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

开发高度敏感和特异的 POCT 测试哮喘触发过敏性 IgE

基本信息

批准号：
10600767
负责人：
Ke Zhang
金额：
$ 27.57万
依托单位：
ALLERDIA INC
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-02-01 至 2024-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10600767
关键词：
Address Affinity Alaskan Allergens Allergic Alternaria American American Indians Antibodies Asian population Aspergillus fumigatus Asthma Betula Genus Binding Biological Assay Black race Canis familiaris Cessation of life Cladosporium Clinical Sensitivity Complex Data Detection Development Devices Dictyoptera Disadvantaged minority Economically Deprived Population Environmental Monitoring Extrinsic asthma Felis catus Future Goals Hispanic Hospitalization Hypersensitivity IgE Immobilization Immunoassay Individual Lateral Measurable Mediating Minority Groups Molds Pathway interactions Penicillium chrysogenum Phase Pollen Pyroglyphidae Resources Risk Sampling Sensitivity and Specificity Signal Transduction Small Business Innovation Research Grant Specificity Testing Time anti-IgE asthmatic clinical application clinical investigation clinically significant commercialization cost cross reactivity design detection sensitivity detector diagnostic accuracy environmental allergen falls follow-up health care availability health disparity manufacture minority health disparity nanoGold novel phase 2 study point of care point of care testing preservation prospective rapid test rapid testing response socioeconomic disadvantage technology platform underserved minority

项目摘要

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.

抽象的该项目的总体目标是开发并最终使新颖的护理测试能够商业化快速，高度准确地检测到对环境过敏原的过敏性IgE作为促进的方法健康的生活和减少少数族裔健康差异。美国哮喘的燃烧不成比例地落在黑色，西班牙裔和美洲印第安人/阿拉斯加人/亚洲人。这些少数群体具有最高的哮喘率，死亡和住院。 IgE介导的过敏性哮喘是主要类型的哮喘类型，包括〜75％在所有的哮喘中。触发IgE介导的过敏性哮喘的最相关的过敏原是环境由于过敏原而不成比例地影响社会经济处于弱势群体和少数群体他们的相对约束生活条件，可用资源较低和获得医疗保健的机会有限，导致现有的健康分配。因此，更准确，方便，低成本，快速和护理启用了IgE测试，能够通过克服误报来快速，准确地识别过敏性IgE 当前的IGE测试将是增强健康生活和降低少数民族健康的关键组成部分差异，但是当前尚未可用且尚未开发这种启用的IGE测试。在下面我们建议开发一种能够快速，准确检测的新型IgE测试方法对与过敏性哮喘相关的常见过敏原的过敏性IgE，以解决健康差异问题，使用Allerdia的专有反向侧向流免疫测定（R-LFIA）技术平台。在AIM 1中，我们将单独建立与哮喘相关的R-LFIA测试的单纯形式通过开发R-LFIA测试触发的IgE特异常见的花粉，桦木和精选的霉菌（notatum notatum，曲霉菌，herbarum cladosporium herbarum，具有高测试灵敏度和特异性的替代品。在AIM 2中，我们将开发一个保健点启用了具有多重能力的快速测试设备，以同时检测负责触发的过敏IgE 使用单个样本的过敏性哮喘。拟议的目标的实现将为A铺平道路这项新型IgE测试在确定负责任时的前瞻性临床研究和应用环境过敏原特异性IGE以快速的方式触发过敏性哮喘，并具有保健能力。