Point-of-care Diagnosis and Surveillance of Known and Emerging Influenza Viruses
已知和新出现的流感病毒的即时诊断和监测
基本信息
- 批准号:8820237
- 负责人:
- 金额:$ 108.37万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2014
- 资助国家:美国
- 起止时间:2014-03-15 至 2019-02-28
- 项目状态:已结题
- 来源:
- 关键词:Amino Acid MotifsAntigensArchivesBiologicalBiological AssayBirdsCategoriesCessation of lifeChildClassificationClinicalCollaborationsComplementary DNAComputer softwareConsensusCountryDatabasesDetectionDevelopmentDiagnosisDiagnosticDiscriminationElementsEpidemiologyFlu virusFundingGenesGenomeGenotypeGuidelinesHealthHemagglutininHumanHybridsInfluenzaInfluenza A Virus, H1N1 SubtypeInfluenza A Virus, H7N9 SubtypeInfluenza A virusInfluenza B VirusInfluenza HemagglutininLibrariesMeasuresMethodsMexicoMicrofluidicsModificationMolecularMolecular Diagnostic TestingMonitorNational Institute of Allergy and Infectious DiseaseNeuraminidaseNoseNucleotidesOligonucleotide PrimersPatient MonitoringPatientsPlasmidsPopulationProcessPropertyPublic HealthRNARecording of previous eventsResearch InstituteReverse TranscriptionRiskRosaSamplingSensitivity and SpecificitySpecimenSwabSymptomsSystemTechnologyTest ResultTestingTherapeuticUnited States National Institutes of HealthValidationVariantViralViral GenomeVirusWashingtonWorld Health Organizationbasecost effectivedesigndiagnostic assayenteric pathogenflugenome sequencingimprovedinfluenza outbreakinfluenza virus straininfluenzavirusinstrumentmeltingmortalitynext generation sequencingnovelnovel viruspandemic diseasepandemic influenzaperformance testspoint of carepoint-of-care diagnosticsprospectivepublic health interventionresearch clinical testingresearch studyrespiratoryswine fluvirus culturewild bird
项目摘要
DESCRIPTION (provided by applicant): Diligent global surveillance of influenza strains is a critical element of the U.S. National Strategy and the World Health Organization's (WHO) strategy for Pandemic Influenza. History has shown the need for rapid recognition of emerging viruses with pandemic potential. Current surveillance relies on slow virus culture, antigen recognition, or molecular assays that are designed to detect known circulating subtypes, although some assays may detect novel viruses as "untyped." Untyped viruses can be either single nucleotide variants or other variants of seasonal subtypes or novel reassortants with pandemic capabilities. The ability to easily and accurately identify and individually track these variants is lacking in current approaches. The objective of the proposal is the development of a field-deployable surveillance system that provides rapid and accurate detection and sequence recognition of current and emerging influenza strains that may present a serious risk to human populations. This system integrates Seattle Childrens Research Institute's (SCRI's) Consensus- Degenerate Hybrid Oligonucleotide Primer (CODEHOP)-based PCR and a fluorescent molecular beacon detection method on Micronics' advanced point-of-care (POC) microfluidics diagnostic platform, called the PanNAT". The integrated PanNAT Flu-CODEHOP system will expand and improve capabilities for in-field and near patient monitoring of influenza infections and emerging pandemics. This technology will detect and discriminate influenza hemagglutinin (HA) and neuraminidase (NA) subtypes and strains by means of CODEHOP-based PCR amplification and "sloppy" molecular beacon (SMB) fluorescent melt curve (Tm) signatures. The assay is incorporated into Micronics' PanNAT disposable cartridge, which is processed by the PanNAT instrument for sample-to-result point of information testing. Current influenza virus strains, both seasonal and pandemic, are identified by comparison with a library of known Tm signatures. Novel viruses resulting in new unique Tm signatures can be monitored for multiple occurrences and geographical spread. For novel viruses, the CODEHOP-derived PCR product contained in the PanNAT cartridge can be directly sequenced to identify the sequence tag corresponding to the new Tm signature. Virus in clinical samples identified with new Tm signatures can be completely sequenced via targeted Next-Gen sequencing, allowing a comprehensive analysis of its evolutionary and pathogenic properties guiding possible therapeutic approaches and other public health measures for the novel emerging strain. Specific aims and milestones include: the development and full integration of nasal swab extraction, cDNA conversion, and amplicon detection and discrimination in the PanNAT Flu-CODEHOP molecular assay (Aim 1); the completion of the PanNAT instrument and cartridges including instrument modification for melt curve analysis and analytical performance testing with standardized synthetic plasmids and clinical samples (Aim 2); and prospective testing of clinical samples and demonstration of substantial equivalence to predicate tests (Aim 3). The successful development of the Flu-CODEHOP assay will further validate the foundational technology of the PanNAT microfluidics POC diagnostic platform providing the basis for additional molecular diagnostic tests for a wide range of respiratory and enteric pathogens or other agents that pose a biological threat to humans.
描述(由申请人提供):对流感病毒株进行全球认真监测是美国国家战略和世界卫生组织 (WHO) 大流行性流感战略的关键要素。历史表明,需要快速识别具有大流行潜力的新兴病毒。目前的监测依赖于缓慢的病毒培养、抗原识别或旨在检测已知的循环亚型的分子测定,尽管一些测定可能会检测出“未分型”的新病毒。 非分型病毒可以是单核苷酸变体或季节性亚型的其他变体或具有大流行能力的新型重配体。当前的方法缺乏轻松、准确地识别和单独跟踪这些变体的能力。该提案的目标是开发一种可现场部署的监测系统,对可能对人类构成严重风险的当前和新出现的流感病毒株提供快速、准确的检测和序列识别。该系统集成了西雅图儿童研究所 (SCRI) 的基于共识的简并混合寡核苷酸引物 (CODEHOP) 的 PCR 和 Micronics 先进的护理点 (POC) 微流体诊断平台(称为 PanNAT)上的荧光分子信标检测方法。集成的 PanNAT Flu-CODEHOP 系统将扩展和提高现场和患者附近流感感染和新出现的流行病监测的能力。该技术将检测和区分流感。通过基于 CODEHOP 的 PCR 扩增和“草率”分子信标 (SMB) 荧光熔解曲线 (Tm) 特征,检测血凝素 (HA) 和神经氨酸酶 (NA) 亚型和菌株。该检测被纳入 Micronics 的 PanNAT 一次性试剂盒中。通过 PanNAT 仪器进行处理,进行从样本到结果的信息测试,通过与已知 Tm 特征库进行比较来识别当前的季节性和流行性流感病毒株。可以监控产生新的独特 Tm 特征的病毒的多次出现和地理传播。对于新型病毒,可以直接对 PanNAT 盒中包含的 CODEHOP 衍生 PCR 产物进行测序,以识别与新 Tm 签名相对应的序列标签。具有新Tm特征的临床样本中的病毒可以通过靶向下一代测序进行完整测序,从而可以对其进化和致病特性进行全面分析,从而指导针对这种新型病毒株的可能治疗方法和其他公共卫生措施。具体目标和里程碑包括:开发并全面整合鼻拭子提取、cDNA 转换以及 PanNAT Flu-CODEHOP 分子检测中的扩增子检测和区分(目标 1);完成 PanNAT 仪器和卡盒,包括用于熔解曲线分析和标准化合成质粒和临床样品分析性能测试的仪器改造(目标 2);临床样本的前瞻性测试并证明与谓词测试的实质等同性(目标 3)。 Flu-CODEHOP检测的成功开发将进一步验证PanNAT微流控POC诊断平台的基础技术,为针对各种呼吸道和肠道病原体或对人类构成生物威胁的其他病原体进行额外的分子诊断测试提供基础。
项目成果
期刊论文数量(0)
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会议论文数量(0)
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JOHN Charles GERDES其他文献
JOHN Charles GERDES的其他文献
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{{ truncateString('JOHN Charles GERDES', 18)}}的其他基金
Point-of-care Diagnosis and Surveillance of Known and Emerging Influenza Viruses
已知和新出现的流感病毒的即时诊断和监测
- 批准号:
8690899 - 财政年份:2014
- 资助金额:
$ 108.37万 - 项目类别:
POC molecular method for detection of known and emerging respiratory viruses.
用于检测已知和新出现的呼吸道病毒的 POC 分子方法。
- 批准号:
7743639 - 财政年份:2009
- 资助金额:
$ 108.37万 - 项目类别:
Rapid point of care HIV PCR diagnostic device
快速护理点 HIV PCR 诊断装置
- 批准号:
7495581 - 财政年份:2008
- 资助金额:
$ 108.37万 - 项目类别:
Microcytometer enrichment and detection of colon cancer*
结肠癌的微细胞计数富集和检测*
- 批准号:
7021339 - 财政年份:2006
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$ 108.37万 - 项目类别:
URINE-BASED POINT-OF-CARE CHLAMYDIA/GONORRHOEA TEST
基于尿液的护理点衣原体/淋病检测
- 批准号:
6529951 - 财政年份:1999
- 资助金额:
$ 108.37万 - 项目类别:
URINE-BASED POINT-OF-CARE CHLAMYDIA/GONORRHOEA TEST
基于尿液的护理点衣原体/淋病检测
- 批准号:
6405704 - 财政年份:1999
- 资助金额:
$ 108.37万 - 项目类别:
URINE BASED POINT OF CARE CHLAMYDIA / GC DIAGNOSTIC TEST
基于尿液的护理点衣原体/GC 诊断测试
- 批准号:
6015721 - 财政年份:1999
- 资助金额:
$ 108.37万 - 项目类别:
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Point-of-care Diagnosis and Surveillance of Known and Emerging Influenza Viruses
已知和新出现的流感病毒的即时诊断和监测
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8690899 - 财政年份:2014
- 资助金额:
$ 108.37万 - 项目类别: