Molbio’s Nipah test kit gets DCGI approval

A test kit for the diagnosis of the Nipah virus manufactured by Molbio Diagnostics has been granted emergency use authorisation (EUA) by the Drug Controller General of India (DCGI).

The test, called Truenat, is a point of care real-time PCR platform manufactured by the Goa-based Molbio Diagnostics. It is the first platform to be authorised by the DGCI for Nipah virus testing.

Prior to the current reported case from Kozhikode in Kerala, India has reported three NiV outbreaks in the past at Siliguri in 2001 and Nadia in 2007 in West Bengal, and Kozhikode and Malappuram in Kerala in 2018.

Nipah virus (NiV) is an emerging zoonotic disease. Signs and symptoms range from asymptomatic to acute respiratory infection and fatal encephalitis.

“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 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. This collaboration with NIV allows us to react quickly in times of need such as emergencies,” Chandrasekhar Nair, director & CTO of Molbio Diagnostics, said.

Truenat is an 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. Truenat machines are deployed across the country for diagnosis of infectious diseases such as TB, Covid-19, hepatitis and now the testing for Nipah Virus can now be performed rapidly, on-demand, and closer to the affected people. This would result in early and fast diagnosis for effective management of the disease and containment of the spread of the virus, the company said.

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, so reliable point of care systems were crucial for universal access to timely testing for infectious diseases.