Rapid and Inexpensive Biochip Based Allergy Testing

描述（由申请人提供）：对于该II期项目，GenTel BioSurfaces建议创建并验证基于生物芯片的测试，用于快速和廉价地诊断常见呼吸道过敏。所提出的设备需要大约10微升的血液，很容易从简单的手指针刺获得，这将显着减少与标准皮肤点刺试验相关的患者不适。在第一阶段，优化的表面和封闭化学允许检测和定量的1 ng/uL的过敏原特异性IgE在人血清中。该测试需要大约一个小时才能完成，并在标准显微镜载玻片格式上使用集成微流体。第二阶段的支持将允许创建一个生物芯片，能够检测和定量IgE抗体，以22种常见的呼吸道过敏（基于威斯康星州的皮肤刺痛面板大学）从一分钟体积的全血。原型设备将交付给合作医生进行测试，并与使用传统技术的结果进行比较。 I型过敏是一种IgE介导的超敏反应性疾病，影响超过25%的人口，其中每年有超过1700万人接受检测。由于许多患者对体外或体内测试所需的静脉穿刺或多次针刺感到不舒服，因此非常需要仅需要少量血液（来自简单的手指针刺）的简单诊断测试。目前用于体外过敏试验的临床方法如RAST需要患者提供相当大量的血液，需要熟练的技术人员来完成，并且结果的周转时间很慢。体内技术，如皮肤点刺试验，需要多次针刺，许多患者感到不舒服，特别是如果过敏反应的结果。此外，初级保健医生通常将患者转诊给过敏症专家进行这些体内皮肤敏感性测试，这给患者和医生增加了显著的费用和困难。第二阶段项目的目标是开发一种过敏生物芯片，能够快速提供准确的结果，患者的不适感很小。

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.