Abstract

Fibrinogen concentration is a major determinant of both clotting and bleeding risk. Clotting and bleeding disorders cause extensive morbidity and mortality, particularly in resource-poor and emergency settings. This is exacerbated by a lack of timely intervention informed by measurement of fibrinogen levels under conditions such as thrombosis or postpartum haemorrhage. There is an absence of simple, rapid, low-cost, and sustainable diagnostic devices for fibrinogen measurement that can be deployed in such environments. Paper-based analytical devices are of significant interest due to their potential for low-cost production, ease of use, and environmental sustainability. In this work, a device for measuring blood plasma fibrinogen using chromatography paper was developed. Wax printing was used to create hydrophobic structures to define the test channel and sample application zone. Test strips were modified with bovine thrombin. Plasma samples (22 μL) were applied, and the flow rate was monitored over 5 min. As the sample traversed the strip, clotting was induced by the conversion of soluble fibrinogen to insoluble fibrin. The flow rate and distance travelled by the sample were dependent on fibrinogen concentration. The device was able to measure fibrinogen concentration in the range of 0.5–7.0 ± 0.3 mg/mL (p < 0.05, n = 24) and had excellent correlation with laboratory coagulometry in artificial samples (r2 = 0.9582, n = 60). Devices were also stable at 4–6 °C for up to 3 weeks.

Highlights

  • Fibrinogen concentration is a major determinant of both clotting and bleeding risk

  • An initial approach employed a vertically suspended paper substrate, with fibrinogen levels determined from the distance travelled by the sample up the strip.[15]

  • Increased fibrinogen concentration led to a decrease in permeability and reduced the distance travelled by the sample

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Summary

Introduction

Clotting and bleeding disorders cause extensive morbidity and mortality, in resource-poor and emergency settings This is exacerbated by a lack of timely intervention informed by measurement of fibrinogen levels under conditions such as thrombosis or postpartum haemorrhage. Bleeding and clotting disorders cause extensive morbidity and mortality, especially in resource-poor settings, which may lack access to suitable testing methods. The orientation of the device and the need for a fluid reservoir make it impractical for point-of-care use Another approach utilized the permeability of the paper to fibrinogen. Increased fibrinogen concentration led to a decrease in permeability and reduced the distance travelled by the sample This method could measure fibrinogen in both plasma and whole blood and had an assay time of 4 min but was only suitable for samples with low fibrinogen concentrations (

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