SBIR Phase I: Single molecule detection of biomarkers using gold nanorods for in-vitro diagnostics

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The broader impact/commercial potential of this Small Business Innovation Research (SBIR) project is to develop a new diagnostic platform technology that is faster, more sensitive, and lower cost as compared with current diagnostic tests. Faster diagnostic results will improve hospital care by quickly and accurately isolating infectious patients and preventing co-infections. Current in-vitro diagnostic tests are, either, very sensitive, requiring significant infrastructure and technical expertise to perform, or, are quick and easy-to-use with poor predictive value. This SBIR project will enable a medical diagnostic platform that works with complex fluids (e.g., whole blood) to distinguish numerous pathogens and clinical biomarkers in a rapid time-frame without compromising on the predictive value. Combining a rapid test with improved sensitivity and an easy "sample-to-answer" method of operation fundamentally disrupts the two existing previously separate market capabilities for medical diagnostics. Additionally, the platform is being developed to be used in a sample-to-answer format so that it can be used in resource-limited settings, and near the point-of-care; for example, in West Africa for diagnosing Ebola virus. This technology addresses a significant market opportunity that is currently experiencing rapid growth.This SBIR Phase I project proposes to develop the use of gold nanorod tags for single molecule counting of biomarkers on an interferometric sensor surface. The use of nanorods with polarization enhancement will result in a 10-fold increase in signal over the use of spherical particles. This allows the use of a lower numerical aperture objective and reduces the imaging constraints because the depth of focus is in microns rather than nanometers. Another advantage as a result of increased signal from nanorods, is that it allows imaging of the sensor at lower magnification. The increase in the field of view enables imaging of entire assays without the need of motorized X-Y stages. The work potentially will result in a diagnostic platform with a significantly lower cost, dramatically reduced instrument size, fewer mechanical failures, and significantly improved acquisition speed. There are two primary objectives for the proposed work. The first is to optimize the use of gold nanorods for detection of protein and nucleic acid biomarkers. The second is to prototype and demonstrate a low-cost nanorod-based instrument. Completion of objectives will enable a path toward commercialization of the technology for in-vitro diagnostics.