New Rapid Diagnostic Tests for Amebiasis

阿米巴病的新快速诊断测试

• 批准号: 7276751
• 负责人: Joel F Herbein
• 金额: $ 100万
• 依托单位: TECHLAB, INC.
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-06-01 至 2009-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7276751
• 关键词: New; Rapid; Diagnostic; Tests; Amebiasis

DESCRIPTION (provided by applicant): Entamoebga histolytica is a protozoan parasite and the causative agent of amebiasis in humans. Intestinal amebiasis causes debilitating diarrhea and dysentery, while extraintestinal amebiasis occurs when the parasite migrates from the intestinal tract to organs throughout the body, most commonly the liver. The NIAID Blue Ribbon Panel on Biodefense Agents B&C targeted E. histolytica as 1 of the 3 parasitic pathogens of highest priority for research because it is environmentally stable, infectious at a low dose, and is a significant cause of morbidity and mortality worldwide. E. histolytica cysts are predominantly acquired through ingestion of contaminated food and water, leading to 50 million cases of amebic colitis and amebic liver abscess annually, and an estimated 100,000 deaths occurring due to infection. Accurate diagnosis of infection by fecal microscopy, antigen testing, PCR, or IFA leads to successful treatment and full recovery. Several issues confound proper diagnosis, including the litany of other organisms that can cause similar intestinal symptoms, the presence of non-pathogenic Entamoeba spp. in the fecal specimen, and the lack of fecal positive results once amebic infections become invasive. E. histolytica must be specifically identified since non-pathogenic strains of Entamoeba spp. colonize the human intestine at 3-10 fold the rate of E. histolytica, making E. histolytica-specific diagnostics of particular value. Proper identification eliminates misdiagnosis of symptoms and treatment with unnecessary and possibly dangerous drugs. Further, a simple method of diagnosis must be made available to identify invasive amebiasis in the absence of positive fecal testing. This STTR Phase II application describes the GMP manufacture of 2 integrated rapid diagnostic tests used for the identification of intestinal and extraintestinal amebic infections in humans. Specific Aim #1 highlights production and FDA clearance of the E. HISTOLYTICA ANTIGEN QUIK CHEKTM test, which is designed to identify E. histolytica-specific antigen in fecal specimens from patients with amebic colitis, and in serum, whole blood, saliva and urine from patients with extraintestinal amebiasis. Specific Aim #2 highlights production and FDA clearance of the E. HISTOLYTICA ANTIBODY QUIK CHEKTM test, which is designed to detect anti-E. histolytica antibodies in serum samples of patients exposed to E. histolytica who are antigen negative. The tests will be manufactured at TechLab, Inc. using reagents developed through our partnership with the University of Virginia. The tests will be provided to UVA and our consortium sites in Bangladesh and Germany for clinical testing. Both sites have access to specimens and patients from areas where amebiasis is endemic. Further, Specific Aim #3 highlights analysis of these 2 tests together in point-of-care environments in order to identify the most effective diagnostic strategy for identifying amebiasis in humans.

描述（由申请人提供）：溶组织内阿米巴是一种原生动物寄生虫，也是人类阿米巴病的病原体。肠道阿米巴病会导致使人衰弱的腹泻和痢疾，而当寄生虫从肠道迁移到全身器官（最常见的是肝脏）时，就会发生肠外阿米巴病。 NIAID 生物防御剂 B&C 蓝丝带小组将溶组织内阿米巴列为最优先研究的 3 种寄生病原体之一，因为它环境稳定、低剂量即可传染，并且是全世界发病和死亡的重要原因。溶组织阿米巴包囊主要通过摄入受污染的食物和水而获得，每年导致 5000 万例阿米巴结肠炎和阿米巴肝脓肿病例，估计有 10 万人因感染而死亡。通过粪便显微镜检查、抗原检测、PCR 或 IFA 对感染进行准确诊断可实现成功治疗和完全康复。有几个问题混淆了正确的诊断，包括可能引起类似肠道症状的其他微生物的一长串、非致病性内阿米巴属的存在。在粪便标本中，一旦阿米巴感染具有侵袭性，粪便中就缺乏阳性结果。由于溶组织内阿米巴属非致病性菌株，因此必须具体鉴定溶组织内阿米巴。溶组织内阿米巴在人体肠道中的定植率是溶组织内阿米巴的 3-10 倍，使得溶组织内阿米巴特异性诊断具有特殊价值。正确的识别可以消除对症状的误诊和使用不必要且可能危险的药物的治疗。此外，必须提供一种简单的诊断方法，以便在粪便检测呈阳性的情况下识别侵袭性阿米巴病。 STTR II 期申请描述了 2 种集成快速诊断测试的 GMP 生产，用于识别人类肠道和肠外阿米巴感染。具体目标#1强调了溶组织阿米巴抗原QUIK CHEKTM测试的生产和 FDA 批准，该测试旨在识别阿米巴结肠炎患者粪便样本以及肠外阿米巴病患者血清、全血、唾液和尿液中的溶组织阿米巴特异性抗原。具体目标#2 强调 E.HISTOLYTICA 抗体 QUIK CHEKTM 测试的生产和 FDA 批准，该测试旨在检测抗大肠杆菌。暴露于溶组织内阿米巴且抗原呈阴性的患者血清样本中存在溶组织内阿米巴抗体。这些测试将在 TechLab, Inc. 生产，使用我们与弗吉尼亚大学合作开发的试剂。这些测试将提供给 UVA 以及我们位于孟加拉国和德国的联盟站点进行临床测试。这两个地点都可以获得来自阿米巴病流行地区的标本和患者。此外，具体目标#3强调在护理点环境中对这两项测试进行分析，以确定识别人类阿米巴病的最有效的诊断策略。