Pathogen Biosensor Array for Syndrome-Based Diagnostics

描述(由申请人提供)：BioScale正在开发一种新型诊断平台，利用基于MEMS传感器阵列的灵敏检测系统对感染性病原体进行快速和多路检测。我们的长期愿景是开发一种端到端系统，该系统包括一个仪器和一次性墨盒，能够快速检测属于传染病综合征的多个目标病原体，包括生物恐怖因子。与目前的检测方法相比，该系统将提供显著的优势，目前的检测方法需要几个小时到几天才能得出结果，而且通常只对单一病原体进行测试。BioScale的平台处于独特的地位，能够在临床上对传染病进行基于症状的诊断，从而创建用于监测生物恐怖事件的分布式基础设施。 我们的总体目标是测试基于免疫传感器的病原体直接检测的可行性。我们的方法通过将捕获的分析物定向到传感器表面的主动方法来加速。第一阶段项目将实现以下目标： 1.在传感器上开发工程捕获表面以减少非特异性结合并实现模型结合分析。2.建立了复杂样品基质中模型分析物的捕获和分离的样品处理方案。 3.开发组件和协议，将分析物定向到传感器并加速其与传感器表面的结合。 4.通过对模拟样本执行完整的细胞检测分析来测试原型系统和分析方案，并生成结合的剂量-反应曲线。将利用这些数据集来评估这一概念的可行性。 通过实现这些第一阶段目标，我们将证明在我们的平台上直接测量未扩增的细菌病原体样本(即无需培养细胞或核酸聚合酶链式反应)的可行性。它将为开发基于综合征的商业诊断系统铺平道路，该系统也包括生物恐怖制剂的诊断。

DESCRIPTION (provided by applicant): BioScale is developing a novel diagnostic platform for rapid and multiplexed detection of infectious agents utilizing a sensitive detection system based on an array of MEMS sensors. Our long-term vision is to develop an end-to-end system comprising an instrument and disposable cartridge that is capable of rapid detection of multiple target pathogens falling within an infectious disease syndrome and including bioterror agents. This system will provide significant advantage over current test methods that take many hours to several days to give results and typically only test for single pathogens. BioScale's platform is in a unique position to enable syndrome-based diagnostics of infectious diseases in the clinic and thereby create a distributed infrastructure for monitoring bioterror events. Our overall aim is to test the feasibility of immunosensor-based direct detection of pathogen agents. Our method is accelerated by active means that direct captured analytes to sensor surfaces. The Phase I project will pursue the following objectives: 1. Develop an engineered capture surface on the sensor to reduce nonspecific binding and implement model binding assays. 2. Develop the sample processing protocols for capture and separation of model analytes in complex sample matrices. 3. Develop components and protocols that direct the analytes to the sensors and accelerate their binding to the sensor surface. 4. Test a prototype system and assay protocols by performing complete cell detection assays on simulated samples and generate binding dose-response curves. These data sets will be utilized to assess the feasibility of this concept. By accomplishing these Phase I aims, we will have demonstrated the feasibility of direct measurement of an un-amplified sample of bacterial pathogens (i.e. without culturing cells or PCR of nucleic acids) on our platform. It will pave the way for the development of commercial syndrome based diagnostic systems that also cover diagnoses of bioterror agents.