I-Corps: A diagnostic platform for the analysis of biomarkers in multiplexed immunoassays

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The broader impact/commercial potential of this I-Corps project is to enable a rapid, high-sensitivity, multiplex, digital immunoassay diagnostic platform. With a short turnaround, the platform is able to test blood samples of critically ill patients suffering from life-threatening conditions. If successfully commercialized, the technology is expected to provide immediate guidance for caregivers to make timely clinical decisions and proactively intervene before disease conditions worsen. The platform can potentially reduce the current mortality rate of infection-related acute illnesses in intensive care units. Additionally, the platform allows for the simultaneous detection of multiple biomarkers in a highly reliable and accurate manner. The I-Corps project will explore the commercialization potential of the digital immunoassay platform, exploring the use by diagnostic companies having clients in clinical laboratory medicine, hospital procurement managers and doctors of pathology, and researchers in biopharmaceutical companies as potential customers.This I-Corps project is based on the development of a prototype digital immunoassay platform using a pre-equilibrium digital enzyme-linked immunosorbent assay microarray. The microarray has been demonstrated to allow real-time profiling of multiple biomarker molecules (proteins and metabolites) for critically ill patients suffering from the side effects of cancer immune therapy and COVID-19 infections. The platform confines antibody-conjugated beads into an array of a large number of femtoliter-sized microwells on a microfluidic chip, each forming a fluorescent pixel turned on when the target analyte is bound. The highly localized confinement of antibody-antigen immune complex formation within such a small volume enables single-molecule detection of individual analyte binding events. The technique counts the number of fluorescence signal-activated pixels from a snapshot image of the entire microwell array taken for highly pre-equilibrated analyte binding events. As a result, the platform achieves high testing speed, high sensitivity, and potentially lower instrumentation cost than current systems.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.