Development of a highly sensitive and specific POCT testing asthma triggering allergic IgE

摘要 该项目的总体目标是开发并最终商业化一种能够 快速、高精度地检测环境过敏原的过敏性IgE作为一种促进 健康生活，减少少数群体的健康差距。美国哮喘的负担不成比例地落在 黑人、西班牙裔和美国印第安人/阿拉斯加原住民/亚洲人。这些少数群体的哮喘发病率最高 死亡率、死亡率和住院率。免疫球蛋白介导的过敏性哮喘是哮喘的主要类型，约占75% 在所有的哮喘中。引发IgE介导的过敏性哮喘的最相关的过敏原是环境 因以下原因对社会经济弱势群体和少数群体造成不成比例影响的过敏原 他们的生活条件相对有限，可用资源较少，获得医疗保健的机会有限，导致 现有的健康差距。因此，更准确、更方便、更低成本、更快速、更具保健性 启用了IgE检测，通过克服假阳性，能够快速准确地识别过敏性IgE 目前的免疫球蛋白E检测将是促进健康生活和减少少数群体健康的努力的关键组成部分 但目前还没有这样一种启用护理点的免疫球蛋白E检测，而且还没有开发出来。在……下面 在这样的背景下，我们提出了开发一种新的能够快速准确地检测IgE的方法 针对与过敏性哮喘相关的常见过敏原的过敏性IgE触发解决健康问题 差异问题，使用Allerdia专有的反向侧向流动免疫分析(R-LFIA)技术平台。 在目标1中，我们将单独建立与哮喘相关的R-LFIA检测IgE的单纯格式 通过开发R-LFIA检测猫、狗、屋尘螨、蟑螂、 常见的花粉、桦树和选定的霉菌(青霉菌、烟曲霉、草枝孢子菌、 和链格孢菌)，具有较高的检测敏感性和特异性。在目标2中，我们将开发一种护理点 可同时检测负责触发的过敏性IgE的多路快速检测装置 使用单一样本的过敏性哮喘。拟议目标的实现将为 新型免疫球蛋白E检测在确定责任人中的前瞻性临床研究和应用 环境过敏原特异性免疫球蛋白E可快速触发过敏性哮喘，具有护理点能力。

Abstract The overall goal of this project is to develop and eventually commercialize a novel point-of-care test capable of rapidly and highly accurately detecting allergic IgE to environmental allergens as an approach to promote healthy living and reduce minority health disparities. The burden of asthma in the US falls disproportionately on Black, Hispanic and American Indian/Native Alaskans/Asians. These minority groups have the highest asthma rates, deaths and hospitalizations. IgE-mediated allergic asthma is the major type of asthma, consisting of ~75% of all the asthmas. The most relevant allergens triggering IgE-mediated allergic asthma are environmental allergens that disproportionately impact the socioeconomically disadvantaged population and minorities due to their relatively constraint living conditions, lower available resources and limited access to healthcare, leading to the existing health disparities. Therefore, a more accurate, convenient, low-cost, rapid and point-of-care enabled IgE test capable of rapidly and accurately identifying allergic IgE by overcoming false positivity of the current IgE tests would be a key component in efforts to enhance healthy living and reduce minority health disparities, but such a point-of-care enabled IgE test is not currently available and yet to be developed. Under such background we propose to develop a novel IgE testing approach capable of rapidly and accurately detecting allergic IgE against the common allergens associated with allergic asthma triggering to address the health disparity issue, using Allerdia’s proprietary Reverse Lateral Flow ImmunoAssay (R-LFIA) technology platform. In Aim 1, we will individually establish a simplex format of R-LFIA testing IgE commonly associated with asthma triggering by developing R-LFIA testing IgE specific for allergens of cat, dog, house-dust mite, cockroach, common pollen, birch, and selected molds (Penicillium notatum, Aspergillus fumigatus, Cladosporium herbarum, and Alternaria alternata) with high test sensitivity and specificity. In Aim 2, we will develop a point-of-care enabled rapid test device with multiplex capacity to simultaneously detect allergic IgE responsible for triggering of allergic asthmas using single sample. Accomplishment of the proposed Aims will pave the way for a prospective clinical investigation and application of this novel IgE testing in determining the responsible environmental allergen-specific IgE triggering allergic asthma in a rapid fashion with point-of-care capacity.