India has approved a new RT-PCR test kit that can detect the Omicron variant of COVID-19 in four hours, Dr Balram Bhargava, director general, Indian Council of Medical Research (ICMR), said.
New Delhi: The Drugs Controller General of India (DGCI) has approved a new RT-PCR test kit that can detect the Omicron variant of COVID-19, Dr Balram Bhargava, director-general, Indian Council of Medical Research (ICMR), said. The test kit called ‘OmiSure’ can detect the Omicron variant of SARS-CoV2 in four hours during the RT-PCR tests, Dr Bhargava said.
“The good news is that the Omicron detecting RT-PCR kit has been developed in partnership with TataMD and ICMR, and has been approved by the drugs controller general of India. This new kit will test for Omicron in four hours, and will augment genome sequencing efforts of the country,” Dr Bhargava was quoted as saying by a Hindustan Times report.
The cost of the test kit has been fixed at Rs 250 and it is likely to be available in the market from January 12, according to the report.
The Tata Medical and Diagnostics has developed the kit ‘OmiSure’ that can detect the Omicron variant of SARS-CoV2 in nasopharyngeal/oropharyngeal specimens during the RT-PCR tests, a senior company executive said on Tuesday.
The test kit ‘OmiSure’ 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, he told PTI.
According to the Indian Medical Research Council, it approved OmiSure on December 30. The kit has been developed for direct and very specific detection of the new variant of SARS-CoV2, he stressed.
Cases have been surging in India as well as the globe after the new variant was classified as ‘Variant of Concern’ by the World Health Organisation in the last week of November.
Vasanthapuram said 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, he said. Therefore, it has two checks in place for Omicron detection without compromising the ability to detect other SARS-CoV-2 variants, Vasanthapuram added.
When asked about the 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, he added.
Vasanthapuram 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. The company also applied for a patent for this kit on December 23.
