Point-of-Care Diagnostic Test for Entamoeba histolytica Cysts

溶组织内阿米巴囊肿的护理点诊断测试

• 批准号: 8479312
• 负责人: Joel F Herbein
• 金额: $ 29.98万
• 依托单位: TECHLAB, INC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-06-04 至 2015-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8479312
• 关键词: Amebiasis; Antibodies; Antibody Formation; Antigens; Area; Bangladesh; Basic Science; Bedside Testings; Biological Assay; Businesses; Caring; Categories; Child; Chitinase; Clinical; Collaborations; Cryptosporidiosis; Cryptosporidium; Cyst; Detection; Development; Developmental Biology; Devices; Diagnostic; Diagnostic Reagent; Diagnostic tests; Diarrhea; Disease; Disease Outbreaks; Dose; Entamoeba; Entamoeba dispar; Entamoeba histolytica; Enteral; Environment; Enzyme-Linked Immunosorbent Assay; Escherichia coli; Evaluation; Event; FDA approved; Feces; Fluorescence; Food Supply; Formalin; Future; Giardia; Giardiasis; Goals; Hour; Human; Immigrant; Immunological Diagnosis; Institution; International; Investigation; Laboratories; Monoclonal Antibodies; Mus; National Institute of Allergy and Infectious Disease; Oryctolagus cuniculus; Outcome; Parasites; Phase; Production; Proteins; Protozoa; Public Health; Reagent; Research; Research Personnel; Resistance; Sampling; Small Business Innovation Research Grant; Small Business Technology Transfer Research; Specimen; System; Testing; Universities; Virginia; Water; Water Supply; Work; biodefense; chlorination; clinical practice; foodborne; improved; innovation; men who have sex with men; next generation; novel diagnostics; pathogen; point of care; point-of-care diagnostics; polyclonal antibody; protein E; prototype; rapid detection; success; tool

DESCRIPTION (provided by applicant): The NIAID Category B priority pathogen Entamoeba histolytica is a public health threat, especially as a cause of diarrhea in travelers to and immigrants from endemic areas, men who have sex with men, and children in the developing world where it is in the top 5 causes of severe diarrhea. It is also a biodefense threat to water and food supplies due to its resistance to chlorination and low infectious dose. Here we propose to develop a point-of-care (POC) fecal antigen diagnostic test. Successful completion of the project will produce the first POC test that detects E. histolytica in both fresh and formalin-fixe specimens]. Investigators: Dr. Herbein at TechLab is an expert in developing enteric diagnostics; having directed the FDA- clearance of diagnostics for Giardia and Cryptosporidia and having served as the PI for multiple Phase I/II SBIR/STTR projects. Dr. Petri at the University of Virginia is an international leader in clinical and basic investigation of amebiasis, and in collaboration with TechLab has developed the only FDA 510(k)-cleared diagnostic test for E. histolytica. [Innovation: Innovative aspects include: (1) development and manufacture of a POC test for amebiasis that can be multiplexed with that of other category B enteric parasites; and (2) production of the first diagnostic test for E. histolytica detection in both fresh and formalin-fixed samples]. [Approach: The following two Specific Aims are proposed to accomplish our goal of a new diagnostic test for amebiasis: 1) Produce monoclonal and polyclonal antibodies against the highly abundant "Jacob" protein of the E. histolytica cyst. 2) Apply these antibodies to produce a POC test for E. histolytica]. Environment: The proposal builds on the longstanding partnership of Dr. Petri at the University of Virginia with Dr. Herbein of TechLab, Inc. for amebiasis diagnostic test development. These two institutions are importantly only two hours apart and that have worked together successfully for over a decade.

描述（由申请人提供）：NIAID B 类优先病原体溶组织内阿米巴对公共健康构成威胁，特别是作为前往流行地区的旅行者和来自流行地区的移民、男男性行为者以及发展中国家儿童的腹泻原因，它是发展中国家严重腹泻的 5 大原因之一。由于其耐氯化性和低感染剂量，它也是对水和食品供应的生物防御威胁。在这里，我们建议开发一种即时护理 (POC) 粪便抗原诊断测试。该项目的成功完成将产生第一个在新鲜和福尔马林固定样本中检测溶组织内阿米巴的 POC 测试]。研究人员：TechLab 的 Herbein 博士是开发肠道诊断的专家；指导 FDA 批准贾第鞭毛虫和隐孢子虫诊断，并担任多个 I/II 期 SBIR/STTR 项目的 PI。弗吉尼亚大学的 Petri 博士是阿米巴病临床和基础研究领域的国际领先者， 并与 TechLab 合作开发了唯一获得 FDA 510(k) 批准的溶组织内阿米巴诊断测试。 [创新：创新方面包括：（1）开发和制造可与其他B类肠道寄生虫多重检测的阿米巴病POC测试； (2) 首次在新鲜样品和福尔马林固定样品中进行溶组织内阿米巴检测诊断测试]。 [方法：提出以下两个具体目标来实现我们对阿米巴病进行新的诊断测试的目标：1) 产生针对溶组织阿米巴囊肿的高丰度“Jacob”蛋白的单克隆和多克隆抗体。 2) 应用这些抗体对溶组织内阿米巴进行 POC 测试]。环境：该提案建立在弗吉尼亚大学 Petri 博士与 TechLab, Inc. 的 Herbein 博士在阿米巴病诊断测试开发方面的长期合作伙伴关系的基础上。重要的是，这两个机构相距仅两个小时，并且已经成功合作了十多年。