DETECTION METHOLOGY FOR MYCOBACTERIA TUBERCULOSIS

病原体的早期定义检测通常是 有效治疗和完全康复。 虽然基于DNA和蛋白质 检测系统广泛用于检测病原体和疾病 标记，一些系统具有有限的能力，以快速生产 对现有和新出现的病原体具有特异性的试剂。 这项研究的总体目标是制定一个通用的、非 快速获得具有高亲和力试剂的免疫学方法， 检测分枝杆菌特异性蛋白靶的特异性 结核 该方法基于重组展示文库 它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联合收割机的个人 从该文库获得的分离物以创建双特异性检测 配合物 分泌蛋白抗原Ag 85、38 kDa和45/47 kDa 结核分枝杆菌复合体， 结核病，将作为最初的目标。 二期研究将应用该技术获得双特异性试剂 对于其他靶标，如果需要，将双特异性抗体并入 现有的分析格式和临床样品中的测试分析有效性。 第三阶段将涉及最后工艺开发， 自动化诊断系统，以及在商业市场上的应用， 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验证性诊断 具有显著改进的特异性和仪器兼容性的系统， 用于研究和临床应用的新检测试剂，以及 生产许可证。 研究产品应用 将通过Promega自己的网络进行商业化;临床产品 这些应用将通过制药合作伙伴进行商业化。 商业上，结核分枝杆菌是一个很好的目标，因为它 目前正在上升，其中大部分与艾滋病有关。 疫情

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.