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Development of a paper-based lateral flow prothrombin assay.

Jerro Saidykhan1, Louise Pointon2, Stefano Cinti3

  • 1Department of Applied Sciences, Centre for Research in Biosciences (CRIB), University of the West of England, Coldharbour Lane, Bristol, BS16 1QY, UK. tony.killard@uwe.ac.uk.

Analytical Methods : Advancing Methods and Applications
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Summary

A new, low-cost paper-based assay accurately measures prothrombin time (PT) for diagnosing bleeding and clotting disorders. This simple diagnostic tool is ideal for resource-limited settings, improving patient care globally.

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Area of Science:

  • Biomedical Engineering
  • Point-of-Care Diagnostics
  • Hemostasis Assays

Background:

  • Disorders of hemostasis cause significant global morbidity and mortality.
  • Conventional prothrombin time (PT) tests are unsuitable for low-resource settings.
  • Paper-based diagnostics offer a promising solution for accessible healthcare.

Purpose of the Study:

  • To develop a simple, low-cost, paper-based lateral flow assay for prothrombin time (PT) measurement.
  • To optimize the assay for reliable performance in resource-limited environments.
  • To evaluate the assay's correlation with standard laboratory PT methods.

Main Methods:

  • Utilized wax printing on chromatography paper to create lateral flow channels.
  • Deposited thromboplastin reagent and calcium chloride onto paper strips.
  • Measured plasma sample flow rates to determine PT, optimizing paper type, reagent concentration, and sample volume.

Main Results:

  • The optimized paper-based assay demonstrated a 6 mm dynamic range for normal and factor-deficient plasmas.
  • Showed good correlation with a laboratory PT assay (Yumizen G200) in artificial plasmas (r² = 0.8112).
  • Exhibited good dynamic range and correlation with hospital PT in patient samples (r² = 0.7209).

Conclusions:

  • Developed a cost-effective, paper-based lateral flow assay for PT measurement.
  • The assay is suitable for use in low-resource settings, offering improved accessibility.
  • This technology has the potential to enhance the diagnosis and management of hemostasis disorders worldwide.