Development of rapid detection tests for B pseudomallei

描述（由申请人提供）：革兰氏阴性杆菌假马利氏伯克氏菌引起人类类鼻疽病，如果不及早治疗，这是一种迅速发展且经常致命的疾病。它在泰国东北部、东南亚和澳大利亚北部地区流行，被列为潜在生物恐怖主义威胁的B类病原体。抗生素治疗困难且时间长，复发率高，目前没有疫苗可用于保护自然或故意暴露的个体。为了指导临床管理的关键早期阶段，需要在血液样本和其他临床材料中快速检测这种生物体的准确测试，但目前还没有。本申请的目的是鉴定假假芽孢杆菌特异性抗原，并利用这些抗原产生单克隆抗体，用于抗原检测的快速现场试验，特别是在急性感染中。此外，这些抗原可以直接用于开发特异性免疫印迹，以评估疾病急性和慢性阶段的抗体反应。为了实现这些目标，InBios（在快速诊断分析的商业开发方面经验丰富）将英国的一个专家小组与泰国东北部的一个小组联合起来，他们可以使用类鼻疽病的动物模型系统，并可以获得临床样本，从而能够对所产生的原型分析进行第一阶段现场测试。这些工具对于在流行地区以及在生物恐怖袭击后发现和监测急性和慢性假芽孢杆菌感染将是非常宝贵的。

DESCRIPTION (provided by applicant): The Gram negative bacterium Burkholderia pseudomallei causes human melioidosis, a rapidly progressing and frequently fatal disease if not treated early. It is endemic in areas of NE Thailand, Southeast Asia and northern parts of Australia and is listed as a Category B agent of potential bioterrorist threats. Antibiotic treatment is difficult and prolonged with significant relapse rates and there is currently no vaccine available for protection of naturally or intentionally exposed individuals. Accurate tests for the rapid detection of this organism in blood samples and other clinical materials are needed to guide the critical early phases of clinical management but are not currently available. It is the purpose of this application to identify antigens specific to B. pseudomallei and use these to generate monoclonal antibodies for inclusion in a rapid field test for antigen detection particularly in acute infections. In addition, these antigens can be used directly to develop specific immunoblots for evaluating antibody responses in acute and chronic phases of disease. To achieve these goals, InBios (experienced in commercial development of rapid diagnostic assays) has brought together a team of experts in the UK with access to an animal model system for melioidosis with a group in Northeastern Thailand with access to clinical samples enabling Phase 1 field testing of the prototype assays produced. These tools will be invaluable in detecting and monitoring acute and chronic B. pseudomallei infections both in endemic areas as well as following a bioterrorist attack.