Made-in-India take a look at package for omicron detection will get ICMR nod

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Omisur, India’s residence testing package developed by Tata Medical and Diagnostics (Tata MD) to establish the omicron variant of COVID-19 in samples taken from nostril and throat, was authorised by the Indian Council of Medical Research (ICMR) on Wednesday. And will likely be accessible for industrial use from January 12.

In addition to figuring out the B.1.1.529 (Omicron) variant, the package can even detect another circulating SARS-CoV-2 variant.

The distinctive take a look at design developed by scientists at Tata MD is a single tube, absolutely multiplexed take a look at (provisional patent software filed), the corporate mentioned. Therefore, it has two probes to detect omicrons with out compromising the flexibility to detect different SARS-CoV-2 variants.

The package, evaluated in partnership with ICMR, reported 100% sensitivity and 99.25 % specificity for detecting variants of SARS-CoV-2, together with Omicron.

OmiSure is the primary take a look at to make use of a mix of two S-gene viral targets to establish oomicrons. The first goal is predicated on S-gene dropout or S-gene goal failure (SGTF) and the second goal is predicated on S-gene mutation amplification (SGMA).

The firm mentioned that they’ve began engaged on enhancing the manufacturing capability, provide chain and uncooked materials stock to ship two lakh OmiSure checks per day.

“This can help halve the cost and complexity of first-line COVID-19 testing and omicron screening. Most states have adopted a dual testing strategy to the point of first-line testing, where samples are first tested with cost-effective routine COVID-19 RT-PCR tests and then, positive for omicron with the more expensive SGTF assay. The samples are tested. and prioritized for sequencing,” the corporate mentioned.

The package, developed by a staff headed by Bengaluru-based Dr V Ravi, former Head of Neurovirology, NIMHANS, and presently Head of R&D, Tata MD, has been listed on the ICMR web site as the one package particularly authorised for omicron detection Is.

Speaking to The Indian Express, Ravi mentioned, “This is not a home testing kit. There are many misconceptions. Omisure is not a self test kit. It detects the viral genetic material and not the viral antigen. This is not a Rapid Antigen Test (RAT). Polymerase chain reaction (PCR) can only be performed in laboratories. This requires specialized equipment, trained people, and a certain amount of biosafety. PCR has been done since the beginning of the pandemic. OmiSure is a real-time PCR so it is not available for public use at home.”

“I started working on the development of the kit a few days after Omicron’s announcement, which was roughly the end of November 2021. Right after Omicron’s first case was reported, we submitted the kit for ICMR evaluation. This is the fastest developed kit globally. From sample collection to reporting like other PCR, the kit takes maximum time of two and a half hours to give the result. Also, the plan is to export the kit as the world level. But it has an advantage of being able to screen the S-gene dropout as well as the unique identity,” defined Ravi.

Ravi, who can be the nodal officer and chairman of the COVID-19 Whole Genome Sequencing Committee in Karnataka, mentioned that Omicron has swept Mumbai and Delhi and kind of changed the delta variant. “It will happen across the country,” he mentioned.

“One thing I learned about this virus from the pandemic is not to give reassurances. Yes, most people are getting mild infections, but that doesn’t mean we should isolate it by saying it’s not going to cause a problem because most people who get infected have already taken a dose or two is vaccinated. We still don’t have data on people who haven’t been vaccinated, whether the infection is mild, moderate or severe. I will tread carefully and advise people to wear masks and avoid crowds so that they do not get infected. Nobody wants to get infected. Our target should be no infection,” he mentioned.

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With inputs from TheIndianEXPRESS

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