A Rapid Lateral Flow Test for TB in Nonhuman Primates

描述(由申请人提供)：本研究的目标是开发一种 以抗体为基础的快速、横向流动的结核病诊断试验 非人灵长类动物。目前的结核病皮肤测试的不可靠性是 动物园灵长类动物频繁爆发破坏性结核病，隔离 设施，以及为医学研究而保留的殖民地。错误 对目前皮试的阳性反应导致了不必要的破坏 每年都有许多健康的动物。一种改良的结核病诊断方法 非人类灵长类动物是迫切需要的。 提出的研究是一种新的诊断方法的可行性研究。 根据结核病抗原抗体的出现，发现了猴结核病 疾病的病程。两家美国生物技术公司将汇集他们的 资源，其中包括一库存储的血清样本和一个有价值的 分枝杆菌重组蛋白和重组多肽的收集 肺结核。第一阶段的研究将评估开发一种 快速侧向血流诊断，只需一滴血，即可 在几分钟内提供准确的结果。建议的化验是基于 创新的专有技术。 确定这一新方法可行性的量化标准 都是声明的，并且需要表现出高度的敏感性和特异性 第一阶段的原型化验 建议的商业应用：不可用

DESCRIPTION (provided by applicant): The goal of the research is to develop a rapid, lateral flow, antibody-based diagnostic test for tuberculosis (TB) in nonhuman primates. The unreliability of the present TB skin test underlies the frequent devastating outbreaks of TB among primates in zoos, quarantine facilities, and in colonies maintained for use in medical research. False positive responses to the present skin test result in the needless destruction of many healthy animals each year. An improved method of diagnosing TB in nonhuman primates is urgently needed. The research proposed is a feasibility study of a new approach to the diagnosis of simian TB, based upon the occurrence of antibodies to TB antigens during the course of the disease. Two U.S. biotechnology companies will pool their resources, which include a bank of stored serum samples and a valuable collection of recombinant proteins and peptides from Mycobacterium tuberculosis. The Phase I research would assess the feasibility of developing a rapid lateral flow diagnostic that would require only a drop of blood and would provide accurate results within minutes. The proposed assay is based upon an innovative proprietary technology. Quantitative criteria for establishing the feasibility of this novel approach are stated, and require demonstrating high sensitivity and specificity of a prototype assay during Phase I. PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE