The Indian Institute of Technology (IIT) Kharagpur announced on Wednesday that their new diagnostic machine that can detect COVID-19 has been accredited by the Indian Council for Medical Research (ICMR). Named COVIRAP, the accuracy of the machine is very close to the RT PCR tests that have now become a standard for COVID-19 tests in the country. The institute has also developed an app to determine the results of the tests accurately.
In a video streamed during the press meet, Dr Suman Chakraborty, Professor at the Mechanical Engineering department and the lead researcher behind COVIRAP, explained how the device and testing process works. "Each testing kit contains three master mixes which can confirm the presence of the virus. After the RNA sample is collected, it is mixed with master mixes and heated to a certain temperature after being inserted in the pre-programmed machine. This is quite similar to what is done in other tests as well. However, there is a second heating step which is exclusive to this device and has been patented, which makes the machine quite unique. After the heating processes are completed, the RNA samples are put on a strip, quite similar to pregnancy strips. Whether a patient is COVID-19 positive or negative is dependent on whether lines appear on the strips or not. The strips are then inserted in a cartridge in the machine from where the app uses the camera and inbuilt analytical tool to determine whether the test is positive or negative."
The machine developed by IIT Kharagpur is portable, low-cost and user-friendly that can be used in the field, anywhere, said the lead researcher. "The machine can be set up in the middle of a field and doesn't require an air-conditioned laboratory. In fact, most of the testing done during the development process was conducted out in the open to test the efficacy of the machine," added Chakraborty. The machine can determine the results of a sample in less than an hour.
Over 200 samples were tested at ICMR-National Institute of Cholera and Enteric Diseases (NICED), an institute accredited by the ICMR, before the certification. During the rigorous testing process, the machine displayed over 93% sensitivity and almost 98% specificity in its results. Sensitivity and specificity are the two common parameters used as indicators of efficacy of any diagnostic test. "The samples of various patients can be tested at once and that makes the machine quite scalable," said Chakraborty.
The machine costs around Rs 5,000 and one test will cost anything between Rs 500 and Rs 600. "The entire machine and testing process was developed at IIT Kharagpur during the lockdown and nothing could be sourced from outside. We are hoping that the per-test cost will decrease once the COVIRAP is mass-produced," said Chakraborty.
Speaking about the commercialisation of COVIRAP, VK Tewari, Director, IIT Kharagpur, 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.” Tewari also spoke about how the institute had been confidentially testing samples at NICED to ensure that it is effective in human RNA samples. "We had already developed a synthetic RNA over two months ago and the team could work on real COVID positive and negative samples at NICED to determine the test's efficacy," he added.
Dr Shanta Dutta, Director of ICMR-NICED added, “The machine can 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.”
Chakraborty further said, “The 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 like influenza, malaria, dengue, Japanese encephalitis, tuberculosis and many other infectious, as well as vector-borne diseases, can be tested using the same machine.”
Further, Dr Arindam Mondal, Assistant Professor, School of Biosciences, IIT Kharagpur, who is also one of the researchers, said, “During the testing phase, all kits 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.”
