For this Phase II project, GenTel BioSurfaces proposes to create and validate a biochip-based test for the rapid and inexpensive diagnosis of common respiratory allergies. The proposed device requires approximately 10 microliters of blood, easily obtained from a simple finger stick, which will significantly reduce patient discomfort associated with standard skin prick tests. In Phase I, optimized surface and blocking chemistries allowed the detection and quantification of 1ng/uL of allergen specific IgE in human serum. The test required approximately one hour to complete and used integrated microfluidics on a standard microscope slide format. Phase II support will allow the creation of a biochip capable of detecting and quantifying IgE antibodies to 22 common respiratory allergies (based on the University of Wisconsin's skin prick panel) from a minute volume of whole blood. The prototype devices will be delivered to collaborating physicians for testing and comparison with results using conventional techniques. ? Type I allergy is an IgE-mediated hypersensitivity disease affecting more than 25% of the population, of which more than 17 million are tested annually. Because many patients are uncomfortable with venipuncture or multiple needle sticks required for in vitro or in vivo tests, a simple diagnostic test requiring only a small amount of blood (from a simple finger stick) is highly desirable. Current clinical methods for in vitro allergy testing such as RAST require patients to provide a sizeable amount of blood, require a skilled technician to complete and have a slow turnaround time for results. In vivo techniques, such as skin prick tests require multiple needle sticks which many patients find uncomfortable, particularly if an allergic reaction results. Furthermore, primary care physicians routinely refer patients to allergy specialists for these in vivo skin sensitivity tests, which add significant expense and difficulty to both patients and doctors. The goal of the Phase II project is to develop a allergy biochip that is capable of providing accurate results rapidly with little patient discomfort. ? ?
