Point-of-care diagnostic for amplification and detection of SARS-CoV-2 RNA

项目总结 严重急性呼吸综合征冠状病毒2(SARS-CoV-2)于2019年底出现，并迅速 传播到世界各地。我们建议开发一种诊断分析方法，它将显示低限度的 通过一种独特的病毒RNA扩增过程检测SARS-CoV-2。通过开发一种方法来浓缩病毒 在真核生物或细菌RNA上，我们可以降低检测下限，并潜在地降低 使用基于RT的诊断时观察到的假阳性和假阴性。因为这种方法是针对病毒的 一般的RNA，它将可用于其他人类单链RNA病毒病原体，如寨卡病毒或登革热。这个 小型企业创新研究(SBIR)第一阶段项目的更广泛影响/商业潜力将是 发展一种新的病毒RNA检测步骤，可用于检测SARS-CoV-2，也可检测其他单链RNA 病毒。通过使用等温方法来扩增病毒RNA，我们的设备将不再需要 昂贵的设备，这增加了检测的机会。拟议的工作将验证 酶对病毒RNA的作用，开发一种系统来提取和检测这些RNA，并降低检测 PoC或家庭诊断的限制。

PROJECT SUMMARY Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) emerged in late 2019 and has rapidly spread around the world. We propose the development of a diagnostic assay that will exhibit a low limit of detection of SARS-CoV-2 via a unique viral RNA amplification process. By developing a method to enrich viral RNAs over eukaryotic or bacterial RNAs we can lower the limit of detection and potentially reduce the level of false positives and negatives observed when using RT-based diagnostics. As this method is specific for viral RNA in general, it will can be used for other human ssRNA viral pathogens, such as Zika or Dengue. The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project will be the development of a new step in viral RNA detection, usable for detecting SARS-CoV-2, but also other ssRNA viruses. By using an isothermal approach to amplify viral RNA our device will eliminate the need for expensive equipment, which increases access to testing. The proposed work will validate the specificity of the enzyme toward viral RNAs, develop a system to extract and detect these RNAs, and lower the detection limit for POC or at-home diagnostics.