Novel Microarray System for In Vitro Allergen Testing

描述（由申请人提供）：5000万美国人患有过敏性疾病，包括哮喘、鼻炎、鼻窦炎、皮炎和食物过敏。过敏是慢性疾病的第六大原因，每年至少涉及200亿美元的医疗费用。对于I型过敏，其表现为血清中IgE水平升高，因此越来越需要能够使用一滴血快速量化300多种最常见过敏原的过敏原特异性IgE的体外免疫分析。这种测试方式可以显著提高过敏诊断的效率，为临床医生提供数据来设计患者特异性的、成本有效的症状管理和治疗方案。一个很有希望的候选者是过敏原微阵列系统。然而，目前的微阵列技术在低成本、可靠性和自动化方面还不能满足临床诊断的严格要求。

DESCRIPTION (provided by applicant): Fifty million Americans suffer from allergic diseases including asthma, rhinitis, sinusitis, dermatitis and food allergy. Allergies constitute the 6th leading cause of chronic disease and involve at least $20 billion in annual health care costs. For type I allergy, which manifests itself by elevated levels of IgE in the serum, there is a growing need for in vitro immunoassays capable of rapidly quantifying allergen-specific IgEs for the over 300 most common allergens using a single drop of blood. Such a testing modality could significantly improve the efficiency of allergy diagnosis by providing the clinician with data to design a patient-specific, cost effective program of symptom management and therapy. One promising candidate is an allergen microarray system. However, current microarray technology is not sufficiently developed to meet the rigorous demands of clinical diagnostics in terms of low cost, reliability and automation. During Phase I, AmberGen in collaboration with Clinical MicroArrays (CMA), a subcontractor on this project, plans to develop and evaluate an integrated microarray system for simultaneous in vitro measurements of hundreds of allergen-specific IgEs. This integrated system will be based on innovations in several areas of microarray technology including array substrates, method for allergen immobilization, array immunoassays and fluorescent readout. Ultra-low fluorescence array substrates will be produced and evaluated which will be based on polystyrene and nitrocellulose thin films. Novel methods of allergen attachment through covalent bonding to surfaces and by directed binding using biotin-streptavidin bridges will be evaluated. A microarray reader which features high sensitivity evanescent wave detection technology will be evaluated. The integrated system including cassette processing of disposable microarrays will be low-cost and highly automated. Dr. Lynda Schneider, an expert in the field of pediatric in vitro allergy diagnostics and Director of the Allergy/Clinical immunology Program at Boston Children's Hospital and Dr. Helen Hollingsworth, an expert in adult allergies and Director of the allergy unit at Boston University Medical Center will serve as consultants. During Phase II, a complete integrated system including a scanner and array processor, along with a prototype microarray containing several hundred antigens will be developed and evaluated in a clinical setting.