The entire rapid test can be conducted in an ultra-low-cost portable device with results available in a smartphone for dissemination within one hour at Rs 400 per test
Researchers at IIT Kharagpur have innovated a novel portable rapid diagnostic device to detect COVID-19 infection. The first-of-its-kind device will bring the testing for COVID-19 out from the walls of expensive laboratories and RT-PCR machines and enable testing at affordable costs for the under-served community across the world.
The entire test, that costs Rs 400, can be conducted in an ultra-low-cost portable enclosure as an alternative to specialised laboratory equipment. The same portable unit can be used for a large number of tests, on mere replacement of the paper cartridge after each test. The device has been proven to produce no false result with accuracy and sensitivity compatible to standard RT-PCR tests.
Considering the impending outbreak of COVID-19 infection with the anticipated increment in number of affected personnel, there is an emergent need to run large numbers of reliable diagnostic tests at affordable cost and minimal infrastructural support, for monitoring the early stages of progression of the disease when many of the infected persons do not exhibit discernible symptoms of infection.
However, the testing technologies currently under use are expensive, despite the innovations in low-cost testing kits, as the actual testing machinery cost remains high. Further, testing mechanism has logistical issues due to the infrastructural requirement of the testing centres. A team of researchers from IIT Kharagpur, contemplating on the challenge, realised that the alternative cannot be new innovations for the existing detection systems like testing kits and PCR machines, but a disruptive approach leading to a new technology and testing process being innovated without sacrifising the scientific rigour and medically acceptable high standards of the test results.
Professor Suman Chakraborty from the Mechanical Engineering Department, and Dr Arindam Mondal from the School of Bio Science, IIT Kharagpur, came up with the concept of a portable non-invasive rapid detection test for COVID-19. The technology essentially deploys a disposable simple paper-strip for chemical analysis and visualisation of results.
The entire test can be conducted in an ultra-low-cost portable enclosure as an alternative to specialised laboratory equipment. The same portable unit can be used for a large number of tests, on mere replacement of the paper cartridge after each test. The new device has been designed to be usable at locations with extremely poor resources in an uncontrolled environment, catering the needs of the underserved population. Moreover, it can be operated by minimally-trained personnel, precluding the needs for skilled technicians.
The research team has validated the detection procedure, taking time of approximately 60 minutes to run each test. While the Institute can produce the testing kit up to a certain scale, patent licensing will facilitate commercialisation opportunities for medical technology companies.
Chakraborty further said, “In assessing the utility of a specific method of disease detection, there is a common failure to recognise that the cost of the test kit may not turn out to be the most critical factor from the viewpoint of affordable diagnosis, unlike what is being commonly portrayed. Rather, the greater challenge is complete elimination of the need for any specialised infrastructure and ensuring the possibility of conducting tests at large scale at low cost without compromised accuracy. In that light, the RT-PCR-based tests suffer from a compelling constraint of requiring an elaborate laboratory infrastructure and support system, including the operational and maintenance cost, to perform the test. The alternative existing approaches to these tests, on the other hand, are either invasive (blood tests) and non-indicative of early stage of development of the infection, or dependent on reagents that are extremely unstable and cannot be implemented in resource-limited settings.”
The equipment developed by IIT Kharagpur Researchers will cost about Rs 2,000 if a pilot facility is used. Use of a large-scale commercial facility will further reduce with increase in the production scalecompared to the RT PCR machine costing Rs 15 lakh.
According to Mondal, the unique portable device developed by the IIT Kharagpur researchers has not only been validated for the diagnostics of COVID-19, but also been designed to be capable of detecting any other kind of RNA virus by following the same generic procedure. The impact of this, therefore, is long-lasting, empowered by the capability of detecting unforeseen viral pandemics in the coming years that may potentially endanger human lives time and again.”
The results from this new technology have been strictly validated by following all established laboratory controls against the benchmarked results obtained from RT-PCR machine, using synthetic viral RNA.
Ready for commercialisation of the product now, any corporate or start-up can approach the institute for technology licensing and commercial scale of production. It is open to tie-ups, including a mode where the government intervenes with regards to meeting low-cost healthcare objective for the under-served community as a policy measure to protect the interest of public health amidst the pandemic situation.