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

这个小型企业创新研究（SBIR）第一阶段项目旨在研究在卷到卷装配线上制造薄膜微阵列设备的可行性。卷到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。该项目的目标有两个方面：(1)研究使用可卷的材料和薄膜的可行性，以确定制造膜上实验室微阵列设备的可能性；(2)开发一种膜上实验室格式的无阀PCR微阵列设备，使PCR扩增子局限于该设备。第一个目标需要(1)用Akonni？S凝胶滴技术在低自身荧光的未经化学修饰的薄膜上，以及(2)识别可以卷（即有利于卷到卷制造）的磁带和薄膜，以创建薄膜上的实验室组件。设计无阀膜上实验室设备的第二个目标也很重要，因为将设计转移到卷到卷的制造过程中，因为省去了与添加阀门组件相关的步骤。在该项目结束时，我们希望通过在pcr -微阵列薄膜实验室设备上积极识别MRSA来证明可行性。该项目的更广泛的影响/商业潜力是能够向更多的人口提供高质量的诊断。由于成本是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日益紧迫。这一挑战可能成为分子诊断中新的多路复用范式的催化剂。然而，在这个项目中，我们将实验室-薄膜制造应用于MRSA，一系列的可能性也出现了，如多种生物的传染病检测、病原基因分型、基因检测、法医、环境筛查、农业检测和生物防御应用。不仅要解决最终测试的可用性，还要解决制造过程，这是在500亿美元的全球诊断市场空间中具有竞争力的一种手段。

This Small Business Innovation Research (SBIR) Phase I 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 objectives of this project are two-fold: (1) investigate the feasibility of using materials and films that can be rolled, so as to determine the possibility of manufacturing a lab-on-a-film microarray device, and (2) develop a valveless PCR-microarray device in a lab-on-a-film format such that a PCR amplicon is confined to the device. The first objective requires (1) printing microarrays with Akonni?s gel drop technology on chemically-unmodified thin films with low autofluorescence, and (2) identifying tapes and films that can be rolled (i.e., conducive to reel-to-reel manufacturing) to create the lab-on-a-film assembly. The second objective of designing a valveless lab-on-a-film device also is important to transfer the design to a reel-to-reel manufacturing process because the steps associated with adding components for a valve are eliminated. At the conclusion of this project, we expect to demonstrate feasibility by positively identifying MRSA on a PCR-microarray lab-on-a-film device. The broader impact/commercial potential of this project is an ability to distribute quality diagnostics to an expanded population. With cost being such an important factor in today's healthcare system, there is a 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. Whereas, for this project, we apply lab-on-a-film manufacturing to MRSA, a range of possibilities also emerge 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 global diagnostics market space.