
NSF Org: |
TI Translational Impacts |
Recipient: |
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Initial Amendment Date: | March 30, 2015 |
Latest Amendment Date: | February 19, 2019 |
Award Number: | 1500236 |
Award Instrument: | Standard Grant |
Program Manager: |
Jesus Soriano Molla
jsoriano@nsf.gov (703)292-7795 TI Translational Impacts TIP Directorate for Technology, Innovation, and Partnerships |
Start Date: | April 1, 2015 |
End Date: | September 30, 2019 (Estimated) |
Total Intended Award Amount: | $200,000.00 |
Total Awarded Amount to Date: | $281,532.00 |
Funds Obligated to Date: |
FY 2017 = $45,700.00 FY 2018 = $35,832.00 |
History of Investigator: |
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Recipient Sponsored Research Office: |
2600 CLIFTON AVE CINCINNATI OH US 45220-2872 (513)556-4358 |
Sponsor Congressional District: |
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Primary Place of Performance: |
2901 Woodside Drive Cincinnati OH US 45221-0030 |
Primary Place of
Performance Congressional District: |
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Unique Entity Identifier (UEI): |
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Parent UEI: |
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NSF Program(s): |
GOALI-Grnt Opp Acad Lia wIndus, Accelerating Innovation Rsrch |
Primary Program Source: |
01001718DB NSF RESEARCH & RELATED ACTIVIT 01001819DB NSF RESEARCH & RELATED ACTIVIT |
Program Reference Code(s): |
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Program Element Code(s): |
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Award Agency Code: | 4900 |
Fund Agency Code: | 4900 |
Assistance Listing Number(s): | 47.084 |
ABSTRACT
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.
PUBLICATIONS PRODUCED AS A RESULT OF THIS RESEARCH
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PROJECT OUTCOMES REPORT
Disclaimer
This Project Outcomes Report for the General Public is displayed verbatim as submitted by the Principal Investigator (PI) for this award. Any opinions, findings, and conclusions or recommendations expressed in this Report are those of the PI and do not necessarily reflect the views of the National Science Foundation; NSF has not approved or endorsed its content.
In this project we aimed to develop an easy-to-use, very low cost, point-of-care device for monitoring the coagulation properties of blood. This is an important consideration for individuals being treated with anticoagulants for cardiovascular disease. By developing this type of device we hope to be able to greatly minimize the frequency and cost of visits to doctors? offices and hospitals for blood testing of these individuals.
The basic device concept uses flow of a droplet of blood obtained from a finger prick through a cellulose sheet (similar to paper). The distance that the blood flows in a given time (a few minutes) is a function of its coagulation condition ? stronger coagulation leads to shorter distances, and vice-versa. We have demonstrated the concept, optimized the device design and operation, and obtained high reproducibility of results. A small-scale human clinical trial with both healthy individuals and patients under anti-coagulation therapy confirmed that this paper-based test for coagulation monitoring is comparable to measurements using conventional desk-top instrumentation. Similar results were obtained with blood from various animal species (bovine, canine, equine, etc.), indicating potential for animal veterinary use.
A study of key product aspects of our device was carried out to assess its potential for commercialization. The study included the competitive landscape, pricing of competitive products, materials cost breakdown of our device platform, performance considerations, such as sensitivity, reproducibility. The results of this study indicated a promising commercial opportunity.
The project enabled the training of a graduate student who obtained her PhD degree based on research performed on the project. Following the PhD degree the individual took a post-doctoral position in the PI's laboratory and also participated in an internship at our industrial partner, Meridian Bioscience. As part of the internship, she investigated the process for developing commercial opportunities for the technology and for obtaining government approvals. The results of our research have been disseminated through 15 journal publications and conference presentations, publication of a PhD thesis and by obtaining a related patent.
Last Modified: 01/23/2020
Modified by: Andrew J Steckl
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