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TrueNat test kit first in India to get ‘emergency use’ approval for Nipah virus diagnosis

TrueNat is a portable, battery-operated RT-PCR platform developed & manufactured in India by Goa-based Molbio Diagnostics. It can test for nearly 30 diseases & results take less than an hour.

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New Delhi: Goa-based Molbio Diagnostics has received emergency use authorisation by the Drugs Controller General of India (DCGI) for their Nipah test kit, making it the first in India to receive regulatory approval to conduct tests for the zoonotic disease.

The move comes days after the death of a 12-year-old boy from the Nipah virus infection in Kerala’s Kozhikode district. Nipah henipavirus is a bat-borne virus that causes infection in humans and other animals.

The Molbio Diagnostics test kit uses TrueNat, a Real-Time PCR platform deployed across the country for diagnosis of infectious diseases such as TB, Covid and Hepatitis, among others.

These kits can make testing for Nipah virus rapid, on-demand, and closer to the affected people, resulting in early and fast diagnosis for effective management of the disease and containment of the spread of the virus, the company said in a statement.

“Covid-19 has brought out the importance of early and accurate testing for better disease management. We, at Molbio, believe that reliable point of care systems are crucial for ensuring universal access to timely testing for infectious diseases, and that is at the heart of our Truenat technology,” said Sriram Natarajan, director, and CEO of Molbio Diagnostics, in a statement.

“Truenat is the first platform to be authorised by the DGCI for Nipah virus testing. We are proud to support our country in fighting Nipah virus,” Natarajan added.

Nipah virus disease may be asymptomatic, but may also lead to acute respiratory infection and fatal encephalitis.

The infection has resurfaced in India after three years. Prior to the most recent case reported from Kozhikode, India has reported three Nipah virus outbreaks in the past in West Bengal’s Siliguri and Nadia in 2001 and 2007 respectively, and Kozhikode and Malappuram in Kerala in 2018.

Also read: As Nipah returns to Kerala, a look at lethal virus that left 17 dead in the state in 2018

Rapid testing, quicker results

Work on the TrueNat test for Nipah virus started in 2018, in collaboration with the ICMR’s National Institute of Virology (NIV), Pune.

“The ability to quickly deploy the platform to the point of need and the rapid testing capability makes it a powerful tool in the diagnosis and containment of the Nipah virus. This collaboration with NIV allows us to react quickly in times of such emergencies,” said Chandrasekhar Nair, director & CTO of Molbio Diagnostics, in the statement.

TrueNat is a portable, battery-operated RT-PCR platform developed and manufactured in India by Molbio. The platform can test for nearly 30 diseases, and results take less than an hour.

The technology has been approved by WHO and ICMR for TB diagnosis, Covid and other diseases.

Like the SARS-CoV-2 virus, Nipah can be diagnosed using the RT-PCR tests used to test for Covid, albeit with a different set of reagents that would help identify the virus.

However, traditional RT-PCR tests can take up to eight hours to complete. The TrueNat tests used the same scientific principle used in RT-PCR tests, but the results can be achieved in half an hour.

(Edited by Poulomi Banerjee)

Also read: Karnataka govt issues advisory to prevent Nipah virus outbreak after Kerala reports cases


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