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）：过去出现了流感的大流行菌株，将来毫无疑问会出现。许多呼吸道病毒，包括普通流感菌株和大流行菌株，具有基本相同的广义症状。公共卫生和临床问题是区分感染了大流行性流感或常见呼吸道病毒的患者需要敏感的诊断系统。 HT-FILMARRAY技术提供了一种密集的格式，可以同时分析包括流感在内的呼吸道病毒，但还表征了流感H和N基因以区分菌株（例如H5N1）。 HT-FILMARRAY采用塑料一次性，其中进行了生化操作的无缝进展，包括：使用2阶段嵌套的多路复用工艺进行核酸制备，逆转录，PCR，并通过高分辨率融化分析确认产品同一性。嵌套的PCR虽然非常敏感，但使用有限的用途，因为它容易受到扩增的污染。 HT-FILMARRAY包含嵌套程序，因此可以实现其最大的强度（灵敏度），而其最大的弱点（Amplicon污染）被消除。高分辨率熔体分析用于确认阳性结果。熔融分析迅速确定曲线形状和熔化温度作为第二层分析，以重新启动阳性结果并消除假阳性结果。在大流行的情况下，实验室之间的沟通将使临床医生能够更好地诊断患者，并提供公共卫生官员的信息，以采取措施，其中包含疫情。提议的是一个软件模块，即使在地理偏远的位置也可以通过安全的Internet连接进行通信和共享数据，允许HT-Filmaray用户进行交流和共享。此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，并以共享和分析的独立数据集。数据挖掘模块将允许将结果一起进行分析，并提供灵活的格式以进行数据比较。数据共享/数据挖掘将允许公共卫生官员使用来自多个位置的HT-FILMARRAY仪器的数据来监视病毒活动，并基于数据做出合理的决定以包含爆发。尽管该提案集中在流感上，但HT-Filmarray将同样有用作为评估年度呼吸道病毒流行病患者的标准工具。