direct and very specific detection’ of the new variant of SARS-CoV2, stressed Vasanthapuram.  He informed that the test run time of this kit is 85 minutes. The result turnaround time, including sample collection and RNA extraction, is 130 minutes.

“Currently, all tests across the globe employ either SGTF or SGMA, but this unique test design combines both. Therefore, it has two checks in place for Omicron detection without compromising the ability to detect other SARS-CoV-2 variants,” Vasanthapuram stated.

When asked about commercialisation, Vasanthapuram said the company has applied for a license with the Central Drugs Standard Control Organisation (CDSCO). He said once the license is approved by the CDSCO, the kit will be manufactured by TATA MD at its Sriperumbudur facility in Tamil Nadu. It currently has the capacity of manufacturing 2,00,000 kits daily but plans are on to ramp up the capacity to 5,00,000 to 10,00,000 by the third week of January.

“The kit will be manufactured for both domestic and international markets,” Vasanthapuram informed. He declined to comment on the price of the kit but said it would be competitive and mostly cost around what the existing RT-PCR tests cost.