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商业化一种新颖的即时护理测试能力快速、高度准确地检测环境过敏原的过敏性 IgE，作为促进健康生活并减少少数族裔的健康差异美国的哮喘负担过重。黑人、西班牙裔和美洲印第安人/阿拉斯加原住民/亚洲人的哮喘发病率最高。 IgE 介导的过敏性哮喘是哮喘的主要类型，约占 75%。在所有哮喘中，引发 IgE 介导的过敏性哮喘的最相关过敏原是环境过敏原。过敏原对社会经济弱势群体和少数群体造成不成比例的影响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也有限，导致因此，需要一种更准确、方便、低成本、快速的即时护理。启用 IgE 测试，能够通过克服假阳性快速准确地识别过敏性 IgE 当前的 IgE 检测将成为加强健康生活和减少少数族裔健康的努力的关键组成部分差异，但这种即时检测 IgE 测试目前尚不可用，且尚未开发。在此背景下，我们建议开发一种能够快速准确检测的新型 IgE 检测方法针对与过敏性哮喘相关的常见过敏原的过敏性 IgE 引发健康问题使用 Allerdia 专有的反向横向流动免疫分析 (R-LFIA) 技术平台解决差异问题。在目标 1 中，我们将单独建立 R-LFIA 测试通常与哮喘相关的 IgE 的单一形式通过开发针对猫、狗、屋尘螨、蟑螂等过敏原的 R-LFIA 测试 IgE 来触发，普通花粉、桦树和选定的霉菌（青霉、烟曲霉、Cladosporium herbarum、和链格孢属 (Alternaria alternata) 具有高测试灵敏度和特异性在目标 2 中，我们将开发一种即时检测方法。启用具有多重能力的快速测试设备，可同时检测负责触发的过敏性 IgE 使用单一样本来评估过敏性哮喘的目标的实现将为以下目标铺平道路：前瞻性临床研究以及这种新型 IgE 检测在确定致病原因方面的应用环境过敏原特异性 IgE 以快速方式触发过敏性哮喘，具有即时护理能力。