Rapid, hand-held paper diagnostic for measuring Fibrinogen Concentration in blood

Bialkower, Marek; McLiesh, Heather; Manderson, Clare A.; Tabor, Rico F.; Garnier, Gil

doi:10.1016/j.aca.2019.12.046

Cited by 5 publications

(11 citation statements)

References 57 publications

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“…In our previous handheld diagnostic, we tested a wide variety of blood conditions. We found that it is not impacted by common conditions such as acidosis, blood alcohol, hypertriglyceridemia, hemolysis, and warfarin administration . However, it is impacted by the presence of thrombin inhibitors.…”

Section: Discussionmentioning

confidence: 69%

“…We also tested the effect of temperature in our previous diagnostic. We found that the test is unaffected by temperatures ranging from 7 to 36 °C . However, at extreme temperatures (i.e., 44 °C), the test wicks further than normal and hence needs a means of protection.…”

Section: Discussionmentioning

confidence: 99%

“…In our previous study, we developed a cheap, handheld paper diagnostic for measuring the fibrinogen concentration in blood. 13 First, thrombin and plasma are added onto horizontally orientated paper strips where the fibrinogen is converted into fibrin. This drastically increases the plasma's hydrophobicity.…”

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confidence: 99%

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Paper Diagnostic for Direct Measurement of Fibrinogen Concentration in Whole Blood

et al. 2020

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The ability to diagnose and treat critically bleeding patients can save more than 2 million lives a year. Diagnosing hypofibrinogenemia is essential in these patients. Recently, with the development of new handheld diagnostics, fibrinogen concentration can be measured rapidly at the point of care. However, these diagnostics can only work with plasma and hence need blood cells to be separated before use. In this study, we demonstrate a handheld fibrinogen diagnostic that works with whole blood. The test works by (1) forming a premixed droplet of a whole blood sample and thrombin solution on a solid surface, (2) allowing it to clot, and (3) dropping a paper strip on top. The further that blood moves down the strip, the lower the fibrinogen concentration. The diagnostic can easily measure plasma fibrinogen concentrations below 1.6 g/L for blood samples with hematocrits between 40 and 50%. Furthermore, diluting blood samples not only increases the test’s sensitivity but also eliminates the effect of hematocrit and thrombin inhibitors. The test can be completed in 3–4 min, making it suitable for diagnosing early hypofibrinogenemia and allowing for fibrinogen replacement therapy in critically bleeding patients.

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Section: Discussionmentioning

confidence: 69%

Section: Discussionmentioning

confidence: 99%

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Paper Diagnostic for Direct Measurement of Fibrinogen Concentration in Whole Blood

et al. 2020

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“…It was capable of reliable measurement of fibrinogen at all concentrations across the full range found in human plasma and is suitable for both hyper- and hypofibrinogenemic conditions, which is in contrast to the very narrow assay range of other recent work. 16 , 17 In addition, the method used here was a simple, robust, and single step, making it more user-friendly, while its design makes it less-prone to errors and interference. It is also compact, portable, and instrument-free, making it highly suited to point-of-care application.…”

Section: Resultsmentioning

confidence: 99%

“…16 A similar approach exploited the resulting differences in hydrophobicity of the paper when exposed to samples of different fibrinogen concentrations, which altered the distance travelled by a dye applied to the paper following sample application. 17 This method could only measure fibrinogen at <2 mg/mL. Both methods require multistep procedures and have the potential to be prone to many interferences such as variations in sample viscosity.…”

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confidence: 99%

Paper-Based Lateral Flow Device for the Sustainable Measurement of Human Plasma Fibrinogen in Low-Resource Settings

et al. 2021

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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 ( r 2 = 0.9582, n = 60). Devices were also stable at 4–6 °C for up to 3 weeks.

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Development of a Paper-based Hematocrit Test and a Lateral Flow Assay to Detect Critical Fibrinogen Concentrations Using a Bottom-Up Pyramid Workflow Approach

Schobesberger,

Thumfart,

Selinger

et al. 2024

ACS Omega

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Fibrinogen is a coagulation factor in human blood and the first one to reach critical levels in major bleeding. Hypofibrinogenemia (a too low fibrinogen concentration in blood) poses great challenges to first responders, clinicians, and healthcare providers since it represents a risk factor for exsanguination and massive transfusion requirements. Thus, the rapid assessment of the fibrinogen concentration at the point of care has gained considerable importance in preventing and managing major blood loss. However, in whole blood measurements, hematocrit variations affect the amount (volume fraction) of plasma that passes the detection zone. In an attempt to accurately determine realistic critical levels of fibrinogen (<1.5 mg/mL) in patients needing immediate treatment and medical interventions, we have developed novel diagnostic systems capable of estimating hematocrit and critical fibrinogen concentrations. A lateral flow assay (LFA) for the detection of fibrinogen has been developed by establishing a workflow employing rapid characterization methods to streamline LFA development. The integration of two detection lines enables (i) the identification of fibrinogen (first line) present in the sample and (ii) the determination of the clinically critical fibrinogen concentrations below 1.5 mg/mL (second line). Furthermore, the paper-based separation of blood cells from plasma provides a semiquantitative estimate of the hematocrit by analyzing the fractions. Initial validation of the point-of-care (PoC) hematocrit test revealed good comparability to a standard laboratory method. The developed diagnostic systems have the ability to accelerate decision-making in cases with major bleeding.

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Rapid, hand-held paper diagnostic for measuring Fibrinogen Concentration in blood

Cited by 5 publications

References 57 publications

Paper Diagnostic for Direct Measurement of Fibrinogen Concentration in Whole Blood

Paper Diagnostic for Direct Measurement of Fibrinogen Concentration in Whole Blood

Paper-Based Lateral Flow Device for the Sustainable Measurement of Human Plasma Fibrinogen in Low-Resource Settings

Development of a Paper-based Hematocrit Test and a Lateral Flow Assay to Detect Critical Fibrinogen Concentrations Using a Bottom-Up Pyramid Workflow Approach

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