HT-Film-Array: a system to assess respiratory viruses with emphasis on influenza

HT-Film-Array：评估呼吸道病毒（重点关注流感）的系统

• 批准号: 7480312
• 负责人: Steven F Dobrowolski
• 金额: $ 172.91万
• 依托单位: BIOFIRE DEFENSE, LLC.
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-08-15 至 2012-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7480312
• 关键词: Adult; Animals; Apple; Biochemical; Biological Assay; Chemistry; Child; Childhood; Clinical; Communication; Computer software; Coupling; Data; Data Analyses; Data Set; Diagnosis; Diagnostic; Disease Outbreaks; Epidemic; Evaluation; Familiarity; Film; Future; Genes; Genotype; Haemophilus influenzae; Healthcare; Healthcare Systems; Hospitals; Human; Infection; Influenza; Influenza A Virus, H5N1 Subtype; Influenza Hemagglutinin; Institution; Internet; Laboratories; Location; Measures; Medical Research; Medical center; Monitor; Movement; Nested PCR; Nucleic Acids; Numbers; Online Systems; Patients; Plastics; Polymerase Chain Reaction; Preparation; Procedures; Process; Public Health; Research Personnel; Resolution; Respiratory Tract Infections; Reverse Transcriptase Polymerase Chain Reaction; Reverse Transcription; Running; Sampling; Secure; Series; Shapes; Specimen; Staging; Standards of Weights and Measures; Symptoms; System; Technology; Temperature; Time; Treatment Protocols; Universities; Utah; Viral Physiology; Virus; base; data mining; influenza outbreak; instrument; instrumentation; melting; pandemic disease; pandemic influenza; programs; respiratory virus; response; software development; sound; tool

DESCRIPTION (provided by applicant): Pandemic strains of influenza have arisen in the past and will unquestionably arise in the future. Numerous respiratory viruses, including common influenza strains and pandemic strains, present with essentially identical generalized symptoms. A public health and clinical concern is distinguishing between patients infected with pandemic influenza or a common respiratory virus, to do so requires a sensitive diagnostic system. HT-FilmArray technology provides a dense format to concurrently assay for a panel of respiratory viruses including influenza but to also characterize the influenza H and N genes to differentiate strains (e.g. H5N1). HT-FilmArray employs a plastic disposable in which is performed a seamless progression of biochemical manipulations including: nucleic acid preparation, reverse transcription, PCR using a 2-stage nested multiplex process, and confirmation of product identity by high-resolution melt profiling. Nested PCR while exquisitely sensitive, has seen limited use as it is prone to amplicon contamination. HT-FilmArray contains the nested procedure such that its greatest strength (sensitivity) is realized while its greatest weakness (amplicon contamination) is eliminated. High-resolution melt profiling is used to confirm positive results. Melt profiling rapidly determines curve shape and melting temperature as a 2nd tier analysis to re-enforce positive results and to eliminate false positive results. In a pandemic scenario, communication between laboratories will enable clinicians to better diagnose patients and provide public health officials information to take steps that will contain the outbreak. Proposed is a software module allowing HT- FilmArray users, even in geographically remote locations, to communicate and share data over a secure internet connection. This data sharing module will enable privileged users to view runs in real-time from remote locations and for independent data sets to be shared and analyzed together. A data mining module will allow results to be analyzed together and provide a flexible format for data comparison. Data sharing/data mining will allow public health officials to monitor viral activity using data from multiple distantly located HT-FilmArray instruments and based upon the data make sound decisions to contain an outbreak. While this proposal is focused upon influenza, HT-FilmArray will be equally useful as a standard tool to assess patients during yearly respiratory virus epidemics.

描述（由申请人提供）：流行性流感病毒株在过去已经出现，并且毫无疑问将来也会出现。许多呼吸道病毒，包括常见流感病毒株和大流行病毒株，都表现出基本相同的普遍症状。公共卫生和临床关注的问题是区分感染大流行性流感或普通呼吸道病毒的患者，为此需要灵敏的诊断系统。 HT-FilmArray 技术提供了一种密集格式，可以同时检测包括流感在内的一组呼吸道病毒，还可以表征流感 H 和 N 基因以区分毒株（例如 H5N1）。 HT-FilmArray 采用一次性塑料，可在其中执行无缝的生化操作，包括：核酸制备、反转录、使用两阶段嵌套多重过程的 PCR，以及通过高分辨率熔解分析确认产品身份。巢式 PCR 虽然极其灵敏，但由于容易受到扩增子污染，其用途受到限制。 HT-FilmArray 包含嵌套程序，可实现其最大优势（灵敏度），同时消除其最大弱点（扩增子污染）。高分辨率熔体分析用于确认阳性结果。作为第二层分析，熔体分析可快速确定曲线形状和熔体温度，以强化阳性结果并消除假阳性结果。在大流行情况下，实验室之间的通信将使临床医生能够更好地诊断患者，并向公共卫生官员提供信息以采取措施控制疫情。所提出的软件模块允许 HT-FilmArray 用户，即使在地理位置遥远的地方，也可以通过安全的互联网连接进行通信和共享数据。该数据共享模块将使特权用户能够从远程位置实时查看运行情况，并共享和分析独立的数据集。数据挖掘模块将允许对结果进行一起分析，并提供灵活的数据比较格式。数据共享/数据挖掘将使公共卫生官员能够使用来自多个远程 HT-FilmArray 仪器的数据来监测病毒活动，并根据这些数据做出明智的决策来遏制疫情。虽然该提案的重点是流感，但 HT-FilmArray 作为评估每年呼吸道病毒流行期间患者的标准工具同样有用。