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

• 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
• 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

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.

摘要 该项目的总体目标是开发并最终商业化一种新的即时检测， 快速和高度准确地检测对环境过敏原的过敏性IgE，作为促进 健康生活和减少少数群体健康差距。美国哮喘的负担不成比例地福尔斯在 黑人、西班牙裔和美洲印第安人/阿拉斯加原住民/亚洲人。这些少数群体的哮喘发病率最高 率、死亡率和住院率。IgE介导的过敏性哮喘是哮喘的主要类型，约占75%。 所有哮喘患者中的一个最相关的过敏原触发IgE介导的过敏性哮喘是环境 过敏原，不成比例地影响社会经济弱势群体和少数民族， 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， 现有的健康差距。因此，一种更准确、方便、低成本、快速和即时的 能够通过克服过敏性IgE的假阳性而快速和准确地鉴定过敏性IgE的启用的IgE测试， 目前的IgE测试将是努力提高健康生活和减少少数民族健康的关键组成部分， 尽管存在差异，但是这种即时护理使能的IgE测试目前不可用并且还有待开发。下 在此背景下，我们建议开发一种新型的IgE检测方法，能够快速准确地检测 过敏性IgE针对常见的过敏原引发的过敏性哮喘，以解决健康 使用Allerdia专有的反向侧流免疫分析（R-LFIA）技术平台， 在目标1中，我们将单独建立一种单一形式的R-LFIA检测IgE通常与哮喘相关 通过开发对猫、狗、屋尘螨、蟑螂的过敏原特异性IgE的R-LFIA测试触发， 普通花粉、桦树和选择的霉菌（青霉，烟曲霉，草枝孢， 和链格孢属（Alternaria alternata）），具有高检测灵敏度和特异性。在目标2中，我们将开发一种即时护理 具有多重能力的能够同时检测引起触发的过敏性IgE的快速检测装置 过敏性哮喘的诊断。实现拟议目标将为 前瞻性临床研究和应用这种新的IgE检测在确定负责 环境过敏原特异性IgE触发过敏性哮喘，以快速的方式与现场护理能力。