Truenat receives EUA by DCGI for Nipah virus tests in India

The DCGI has given Truenat the first Emergency Use Authorization (EUA) for performing Nipah virus testing in India. It’s a point-of-care Real-Time PCR tool created by Molbio Diagnostics in Goa to identify the presence of the virus.

Nipah virus (NiV), zoonotic disease that remerged in Kozhikode district in Kerala is causing distress to people and the healthcare system as the state is already under the grip of COVID cases. Signs and symptoms of the fatal disease range from asymptomatic to acute respiratory infection and fatal encephalitis. Prior to the current reported case from Kozhikode, India has reported three NiV outbreaks in the past (Siliguri in 2001 and Nadia in 2007 (West Bengal) and Kozhikode and Malappuram in Kerala in 2018).

The Truenat platform that gai­ned traction in the last one year, has been designed and manufactured indigenously, is portable, battery-operated and IoT-enabled point of care. The platform can display results in less than an hour and has been used to detect nearly 30 diseases including TB, COVID-19, dengue, chikungunya, hepatitis, HPV in the past.

Elaborating on the development process of Truenat for Nipah testing, Dr. Chandrasekhar Nair, Director and CTO of Molbio Diagnostics said “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 the diagnosis and containment of the Nipah Virus.”

DCGI approval for the truenat machine will help in early diagnosis of the disease for effective management and containment of the virus in the state.