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

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.