The Indian Council of Medical Research (ICMR) on Thursday approved a novel RT-qPCR test kit by Chennai-based KRIYA Medical technologies that can detect influenza (H1N1, H3N2, Yamagata and Victoria sublineages), Covid-19, and respiratory syncytial virus (RSV).
The approval of the kit marketed as KRIVIDA Trivus comes even as several parts of the country are facing a significant rise in these viruses.
The three pathogens have similar initial symptoms but differ in how the illness progresses, how easily they spread, and how they are treated.
The KRIVIDA Trivus effectively distinguishes influenza, SARS-CoV-2 and respiratory syncytial virus, within the shortest TAT (turnaround time), -- cycle time of 27 minutes, and the time taken for the result to be read can vary between 50-60 minutes. This can enable an immediate line of treatment, the company said in a statement.
The kit can also be used in all the available RT-PCR equipment.
The ICMR evaluated the kit at National Institute of Virology, Pune, using 225 known positive samples and 85 negative samples. The overall sensitivity of KRIVIDA Trivus is 99.11 per cent and specificity is 100 per cent.
"Over the last several weeks, we have seen an increase in the number of H3N2 cases, as well as a rise in the number of Covid-19 infections in the country. We need a test that can clearly differentiate between these infections and help doctors create the right treatment plan," said Anu Moturi, CEO and Founder, KRIYA Medical Technologies, in a statement.
"Our product is designed to detect presence or absence of all three pathogens. The conventional RT-PCR kits which detect just the presence or absence of SARS-CoV-2 should be replaced by KRIVIDA Trivus," added Dr. Shanmuga Priya, Head Of Research and Development, at the company.
"Our kit provides a more meaningful report about not just the presence or absence of these infections but also about coinfections, as these are often severe and they require a syndromic approach in management," Priya said.
The test kit will be produced at KRIYA's state-of-the-art manufacturing facility in Oragadam in Chennai. The test is priced competitively, and it will soon be commercially available across the country, the company said.