NIV’s Truenat test kit gets emergency use approval from DCGI for Nipah virus

PUNE Pune’s National Institute of Virology’s (NIV) Truenat test kits has received emergency use approval from the Drugs Controller General of India for the diagnosis of the Nipah virus

PUNE Pune’s National Institute of Virology’s (NIV) Truenat test kits has received emergency use approval from the Drugs Controller General of India for the diagnosis of the Nipah virus.

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An outbreak of the Nipah virus is currently seen in Kerala.

Leveraging the large footprint of Truenat machines deployed across the country for diagnosis of infectious diseases such as TB, Covid-19, and Hepatitis, a Truenat testing kit for he Nipah virus will help diagnose eh virus rapidly, on demand, and closer to affected people, resulting in effective management of the disease and containment of the spread of the virus.

The kit has been made in collaboration with a Goa- based firm Molbio Diagnostics.

Sriram Natarajan, director and CEO of Molbio Diagnostics said, “Covid-19 has brought out the importance of early and accurate testing for better disease management. Truenat is the first platform to be authorised by the DGCI for Nipah virus testing.”

Nipah virus (NiV) is an emerging zoonotic disease that causes severe infections in humans. Signs and symptoms range from asymptomatic to acute respiratory infection and fatal encephalitis.

Prior to the current reported case from Kozhikode, when a 12-year old boy died on September 5, India had reported three NiV outbreaks in the past - Siliguri in 2001, Nadia in 2007 (West Bengal) and Kozhikode and Malappuram in Kerala in 2018.

“The R&D work on the Truenat test for Nipah virus was first started in 2018 in collaboration with the National Institute of Virology, Pune (ICMR), to enable the detection of the infectious virus during outbreak situations. The ability to quickly deploy the platform to the point of need and the rapid testing capability makes it a powerful tool in diagnosis and containment of the Nipah virus. This collaboration with NIV allows us to react quickly in times emergencies,” said Dr. Chandrasekhar Nair, director of the company.

Truenat is a battery-operated, IoT-enabled point of care RT-PCR platform developed and manufactured by Molbio. The platform can test for nearly 30 diseases, and results take less than an hour.

Truenat is a WHO approved frontline platform for TB diagnosis and approved by ICMR for TB, Covid-19 and other diseases.