Core--Diagnostics

核心——诊断

• 批准号: 7150234
• 负责人: Robert G Hamilton
• 金额: $ 12.67万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-07-01 至 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7150234
• 关键词: allergens; biomedical facility; cooperative study; diagnostic respiratory lavage; histology; hypersensitivity; immunoglobulin E; immunologic assay /test; in situ hybridization; serology /serodiagnosis; technology /technique development

The allergen-specific IgE antibody to total serum IgE ratio is a key variable being investigated in relation to allergic symptom induction in this Program Project. The Diagnostic Core will conduct two main activities. In Aims 1 and 2, the Diagnostic Core will provide a service function in which analytical measurements will be performed on serum, cells, tissues, and lavage fluids collected on subjects in the project using validated assays. In Aims 3 and 4, the Diagnostic Core will investigate several hypotheses fundamental to improving the analytical sensitivity of allergen-specific IgE assays and validating the accuracy of the total and "free" (non-Omalizumab bound) total and allergen-specific IgE assays. More specifically, in Aim 1, the Diagnostic Core will provide state-of- the-art serologic, immunohistology, in situ hybridization, mediator and cytokine, nasal lavage chemistries and aeroallergen testing on specimens collected during recruitment and the longitudinal monitoring phases of the studies. Serologic testing (total and allergen-specific IgE, tryptase), nasal lavage chemistries, immunohistology, in situ hybridization, aeroallergen (Pel d 1) and cat extract validation will be performed in or under the auspices of the CLIA-88 certified Johns Hopkins Dermatology Allergy and Clinical Immunology (DACI) Reference Laboratory. In Aim 2, The Diagnostic Core Group will quantify "free" (non-Omalizumab bound) total IgE measurements in serum of subjects who have received Omalizumab to reduce free IgE levels, using our newly developed immunoenzymetric assay. A free allergen-specific IgE antibody assay will also be developed and configured on the ImmunoCAP platform to permit free specific to total IgE ratios to be computed. Aim 3 will investigate the hypothesis that 1 nanogram of allergen-specific IgE antibody as measured in a 3rd generation FDA-cleared assay equals 1 nanogram of total serum IgE. Verification of this quantitative relationship is critical to the accurate measurement of the specific to total IgE ratio. Aim 4 will investigate the hypothesis that the allergen-specific to total serum IgE ratio in allergic subjects before treatment with an IgE lowering drug (Omalizumab) remains constant for months during and following treatment, despite a expected many fold increase in total serum IgE. It is anticipated that Aims 3 and 4 will be completed within year 1 of the program so that free specific to total IgE ratio measurements will be available to investigations conducted in the 3 projects in this program.

对总血清IgE比率的过敏原特异性IgE抗体是研究的关键变量 该计划项目中的过敏症状诱导。诊断核心将进行两项主要活动。在 目的1和2，诊断核心将提供一个服务功能，其中分析测量将为 使用经过验证的测定法对项目中的受试者收集的血清，细胞，组织和灌洗液进行。 在目标3和4中，诊断核心将调查几个基本的假设，以改善分析 过敏原特异性IgE分析的敏感性并验证总和“免费”的准确性 绑定）总和过敏原特异性IgE分析。更具体地说，在AIM 1中，诊断核心将提供最新 ART血清学，免疫组织学，原位杂交，介体和细胞因子，鼻腔灌洗化学和 对募集过程中收集的标本和纵向监测阶段收集的标本测试 研究。血清学测试（总和过敏原特异性IgE，胰蛋白酶），鼻腔灌洗化学，免疫组织学， 原位杂交，将在主持人或下进行猫萃取验证（PEL D 1）和CAT提取物验证 CLIA-88认证的Johns Hopkins皮肤病学和临床免疫学（DACI）参考 实验室。在AIM 2中，诊断核心组将量化“自由”（非摩alizab结合）总IgE 使用我们的新的 开发的免疫酶法测定法。也将开发免费的过敏原特异性IgE抗体测定法，并 配置在免疫平台上，以允许计算自由到总IgE比率。目标3意志 研究以下假设：在第三代中测量的1个过敏原特异性IgE抗体的纳米图 FDA清除测定等于1纳米血清IgE。验证这种定量关系至关重要 准确测量特异性与总IgE比率。 AIM 4将调查以下假设 过敏原特异性血清IgE比在过敏性受试者中使用IgE降低药物治疗前 （Omalizumab）在治疗期间和之后几个月保持恒定，尽管预计会有很多折叠 总血清IgE增加。预计目标3和4将在该计划的第1年内完成，因此 该特定于总IGE比率测量的自由度将用于在3个项目中进行的调查 这个程序。