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

SBIR 第一阶段：胶片实验室诊断测试的卷对卷组装

• 批准号: 1046558
• 负责人: Christopher Cooney
• 金额: $ 15万
• 依托单位: Akonni Biosystems Inc.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-01-01 至 2011-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1046558&HistoricalAwards=false
• 关键词: SBIR; Phase; Reel; Assembly; Lab

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.

这个小型企业创新研究(SBIR)第一阶段项目旨在调查在卷轴到卷轴装配线上制造胶片上实验室微阵列设备的可行性。卷轴到卷轴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部件。该项目的目标有两个：(1)调查使用可卷曲的材料和薄膜的可行性，以确定制造胶片实验室微阵列设备的可能性，以及(2)开发一种无阀的胶片实验室形式的聚合酶链式反应-微阵列设备，以便将聚合酶链式反应扩增扩增片段限制在该设备上。第一个目标要求(1)使用阿康尼？S凝胶滴技术在低自发荧光的未经化学修饰的薄膜上打印微阵列，以及(2)识别可卷绕(即，有利于卷轴到卷轴制造)的带子和薄膜，以创建胶片上实验室组件。设计无阀薄膜实验室装置的第二个目标对于将设计转移到卷轴到卷轴制造工艺也很重要，因为消除了与添加阀门部件相关的步骤。在本项目结束时，我们希望通过在聚合酶链式反应微阵列膜上实验室设备上肯定地鉴定MRSA来证明其可行性。该项目更广泛的影响/商业潜力是向更多的人口分发高质量诊断的能力。由于成本是当今医疗体系中的一个如此重要的因素，因此有必要研究提供高质量诊断的新途径，这一点日益紧迫。这一挑战可能会成为分子诊断学中一种新的多重范式的催化剂。然而，对于这个项目，我们将胶片实验室制造应用于MRSA，也出现了一系列可能性，如多种生物的传染病测试、致病基因分型、基因测试、法医学、环境筛选、农业测试和生物防御应用。不仅要解决终端测试的可用性，还要解决制造过程，这是在价值500亿美元的全球诊断市场空间中保持竞争力的一种手段。