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

支撑这一提议的关键概念是，检测最有可能传播SARS-CoV-2的个体对于缓解大流行和重新开放美国至关重要。我们的方法有意识地与大多数现有的核酸检测平台形成对比，这些平台以最大限度地提高检测灵敏度为前提。我们认为，追求最大的灵敏度与当前广泛人群检测的需求不一致，在公共卫生紧急情况下，核酸检测的设计应以尽可能低的成本，在尽可能多的环境中，最大限度地增加可以检测与活病毒脱落一致的高病毒载量的人数。为了实现这一目标，我们将一种经过验证的超快速核酸提取方法与扩增核酸的快速检测相结合，该方法既可以在集中参考实验室大规模扩展，也可以在护理点检测提供者中使用。关键的使能技术是一种新的，但经过验证的核酸提取方法，可以可靠，快速，轻松地从各种样品类型（包括鼻拭子和唾液）中以高度平行的形式提取，纯化和浓缩病毒RNA。用这种提取方法制备的RNA可以可靠地扩增，并在等温扩增后使用简单的比色法检测。这两种技术结合起来提供了一个测试平台，可以在集中实验室和护理点使用没有经过专门培训的技术人员支持测试/隔离/跟踪，以低成本每周进行数百万次测试。

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.