Rapid Test for Monitoring Dust Mite Avoidance in Homes

描述（由申请人提供）：家中发现的来自尘螨、动物皮屑、蟑螂和真菌的过敏原通常与哮喘的发生有关。减少过敏原暴露是哮喘管理的主要目标，但没有简单的测试可以使过敏患者和消费者在家中测量过敏原暴露。在第一阶段，证明了使用 2 类螨虫过敏原侧流检测作为家用过敏原检测套件的一部分的可行性。该测试可在 10 分钟内检测出灰尘样本中的螨虫过敏原，并与酶免疫分析 (ELISA) 结果相关联，并用于监测家庭中的过敏原水平以及干预程序（蒸汽清洁）后过敏原水平的变化。第二阶段的目标是优化螨过敏原测试，并调查以下假设：使用该测试作为教育患者了解过敏原暴露的工具将鼓励实施和遵守过敏原避免程序。将比较螨虫第 1 组和第 2 组过敏原测试的预测价值，以选择过敏原评估的最佳测试。一项随机对照试验将研究过敏患者对避免程序的依从性，将定期使用螨测试的患者与那些有教育材料但没有测试的患者进行比较。将为猫、狗和蟑螂过敏原开发快速测试，目的是制作针对多种过敏原的单一过敏原测试卡，可用于筛查家庭中的过敏原暴露情况。拟议的商业应用：尚无针对过敏原的有效消费者测试。 INDOOR Biotechnologies 将通过销售过敏原控制产品、室内空气质量检测服务和家庭清洁产品的经销商推销该测试。几家公司对销售过敏原测试表现出了浓厚的兴趣。我们的目标是在第二阶段结束时向市场推出 100,000 项测试。侧流技术将能够开发食品和乳胶过敏原测试，以及使用基因工程过敏原的新一代快速过敏原诊断测试。第二阶段项目将开发基于消费者的过敏原测试，从而利用环境控制程序改善哮喘管理。

DESCRIPTION (provided by applicant): Allergens found in the home derived from dust mites, animal dander, cockroaches and fungi are commonly associated with the development of asthma. Reducing allergen exposure is a primary goal of asthma management, yet there are no simple tests that enable allergic patients and consumers to measure allergen exposure in the home. In Phase I, the feasibility of using a lateral flow test for mite Group 2 allergen as part of home based allergen detection kit was demonstrated. The test detected mite allergen in dust samples within 10 minutes, correlated with enzyme immunoassay (ELISA) results, and was used to monitor allergen levels in homes and changes in allergen levels following an intervention procedure (steam cleaning). The aims of Phase II are to optimize tests for mite allergen and to investigate the hypothesis that using the test as a tool to educate patients about allergen exposure will encourage implementation and compliance with allergen avoidance procedures. The predictive value of tests for mite Group 1 and Group 2 allergens will be compared to select the optimal test for allergen assessment. A randomized controlled trial will study allergic patients compliance with avoidance procedures, comparing patients who use the mite test on a regular basis, with those who have educational materials but no test. Rapid tests will be developed for cat, dog and cockroach allergens, with the aim of producing a single allergen test card for multiple allergens that can be used to screen for allergen exposure in the home. PROPOSED COMMERCIAL APPLICATIONS: Effective consumer tests for allergens are not available. INDOOR Biotechnologies will market the test through distributors that sell allergen control products, indoor air quality testing services, and household cleaning products. Several companies have expressed strong interest in marketing the allergen tests. Our goals are to market 100,000 tests by the end of Phase II. Lateral flow technology will enable tests for food and latex allergens to be developed, as well as a new generation of rapid allergen diagnostic tests using genetically engineered allergens. The Phase II project will result in the development of consumer based allergen tests that will improve asthma management using environmental control procedures.