Award Abstract # 1500236
PFI:AIR - TT: Developing an Engineering Prototype for Ultra-Low-Cost Blood Coagulation Diagnostics Using Paper-based Microfluidics

NSF Org: TI
Translational Impacts
Recipient: CINCINNATI UNIV OF
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 2015 = $200,000.00
FY 2017 = $45,700.00

FY 2018 = $35,832.00
History of Investigator:
  • Andrew Steckl (Principal Investigator)
    a.steckl@uc.edu
  • Giovanni Pauletti (Co-Principal Investigator)
  • Michael Hegener (Co-Principal Investigator)
Recipient Sponsored Research Office: University of Cincinnati Main Campus
2600 CLIFTON AVE
CINCINNATI
OH  US  45220-2872
(513)556-4358
Sponsor Congressional District: 01
Primary Place of Performance: University of Cincinnati Main Campus
2901 Woodside Drive
Cincinnati
OH  US  45221-0030
Primary Place of Performance
Congressional District:
01
Unique Entity Identifier (UEI): DZ4YCZ3QSPR5
Parent UEI: DZ4YCZ3QSPR5
NSF Program(s): GOALI-Grnt Opp Acad Lia wIndus,
Accelerating Innovation Rsrch
Primary Program Source: 01001516DB NSF RESEARCH & RELATED ACTIVIT
01001718DB NSF RESEARCH & RELATED ACTIVIT

01001819DB NSF RESEARCH & RELATED ACTIVIT
Program Reference Code(s): 019Z, 8019
Program Element Code(s): 150400, 801900
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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(Showing: 1 - 10 of 11)
H. Li and A.J. Steckl "A Review of Paper Microfluidics for POC Whole Blood Analysis" ACS Analytical Chemistry , v.91 , 2019 , p.352 10.1021/acs.analchem.8b03636
H. Li, D. Han, G. M. Pauletti and A. J. Steckl "Point-Of-Care Blood Coagulation Monitoring Using Lateral Flow Device" MicroTAS 2014 Conference Proceedings , 2014 , p.1575 978-0-9798064-7-6/TAS 2014/$20©14CBMS-0001
H. Li, D. Han, G. M. Pauletti and A.J. Steckl "Engineering a simple lateral flow device for animal blood coagulation monitoring" AIP Biomicrofluidics , v.12 , 2018 , p.014110 10.1063/1.5017496
H. Li, D. Han, G. M. Pauletti and A.J. Steckl "Point-of-Care Blood Coagulation Properties of Non-Human Mammals Using Lateral Flow Devices" AIP Biomicrofluidics , v.12 , 2018 , p.014110 doi.org/10.1063/1.5017496
H. Li, D. Han, G. M. Pauletti, M.A. Hegener, and A. J. Steckl "Correcting the Effect of Hematocrit in Whole Blood Coagulation Analysis on Paper-Based Lateral Flow Device" RSC Analytical Methods , v.10 , 2018 , p.2869 10.1039/C8AY00192H
H. Li, D. Han, G. M. Pauletti, M. Hegener, and A. J. Steckl "Effect of hematocrit concentration on blood coagulation properties in lateral flow devices" AIP Biomicrofluidics , v.11 , 2017 , p.024116 10.1063/1.4979815
H. Li, D. Han, G. M. Pauletti, M. Hegener, and A. J. Steckl "Effect of hematocrit concentration on blood coagulation properties in lateral flow devices" AIP Biomicrofluidics , v.11 , 2017 , p.024116 doi.org/10.1063/1.4979815
H. Li, D. Han, G. Pauletti, and A. J. Steckl "Lateral Flow Diagnostic Device for Blood Coagulation" Lab-on-a-Chip , v.14 , 2014 , p.4035 10.1039/C4LC00716F
Hua Li, Andrew Steckl "Paper Microfluidics for Point-of-Care Blood-Based Analysis and Diagnostics" Analytical Chemistry , v.91 , 2019 , p.352 10.1021/acs.analchem.8b03636
M.A. Hegener, H. Li, D. Han, A. J. Steckl, and G. M. Paulett "Point-of-Care Coagulation Monitoring: First Clinical Experience Using a Paper-Based Lateral Flow Diagnostic Device" Biomedical Microdevices , v.19 , 2017 10.1007/s10544-017-0206-z
M.A. Hegener, H. Li, D. Han, A. J. Steckl, and G. M. Pauletti "Point-of-Care Coagulation Monitoring: First Clinical Experience Using a Paper-Based Lateral Flow Diagnostic Device" Biomedical Microdevices , v.19 , 2017 doi.org/10.1007/s10544-017-0206-z
(Showing: 1 - 10 of 11)

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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