Truenat Test
In 2021 The Drugs Controller General of India (DCGI) has granted emergency use authorization (EAU) to Molbio Diagnostics' Truenat, a real-time PCR platform, for Nipah virus (NiV) tests.
Goa-based healthcare company Molbio manufactures ‘Truenat Real-Time PCR’.
While Truenat machines are deployed across the country for diagnosis of infectious diseases such as TB, covid-19, hepatitis, and others, this is the first kit in India to receive regulatory approval for Nipah virus test.
Truenat is an indigenous portable, battery-operated, IoT-enabled point of care RT-PCR platform that can test nearly 30 diseases, and results take less than an hour.
The kit employs a combination of reagents that inactivate the clinical specimens during the nucleic acid extraction.
This method allows the extraction of inbuilt NiV internal-positive control along with the extraction of the suspected sample.
Need of it
The major hurdles in containing the NiV outbreaks include, the unavailability of containment facilities for quick diagnosis, delay in diagnosis with respect to sample transportation to the reference laboratory and time to positivity (TTP).
Timely detection of NiV can play an important role in the patient management and help curb further spread of infection.
Diagnosis of NiV is primarily carried out using nucleic acid amplification tests, serologic tests and virus isolation.
Real-time reverse transcription polymerase chain reaction (RT-PCR) is considered as an accurate and quick method for NiV diagnosis.
However, it requires well-defined infrastructure, expensive reagents and equipment which are generally not available in resource-poor settings or remote areas.
Also there are issues related to biosafety at the time of collection and transportation of infectious specimens to the reference laboratory.
Hence, it is imperative to develop point-of-care diagnostic tests for rapid diagnosis of NiV that can be used in the field/remote areas affected with NiV.
Why it is in news?
Kerala has been accorded sanction by the Indian Council for Medical Research (ICMR) to use Truenat test to diagnose Nipah.
Hospitals with BSL 2 level labs can perform the test.
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