Development of a disposable test kit for the determination of blood coagulation rate in patiens using warfarin applying to cardiology clinic

Aim: This study aimed to develop and evaluate a portable, reliable, and cost effective lateral flow-based test kit for INR measurement in patients using warfarin. Factors influencing the performance of the test kit, such as membrane type, surfactant usage, and parameter optimization, were systematically analyzed. Material and method: The lateral flow-based test kit used in the study was optimized with different membrane types (TLC and NC) and surfactants (Tween20 and SDS). Performance evaluations were carried out using Taguchi and TOPSIS methods. The clinical accuracy of the test was assessed through ROC analysis, evaluating the kit's effectiveness in INR measurement. Results: Among surfactants, Tween20 increased flow rate but caused variations, whereas SDS ensured more stable flow. ROC analysis results showed that the test kit exhibited moderate discriminatory power in INR measurement. TOPSIS analysis identified optimal parameter combinations, achieving time and cost efficiency. Conclusion: This study demonstrated that the developed lateral flow-based test kit offers a viable alternative for INR measurement in patients using warfarin. The kit's low-cost and portable design provides significant advantages, particularly in regions with limited access to laboratories. Keywords: Lateral Flow Test, INR Measurement, Warfarin, Taguchi Method, TOPSIS, Membrane Performance