A RAPID SERODIAGNOSTIC TEST FOR TUBERCULOSIS

描述（改编自申请人的摘要）：结核病（TB）的控制， 这种疾病每年在全世界造成300万人死亡， 及时诊断。拟议工作的目标是开发一个简单的， 一种快速、准确和廉价的活动性结核病血清学诊断方法， 薄层免疫层析（TLIC）形式和多种重组抗原 结核分枝杆菌 结核病的血清学诊断测试需要多抗原混合物，因为 血清抗体识别抗原的患者间差异。 I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学诊断。预计第二阶段的拟议工作 1)在抗原组成和检测方面推进检测开发 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一种测试方法， 特异性接近100%，在涂片阳性中的敏感性为90 肺结核结核病快速血清诊断试验的商业机会 具有所提出的规格是巨大的。 拟议商业应用：不可用

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