Development of a disposable non-instrumented prothrombin time test (PF) for home use is proposed. Preliminary data using flow channels built with precision engineered fabric demonstrated the potential of the proposed test device. The end points of the flow of the blood samples stopped due to clotting were repeatable, easy to read, and there was correlation between PT observed and the bar length observed. A simple and accurate disposable device is potentially a powerful tool to help patient to monitor their PT at home weekly. We propose to further study, optimize, and develop a non-instrumented device that will he less expensive and more convenient for both the physician and patient to monitor PT values than instruments that are currently available.
There are more than 2 million patients in the U.S.A. alone that are taking oral anti-coagulation therapy, and need to monitor their PT weekly. The potential market for a use monitoring device is very large. The proposed device is expected to provide a simple, and accurate alternative to the current techniques.