New Diagnostics for Amebiasis

阿米巴病的新诊断方法

• 批准号: 6736678
• 负责人: David M. Lyerly
• 金额: $ 49.85万
• 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 2006-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6736678
• 关键词: Bangladesh; Entamoeba histolytica; Middle East; amebiasis; biotechnology; clinical research; communicable disease diagnosis; diagnosis design /evaluation; diagnostic tests; enzyme linked immunosorbent assay; feces; human subject; microorganism antigen; patient oriented research; polymerase chain reaction; rapid diagnosis; serology /serodiagnosis; southeast Asia

DESCRIPTION (provided by applicant): Entamoeba histolytica, the cause of amoebiasis, is a Category B pathogen considered in the top three biodefense parasites because it is difficult to diagnose. The disease caused by this protozoan pathogen occurs due to intestinal and extra-intestinal infections, both of which are major problems in developing countries. For these reasons, there is an urgent need for new and improved diagnostics for this organism and its disease. In Phase I we will continue and expand our developmental work on stool dipstick antigen detection tests for intestinal amebiasis, including critical clinical evaluations in Bangladesh, Vietnam, and Turkey. Clinical investigators will utilize PCR technology to evaluate test performance. We will transfer the technology to a manufacturer of rapid membrane tests and establish test performance of dipsticks manufactured under GMP. Data for 510(k) submissions to the Food and Drug Administration will be collected from in-house performance studies and on-site clinical evaluations. As a logical extension of this work, the dipsticks will be evaluated for the detection of circulating antigen in persons with amebic liver abscess. We will extend efforts on an ELISA for use by military and reference labs for the detection of lectin in fixed specimens. The ELISA will be manufactured under GMP at TechLab and evaluated on-site at reference laboratories in the U.S. The data for a 510(k) submission will be collected and submitted to the FDA. In addition to the ELISA, efforts will continue on a stool antigen detection dipstick that works with fixed specimens for use in the U.S. and other industrialized countries. For extra-intestinal amebiasis, the highest sensitivity diagnostic approach utilizes detection of both serum antigen and antibody. Therefore, we will develop a new serodiagnostic test for extra-intestinal amebiasis utilizing lecA (a recombinant peptide of the lectin) as the capture antigen. In Phase II, clinical evaluations will be extended to include on-site studies in other countries. In addition, we will expand efforts to develop tests for E. histolytica cysts as well as develop a panel test for E. histolytica/Cryptosporidium/Giardia. This project will lead to a battery of tests that have broad application in the diagnosis of amebiasis, making these tests suitable for biodefense purposes and for improving global healthcare.

描述（由申请人提供）：阿米巴病的原因Entamoeba Histolictica是B类病原体在前三名Biodefense寄生虫中考虑的，因为很难诊断。这种原生动物病原体引起的疾病是由于肠道和肠外感染引起的，这两者都是发展中国家的主要问题。由于这些原因，迫切需要对这种生物体及其疾病进行新的和改进的诊断。在第一阶段，我们将继续进行并扩大我们在肠式抗原检测检测测试的发展工作，包括肠道阿米巴病，包括孟加拉国，越南和土耳其的关键临床评估。临床研究人员将利用PCR技术评估测试性能。我们将将技术转移到快速膜测试的制造商中，并确定根据GMP制造的量油尺的测试性能。从内部绩效研究和现场临床评估中，将收集510（k）提交给食品药物管理局的数据。作为这项工作的逻辑扩展，将评估量油尺，以检测患有Amebic肝脓肿的人的循环抗原。我们将扩大对ELISA的努力，用于使用军事和参考实验室，以检测固定标本中的凝集素。 ELISA将根据GMP在TechLab制造，并在美国的参考实验室进行现场评估，将收集510（k）提交的数据并提交给FDA。除了ELISA外，还将继续进行粪便抗原检测钉，该检测钉与固定标本一起在美国和其他工业化国家使用。对于肠外肌动脉症，最高灵敏度诊断方法利用了血清抗原和抗体的检测。因此，我们将使用LECA（一种凝集素的重组肽）作为捕获抗原开发一种新的血清诊断测试，用于肠外肌动脉症。在第二阶段，将扩展临床评估，以包括其他国家的现场研究。此外，我们将扩大努力为溶组织溶血性大肠杆菌囊肿开发测试，并为E. stolytica/Cryptosporidium/Giardia开发小组测试。该项目将导致一系列测试，这些测试在诊断Amebiasis的诊断中具有广泛的应用，使这些测试适合生物化的目的并改善了全球医疗保健。