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我们建议开发一种快速（20分钟内），即时（POINT OF CARE）逆转录酶环介导扩增（RT-LAMP）检测SARS COV-2病毒从人类鼻腔和口腔拭子和唾液样本。我们的SARS-CoV 2 RT-LAMP检测将在我们的Novel Dx系统上实施，该系统包括一种易于使用、价格合理、超便携的仪器，可在一个独立的一次性测试专用盒上进行全自动核酸扩增测试（NAAT）。 该检测方法的开发将使SARS CoV-2检测能够在无实验室的医疗环境中进行，如CLIA豁免的诊所和医生办公室，以及在非医疗环境中进行，包括办公室，零售中心，机场和家庭。除了在我们的NovelDx仪器/检测盒系统上开发和实施SARS COV-2 RT-LAMP检测外，还将开发的LAMP检测本身作为中高通量SARS-CoV-2检测解决方案在实验室中实施。 这样做将大大提高美国SARS-CoV-2检测的能力和可及性，使快速，高灵敏度和特异性的等温分子检测能够在基本实验室进行，否则将无法进行典型的PCR热循环核酸分析。将根据FDA紧急使用授权（EUA）指南对Novel Dx SARS-CoV-2检测进行分析和临床研究，以获得使用授权。随后，我们的目标是开发多重Flu-A/Flu-B/SARS-CoV-2检测试剂盒，以检测和区分流感和COVID-19感染。我们计划向美国医疗机构提交Novel Dx Flu-A/Flu-B/SARS-CoV-2检测试剂盒的双重510（k）和CLIA豁免申请。

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.