Rapid Point of Care Diagnostic Assay for Pandemic Influenza

项目简介(由申请人提供)：项目摘要我们建议建立一种Liat(Tm)禽流感检测方法，以便在25分钟内具体检测和区分潜在的大流行性禽流感A/H5、A/H7和A/H9。我们还将开发一个高吞吐量的Liat工作站，并升级我们的一次性制造系统，以应对在大流行流感爆发期间患者负荷极高的挑战。我们将使用流感病毒株进一步确定该检测的分析敏感性和特异性。我们将进一步制定流感生物标志物监测和产量提升计划，以确保预防大流行。由此产生的Liat禽流感检测不仅将为美国提供一种高通量、灵活和护理点检测，以快速识别和跟踪潜在的人类大流行禽流感疫情，而且还将提供一种广谱技术，可能允许快速纳入新的大流行流感毒株。Liat系统的简单性和无差错测试特性也可能使Liat禽流感检测成为首个CLIA豁免的核酸测试，这代表着生物样本测试和临床诊断方面的重大进步。相关性(见说明)：Liat禽流感检测将是第一个能够在不到25分钟的时间内在急诊室或其他患者附近检测到潜在的大流行性禽流感并对其进行分型的核酸测试。该检测也将是第一批护理点核酸测试之一，从而推动体外分子诊断的状态。通过满足对快速、敏感、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.