SBIR Phase I: Modular, Paper-based, Secured Diagnostics for Managing Viral Outbreaks (COVID-19)

The broader impact of this Small Business Innovation Research (SBIR) Phase I Project is a cost-effective way to manage and track viral outbreaks in animal, human, and plant populations, including tracking for situations like the COVID-19 pandemic. It overcomes the challenges of current viral screening methods, namely PPE required for collecting samples, handling of samples to centralized analytic sites, cost of tests, and reliance on limited reagents. The platform proposed in this project could be used on-site at an animal production facility or at home. The scanner can be placed at many municipal and commercial locations (e.g., drug stores) or the envelope can be conveniently mailed for assessment. The dual read modality gives timely feedback to the client, as well as the capability for anonymous aggregation of readout data - essential for real-time tracking of viral outbreak and informing resource allocation to mitigate spread. This diagnostic platform would generate impact, allowing: 1) animal producers to mitigate virus spread and reduce loss and 2) businesses, schools, and other organizations to make real-time data-driven decisions on closures and health policies. The proposed project focuses on assessing technical feasibility of three critical elements of a diagnostic platform: (1) the ability to couple isothermal RNA amplification directly to cell-free extract using custom formulations, to simplify usability (eliminate current off-card amplification with commercial kits) and reduce cost; (2) Production of a scalable and efficient cell-free extract well-suited for amplification of reporter proteins by RNA circuits to increase the rate of protein production and reduced RNA degradation. The performance of this extract will inform the time to result as well as the cost of card, necessary metrics for translation; and (3) production of new toehold riboregulators (2 to 3) selective to virus targets relevant to the animal industry (e.g., swine flu, porcine respiratory). These will also inform the limits of detection. This project will evaluate the feasibility of such as system. 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.