The Drugs Controller General of India has approved ‘OmiSure’, the first test kit that can detect Omicron variant in RT-PCR tests.
In a health Ministry Press briefing held on 5 January, Balram Bhargava, DG ICMR said “The good news is that the Omicron detecting RT-PCR kit has been developed in partnership with Tata MD and ICMR DELHI and is approved by DCGI.”
Developed by Tata Medical and Diagnostics, the Covid test kit detects the Omicron variant of SARS-CoV2 in nasopharyngeal/oropharyngeal specimens during the RT-PCR tests.
Omisure is the first test globally to employ a combination of two S gene viral targets – one based on S gene dropout or S Gene target failure (SGTF) and the other based on S Gene mutation amplification (SGTF).
Speaking to the media, Ravi Vasanthapuram, the Head of the Research and Development of TATA MD, said that “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.”
The device has two checks in place for omicron detection without compromising the ability to detect other SARS-COV-2 strains. The Kit was independently validated at ICMR-NIV Pune.
“The new kit will test for Omicron in 4 hours and will augment the genome sequencing efforts,” DG, ICMR said while addressing the media. This kit’s test run time is 85 minutes. The total turnaround time for the results is 130 minutes, which includes sample collection and RNA extraction.
As per some media reports, Tata executives have decided to set the retail price of a singular Omisure kit for the laboratory at Rs 250.
Recently, COVID19 cases have been surging in India as well as other parts of the world after the new variant, Omicron, was classified as ‘Variant of Concern’ by the World Health Organisation in November 2021.
As per the latest report of the Union health ministry, India witnessed the largest single-day increase of 495 Omicron cases, bringing the total number of infections of the novel coronavirus strain to 2,630. Maharashtra has the most cases with 797, followed by Delhi with 465, Rajasthan with 236, Kerala with 234, Karnataka with 226, Gujarat with 204, and Tamil Nadu with 121.