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Design to Implementation Study for Development and Patient Validation of Paper-Based Toehold Switch Diagnostics
Published on: June 17, 2022
Rapid paper diagnostic for plasma fibrinogen concentration
Marek Bialkower1, Heather McLiesh, Clare A Manderson
1BioPRIA and Department of Chemical Engineering, Monash University, Clayton, Australia. Gil.Garnier@Monash.edu.
A novel paper-based diagnostic accurately quantifies fibrinogen concentration in blood. This rapid, low-cost test can aid in diagnosing hypofibrinogenemia and prevent life-threatening hemorrhage.
Area of Science:
- Biochemistry
- Hematology
- Medical Diagnostics
Background:
- Fibrinogen is a critical blood protein for clot formation, essential for hemostasis.
- Early depletion of fibrinogen (hypofibrinogenemia) in bleeding patients necessitates urgent replenishment to prevent fatal hemorrhage.
- Current methods for measuring fibrinogen levels lack the speed, sensitivity, cost-effectiveness, and ease of use required for rapid clinical assessment.
Purpose of the Study:
- To develop a novel, rapid, sensitive, and cost-effective paper-based diagnostic assay for quantifying fibrinogen concentration.
- To enable timely diagnosis of hypofibrinogenemia at the point of care.
Main Methods:
- A two-step paper-based diagnostic process was developed.
- Plasma is applied to thrombin-treated paper strips, converting fibrinogen to fibrin.
- Strips are subsequently immersed in a dye bath, with elution measured to correlate with fibrinogen concentration via hydrophobicity changes.
Main Results:
- The diagnostic accurately quantifies fibrinogen concentrations within the clinically relevant range of 0-2 g L-1.
- The assay requires minimal sample volume (12 μL plasma) and reagents (60 mU thrombin).
- The entire testing procedure is completed rapidly, within 7.5 minutes.
Conclusions:
- The developed paper-based diagnostic offers a precise and efficient method for measuring fibrinogen levels.
- This assay has the potential to significantly improve point-of-care testing for hypofibrinogenemia.
- The technology could revolutionize patient care in emergency settings, potentially saving lives by enabling faster treatment decisions.
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