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

这个PFI: AIR技术翻译项目专注于翻译基于毛细血管的纸微流体，以满足超低成本血液凝固诊断的需求。这种诊断设备对因心血管疾病而接受血液稀释剂治疗的患者很重要。这些患者需要持续的血液凝固分析，以监测抗凝药物的疗效。如果抗凝药物水平过低，血栓形成的风险就很高。相反，如果药物水平过高，则可能发生严重出血。传统的医院或实验室凝血测量既昂贵又耗时。该项目将开发出简单的纸质诊断筛查设备的工程原型，这些设备具有以下几个独特的特点：快速指示血液凝固状态；易于使用，不需要其他设备，从而允许患者操作家庭使用；超低成本，一次性使用，防止污染；快速响应时间。与领先的血液凝固便携式测量系统相比，这些功能大大节省了成本，从而大大扩展了目前服务不足人群的即时护理检测的可用性。该项目解决了在从研究发现向商业应用转化的过程中，使用基于纸张的横向流动测定（LFA）血液样本的技术差距。这包括特定设计的检测试剂盒（LFA材料和盒），用于小血液样本量，增强对凝血条件的敏感性，低成本的可制造性。一个主要考虑因素是工业质量制造工艺的发展，特别是考虑到LFA硝化纤维素（NC）膜中可重复的流体流动。通过机械切割数控膜的几何定义将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创业与商业化中心获得创业和技术翻译经验。该项目与工业伙伴合作，将这项技术从研究发现转化为商业现实。Meridian Bioscience Inc.将提供总体原型工程、产品成本评估和监管要求方面的指导。诊断咨询网络公司将提供LFA装置设计和优化方面的具体协助。

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.