16th September 2021 Editorial by: rapidvirology staff writer
India Grants EUA for Point-of-Care Nipah Virus Test
The Drugs Controller General of India (DCGI) has given emergency use authorization (EUA) to the TrueNat™ Nipah virus test, a chip-based rapid RT-PCR point-of-care test made by Goa-based Molbio Diagnostics that provides a semi-quantitative result in just over half an hour.
This is the first kit in India to receive regulatory approval to conduct tests for Nipah.
- Assay based on Taqman chemistry
- High primer sensitivity and specificity
- Micro chip-based real-time PCR assay
- Minimal sample requirement @ 6µL
- Smart chip with pre-set data for quantitation of results
- Chip re-use lock
- Reaction port with contamination/evaporation resistant design
“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. This collaboration with NIV allows us to react quickly in times of need, such as emergencies,” said Dr. Chandrasekhar Nair, Director & CTO of Molbio Diagnostics.
This announcement comes within days after the tragic death of a 12-year old boy who contracted the virus in the city of Kozhikode in Kerala, India. The Union Health Ministry dispatched a team from the National Centre for Diseases Control, Delhi, and the National Institute of Virology in Pune. The team has set up a virology laboratory at the Kozhikode medical college hospital to speed up tests.
After a 14-day incubation period, no new cases have been found and restrictions have eased in the area. Investigators are still looking for the source of the infection.
Request information using the button provided below or visit MolbioDiagnostics.com to learn more.
Date Published: 16th September 2021
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