Truenat Test Kit Gets Regulatory Approval For Diagnosis Of Nipah In India

Truenat, an innovative point of care Real-Time PCR platform manufactured by Goa-based Molbio Diagnostics, has received Emergency Use Authorization by the DCGI for their Nipah test.

Truenat, an innovative point of care Real-Time PCR platform manufactured by Goa-based Molbio Diagnostics, has received Emergency Use Authorization by the DCGI for their Nipah test. This is the first kit in India to receive regulatory approval to conduct tests for Nipah.

Nipah virus (NiV) is an emerging zoonotic disease that causes severe disease in humans. Signs and symptoms 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).

Leveraging the large footprint of Truenat machines deployed across the country for diagnosis of infectious diseases such as TB, COVID-19, Hepatitis, etc., testing for Nipah Virus can now be performed rapidly, 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.

“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. Truenat is the first platform to be authorized by the DGCI for Nipah virus testing. We are proud to support our country in fighting Nipah Virus,” said Mr. Sriram Natarajan, Director and CEO of Molbio Diagnostics.

“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 of need such emergencies,” said Dr. Chandrasekhar Nair, Director & CTO of Molbio Diagnostics.

Truenat is a truly indigenous portable, battery-operated, IoT-enabled point of care 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.

A WHO approved frontline platform for TB diagnosis and approved by ICMR for TB, Covid-19 and other diseases, Truenat Real-Time PCR technology is globally recognized as a decentralized molecular diagnostic tool that can test multiple diseases right at the first point of patient contact. Truenat is already playing a critical role in the management of infectious diseases such as TB, COVID-19, Dengue, Chikungunya, Hepatitis, HPV, etc. in the country.

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