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、明确地检测病原体通常是关键 有效治疗并完全康复。 尽管基于 DNA 和蛋白质 检测系统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 针对现有和新兴病原体的特异性试剂。 拟议研究的总体目标是开发一种通用的、非 免疫学方法快速获得高亲和力的试剂 检测分枝杆菌特异性蛋白质靶点的特异性 结核。 该方法基于重组展示文库 使用生物素羧化酶载体蛋白（BCCP）作为支架。 在 第一阶段，将开发方法来分析和结合个体 从该文库中获得的分离物可用于创建双特异性检测 复合物。 分泌蛋白抗原 Ag85、38kDa 和 45/47kDa 结核分枝杆菌复合体，其病原体 结核病，将作为初步目标。 II期研究将应用该技术获得双特异性试剂 对于其他目标，如有必要，请将双特异性纳入 现有的测定格式和测试临床样品中测定的有效性。 第三阶段将涉及最终工艺开发，并纳入 自动化诊断系统，以及在商业市场中的应用 与私营制药诊断公司的合作伙伴关系。 拟议的商业应用 预期的商业应用包括新的确认诊断 系统的特异性和仪器兼容性大大提高， 用于研究和临床应用的新型检测试剂，以及新型 许可的制造过程。 研究产品应用 将通过 Promega 自有网络进行商业化；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极好的目标，因为它 目前呈上升趋势，其中大部分增长与艾滋病有关 流行性。