Analysis of Whole Blood Prothrombin Time/ International Normalized Ratio Using Image Processing
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Date
2021-03
Journal Title
Journal ISSN
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Publisher
Research in Medical and Engineering Sciences
Abstract
Purpose: Patients who had undergone mechanical heart valve replacements, who have atrial fibrillation
or deep vein thrombosis, need drugs called oral anticoagulants to prevent blood clotting and need regular
testing of Prothrombin Time/International Normalized Ratio. Conventional laboratory approaches are
time consuming, need blood component separation and a regular visit to clinical labs. The burden of
PT measurement on the clinical laboratory is huge globally, which raise need for point of care, quick
and user-friendly device. Methods: In this study we have proposed a handheld device based on the
image processing for the PT/INR detection. Cost effective disposable strips were fabricated using
thromboplastin as reagent. Device and strips were tested for 100 samples in clinical set up as per the
ISO standard 17593 “Clinical laboratory testing and in vitro medical devices - Requirements for in vitro
monitoring systems for self-testing of oral anticoagulant therapy”. Results: Data was compared with the
values obtained from clinical laboratory using automated coagulometer T Coag DT-100 (Trinity), and
commercially available Point of Care (POC) device from Roche, Diagnostics. A correlation coefficient (r)
of 0.87 & 0.77 was observed between lab vs Chitra device and Chitra device vs commercially available
device, respectively. Conclusion: Clinically accepted correlation may be obtained after automation of
the strip fabrication technique. The proposed device is cost effective and easy to operate and works on
the novel approach of image processing. To best of our knowledge this is the first report on the image
processing-based PT/INR monitoring device.
Description
Keywords
Prothrombin time; International normalized ratio; Medical device; Image processing
Citation
Nair SS, Rakhi MR, Sadanandan L,Harikrishnan S and Bhatt A. Analysis of Whole Blood Prothrombin Time/ International Normalized Ratio Using Image Processing. Research in Medical and Engineering Sciences. 2021;9(2):999-1006