SBIR-STTR Award

GenTel BioSurfaces (GenTel) seeks to establish the technical merit and feasibility of an allergen biochip for use as a rapid, inexpensive and easy-to-use in vitro method for identifying elevated allergen-specific IgE titers in serum. This biochip is based upon a uniform gold surface that is highly amenable to chemical modification and uses a unique microchannel technology (Array 2 Microchannels). On-chip microchannels enable many discreet interactions to be studied simultaneously and allow rapid, on-chip generation of a standard curve. Quantification is obtained in an analogous manner to an enzyme linked immunosorbent assays (ELISAs). Together, these technologies allow GenTel to develop a robust allergen biochip that can be used to rapidly quantitate allergen-specific IgE titers in serum. This biochip will find applications in the clinical and research communities including, but not limited to, allergen-specific IgE profiling of human patients, monitoring vaccine and therapeutic antibody efficacy in animal models, antigenic determination and localization of antibody populations. The objectives of this proposal are to: (1) Select optimal surface chemistry for attachment of allergens as measure by the highest, specific binding of target IgE; (2) develop and determine optimal surface chemistry for blocking non-specific adsorption of human serum components to the array surface as measured by the highest signal: noise ratio and (3) to validate the ability of the proposed allergen biochip to quantitatively determine the titer of an allergen-specific IgE using our innovative Array" Microchannels by comparing the results to those obtained by ELISA. A follow-up Phase II proposal will broaden the number of allergens tested and further develop our Array 2 Microfluidics technology by integrating sample purification with the biochip. This will enable direct application of whole blood to the biochip and an inexpensive chip-reading allergy test with a turnaround time of about one hour.

Thesaurus Terms:
biomedical equipment development, clinical biomedical equipment, diagnosis design /evaluation, hypersensitivity, microarray technology, rapid diagnosis, serology /serodiagnosis amine, biochemistry, immunoglobulin E, isothiocyanate, molecular film, peptide, polyethylene glycol, polymer, succinimide, surface property bioengineering /biomedical engineering, clinical research, enzyme linked immunosorbent assay, human subject, human tissue

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