RT-PCR kit to detect Omicron gets DCGI approval

The kit, called Omisure and developed by TataMD, will speed up detection of the variant that right now requires genome sequencing that only specialist, large laboratories carry out. Genome sequencing can take multiple days.
A healthcare worker collects a swab sample of a passenger for Covid-19 test, at Bandra Terminus, in Mumbai on Wednesday. (PTI)
A healthcare worker collects a swab sample of a passenger for Covid-19 test, at Bandra Terminus, in Mumbai on Wednesday. (PTI)
Updated on Jan 06, 2022 04:58 AM IST
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By, New Delhi

India has approved a new RT-PCR test kit that can detect whether a sample is Covid-19 positive and if the variant is Omicron, a top government expert announced on Wednesday.

The kit, called Omisure and developed by TataMD, will speed up detection of the variant that right now requires genome sequencing that only specialist, large laboratories carry out. Genome sequencing can take multiple days.

The company said in a statement that the price has been fixed MRP 250 a test to the laboratories. According to the company, the kit will be available in market from January 12.

“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,” said Balram Bhargava, director general, Indian Council of Medical Research (ICMR).

“This kit is unique in the sense that it works on two levels: one is it detects Sars-CoV-2, and it has two specific targets for the S gene that are Omicron-specific targets. If the two S gene targets light up, the Covid-19 positive sample is of Omicron variant,” said Dr Nivedita Gupta, senior ICMR scientist.

The company said it is the first such test to use this method.

“Tata MD will work with regulatory bodies, and central and state governments to make the product available in India and globally. In parallel, we have begun work to scale up our production capability, supply chain and raw material inventory to deliver two lacs OmiSure tests per day,” read the company statement.

The kit evaluated in partnership with ICMR reported 100% sensitivity and 99.25% specificity for Sars-CoV-2 variants, including Omicron.

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  • ABOUT THE AUTHOR

    Rhythma Kaul works as an assistant editor at Hindustan Times. She covers health and related topics, including ministry of health and family welfare, government of India.

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Friday, January 21, 2022