With ICMR certification, Rs 500 COVIRAP “well set to replace PCR-based tests to a large extent”

IIT Kharagpur’s new method implements a highly reliable and accurate molecular diagnostic procedure, conducted in an ultra-low-cost portable device unit; open to tie ups for technology licensing and commercial scale of production

COVIRAP, the diagnostic machine developed by IIT Kharagpur researchers, has been successfully validated for its efficacy in COVID-19 detection by the Indian Council of Medical Research (ICMR) after being tested as per ICMR guidelines, at ICMR-National Institute of Cholera and Enteric Diseases (NICED).

The novel diagnostic platform, developed by a team of researchers lead by Prof Suman Chakraborty, Professor, Department of Mechanical Engineering, IIT Kharagpur, and Dr Arindam Mondal, Assistant Professor, School of Bio-Science, IIT Kharagpur, has reportedly been designed to be fairly easy to conduct, affordable, produced results within one hour and can be conducted in an ultra-low-cost portable device unit. The test results are rendered via a custom-made mobile application for dissemination without requiring manual interpretation.

Lauding the IIT Kharagpur researchers, Dr Ramesh Pokhriyal Nishank, Hon’ble Minister of Education, Government of India, said, “I am glad the researchers from IIT Kharagpur have achieved the goal of Atmanirbhar Bharat through this medical technology innovation. This would go on impacting the lives of many in rural India as the device is portable and can be operated on a very low energy supply. Minimally trained rural youth can operate this device.”

Commenting on the low cost of the test, he said, “This innovation has made high-quality and accurate COVID testing affordable for the common people with a testing cost of around ₹500/- which can further be reduced through government intervention. As informed by IIT Kharagpur, this machine can be developed at a cost of less than ₹10,000/- with minimal infrastructural requirement making the technology affordable to common people. The testing process in this new machine is completed within one hour. I congratulate Prof V K Tewari, Director, IIT Kharagpur, and the research team led by Prof Suman Chakraborty and Dr Arindam Mondal for this path-breaking innovation taking molecular diagnostics from high-end labs to the field.”

The project received financial support from the Institute in late April 2020 as Prof Tewari decided to establish a dedicated fund to support COVID-19 related research and product development as per an initiative by the Ministry of Education, Government of India following the vision of Dr Ramesh Pokhriyal Nishank, Hon’ble Minister of Education, Government of India.

Speaking about this test, Prof Tewari said, “This is indeed one of the greatest contributions in the history of medical science, particularly in the area of virology, and is well set to replace PCR-based tests to a large extent.”

Speaking about the commercialisation of COVIRAP, Prof Tewari said, “While the Institute can produce the testing kit up to a certain scale, patent licensing will facilitate commercialisation opportunities for medical technology companies. Any corporate or start-up can approach the Institute for technology licensing and commercial scale of production. The Institute is open to tie-ups, with due measures of protecting the interest of public health amidst the pandemic situation.”

Subsequent financial support to this project was provided by the IIT Foundation, US, to meet the various expenses in the clinical testing phase. Partial financial support has also been provided from the Common Research and Technology Development Hub on Affordable Healthcare, established by Council of Scientific and Industrial Research (CSIR), Government of India, at IIT Kharagpur.

Elaborating on the validation process of COVIRAP, Dr Mamta Chawla Sarkar, an internationally acclaimed virologist who oversaw the patient trials on behalf of ICMR-NICED said, “A detailed scrutiny of the 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 with so far. 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.”

Further, Dr Shanta Dutta, Director, ICMR-NICED added, “While overseeing the testing and validation, I was very impressed with the portable low-cost machine unit that can truly be a game-changer for COVID-19 diagnostics at peripheral laboratories with the support of unskilled human resources as operators. This now needs a rapid commercial scale-up to cater to the needs of the underserved population. ICMR-NICED will be pleased to facilitate support for further improvisations in the method towards even superior performance.”

The tests conducted there have apparently revealed that the results from this new assay are of standards comparable to the celebrated 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.

ICMR-NICED has further certified the test to be extremely user-friendly. Notably, the number of tests per one-hour batch in a single machine unit can be further increased to much higher limits, for the purpose of testing on a mass scale.

Elaborating on this test, Prof Suman Chakraborty, Professor, Department of Mechanical Engineering Department, IIT Kharagpur, said, “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, falling under the category of ‘isothermal nucleic acid-based tests’ (INAT), can be performed in the same machine. In other words, influenza, malaria, dengue, Japanese encephalitis, tuberculosis and many other infectious, as well as vector-borne diseases, can be tested using the same machine. This will virtually minimise the need for thermal cyclers or real-time PCR machines, without sacrificing the expected high standards of a molecular diagnostic test.”

Further, Dr Arindam Mondal, Assistant Professor, School of Biosciences, IIT Kharagpur, said, “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 the testing.”

“Today, it is COVID-19; yesterday, it was leprosy and tuberculosis; tomorrow, it will be something else. This technology is all set to create a revolution in rapid and low-cost detection of all these, by bringing high-end molecular diagnostics from the lab to the field. The impact of this, therefore, is long-lasting, empowered by the capability of detecting unforeseen pandemics in the coming years that may potentially endanger human lives time and again,” remarked Prof Suman Chakraborty.

A demonstration video of ‘COVIRAP’ can be downloaded from https://fromsmash.com/Demo-Video-IIT-Kharagpurs-COVIRAP