RAPID: Development of an ultrasensitive thermal contrast amplification lateral flow immunoassay for rapid, point-of-care COVID-19 diagnosis

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Innovative and unique thermal contrast technology will be used to detect heat from laser irradiated gold nanoparticles to vastly improve the sensitivity of rapid diagnostics tests (i.e. lateral flow assays) designed to detect and diagnose COVID-19. This technology, which has been used to significantly improve lateral flow assays for HIV, malaria, Strep and influenza, will enable widespread, inexpensive ( $1/test), rapid (≤ 10 minutes), point-of-care detection of COVID-19. Such detection does not exist and cannot exist using the current methodologies for detecting both early (i.e. viral protein) and late (i.e. antibody) stages of COVID-19 infection. These new, thermal contrast lateral flow assays, along with new thermal contrast “reading” technology, will accelerate effective and targeted testing and surveillance of disease spread and management and bring enormous benefits to both national and global society. While first deployment will be in clinical settings, it is envisioned that this technology can eventually be used at schools, airports, sporting and entertainment events and even at home to assess the infection and spread of COVID-19 and other infectious diseases.The proposed research will develop new lateral flow assays to be used with innovative thermal contrast technology for highly sensitive, inexpensive, point-of-care detection of COVID-19. This new paradigm will, in the long term, be applied to a wide variety of diseases. Lateral flow assays are arguably the cheapest, fastest and easiest to use rapid diagnostic assays in the world. While they are used qualitatively for numerous diseases, they have weaknesses that include lack of sensitivity and quantification of disease burden. Both of these issues are addressed through our novel Thermal Contrast Assay technology. To address this specifically for COVID-19, two approaches are proposed: 1) optimizing gold nanoparticles and lateral flow assays for binding either COVID-19 protein or COVID-19 antibody analytes, and 2) the use of a new quantitative figure of merit called the “Binding Ratio” to rapidly identify reagents and components for optimized thermal contrast lateral flow assays. This project is part of a larger effort with industry partners to scale up the manufacturing of a proprietary thermal contrast reader so that it will be affordable for point-of-care clinical settings such as doctors’ offices, urgent care settings, emergency rooms, and field hospitals.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.