Rapid and Inexpensive Biochip Based Allergy Testing

描述(由申请人提供)：对于这个第二阶段项目，Gentel BioSurFaces建议创建并验证一种基于生物芯片的测试，用于快速且廉价地诊断常见的呼吸道过敏。建议的设备需要大约10微升的血液，很容易从一个简单的手指棒获得，这将显著减少患者与标准皮肤点刺试验相关的不适。在第一阶段，优化的表面和封闭化学反应允许检测和定量人血清中1 ng/ul的过敏原特异性IgE。这项测试需要大约一个小时才能完成，并在标准显微镜载玻片上使用了集成的微流体。第二阶段的支持将允许创建一种生物芯片，能够从微量的全血中检测和定量22种常见呼吸道过敏的IgE抗体(基于威斯康星大学的皮肤点刺小组)。原型设备将被交付给合作的医生进行测试，并使用传统技术与结果进行比较。 I型过敏症是一种由IgE介导的过敏性疾病，影响着25%以上的人口，其中每年有1700多万人接受检测。由于许多患者对体外或体内测试所需的静脉穿刺法或多根针刺感到不舒服，因此一种只需少量血液(从简单的手指棒中提取)的简单诊断测试是非常可取的。目前的体外过敏测试方法，如RAST，需要患者提供相当数量的血液，需要熟练的技术人员才能完成，而且结果的周转时间很慢。体内技术，如皮肤点刺试验，需要多根针刺，许多患者感到不舒服，特别是在引起过敏反应的情况下。此外，初级保健医生通常会将患者转介给过敏专家进行这些活体皮肤敏感性测试，这会给患者和医生带来巨大的费用和困难。第二阶段项目的目标是开发一种过敏生物芯片，能够在患者几乎不感到不适的情况下快速提供准确的结果。

DESCRIPTION (provided by applicant): 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.