A simple and rapid point-of-care (POC) test for SARS-CoV-2

目前迫切需要提高加拿大和其他地方对COVID-19（SARS-CoV-2）的诊断检测能力。然而，目前批准的测试，以及那些在管道中，遭受一个或多个缺陷，如关键的生物试剂的竞争，高假阴性率，成本，差的用户友好性，或在加拿大有限的可用性。此外，目前的测试方法依赖于使用拭子收集样本，然后将拭子运送到中央测试设施，这种方法受到很长时间延迟的困扰。该提案的目标是开发一种基于新型RNA处理方法和等温扩增技术的SARS-CoV-2快速即时检测方法，并与纸传感装置相结合。 该测试将利用一种新的DNAzyme从病毒中切除RNA，然后进行滚环扩增以扩增RNA并将输出转化为长DNA链。 DNA输出将在能够产生颜色变化的纸装置上富集，如果测试样品中存在病毒。 测试的简单性将允许它在家里，在机场或其他入境点，或在游轮上完成，并将允许在一个小时内“样本到答案”，而无需访问外部测试位置。这将减轻一线工作人员和集中实验室的负担，同时最大限度地减少潜在感染患者对社区的暴露。 此类检测还将使识别无症状携带者变得更加容易，将允许对潜在接触者进行更快速的检测，并最终有助于在早期阶段控制未来的疫情，从而减少采取物理距离措施所需的潜在时间。

There is presently an urgent need to increase the diagnostic testing capability for COVID-19 (SARS-CoV-2) in Canada and elsewhere. However, currently approved tests, as well as those in the pipeline, suffer from one or more deficiencies, such as competition for crucial biological reagents, high false-negative rates, cost, poor user-friendliness, or limited availability in Canada. In addition, current testing methods, which rely on sample collection using a swab, followed by the shipping of swabs to a central testing facility, are plagued by very long delays. The goal of this proposal is to develop a rapid point-of-care test for SARS-CoV-2 based on a novel RNA processing method and an isothermal amplification technique, coupled to a paper sensing device. The test will utilize a novel DNAzyme to excise RNA from the virus, followed by rolling circle amplification to amplify the RNA and convert the output to a long DNA strand. The DNA output will be enriched on a paper device that is capable of generating a color change if the virus is present in the test sample. The simplicity of the test will allow it to be done at home, in airports or other points-of-entry, or on cruise ships, and will allow "sample-to-answer" in under an hour, with no need to visit an external testing location. This will reduce the burden on front-line workers and centralized labs, while minimizing exposure of potentially infected patients to the community. Such tests will also make it easier to identify asymptomatic carriers, will allow for more rapid testing of potential contacts, and ultimately help to contain future outbreaks at an earlier stage, thus reducing the potential time needed for physical distancing measures.