A RAPID SERODIAGNOSTIC TEST FOR TUBERCULOSIS

结核病快速血清诊断检测

• 批准号: 6072567
• 负责人: KONSTANTIN P LYASHCHENKO
• 金额: $ 34.44万
• 依托单位: CHEMBIO DIAGNOSTIC SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-07-15 至 2002-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6072567
• 关键词: Mycobacterium tuberculosis; bacterial antigens; diagnosis design /evaluation; diagnosis quality /standard; enzyme linked immunosorbent assay; human tissue; method development; rapid diagnosis; recombinant proteins; respiratory disorder diagnosis; serology /serodiagnosis; thin layer chromatography; tuberculin test; tuberculosis

DESCRIPTION (Adapted from Applicant's Abstract): Control of tuberculosis (TB), a disease that causes 3 million deaths a year worldwide, requires rapid methods for timely diagnosis. The goal of the proposed work is to develop a simple, rapid, accurate and inexpensive serodiagnostic assay for active TB using a thin-layer immunochromatography (TLIC) format and multiple recombinant antigens of Mycobacterium tuberculosis. Serodiagnostic tests for TB require multiantigen cocktails because of patient-to-patient variation in recognition of antigens by serum antibodies. Phase I studies have already identified eight antigens suitable for cocktail development and demonstrated that TLIC methodology is applicable to multiantigen-based TB serodiagnostics. Work proposed for Phase II is expected 1) to advance test development in terms of antigen composition and assay conditions, 2) to validate the diagnostic performance of selected cocktails in different TB cohorts and control groups, and 3) to establish methodologies for batch production of antigens. The goal of Phase II studies is to develop a test having a specificity close to 100% and a sensitivity of 90% in smear-positive pulmonary TB. The commercial opportunities for a rapid serodiagnostic TB test having the proposed specifications are immense. PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE

描述（改编自申请人的摘要）：结核病（TB）的控制， 一种每年导致全球 300 万人死亡的疾病，需要快速的方法 以便及时诊断。拟议工作的目标是开发一个简单的、 使用一种快速、准确和廉价的血清诊断方法检测活动性结核病 薄层免疫层析 (TLIC) 格式和多种重组抗原 结核分枝杆菌。 结核病血清诊断检测需要多抗原混合物，因为 血清抗体对抗原的识别存在个体差异。 一期研究已经确定了八种适合鸡尾酒的抗原 开发并证明 TLIC 方法适用于 基于多抗原的结核病血清诊断。预计第二阶段拟议工作 1) 推进抗原组成和检测方面的测试开发 条件，2）验证所选鸡尾酒的诊断性能 不同的结核病队列和对照组，以及 3) 建立方法 抗原的批量生产。第二阶段研究的目标是开发测试 涂片阳性的特异性接近 100%，敏感性为 90% 肺结核。快速血清诊断结核病检测的商业机会 所提出的规格是巨大的。 拟议的商业应用：不可用