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

支持这一提议的关键概念洞察力是，检测最有可能传播SARS-CoV-2的个人对于缓解大流行和重新开放美国至关重要。我们的方法与大多数现有的核酸测试平台形成了有意识的对比，大多数现有的核酸测试平台都是从最大化检测灵敏度为目标的前提开始的。我们认为，争取最大限度的敏感性与当前对基于广泛人群的检测的需求不符，在公共卫生紧急情况下，核酸检测的设计应该是在最大数量的环境中以尽可能低的成本最大限度地检测与活病毒脱落相一致的高病毒载量的人数。为了实现这一点，我们将一种经过验证的超高速核酸提取方法与快速检测放大的核酸结合在一起，这种分析既可以在集中式参考实验室中大规模进行，也可以被护理点检测提供商使用。关键的实现技术是一种新的、但经过验证的核酸提取方法，该方法可靠、快速、容易地从各种类型的样本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，并在等温扩增后用简单的比色法进行检测。这两项技术结合在一起提供了一个测试平台，可以在集中式实验室和护理点使用没有专门培训的技术人员来支持测试/隔离/跟踪，以低成本实现每周数百万次的测试。

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.