STTR Phase I: Advanced Microfluidic Devices for Point-of-Care COVID-19 Serological Testing

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase I project may reach millions of people and provide a key tool in safeguarding the public health through the COVID-19 pandemic. Sensitive, selective and quantitative detection usually requires complex laboratory-based methods and instrumentation to achieve consistent results; however, this project advances technologies to simplify the process. Antibody testing provides information regarding previous infections; a simple tool to detect presence at low concentrations enables better testing to manage social distancing needs. The proposed technology aims to make blood testing for SARS-Cov-2 simple and quantitative for two types of antibodies. The device will be developed to take patient samples directly with no complicated sample prep. Unique reagents will be created for selective detection of the SARS-CoV-2 antibodies. This Small Business Technology Transfer (STTR) Phase I project aims to develop the next generation of low-cost point of care immunoassay technology with direct application to infectious disease detection. The technology proposed here combines a new approach to controlling capillary flow driven systems applied to the steps of a traditional ELISA in a disposable device. The device developed in this project will detect SARSCoV-2 specific antibodies in patient samples, and will be able to provide information about the phase of the immune response of a patient. Additionally, adaption of ELISA-like enzymatic amplification into a point-of-care device will provide greater sensitivity and selectivity than traditional lateral flow assays, increasing assay sensitivity and improving detection of early infections. The immunoassays will be evaluated with deidentified patient samples and compared to state of the art laboratory-based detection methods. 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.