RAPID SERODIAGNOSTIC TEST FOR TUBERCULOSIS

全世界每年出现800万例结核病， 是单一传染源导致死亡的主要原因 识别患病个体对于结核病控制至关重要， 因为快速诊断通常导致及时开始治疗。 目前唯一快速诊断结核病的方法是显微镜检查 痰涂片检查。在低收入国家， 结核病的患病率，痰涂片显微镜检查往往有不可接受的低 灵敏度正在开发的其他方法可能是 负担不起拟议工作的总体目标是制定一个 快速、简单、准确和廉价的结核病血清学诊断试验。 该测试将需要一滴全血，没有设备， 技术人员，并将只需要几分钟的时间来执行， read. 准确的血清学诊断测定必须基于多种抗原， 结核分枝杆菌，因为结核病患者产生的抗体 能与多种抗原反应一期工程拟开展的工作 将在以下各项中确定最适合快速免疫测定形式的 许多（至少12种）血清学反应性、纯化的重组 抗原选定的抗原将用于配制多抗原 鸡尾酒一种多抗原混合物， 血清学诊断试验将发展成为商业诊断试剂盒 在第二阶段的结核病。 拟定商业应用： 开发可利用的快速护理点血清诊断 在实验室和非实验室环境中由非技术人员进行。 这种测试将提供现场确定结核病感染 允许立即进行治疗的状态。等 测试将是耗时培养/涂片的低成本替代方案 和/或X射线，并且是一种经济的替代品，特别是在开发 国家

With eight million cases arising each year worldwide, tuberculosis (TB) is the leading cause of death from a single infectious agent. Identification of diseased individuals is crucial for TB control, because rapid diagnosis usually leads to timely initiation of therapy. The only current method for rapid TB diagnosis is microscopic examination of sputum smears. In low-income countries with high- prevalence of TB, sputum smear microscopy often has unacceptably low sensitivity. Other methods being developed are likely to be unaffordable. The overall goal of the proposed work is to develop a rapid, simple, accurate, and inexpensive serodiagnostic assay for TB. The test will require one drop of whole blood, no equipment and no skilled personnel, and will take only a few minutes to execute and to read. An accurate serodiagnostic assay must be based on multiple antigens of Mycobacterium tuberculosis, because antibodies produced by TB patients react with a board number of antigens. Work proposed for Phase I project will identify the most suitable for a rapid immunoassay format among many (at least twelve) serologically reactive, purified recombinant antigens. Selected antigens will be used to formulate multi-antigen cocktails. A multi-antigen cocktail yielding a highly accurate serodiagnostic assay will be developed into a commercial diagnostic kit for TB during Phase II. PROPOSED COMMERCIAL APPLICATION: Development of rapid point of care serodiagnostics that can be utilized in both laboratory and non-laboratory settings by non-skilled persons. Such a test would provide on the spot determination of TB infection status allowing for immediate therapeutic treatment to being. Such as test would be a low cost alternative to time consuming culture/smear and/or x-ray and be an economic alternative especially in developing countries.