Automated Near-Patient Molecular Diagnostics and Discrimination of Seasonal Infl

描述（由申请人提供）：我们建议基于IQuum专有的试管实验室（Liat）平台对流感病毒的快速即时护理核酸检测进行分析和临床性能研究。我们开发了Liat“流感检测”，可在不到28分钟的时间内使用鼻咽拭子样本检测并区分季节性流感和潜在的新型非季节性甲型流感病毒。利用Liat“分析仪，Liat流感分析自动化所有测试过程，包括样品制备，核酸纯化，逆转录酶聚合酶链反应（RT-PCR）和实时检测。Liat系统的易于使用，生物控制和故障安全测试功能将允许真正的护理点应用。通过确定第一个近病人流感核酸检测的分析和临床表现，该项目将解决对敏感、特异性和快速流感检测的迫切需求，使任何临床医生或普通保健医生能够识别季节性流感毒株，从而为公共卫生疾病监测和控制提供重要价值。在该项目的第一阶段，我们试图使用与临床样本中发现的病毒株相似的病毒株来建立Liat流感检测的分析性能特征。在II期，我们打算在一项多地点临床研究中进一步表征和验证该检测方法。这一项目的成果将实现防范流感的一项关键目标，并提供保障公众健康所需的诊断工具。公共卫生相关性：Liat流感检测将使临床医生和普通保健医生能够在不到28分钟的时间内，在关键的靠近患者地点（如急诊室）检测和区分季节性流感和潜在的新型非季节性甲型流感毒株。该检测将成为首批即时核酸检测之一，从而提高体外分子诊断的水平。通过确定该检测方法的分析和临床性能，该项目将满足对快速、敏感、特异和易于使用的流感检测方法的迫切需求，为公共卫生疾病监测和控制提供重要价值。

DESCRIPTION (provided by applicant): We propose to perform analytical and clinical performance studies on a rapid point-of-care nucleic acid test for influenza virus based on IQuum's proprietary lab-in-a-tube (Liat") platform. We have developed the Liat" Influenza Assay, which detects and differentiates seasonal influenzas from potentially novel non- seasonal influenza A viruses using nasopharyngeal swab samples in less than 28 minutes. Utilizing the Liat" Analyzer, the Liat Influenza Assay automates all testing processes, including sample preparation, nucleic acid purification, reverse transcriptase polymerase chain reaction (RT-PCR), and real-time detection. The ease-of- use, bio-containment and fail-safe testing features of the Liat system will allow true point-of-care application. By determining the analytical and clinical performance of the first near-patient influenza nucleic acid test, this project will address the critical need for a sensitive, specific and rapid influenza assay that will enable any clinician or general healthcare practitioner to identify seasonal influenza strains, thus providing significant value to public health disease surveillance and control. In Phase I of this project, we seek to establish the analytical performance characteristics of the Liat Influenza Assay using viral strains similar to those found in clinical samples. In Phase II, we intend to further characterize and validate the assay in a multi-site clinical study. The outcome of this project will fulfill a key goal of influenza preparedness and provide the diagnostic tools need to safeguard public health. PUBLIC HEALTH RELEVANCE: The Liat" Influenza Assay will allow clinicians and general healthcare practitioner to detect and discriminate seasonal influenzas from potentially novel non-seasonal influenza A strains at critical near patient sites, such as emergency rooms, in less than 28 minutes. The assay will be among the first point-of-care nucleic acid tests, thus advancing the state of in vitro molecular diagnostics. By determining the analytical and clinical performance of the assay, this project will address the critical need for a rapid, sensitive, specific, and easy-to-use influenza assay, providing significant value to public health disease surveillance and control.