Test kit to detect Nipah may soon get DCGI nod

TrueNat platform also ready with kits for 28 infections like zika
Nipah virus has been reported again in Kerala after three years.
Nipah virus has been reported again in Kerala after three years.

BENGALURU: TrueNat-MTB, the only World Health Organisation and the Indian Council of Medical Research (ICMR) approved point-of-care platform for Tuberculosis, and also noted for its Covid-19 testing, has now come up with test kits to detect Nipah virus. 

On Monday, it applied for emergency approval from the Drug Controller General India for commercial manufacturing of test kits for Nipah virus. Sources confirmed that the approval is said to arrive this week. TrueNat is a Polymerase Chain Reaction (PCR), a battery-operated portable diagnostic platform developed by Goa-based Molbio Diagnostics.

According to sources from the health ministry, the test kits for Nipah were developed way back in 2018, during the first outbreak in Kerala, in coordination with the National Institute of Virology, Pune. The kits were also used by the NIV to detect Nipah virus and had shown significant results.

“The test kits are very easy to use. Even recent cases like the death of a boy infected with Nipah was also detected using TrueNat. We are hoping that the approvals come as early as possible for commercial use so that the detection becomes faster,” a senior official said.

TrueNat kits are basically portable, battery-operated, rugged devices with ready-to-use room temperature stable reagents. The fully automated protocols ensure that testing can be done by minimally trained technicians and the in-built data transfer provision enables remote interventions and remote monitoring.

“The availability of machines already at most of the PHCs across the country will make it easier to just replace the Covid and TB test kits to Nipah kit and use it. The ICMR has also approved the ease of using the test kits at NIV and we are expecting the approvals to come anytime in the next two days and definitely within this week,” a source said.

Health experts from Karnataka agree that such test kits will help in containing the spread as detection becomes faster. “With Nipah detected in Kerala, though the numbers are small, we will still have to be cautious. Such test kits will surely help,” said Dr Sanjay Gururaj, Physician, Paediatrician from SHRC Hospial in Bengaluru. 

The testing platform, meanwhile, is also ready with kits for testing 28 infections like zika, cholera, sickle cell anaemia, influenza, mumps, syphillis and yellow fever among others. They are also developing 30 other kits to detect Leptospira, Rubella, H5N1, Rotavirus, HIV-2 etc. 

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