Rapid Diagnostics for Category B Enteropathogens

B 类肠道病原体的快速诊断

• 批准号: 6695791
• 负责人: William A Petri
• 金额: $ 45.42万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-30 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6695791
• 关键词: biohazard detection; bioterrorism /chemical warfare; clinical research; communicable disease diagnosis; cooperative study; diagnosis design /evaluation; enteric bacteria; human subject; rapid diagnosis

DESCRIPTION (provided by applicant): This project is based on a unique decade-Iong University-Industry partnership in the development and production of stool diagnostic tests for enteric pathogens. Our goal is to produce rapid, sensitive, specific and cost-effective diagnostics appropriate for public health laboratories and point-of-care use for the highest priority Category B enteropathogens. Our hypothesis is that real-time multiplex PCR is the future of enteropathogen diagnostic tests for public health laboratories and that dipstick-formatted antigen detection tests are ideally suited for point-of-care use. Preliminary studies by the Program Investigators have resulted in FDA 510k-approved stool antigen detection tests for Category B agents Entamoeba, Giardia and Cryptosporidia. Project investigators have also pioneered methodology for DNA extraction from stool and therefore have the immediate capability to develop improved and cost-effective diagnostic tests for all 3 of the major biodefense Category B enteric protozoa threat agents. Project 1 will develop stool antigen detection dipstick tests for point-of-care diagnosis of Biodefense Category B Enteric Protozoa and Shiga toxin. Project 2 will develop real-time multiplex PCR using molecular beacons, FRET and/or Taqman probes for public health laboratory diagnosis of Biodefense Category B Enteropathogens. Project 3 will field validate the diagnostic tests produced by Projects 1 and 2 and will correlate protozoal genotype with virulence. The Laboratory Core will provide reagents, testing, and be the clearinghouse for obtaining, culturing and distributing Category B enteric parasites and bacteria for Projects 1-3. The Administrative Core will coordinate activities of the three projects, and facilitate scientific exchange and interactions of investigators. It will also provide administrative oversight and financial accountability. Successful completion of these studies will yield high throughput diagnostic tests that target multiple enteropathogens simultaneously in a single sample.

描述（由申请人提供）：该项目基于独特的十年IONG University-Industry合作伙伴关系，用于开发和生产肠道病原体的粪便诊断测试。我们的目标是生产适用于公共卫生实验室的快速，敏感，特定和具有成本效益的诊断，以及用于最高优先级的B肠病毒的服务点的使用点。我们的假设是，实时多重PCR是公共卫生实验室的肠病诊断测试的未来，并且理想地适合使用量强的抗原检测测试。该计划研究人员的初步研究导致了FDA 510K批准的粪便抗原检测测试，用于B类代理，贾第霉菌和隐孢子虫。项目调查人员还开创了从粪便中提取DNA的方法，因此具有直接的能力，可以为所有三种主要生物植物类型B肠道原生动物威胁者提供改进和具有成本效益的诊断测试。项目1将开发凳子抗原检测钉测试，以用于生物浮雕类别B肠性原生动物和志贺毒素的护理点诊断。项目2将使用分子信标，FRET和/或TAQMAN探测器进行实时多重PCR，用于Biodefense B类肠道病毒的公共卫生实验室诊断。项目3将现场验证项目1和2的诊断测试，并将原生动物基因型与毒力相关联。实验室核心将提供试剂，测试，并成为获得，培养和分发B肠寄生虫和项目1-3的细菌的交换所。行政核心将协调这三个项目的活动，并促进研究人员的科学交流和互动。它还将提供行政监督和财务责任。这些研究的成功完成将产生高通量诊断测试，该测试在单个样本中同时靶向多个肠病毒。