RADX TECH 2375 - POINT OF NEED, SALIVA-BASED, COVID-19 TESTING PLATFORMS

The key conceptual insight underpinning this proposal is that detecting individuals who are most likely to transmit SARS-CoV-2 is essential to mitigating the pandemic and reopening America. Our approach consciously contrasts with most existing nucleic acid testing platforms, which begin from the premise that maximizing detection sensitivity is the goal. We argue that striving for maximum sensitivity is at odds with the current needs for broad population based testing and that in a public health emergency, nucleic acid testing should be designed to maximize the number of people who can be tested for high viral loads consistent with shedding of live virus, in the greatest number of settings, at the lowest possible cost. To achieve this we couple a proven, ultrafast nucleic acid extraction method with rapid detection of amplified nucleic acids in an assay that can be both massively scaled in centralized reference labs and also used by point-of-care testing providers. The key enabling technology is a new, but proven, nucleic acid extraction method that reliably, quickly, and easily extracts, purifies, and concentrates viral RNA from a variety of sample types including nasal swabs and saliva in a highly parallel format. RNA prepared using this extraction method can be reliably amplified and detected using a simple colorimetric assay following isothermal amplification. These two technologies combined provide a testing platform that can enable millions of tests a week, at low cost, in both centralized laboratories and at point-of-care using technicians with no specialized training to support test/isolate/trace.