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我们建议建立一种快速(不到20分钟)的护理点(PoC)逆转录环介导的扩增(RT-LAMP)检测方法，用于从人的鼻拭子、口腔拭子和唾液样本中检测SARS COV-2病毒。我们的SARS-CoV2 RT-LAMP检测将在我们的新型Dx系统上实现，该系统包括一个易于使用、价格实惠的超便携仪器，该仪器可以对一个独立的、一次性的、特定于检测的试剂盒执行全自动核酸扩增测试(NAAT)。这种检测方法的开发将使SARS CoV-2检测能够在没有实验室的医疗保健环境中进行，例如CLIA豁免的诊所和医生办公室，以及在办公室、零售中心、机场和家庭等非医疗保健环境中进行。除了在我们的NovelDx仪器/试剂盒系统上开发和实施SARS COV-2 RT-LAMP检测，用于护理点和无实验室设置，开发的LAMP检测本身将作为中高通量SARS-CoV-2检测解决方案在实验室实施。这样做将极大地提高美国的SARS-CoV-2检测能力和可及性，使其能够在基础实验室中进行快速、高度敏感和特定的等温分子测试，而这些实验室不具备典型的基于聚合酶链式反应热循环的核酸分析设备。对新型Dx SARS-CoV-2测试的分析和临床研究将根据FDA的紧急使用授权(EUA)指南进行，以获得使用授权。随后，我们的目标是建立一种检测和鉴别流感和新冠肺炎感染的多重流感-A/流感-B/SARS-CoV-2方法。我们计划提交一份双重510(K)和CLIA豁免申请，向美国医疗机构销售新型Dx Flu-A/Flu-B/SARS-CoV-2检测。

We propose to develop a rapid (under 20-minute), point-of-care (PoC) Reverse Transcriptase Loop-mediated Amplification (RT-LAMP) test for the detection of SARS COV-2 virus from human nasal and oral swab and saliva samples. Our SARS-CoV2 RT-LAMP assay will be implemented on our Novel Dx system which comprises an easy-to-use, affordable, ultraportable instrument that performs a fully-automated nucleic acid amplification test (NAAT) on a self-contained, disposable, test-specific cartridge. Development of this assay will enable SARS CoV-2 testing to be performed in lab-free healthcare settings such as CLIA-waived clinics and physician offices as well as in non-healthcare settings including offices, retail centers, airports and homes. In addition to the development and implementation of a SARS COV-2 RT-LAMP assay on our NovelDx instrument/cartridge system for point-of-care and lab-free settings, the developed LAMP assay will itself be made available for implementation in labs as a mid-to-high throughput SARS-CoV-2 testing solution. Doing so will greatly increase U.S. capacity for and accessibility to SARS-CoV-2 testing by enabling rapid, highly sensitive and specific isothermal molecular tests to be performed in basic laboratories not otherwise equipped for typical PCR thermocycling-based nucleic acid analyses. Analytical and Clinical Studies on the Novel Dx SARS-CoV-2 test will be performed as per the FDA Emergency Use Authorization (EUA) Guidance, to obtain use authorization. Subsequently we aim to develop a multiplex Flu-A/Flu-B/SARS-CoV-2 assay to detect and differentiate between Influenza and COVID-19 infections. We plan to submit a dual 510(k) and CLIA waiver application for marketing the Novel Dx Flu-A/Flu-B/SARS-CoV-2 test to US healthcare facilities.