Automated Near-Patient Molecular Diagnostics and Discrimination of Seasonal Infl

自动化近病人分子诊断和季节性流感判别

• 批准号: 8035394
• 负责人: SHUQI CHEN
• 金额: $ 84.86万
• 依托单位: IQUUM, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-01 至 2012-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8035394
• 关键词: Accident and Emergency department; Address; Adult; Biological Assay; Blood Circulation; Capital; Centers for Disease Control and Prevention (U.S.); Characteristics; Childhood; Clinical; Clinical Research; Confidentiality; Containment; Data; Data Analyses; Data Collection; Detection; Development; Devices; Diagnosis; Diagnostic; Diagnostic Errors; Diagnostic tests; Discrimination; Disease; Dose; Ensure; Enzymes; Evaluation; Excision; Foundations; Funding; Goals; Gold; Government; Guidelines; H7N7; Health; Health Personnel; Healthcare; Hospitals; Human Resources; Immunoassay; In Vitro; Infection; Influenza; Influenza A Virus, H5N1 Subtype; Influenza A virus; Influenza B virus; Information Systems; Label; Laboratories; Life; Manuals; Marketing; Methods; Molecular; Monitor; Multi-Institutional Clinical Trial; Nasal Lavage Fluid; National Institute of Allergy and Infectious Disease; Nose; Nucleic Acid Amplification Tests; Nucleic Acids; Outcome; Patients; Performance; Persons; Phase; Physicians' Offices; Population; Preparation; Process; Production; Protocols documentation; Public Health; Publishing; Qualifying; Quality Control; Readiness; Reagent; Reference Standards; Reporting; Reproducibility; Research; Resources; Reverse Transcriptase Polymerase Chain Reaction; Reverse Transcription; Safety; Sampling; Scanning; Site; Small Business Innovation Research Grant; Solid; Specimen; Swab; System; Technology; Test Result; Testing; Time; Training; Tube; Validation; Viral; Virus; Virus Diseases; base; clinical application; commercialization; cost; disorder prevention; flu transmission; improved; influenzavirus; inhibitor/antagonist; manufacturing process; meetings; novel; nucleic acid detection; nucleic acid purification; operation; pandemic disease; pandemic influenza; point of care; product development; respiratory; response; sample collection; seasonal influenza; tool; touchscreen; viral RNA; young adult

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.

描述（由申请方提供）：我们拟对基于IQuum专有试管实验室（Liat）平台的流感病毒快速床旁核酸检测进行分析和临床性能研究。我们开发了Liat”Influenza Assay，可在28分钟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 Influenza Assay自动化所有检测过程，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系统的易用性、生物防护和故障安全测试功能将允许真正的护理点应用。通过确定第一个近患者流感核酸检测的分析和临床性能，该项目将满足对灵敏、特异和快速流感检测的迫切需求，使任何临床医生或全科医生都能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。在本项目的I期，我们试图使用与临床样本中发现的病毒株相似的病毒株确定Liat Influenza Assay的分析性能特征。在II期，我们打算在多中心临床研究中进一步表征和验证该检测试剂盒。该项目的成果将实现流感防备的一个关键目标，并提供保障公共卫生所需的诊断工具。公共卫生相关性：Liat”Influenza Assay将使临床医生和全科医疗保健从业者能够在28分钟内在患者附近的关键场所（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病毒株。该检测将是首批即时核酸检测之一，从而推进了体外分子诊断的发展。通过确定该检测试剂盒的分析和临床性能，该项目将满足对快速、灵敏、特异和易于使用的流感检测试剂盒的迫切需求，为公共卫生疾病监测和控制提供重要价值。