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

基本信息

批准号：
7672002
负责人：
SHUQI CHEN
金额：
$ 31.38万
依托单位：
IQUUM, INC.
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-03-01 至 2009-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7672002
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 Figs - dietary Foundations Funding Goals Gold Government Guidelines H7N7 Health Personnel Healthcare Hospitals Human Resources Immunoassay In Vitro Infection Influenza 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 Operative Surgical Procedures Outcome Patients Performance Persons Phase Physicians&apos 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 flu transmission improved influenzavirus inhibitor/antagonist manufacturing process meetings novel nucleic acid detection nucleic acid purification pandemic disease pandemic influenza point of care product development public health relevance respiratory response sample collection seasonal influenza tool touchscreen viral RNA young adult

项目摘要

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（由申请人提供）：我们建议基于Iquum专有的实验室中的实验室（LIAT-Tube（LIAT））平台对流感病毒的快速护理核酸测试进行分析和临床性能研究。我们开发了LIAT“流感” Assay，它使用了季节性的季节性的季节性的季节性的季节性的季节性的季节性的季节性，并分化少于28分钟。利用LIAT“分析仪）LIAT流感测定可以使所有测试过程自动化，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。核酸测试，该项目将解决对敏感，特定和快速的流感测定法，这将使任何临床医生或一般医疗保健从业人员都能识别季节性的流感菌株，从而为公共卫生疾病监测提供了显着的价值，从而在该项目的I期中提供了临床临床的临时性ii，我们打算在多站点临床研究中进一步验证和验证该项目的结果。在不到28分钟的时间内，在急诊室等病人地点附近。该测定法将是第一个护理点核酸测试之一，从而推进体外分子诊断的状态。通过确定测定的分析和临床性能，该项目将解决快速，敏感，特定和易于使用的流感测定的关键需求，从而为公共卫生疾病监视和控制提供了重要价值。