Bengaluru (TIP) : India’s home-grown testing kit OmiSure, developed by the Tata Medical and Diagnostics (Tata MD) to identify the Omicron variant of Covid-19 in samples taken from the nose and throat, was approved by the Indian Council of Medical Research (ICMR) Wednesday and will be available for commercial use from January 12. Apart from identifying the B.1.1.529 (Omicron) variant, the kit can also detect any other circulating SARS-CoV-2 variant.
The company said the unique test design developed by scientists at Tata MD is a single tube, fully multiplexed test (provisional patent application filed). Therefore, it has two checks in place for Omicron detection without compromising the ability to detect other SARS-CoV-2 variants.
The kit evaluated in partnership with the ICMR reported 100 per cent sensitivity and 99.25 per cent specificity for detection of variants of SARS-CoV-2, including Omicron.
OmiSure is the first test to use a combination of two S-gene viral targets to identify Omicron. 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). The company said that they have begun working to scale up the production capability, supply chain and raw material inventory to deliver two lakh OmiSure tests per day. “It can help cut half the cost and complexity of first-line Covid-19 testing and Omicron screening,” the company said.