The RT-PCR test, the only gold-standard test known for the detection of several infectious diseases, is challenged by the needs of a high-end equipment (Real time-PCR machine), extremely sophisticated infrastructure and skilled technicians to perform the testing. The available alternative low-cost alternatives, namely, the rapid antigen tests, on the other hand, are known to give false negative results typically at early stages of the infection, so that their reliabilities for detecting infectious patients are grossly limited. In view of this, there has been a long-standing requirement of a significantly improved rapid test that may be administered by minimally-trained frontline workers outside controlled laboratory settings, albeit with uncompromised accuracy.

Responding to this challenge, our research team developed a new piece-wise isothermal nucleic acid testing technology for diagnosing a plethora of pathogen-associated infections, including but not limited to COVID-19. Disrupting the perception that high-quality molecular diagnostics necessarily demands sophisticated laboratory and human resources, this diagnostic procedure is the first of its kind, highly accurate ultra-low-cost point-of-care nucleic acid-based test having the simplicity and user-friendliness of a common rapid test. Rapid dissemination of the test outcome (within 1 hour of sample collection) as well as the capability of operation outside laboratory settings hallmarks its value proposition as an affordable alternative to the celebrated RT-PCR test for monitoring the spread of infection at the community level in an extremely effective manner. This opens up the possibilities of frequent routine screening at common community locations including schools, shopping complexes, offices, etc. during the regularization phase of the common daily activities post-pandemic. Direct testing from swab/ saliva sample without requiring specialized procedures such as RNA-extraction, and implementation by unskilled frontline-workers in uncontrolled environments are two exclusive unique technical features of this test, leaving apart the user-friendliness, rapidity, and low cost. Innovation of this new technology has already promised to reach he last-mile of the underserved-population, with unprecedented fusion between deep science and compelling responsiveness for public-health.

In organized clinical trials, this technology has been demonstrated to be successful in capturing commonly missed instances of early infection and asymptomatic disease presentation. This could result in dramatic improvements in disease management and epidemic/ pandemic control in several unforeseen events that may potentially endanger human lives time and again in the future. This envisaged trade-off between the scientific standards of high-end laboratory based tests with the elegance of common rapid tests, thus, appears to be the future of molecular diagnostics for public health management, with no distinction between consumers having expected variabilities in economic barrier, and in the process 'democratize' disease diagnostics by bringing high-end lab tests to the ambit of the bottom of the community pyramid in the green field, with a dream of nullifying any differential access to quality primary healthcare of the haves’ and the have-nots’.

This work has been done in collaboration with the research team of Dr. Arindam Mondal, School of Bioscience. The patient trials have been coordinated by Dr. Med. Indranath Banerjee, nodal Officer of COVID-19 at the B. C. Roy Technology Hospital, IIT Kharagpur.

References

S. Banerjee et al., “Piecewise Isothermal Nucleic Acid Testing for Infectious Disease Detection with Sample-to-Result Integration at the Point-of-Care”, ACS Sensors, vol. 6, pp. 3753-3764, 2021