A novel point of care diagnostic device:: Impedimetric detection of a biomarker in whole blood

There is an unmet medical need for a more reliable and earlier assessment of patients suspected of having a deep vein thrombosis. We describe a novel approach which is developing a highly reliable, accurate, portable and handheld prototype medical diagnostic device to improve radically the speed, accuracy and reliability with which DVT and related blood clotting conditions can be assessed. The device will measure whole blood concentration of D-dimer, a recognized biomarker of increased blood clotting activity, and through innovation in the development of a novel detection, measurement and reporting system, will offer the opportunity to use the test in the point of care setting. The device combines innovation in antibody bio-engineering for high specificity inummoassay-based diagnostics and nano/micro engineered impedimetric analysis electrodes ncorporating a biocompatible polymer substrate with development of a disposable inicrofluidic manifold specifically enabling diagnostics at the point-of-first-contact.