A RAPID SERODIAGNOSTIC TEST FOR TUBERCULOSIS

描述(改编自申请者摘要)：结核病的控制， 一种每年导致全球300万人死亡的疾病，需要快速的治疗方法 以便及时诊断。拟议工作的目标是开发一种简单、 一种快速、准确、廉价的活动性肺结核血清学诊断方法 薄层免疫层析(TLIC)形式与多种重组抗原 结核分枝杆菌。 结核病的血清诊断测试需要多抗原鸡尾酒，因为 患者与患者之间通过血清抗体识别抗原的差异。 第一阶段的研究已经确定了八种适合鸡尾酒的抗原。 开发并论证了TLIC方法学适用于 基于多抗原的结核血清学诊断。第二阶段的拟议工作预计将进行 1)在抗原组成和检测方面推进测试发展 条件，2)验证选定鸡尾酒的诊断性能 不同的结核病队列和控制组，以及3)建立方法学 抗原的批量生产。第二阶段研究的目标是开发一种测试 对涂阳的特异度接近100%，灵敏度达90% 肺结核病。快速血清诊断结核病检测的商机 拥有建议的规格是巨大的。 建议的商业应用：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