Point-of-Care Diagnostic Test for Entamoeba histolytica Cysts

描述（由申请人提供）：NIAID B类优先病原体溶组织内阿米巴是一种公共卫生威胁，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、男男性行为者和发展中国家儿童的腹泻原因，它是严重腹泻的前五大原因之一。由于其抗氯化和低感染剂量，它也对水和食物供应构成生物防御威胁。在这里，我们建议开发一种即时护理（POC）粪便抗原诊断试验。该项目的成功完成将产生第一个POC测试，可以在新鲜和固定福尔马林的标本中检测溶组织芽胞杆菌。研究人员：TechLab的Herbein博士是开发肠道诊断的专家；曾指导FDA批准贾第鞭毛虫和隐孢子虫的诊断，并担任多个I/II期SBIR/STTR项目的PI。弗吉尼亚大学的佩特里博士是阿米巴病临床和基础研究领域的国际领军人物，

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. PUBLIC HEALTH RELEVANCE: Entamoeba histolytica is a biodefense threat and an important cause of diarrhea in: (a) travelers to, and immigrants from, endemic areas; (b) in men who have sex with men; and (c) in children in the developing world. We propose to produce a "point-of-care" assay for amebiasis that is rapid and easy to use, and that specifically detects E. histolytica (and not the non-pathogen E. dispar) in both fresh and fixed stool specimens.]