RAPID ACCELERATION OF DIAGNOSTICS (RADX) PROGRAM: TECH PROJECT NO 2375 - MASSIVELY PARALLEL CENTRALIZED AND DECENTRALIZED ULTRAFAST COVID-19INFECTIOUS

支持这一提议的关键概念是，检测出最有可能传播SARS-CoV-2的个体对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，后者开始的前提是以最大化检测灵敏度为目标。我们认为，努力实现最大灵敏度与当前广泛人群检测的需求不一致，在突发公共卫生事件中，核酸检测的设计应在尽可能低的成本下，在尽可能多的环境中，最大限度地增加可以检测高病毒载量的人数，并与活病毒脱落一致。为了实现这一目标，我们将一种经过验证的超快核酸提取方法与快速检测扩增核酸的方法结合起来，这种方法既可以在集中参考实验室中大规模使用，也可以由即时检测提供者使用。关键的使能技术是一种新的，但经过验证的核酸提取方法，该方法可靠，快速，容易地从各种样本类型（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。使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测定法进行检测。这两种技术相结合提供了一个测试平台，可以在中心实验室和护理点使用未经专业培训的技术人员以低成本每周进行数百万次测试，以支持测试/隔离/跟踪。

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.