PFI:AIR - TT: Developing an Engineering Prototype for Ultra-Low-Cost Blood Coagulation Diagnostics Using Paper-based Microfluidics

PFI:AIR - TT：使用纸基微流体开发超低成本凝血诊断工程原型

• 批准号: 1500236
• 负责人: Andrew Steckl
• 金额: $ 20万
• 依托单位: University of Cincinnati Main Campus
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-04-01 至 2019-09-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1500236&HistoricalAwards=false
• 关键词: PFI; AIR; TT; Developing; Engineering

This PFI: AIR Technology Translation project focuses on translating capillary-based paper microfluidics to fill the need for ultra-low-cost blood coagulation diagnostics. The diagnostic device is important for patients who receive blood thinner medication because of cardiovascular disease. These patients require constant blood coagulation analysis in order to monitor the efficacy of the anticoagulation medication. If the anticoagulant drug level is too low, the risk of blood clot formation is high. Conversely, if the drug level is too high severe bleeding (hemorrhage) can occur. Conventional hospital- or lab-based coagulation measurement is expensive and time consuming. The project will result in the development of engineering prototypes of simple paper-based diagnostic screening devices with several unique features: rapid indication of blood coagulation status; ease of use, with no other apparatus needed, thus allowing patient-operated home use; ultra-low-cost allowing one time use and preventing contamination; fast response time. These features provide significant cost savings compared to the leading competing blood coagulation portable measurement systems, thus greatly expanding the availability of point-of-care testing to currently underserved segment of the population. This project addresses technology gaps in using blood samples with paper-based lateral flow assays (LFA) as it translates from research discovery toward commercial application. This includes specific design of test kits (LFA materials and cassettes) for use of small blood sample volume, enhanced sensitivity to coagulation conditions, low-cost manufacturability. A major consideration is the development of industrial-quality manufacturing processes, with particular consideration to reproducible fluid flow in the LFA nitrocellulose (NC) membranes. The geometrical definition of the NC membrane by mechanical cutting will be compared to a laser milling approach. In addition, personnel involved in this project (research assistant and research associate) will receive entrepreneurship and technology translation experiences through the Center for Entrepreneurship & Commercialization at the University of Cincinnati.The project engages with industrial partners in this technology translation effort from research discovery toward commercial reality. Meridian Bioscience Inc. will provide guidance with overall prototype engineering, evaluation of product costs, regulatory requirements. Specific assistance with the design and optimization of the LFA unit will be provided by Diagnostic Consulting Network Inc.

该PFI：AIR技术翻译项目专注于翻译基于毛细管的纸微流体技术，以满足超低成本血液凝固诊断的需求。 该诊断设备对于因心血管疾病而接受血液稀释剂药物治疗的患者非常重要。 这些患者需要持续进行凝血分析，以监测抗凝药物的疗效。 如果抗凝药物水平过低，则血栓形成的风险很高。相反，如果药物水平过高，可能会发生严重出血（出血）。 传统的基于医院或实验室的凝血测量昂贵且耗时。该项目将导致开发简单的基于纸张的诊断筛查设备的工程原型，该设备具有以下几个独特的功能：快速指示血液凝固状态;易于使用，无需其他设备，从而允许患者操作家庭使用;超低成本，允许一次性使用并防止污染;快速响应时间。与领先的竞争对手凝血便携式测量系统相比，这些功能可显著节省成本，从而将即时检测的可用性大大扩展到目前服务不足的人群。该项目解决了使用血液样本与纸基侧向流测定（LFA）的技术差距，因为它从研究发现转化为商业应用。这包括针对小血样体积使用的检测试剂盒（LFA材料和试剂卡）的特定设计、对凝血条件的增强灵敏度、低成本可制造性。一个主要的考虑因素是工业质量生产工艺的发展，特别是考虑到LFA硝化纤维素（NC）膜中的可再生流体流动。将通过机械切割的NC膜的几何定义与激光铣削方法进行比较。此外，参与该项目的人员（研究助理和研究助理）将通过辛辛那提大学的创业商业化中心获得创业和技术翻译经验。该项目与工业合作伙伴一起参与从研究发现到商业现实的技术翻译工作。 Meridian Bioscience Inc将提供指导与整体原型工程，评估产品成本，法规要求。诊断咨询网络公司将为LFA装置的设计和优化提供具体援助。