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，尚未开发出能够在30分钟内直接在需要时以高置信度准确诊断常见呼吸道病毒的测试产品。我们建议开发一种创新的设备和试剂，用于多种RNA病原体的分子诊断，这将为快速患者护理设定新的标准。该题为“呼吸道病毒的护理点检测”的申请寻求开发用于流感病毒A和B的处理、检测和数字读出的交钥匙解决方案， 以及呼吸道合胞病毒（RSV）。对操作设备的人员的培训要求最低。新的分子技术、简单的方案和驻留在单个廉价设备中的可负担得起的多重检测能力的组合将使得能够对许多严重的传染性病原体进行近点护理诊断。实现这一目标的研究设计包括四个处理要素：1）可在一分钟内完成的一步样品制备，2）在20分钟内进行病毒RNA的等温扩增，3）在几分钟内进行甲型流感病毒、乙型流感病毒B和RSV的多重序列特异性检测，包括内置标准品，以及4）以电子形式数字读出结果。所有这些步骤 发生在包含一次性试剂盒的小的4 × 6英寸仪器内。使这项改变游戏规则的技术成为可能的一个关键因素是开发了一种新型酶，可以将RNA转化为DNA，并在几分钟内等温扩增。这些属性允许设计不使用任何微流体、泵或阀的装置。大大简化的结构大大降低了成本。这项新技术是低资源和战场环境的理想选择，并具有作为非处方设备的长期潜力。作为本申请的一部分开发的试验器械和试剂将在临床环境中由外部专家进行确认。在项目的第三阶段，我们将申请FDA对仪器和试剂的许可，并在美国和地球仪的其他市场销售诊断设备。

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.