Rapid Point of Care Diagnostic Assay for Pandemic Influenza

描述（由申请人提供）：项目摘要我们建议开发一种Liat（tm）禽流感检测试剂盒，能够在不到25分钟的时间内特异性检测和区分潜在的大流行性禽流感A/H5、A/H7和A/H9。我们亦将开发高通量Liat工作站，并提升我们的一次性生产系统，以应付流感大流行期间极高的病人负荷的挑战。我们将使用流感病毒株进一步确定分析灵敏度和特异性。我们将进一步制定流感生物标志物监测和生产加速的计划，以确保大流行的准备。由此产生的Liat Avian Influenza Assay不仅将为美国提供高通量，灵活和即时检测的检测方法，用于快速识别和跟踪潜在的人类大流行性禽流感爆发，而且还提供了一种广谱技术，可以快速掺入新出现的大流行性流感毒株。Liat系统的简单性和无错误测试功能也可以使Liat禽流感检测试剂盒成为第一个CLIA豁免的核酸测试，这代表了生物样本测试和临床诊断的重大进步。相关性（参见说明）：Liat禽流感检测试剂盒将是第一个能够在25分钟内在急诊室或其他患者附近检测和分型潜在大流行性禽流感的核酸检测。该检测也将是首批即时核酸检测之一，从而推进体外分子诊断的发展。通过解决对快速、灵敏、特异和易于使用的流感检测的迫切需求，该项目将为公共卫生疾病监测和控制提供重要价值。

DESCRIPTION (provided by applicant): Project summary We propose to develop a Liat(tm) Avian Influenza Assay to enable the specific detection and differentiation of potential pandemic avian influenza A/H5, A/H7 and A/H9 in less than 25 minutes. We will also develop a high throughput Liat Workstation and upgrade our disposable manufacturing systems to meet the challenge of extremely high patient loads during pandemic influenza outbreaks. We will further determine analytical sensitivity and specificity of the assay using influenza viral strains. We will further develop plans for influenza biomarker surveillance and production ramp-up to ensure pandemic preparedness. The resulting Liat Avian Influenza Assay will not only provide the US with a high-throughput, flexible and point-of-care assay for quickly identifying and tracking potential human pandemic outbreaks of avian influenza, but offer a broad spectrum technology that may allow for rapid incorporation of emerging pandemic influenza strains. The simplicity and error free testing features of the Liat system may also qualify the Liat Avian Influenza Assay as the first CLIA-waived nucleic acid test, which represents a significant advancement in biological sample testing and clinical diagnostics. RELEVANCE (See instructions): The Liat Avian Influenza Assay will be the first nucleic acid test that will be capable of detecting and subtyping potentially pandemic avian influenza in emergency rooms or other near patient sites in less than 25 minutes. The assay will also be among the first point-of-care nucleic acid tests, thus advancing the state of in vitro molecular diagnostics. By addressing the critical need for a rapid, sensitive, specific, and easy-to-use influenza assay, this project will provide significant value to public health disease surveillance and control.