Abstract

Rapid Sensitive and Simple NAAT Self-testing for SARS-CoV-2 with Paper-based Microfluidics

Paul Yager, Professor/Vice Chair, University of Washington

Whether to guide treatment of an individual’s infection, or to manage an ongoing pandemic, or to prevent the next one, there is an urgent need for low-cost rapid diagnostic devices capable of identifying the cause of infectious disease that work wherever the person is, not just in a centralized laboratory.  “Ubiquitous diagnostics” can bring the best diagnostic capabilities to homes, physicians’ office laboratories and pharmacies in the developed world, or to places in the developing world where nothing is available now.  We had been working to develop simple single-use instrument-free devices for nucleic acid amplification tests (NAATs) for the presence of respiratory diseases, Chlamydia and gonorrhea, Mycobacterium tuberculosis and HIV.  To enable these devices, we have created a suite of stand-alone or integrated sample-handling components that can process blood, urine or swabs.  With the outbreak of the COVID-19 pandemic, we have pivoted to detection of the SARS-CoV-2 virus to address the unmet need for self-testing in the home at sensitivity levels that would allow detection of presymptomatic cases.  We will show recent progress in reducing such processes to a few user-friendly steps appropriate for untrained users.  We have established UbiDX to commercialize the SARS-CoV-2 test and multiplexed panels of pathogens for use in self-testing in a variety of scenarios.