DETECTION METHOLOGY FOR MYCOBACTERIA TUBERCULOSIS

结核分枝杆菌的检测方法

• 批准号: 2536423
• 负责人: Mary Haak-Frendscho
• 金额: $ 9.08万
• 依托单位: PROMEGA CORPORATION
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-04-01 至 1999-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2536423
• 关键词: Mycobacterium tuberculosis; bacterial proteins; communicable disease diagnosis; diagnosis design /evaluation; enzyme linked immunosorbent assay; human tissue; ligands; method development; peptide library; protein purification; transport proteins

Early, definition detection of pathogenic agents often is key to effective treatment and full recovery. Although DNA and protein-based detection systems are widely used to detect pathogen and disease markers, a number of systems have limited capacity to rapidly produce reagents specific for existing and emerging new pathogens. The overall goal of the proposed research is to develop a general, non- immunological method to rapidly obtain reagents with high affinity and specificity for detecting protein targets specific for Mycobacteria tuberculosis. The approach is based on a recombinant display library that uses biotin carboxylase carrier protein (BCCP) as a scaffold. In Phase I, methods will be developed to assay and combine individual isolates obtained from this library to create bispecific detection complexes. The secreted protein antigens Ag85, 38kDa and 45/47kDa complex of Mycobacteria tuberculosis, the causative agent of tuberculosis, will serve as the initial targets. Phase II studies will apply the technology to obtain bispecific reagents for other targets if necessary, incorporate the bispecifics into existing assay formats and test assay effectiveness in clinical samples. Phase III will involve final process development, incorporation into automated diagnostic systems, and application in commercial markets via partnerships with private pharmaceutical diagnostics firms. PROPOSED COMMERCIAL APPLICATION Anticipated commercial applications include new confirmatory diagnostic systems with greatly improved specificity and instrument compatibility, new detection reagents for research and clinical applications, and new manufacturing processes for licensing. Research product applications will be commercialized through Promega's own network; clinical product applications will be commercialized through a pharmaceutical partner. Commercially, Mycobacteria tuberculosis is an excellent target since it is currently on the rise, with much of the increase linked to the AIDS epidemic.

早期，病原体的定义检测通常是关键 治疗有效，痊愈。尽管基于DNA和蛋白质的 检测系统被广泛用于检测病原体和疾病 标记，许多系统快速生产的能力有限 专门针对现有和新出现的病原体的试剂。 拟议研究的总体目标是开发一种通用的、非 一种快速获得高亲和力试剂的免疫学方法 检测分枝杆菌特异性蛋白质靶标的特异性 肺结核。该方法是基于重组展示文库的 它以生物素羧化酶载体蛋白(BCCP)为支架。在……里面 第一阶段，将开发检测和合并个体的方法 从该文库获得的分离株建立双特异性检测 复合体。分泌型蛋白抗原Ag85、38 kDa和45/47 kDa 结核分枝杆菌复合体，致病因子 结核病，将作为最初的目标。 第二阶段的研究将应用这项技术来获得双特异性试剂 对于其他目标，如有必要，将双指定合并到 现有的分析格式和在临床样本中测试分析的有效性。 第三阶段将涉及最终流程开发，纳入 自动诊断系统，并通过以下方式在商业市场中应用 与私营制药诊断公司建立伙伴关系。 建议的商业应用 预期的商业应用包括新的确认性诊断 系统的专属性和仪器兼容性大大提高， 用于研究和临床应用的新检测试剂，以及新的 许可的制造流程。研究产品应用 将通过Promega自己的网络进行商业化；临床产品 应用程序将通过制药合作伙伴进行商业化。 在商业上，结核分枝杆菌是一个很好的靶子，因为它 目前呈上升趋势，其中大部分增长与艾滋病有关 流行病。