Tata Medical and Diagnostics has developed a test kit that can detect the Omicron variant of Covid-19. Named OmiSure, it is a Real-time RT-PCR test developed in India for the direct and specific identification of the Omicron SARS-CoV-2 variant in nasopharyngeal/oropharyngeal specimens. In addition, the test is also capable of reliable detection of any other circulating SARS-CoV-2 variants. 

The test kit is compatible with all standard Real-Time PCR machines with a test run time of 85 minutes. The result turnaround time, including sample collection and RNA extraction, is 130 minutes.

Globally, Tata MD CHECK OmiSure is the first test to use a combination of two S-gene viral targets to identify Omicron reliably. 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).

Currently, all tests across the globe employ either SGTF or SGMA. This 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 Indian Council of Medical Research (ICMR) reported 100% sensitivity and 99.25% specificity for SARS-CoV-2 variant detection, including Omicron. OmiSure is listed on the ICMR website as the only kit approved specifically for Omicron detection.

OmiSure has been validated with the help of ICMR-NIV as a commercial IVD test and demonstrated high performance in SARS-CoV-2 detection and Omicron identification (100% sensitivity and 99.25% specificity).

Tata MD will work with regulatory bodies, and central and state governments to make the product available in India and globally.

In parallel, they have also begun work to scale up production capability, supply chain and raw material inventory to deliver two lacs OmiSure tests per day.