Point of Care Detection of Respiratory Viruses

描述（由申请人提供）：呼吸道感染在全球范围内对健康和经济产生重大影响。目前用于诊断呼吸道病毒感染（如流感）的检测产品不足以及时诊断成功实施抗病毒治疗所需的疾病。不幸的是，目前还没有开发出一种能够在30分钟内直接在需要的地方准确诊断出常见呼吸道病毒的测试产品。我们建议开发一种用于多种RNA病原体分子诊断的创新设备和试剂，这将为快速患者护理树立新的标准。这一名为“呼吸道病毒即时检测”的应用程序旨在开发一种处理、检测和数字读出甲型和乙型流感病毒的全套解决方案。

DESCRIPTION (provided by applicant): Respiratory infections have a significant health and economic impact worldwide. Current test products for the diagnosis of respiratory viral infections such as influenza are inadequate for the timely diagnosis needed for successful implementation of antiviral treatment. Unfortunately a test product that can accurately diagnose common respiratory viruses with high confidence in less than 30 minutes directly at point of need has not yet been developed. We propose to develop an innovative device and reagents for the molecular diagnosis of multiple RNA pathogens that will set a new standard for rapid patient care. This application entitled "Point of Care Detection of Respiratory Viruses" seeks to develop a turnkey solution for the processing, detection, and digital readout of influenza viruses A and B, as well as respiratory syncytial virus (RSV) in 30 minutes. Training requirements for personnel operating the device are minimal. The combination of novel molecular technologies, simple protocol, and affordable multiplex testing capabilities residing in a single, inexpensive device wil enable near point of care diagnostics for a number of serious infectious agents. The research design for achieving this goal includes four processing elements: 1) A one step sample prep that can be completed in a minute, 2) Isothermal amplification of viral RNA in 20 minutes, 3) multiplex sequence specific detection of influenza A, influenza B and RSV including built in standards in a few minutes, and 4) a digital readout of results in electronic form. These steps all occur within a small 4 x 6 inch instrument containing a disposable reagent cartridge. A key factor enabling this game changing technology is the development of a novel enzyme that converts RNA to DNA and isothermally amplifies it in minutes. These attributes have allowed the design of a device that does not use any microfluidics, pumps or valves. The greatly simplified construction significantly reduces the cost. This new technology is ideal for to low resource and battlefield settings, and has long term potential as an over the counter device. The test device and reagents developed as part of this application will be validated in a clinical setting with outside experts. During Phase III of the project we will apply for FDA clearance of the instrument and reagents and commercialize the diagnostic device in the US and other markets around the globe.