SBIR Phase II: Reel-to-Reel Assembly of Lab-on-a-Film Diagnostic Tests

这个小型企业创新研究 (SBIR) 第二阶段项目旨在研究制造薄膜实验室的可行性？卷到卷装配线上的微阵列装置。 卷对卷制造有可能大幅降低设备成本，因为每小时可以组装数百个零件。 该项目的目标是证明使用卷到卷组装设备制造用于凝胶滴微阵列的无阀分子横向流动池的可行性。 该项目结束时，目标是通过在卷轴制造的胶片实验室上积极鉴定传染病临床样本来证明可行性？组件。 该项目更广泛的影响/商业潜力是向更多人群分发高质量诊断的潜力。 由于成本成为当今医疗保健系统中如此重要的因素，因此研究提供高质量诊断的新途径的需求变得越来越紧迫。 这一挑战可能成为分子诊断中新的多重范例的催化剂。 一系列可能性适用于这种范例，例如多种生物体的传染病测试、致病基因分型、基因测试、法医学、环境筛查、农业测试和生物防御应用。 不仅要解决最终测试的可用性，还要解决制造过程的问题，这是在 500 亿美元的全球诊断市场空间中保持竞争力的一种手段。

This Small Business Innovation Research (SBIR) Phase II project is designed to investigate the feasibility of manufacturing a Lab-on-a-Film? microarray device on a reel-to-reel assembly line. Reel-to-reel manufacturing has the potential to drastically reduce device cost because hundreds of parts per hour can be assembled. The goal of this project is to demonstrate the feasibility of manufacturing valve-less molecular lateral flow cells for gel drop microarrays using reel-to-reel assembly equipment. At the conclusion of this project, the goal is to demonstrate feasibility by positively identifying clinical samples for infectious disease on reel-to-reel manufactured Lab-on-a-Film? assemblies. The broader impact/commercial potential of this project is the potential to distribute quality diagnostics to an expanded population. With cost being such an important factor in today?s healthcare system, the need to investigate new avenues for offering quality diagnostics arises with increasing urgency. This challenge may become a catalyst for a new multiplexing paradigm in molecular diagnostics. A range of possibilities apply to this paradigm such as infectious disease testing for multiple organisms, pathogenic genotyping, genetic testing, forensics, environmental screening, agriculture testing, and biodefense applications. Addressing not only the usability of the end test, but also the manufacturing process is a means to be competitive in a 50 billion dollar global diagnostics market space.