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World’s First Test Kit Detects Omicron Variant by Combining Gene Dropout and Mutations Specific Detection

By LabMedica International staff writers
Posted on 10 Jan 2022

Illustration

The world’s first test kit that can detect the B.1.1.529 (Omicron) variant by combining S-gene target failure (SGTF) and S-gene mutation amplification (SGMA) promises to cut down procedural delays in genome sequencing to ascertain the latest SARS-CoV-2 variant.

Tata Medical & Diagnostic Centre (Tamil Nadu, India) has developed the first-of-its-kind RT-PCR test kit dubbed OmiSure that can capture both the gene dropout and specific mutation to detect the Omicron variant of COVID-19 on nasal and oral swab samples. The test is compatible with all common Real-Time PCR devices and has been approved by India’s regulatory body, the Indian Council of Medical Research (ICMR). It has been designed to pick up all SARS-CoV-2 variants, but specifically pulls out Omicron. The test takes about 2.5 hours from specimen collection to reporting and can be performed in all RT-PCR labs without the need for any special training.

OmiSure is a real time PCR test and not a home testing kit as it detects viral genetic material and not viral antigen. It is also not a Rapid Antigen Test (RAT) and reportedly requires a certain amount of bio-safety. The single tube, fully multiplexed test comes with two checks in place for Omicron detection and has reported 100% sensitivity and 99.25% specificity for the detection of variants of SARS-CoV-2, including Omicron.

OmiSure can help eliminate the need for genome sequencing to detect Omicron amidst the fresh surge in cases that is exerting pressure on laboratories across the world. The company is also planning to export OmiSure kits and has applied for licensure to the European Union and US Food and Drug Administration (USFDA).

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