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

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.