New Delhi: The Drugs Controller General of India (DCGI) has granted emergency use authorization (EAU) to Truenat, a real-time PCR platform, to conduct Nipah virus tests, the company said on Wednesday.
Manufactured by Goa-based Molbio Diagnostics, this is the first kit in India to receive regulatory approval to conduct tests for Nipah.
Truenat is an indigenous portable, battery-operated, Internet of Things-enabled RT-PCR platform developed and manufactured in India. It can test for nearly 30 diseases, and results take less than an hour.
Truenat is already playing a critical role in the management of infectious diseases such as TB, Covid-19, dengue, chikungunya, hepatitis, and HPV in the country.
"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. We are proud to support our country in fighting Nipah Virus," Molbio Diagnostics Director and CEO Sriram Natarajan said in a statement.
Nipah virus is an emerging zoonotic disease that causes severe disease in humans. Signs and symptoms range from asymptomatic to acute respiratory infection and fatal encephalitis.
Last week, it claimed the life of a 12-year-old boy in Kerala amid a Covid surge.
Previously, India has seen three outbreaks: Siliguri in 2001 and Nadia in 2007 (both West Bengal), and Kozhikode and Malappuram in Kerala in 2018.
Molbio first started R&D work on the Truenat test for the Nipah virus in 2018 in collaboration with the National Institute of Virology, Pune.
"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 as emergencies," Molbio Diagnostics Director and CTO, Dr Chandrasekhar Nair, said in the statement.
Truenat is also approved by the World Health Organisation for TB diagnosis and approved by the ICMR for TB, Covid-19 and other diseases.