SBIR-STTR Award

In vitro tests provide indispensable information to medical professionals to diagnose and treat disease. Such tests are usually performed in a laboratory remote from the patient and take hours or days before results are available. Biotrack has developed a novel prothrombin time monitor designed for patient-side use. The test uses a drop of fingerstick blood, is simple and rapid to perform, and is as accurate and precise as laboratory methods.The purpose of this project is to extend this system to other tests important in managing cardiovascular conditions. These include drug tests for monitoring and adjusting cardioactive pharmaceutical therapy and enzyme tests as markers of cardiovascular damage. Specifically, researchers will develop a portable immunoassay system using laser optics and reagent addition by capillary flow in whole blood samples, providing immediate results.In Phase I, Biotrack will select a model analyte (lidocaine - used as an antiarrhythmic) and assemble the components to demonstrate feasibility of an in vitro immunochemical biosensor. In Phase II, Biotrack would design and fabricate a preprototype system that would perform in a clinical setting.National Heart, Lung, and Blood Institute (NHLBI)

In vitro measurement of therapeutic drugs in blood provides the physician indispensible information in determining proper therapy. The value of the information is compromised by the long time required by conventional measurement techniques. Biotrack proposes to develop a portable immunoassay system to quantitate concentrations of lidocaine, a cardiac-active drug, monitoring of which is crucial during therapy. The system will deliver objective, immediate results, patient-side, using an unmeasured drop of blood from a finger-stick as the sample. Chemistry developed in Phase I will be incorporated into a disposable reagent cartridge in dry (stable) form. Reaction between blood sample and reagent will be monitored by an instrument which has laser optics. Calibration will be achieved by reference to a standard method. Calibration data will be encoded on the reagent cartridge and read by the instrument. At the en of Phase II a working system will be available. Commercial application of the system in Phase III would take about a year for prototype development and clinical trials.

Thesaurus Terms:
Biomedical Engineering, Instrumentation Clinically Oriented Biomedical Resources, Instrumentation Resources Blood Cells, Erythrocytes Cardiovascular Agents Cardiovascular Agents, Antiarrhythmic Agents Cardiovascular Agents, Cardiotonic And Cardioprotective Drugs Chemistry, Clinical, Blood Heart Pharmacology Human, Human Tissues, Fluids Etc. From Non-Related Sources Outside Immedia Immunological Tests And Immunoassay, Agglutination Reaction (Agglutinin) Immunological Tests And Immunoassay, Immunoassay Phenylamides, LidocaineNational Heart, Lung and Blood Institute (NHLBI)