A diagnostic machine to carry out tests to detect coronavirus infection, developed by researchers from IIT-Kharagpur – COVIRAP – has received approval from the Indian Council of Medical Research (ICMR). The test has been validated for its efficacy in Covid-19 detection by the ICMR.
According to the researchers, the test is fairly easy to conduct, affordable and can produce results within one hour. The test can also detect extremely low levels of viral loads, thus diagnosing the infection in very early stages, they said.
At an online press conference on Wednesday, IIT-Kharagpur Director Professor V K Tewari told mediapersons that various commercial units have already approached the institute for patent licencing to enable this innovation to reach the common people.
This new testing method implements a highly reliable and accurate molecular diagnostic procedure, conducted in an ultra low-cost portable device unit, said Tewari. The test costs only Rs 500, he added.
After rigorous testing with patient samples by an authorised ICMR laboratory, in adherence with the council’s strict guidelines, it has granted certification for the Covid-19 diagnostic test, said Tewari.
This technology is set to replace RT-PCR-based tests to a large extent, said Tewari. While the institute can produce the testing kit up to a certain scale, patent licencing will facilitate commercialisation opportunities for medical technology companies, he said.
The research team was led by Professor Suman Chakraborty and Dr Arindam Mondal.
According to the researchers, the patented machine unit has not only been proven to be robust during patient sample testing, but also extremely flexible and generic. This means that other than Covid-19 testing, many other tests that fall under the category of ‘isothermal nucleic acid-based tests’ (INAT), can be performed in the same machine.
“During the testing phase of patient samples, all kits, exclusively developed at IIT- Kharagpur, were transported in an uncontrolled environment for hours to the testing unit, which shows high levels of stability of the reagents that are being used for testing,” they said.
Dr Mamta Chawla Sarkar, a virologist who oversaw the patient trials on behalf of ICMR-National Institute of Cholera and Enteric Diseases (NICED), said, “A detailed scrutiny of testing results has clearly shown that this assay holds the capability of detecting extremely low levels of viral loads that any other method based on similar principles of testing, even those from the most celebrated research groups across the world, could not come up… In practice, this means that very early stages of infection can be detected, thereby isolating the patient and arresting the uncontrolled spread of infection in the community via asymptomatic patients.”
IIT-Kharagpur researchers said that this machine can be developed at a cost of less than Rs 10,000, with minimal infrastructural requirement, making the technology affordable to common people.
Dr Shanta Dutta, director of ICMR-NICED, said this portable low-cost machine unit now needs a rapid commercial scale-up to cater to the needs of the underserved population. The tests conducted there have revealed that the results from this new assay are of standards comparable to RT-PCR tests, with a remarkably high level of specificity and sensitivity, the two common parameters used as indicators of efficacy of any diagnostic test, said Dr Dutta.
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