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: 8251565
• 负责人: Joel F Herbein
• 金额: $ 29.94万
• 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 2014-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8251565
• 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. 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.]

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，尤其是在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中引起腹泻，是严重腹泻的前5大原因。由于其对氯化的抗性和低感染剂量，它也是对水和食物供应的生物防御威胁。在这里，我们建议开发一种即时（POC）粪便抗原诊断测试。该项目的成功完成将产生第一个检测E的POC测试。新鲜标本和福尔马林固定标本中的溶组织菌]。研究者：TechLab的Herbein博士是开发肠道诊断的专家;曾指导FDA批准贾第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的国际领导者， 并与TechLab合作开发了唯一一种FDA 510（k）批准的E.溶组织剂【创新：创新方面包括：（1）开发和生产可与其他B类肠道寄生虫多重检测的阿米巴病POC检测试剂;（2）生产首个E.新鲜和福尔马林固定样品中的溶组织菌检测]。[方法：本研究拟通过以下两个方面来实现阿米巴病诊断新方法的研究目标：1）制备抗高丰度的大肠杆菌雅各布蛋白的单克隆抗体和多克隆抗体;溶组织囊肿 2)应用这些抗体进行大肠杆菌的POC检测。溶组织剂]。环境：该提案建立在弗吉尼亚大学Petri博士与TechLab公司Herbein博士的长期合作关系基础上。用于阿米巴病诊断测试开发。重要的是，这两个机构之间只有两个小时的车程，并且已经成功地合作了十多年。 公共卫生相关性：溶组织内阿米巴是一种生物防御威胁，也是导致以下人群腹泻的重要原因：（a）前往流行地区的旅行者和来自流行地区的移民;（B）男男性行为者;（c）发展中国家的儿童。我们建议建立一种快速、简便的阿米巴病即时检测方法，并能特异性地检测E。而非非病原体E. dispar）在新鲜和固定的粪便标本中。