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，特别是作为引起严重腹泻的前五大原因之一的腹泻的原因是来自流行地区的旅行者和移民、男男性行为者和发展中国家的儿童。由于其耐氯化和低感染量，它也是对水和食物供应的生物防御威胁。在这里，我们建议开发一种护理点(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，在新鲜标本和福尔马林固定标本中都能检测到溶解组织肠杆菌)。研究人员：TechLab的Herbein博士是开发肠道诊断方面的专家；曾指导FDA批准贾第鞭毛虫和隐孢子虫的诊断，并担任过多个I/II期SBIR/STTR项目的PI。弗吉尼亚大学的佩里博士是阿米巴病临床和基础研究的国际领先者， 在与TechLab的合作下，已经开发出唯一一种FDA 510(K)批准的溶组织埃希氏菌诊断测试。[创新：创新方面包括：(1)开发和制造一种可与其他B类肠道寄生虫复合使用的阿米巴病POC检测方法；以及(2)在新鲜样品和福尔马林固定样品中生产第一种检测溶组织埃希氏菌的诊断方法]。[方法]为了实现我们的阿米巴病新诊断试验的目标，我们提出了以下两个具体目标：1)制备针对溶组织棘球绦虫包囊高度丰富的“Jacob”蛋白的单抗和多克隆抗体。2)应用这些抗体以产生溶解组织埃希氏菌的POC测试]。环境：该提案建立在弗吉尼亚大学的佩里博士与TechLab公司的Herbein博士长期合作开发阿米巴病诊断测试的基础上。重要的是，这两个机构相距只有两个小时，十多年来一直在一起成功地合作。

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.