SBIR Phase II: Hybrid DNA-Protein Quantification Platform for Point-of-Care Diagnosis

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is the creation of the first all-in-one automated diagnostic test for infections caused by Treponema pallidum at the point-of-care. This point-of-care diagnostic device is designed to accelerate pathogen detection in decentralized settings, significantly reducing the interval between testing and therapeutic intervention. This advancement may help lower rates of perinatal transmission and reduce the economic and clinical burden associated with delayed diagnosis. The platform's underlying technology is adaptable to other infectious agents, offering a scalable solution for rapid and accurate detection of high-impact bacterial and viral diseases. This Small Business Innovation Research (SBIR) Phase I project addresses the need for easier testing solutions to provide comprehensive diagnosis on-site with the patient. This project will combine two antibody tests including quantitative Rapid Plasma Reagin (RPR) into an automated cartridge for rapid and complete diagnosis at the point-of-care. The research proposed in this project will develop magnetic particle-enabled assays for each antibody test and integrate the assays into a multiplexed plastic cartridge. These cartridges, combined with a portable instrument, will enable all steps required for diagnosis of infections caused by Treponema pallidum to be completed within minutes in an affordable and easy-to-use format. 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.