SBIR Phase I: Early Diagnosis of the COVID-19 Cytokine Storm via Point-of-Care Antibody Profiling

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to predict a patient’s risk for developing an adverse and often lethal response to certain viral infections, such as COVID-19. This project proposes a fast and accurate test for the severity of COVID-19 infection. The proposed assay has the potential to enable early intervention and save lives. It can potentially be used for many other infections and public health hazards beyond COVID-19. This Small Business Innovation Research (SBIR) Phase I project will produce a new technology capable of diagnosing immune response dysregulation to any infectious disease (e.g., SARS-CoV-2, dengue, influenza, hepatitis C, etc.) that progress through an antibody dependent enhancement (ADE) mechanism. While infection by the SARS-CoV-2 virus begins as a mild illness, some patients experience a sudden and rapid decline in health, precipitated by a massive release of pro-inflammatory cytokines, i.e., a “cytokine storm,” Cytokine storms cause hyperinflammation of the lungs, which leads to acute respiratory distress syndrome (ARDS), the leading cause of COVID-19 mortality. Unfortunately, there is presently no test capable of predicting this event. This project aims to fill this medical technology gap via the development of a highly multiplexed, rapid, sensitive, disposable immunoassay specific to COVID-19 infections to be deployed at scale. The effort will include designing, building, and optimizing a prototype immunoassay based on nanopore technology innovations and analytically validating the developed technology against industry standards. 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.