Rapid Ultra-Sensitive On-Site Biowarfare Agent Detection

描述（由申请人提供）：2001年的生物恐怖主义袭击突出了对快速、超灵敏、具有成本效益和用户友好的测试的迫切需要，以便在暴露点同时筛查多种类型的生物战剂。拟议项目的目标是证明MultiPath TM测试满足这一重要需求的潜力。MultiPath TM检测被设计用于快速检测多种不同的试剂，具有核酸扩增检测的超灵敏度，但具有非处方免疫分析“条”检测的成本效益和用户友好性。该测试的新功能来自于融合专有技术和现有技术的独特组合。MultiPath TM测试使用高强度的目标特异性HiLiter TM微珠标记，其产生的信号非常强烈，通过对曝光的即时胶片进行目视检查，可以轻松检测到单个显微镜微珠。标记和检测策略通过消除对光源、成像光学器件、光电检测器和支持电源的需要来提高成本效益和便携性。本提案所述的初步工作表明，这一办法的关键要素是可行的。拟议的项目将使用三个模型目标（细菌，病毒和蛋白质）来证明MultiPath TM测试的可行性，这些目标模拟了可能用于生物战的目标谱。该提案的具体目的是：（1）证明高强度HiLiter TM微珠用于三个模型靶;（2）证明新颖而强大的射流系统的功效，但简单而廉价;（3）证明MultiPath TM测试成像系统的可行性，该系统包括即时胶片检测单元、扫描仪和成像软件;以及（4）证明了将该系统集成以扫描包含低水平靶的样品的可行性。第一阶段的结果，除了证明多路径TM测试的可行性，将支持第二阶段的目标，即开发一个多路径TM测试原型，并显示其在“金标准”测试的背景下，“真实的”样本的有效性。MultiPathTM测试的竞争优势包括涵盖测试关键功能的知识产权、前所未有的高端结果和客户友好属性的功能列表以及直接的商业化路径。除了解决庞大且不断增长的生物恐怖主义市场外，MultiPathTM测试还解决了医疗保健领域尚未满足的重大测试需求（传染病、癌症、心血管疾病）和工业微生物学（食品、饮料、制药）。MultiPath TM测试将为一级和二级市场带来的价值预计将吸引大公司作为合作伙伴，以支持商业开发、营销和分销。

DESCRIPTION (provided by applicant): The bioterrorism attacks of 2001 highlighted the acute need for rapid, ultra-sensitive, cost-effective, and user-friendly tests to simultaneously screen for multiple types of biowarfare agents at the point of exposure. The goal of the proposed project is to demonstrate the potential of the MultiPath TM test to meet this important need. The MultiPath TM test is designed to rapidly detect multiple disparate agents with the ultra-sensitivity of a nucleic acid amplification test but with the cost-effectiveness and user-friendliness of over-the-counter immunoassay "strip" tests. The test's novel capabilities arise from melding a unique combination of proprietary and existing technologies. The MultiPath TM test uses high-intensity target-specific HiLiter TM microbead labels which produce a signal so intense that individual microscopic beads are easily detected by visual inspection of exposed instant film. The labeling and detection strategy enhances cost-effectiveness and portability by eliminating the need for a light source, imaging optics, photodetectors, and the supporting electrical power sources. Preliminary work described in this proposal indicates the feasibility of key elements of this approach. The proposed project will demonstrate the feasibility of the MultiPath TM test using three model targets (a bacterium, virus, and protein) that emulate the spectrum of targets that might be used in biowarfare. The Specific Aims of the proposal are to (1) demonstrate the use of high-intensity HiLiter TM microbeads for the three model targets; (2) demonstrate the efficacy of a fluidics system that is novel and powerful, yet simple and inexpensive; (3) demonstrate the feasibility of the MultiPath TM test imaging system comprising an instant film detection unit, a scanner, and imaging software; and (4) demonstrate the feasibility of integrating this system to scan samples containing low levels of targets. The Phase 1 results, besides demonstrating the feasibility of the MultiPath TM test, will support the Phase 2 goals which are to develop a MultiPath TM test prototype and show its efficacy in comparisons to "gold standard" tests in the context of "real world" samples. Competitive advantages of the MultiPath TM test include the intellectual property covering key features of the test, an unprecedented feature list of high-end results and customer-friendly attributes, and straightforward commercialization path. Besides addressing the large and growing bioterrorism market, the MultiPath TM test addresses significant unmet testing needs in healthcare (infectious disease, cancer, cardiovascular disease) and in industrial microbiology (food, beverage, pharmaceutical manufacturing). The value that the MultiPath TM test will bring to both the primary and secondary markets is expected to attract large corporations as partners to support commercial development, marketing, and distribution.