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RT-PCR test kit for Omicron ready, will approach ICMR if need arises, says TrueNat maker

Molbio Diagnostics director & chief technical officer Chandrasekhar Nair, awarded Infosys Prize 2021 this month, says they are waiting to see 'impact' of variant on public health.

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New Delhi: An RT-PCR test kit that can specifically detect the Omicron variant of the SARS-CoV-2 virus is ready and can be rolled out any time the need arises, Chandrasekhar Nair, director and chief technical officer at Molbio Diagnostics, has said.

Molbio Diagnostics is the manufacturer of the TrueNat testing platform that allows RT-PCR tests to be carried out without the need for specialised laboratory equipment and personnel.

Nair was awarded the Infosys Prize 2021 earlier this month, in the category of Engineering and Computer Science, in recognition of the development and large-scale commercialisation of TrueNat devices.

The Omicron variant has mutations in its spike protein that make it possible for some RT-PCR tests to identify the variant without the need for a genome sequencing test.

“We have already designed a test on Omicron. As and when there is a need, we will approach the ICMR,” Nair told ThePrint. “We also have to see what the impact is on public health, whether there is a need for such a test,” he said.

A research-driven company that continually looks at new and emerging pathogens, Molbio Diagnostics started working on the Covid-19 tests when it was first reported, said Nair.

As a result, when the need to scale up testing in the country arose, the government was able to quickly redeploy those systems to perform Covid testing and increase the capacity dramatically, he added.

Currently, about 4,000 TrueNat devices are deployed across the country with the capacity to carry out 400,000 tests on a daily basis.

Also Read: Booster shot of Pfizer vaccine can cut mortality from Delta variant by 90%, says Israeli study

‘A tool both sensitive and specific’

Speaking about the journey of TrueNat during the pandemic, Nair recalled that he ventured into entrepreneurship in 2000 with the idea of working on technologies that would make healthcare precise, rather than presumptive.

“We were very enamoured by this tool called PCR (polymerase chain reaction). As an engineer, I find this tool very interesting, because it is very sensitive and at the same time it is very specific — normally the two don’t go together,” he said.

The polymerase chain reaction method helps in rapidly making copies of a specific genetic sample, allowing scientists to take a very small sample and amplify it to a large enough amount to study in detail. PCR is the basis of most Covid tests across the world.

In medical diagnosis, test sensitivity is the ability of a test to correctly identify those with the disease, whereas test specificity is the ability of the test to correctly identify those without the disease.

“Before the H1N1 epidemic, nobody even knew about PCR tests outside the research laboratories. It was not very prevalent as a medical diagnosis,” said Nair, adding that he wanted to make PCR independent, such that one could open a box and run PCR under a tree if they were required to.

“We designed it with the expectation that we will not get anything where we want to operate this machine,” he added. “So we designed a battery-operated field-usable platform which requires minimal training.”

Also Read: Effective against other variants, Regeneron antibody cocktail fails to tackle Omicron: Study

Pre- and post-pandemic healthcare

The Covid RT-PCR test is, however, only the latest milestone in TrueNat’s journey, spanning decades, said Nair, describing the journey as intensive.

“It was in 2014 that we started engaging with ICMR to diagnose TB at point of care. It was in 2018-19 when we got ICMR certification for TB diagnosis,” he added.

“Subsequently, we conducted studies for WHO approval and we had an order from the Government of India to deploy over 1,000 devices across the country just before the pandemic,” Nair said.

The upside of the pandemic, according to him, is that it has made the country’s healthcare better equipped than before.

“We have really increased the diagnostic network reach, and awareness has increased tremendously. That will result in better outcomes for patients as well as the healthcare system in India,” he added.

Nair said: “We have to be completely self-sufficient for our own needs. We need to continuously invest in technologies and healthcare preparedness, such that we can ensure that pandemics do not completely disrupt us in the future.”

Nair pointed out that while TrueNat manufacturing takes place in India, semiconductor components still need to be imported.

“Although the design is ours, and the assembly happens in India, we still have to import the components,” he said, adding that India “missed the bus” on semiconductor manufacturing a little while ago.

“The TrueNat platform already supports some 30 diagnostic tests, and at any point of time our research team is working on at least 30 more pathogens. We are also proactive in looking at what needs to be done,” he said.

(Edited by Poulomi Banerjee)

Also Read: AstraZeneca’s antibody cocktail gets US nod for Covid prevention in those with low immunity


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