SBIR Phase I: Rapid Antigen-based SERS assay for COVID-19 Detection (COVID-19)

The broader impact and commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to allow testing of potential COVID-19 patients using a rapid and highly accurate diagnostic test, particularly for patients who are asymptomatic. This will provide a significant advantage in “flattening the curve” of the number of cases by preventing these patients from inadvertently infecting their family and community members. Current protocols require days to return a result, creating problems for public health. This test, the first of many that can be produced using the underlying platform technology, would improve: 1) the ability to rapidly identify patients with active COVID-19 cases for expeditious clinical intervention, reducing transmission by that patient; and 2) outcomes because of the higher performance and accuracy. This Small Business Innovation Research (SBIR) Phase I project addresses the lack of rapid, accurate testing for COVID-19 in near patient settings. This effort will develop an infectious disease platform that combines: 1) DNA aptamers, a recognition element for target proteins; 2) surface enhanced Raman scattering (SERS), a vibrational spectroscopic detection method; 3) and orthogonal partial least squares differential analysis, a well-established statistical method often applied to vibrational spectroscopy-based analyses. By employing aptamers that target SARS-CoV-2 related proteins (e.g. the spike (S) protein), this assay is anticipated to identify the presence of this protein under 30 minutes after oro- or naso-pharyngeal sample is collected, and is ultimately expected to achieve >95% clinical sensitivity and specificity. 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.