In Vitro Assay for Chemical Allergens

描述(申请人提供)：过敏性接触性皮炎(ACD)是工业化国家最常见和最昂贵的健康问题之一。目前，有超过10万种化学品在商业使用，每年还有另外2000种新化学品和许多新产品配方被测试或上市。所有这些材料都必须进行过敏性筛查。 在第一阶段，开发了一种基于人树突状细胞的检测方法，可以对过敏原做出敏感和特异的反应。这种未经优化的检测方法比目前基于动物的检测方法便宜约10倍。此外，该分析避免了动物福利问题和与物种外推相关的不确定性。在第二阶段，将扩大测试材料的数据库，并最终确定体外检测方法和预测模型。将对该分析的重复性进行评估，并在证明实验室间可转移性后，进行多实验室GLP验证研究。最后，将开发一种优化的检测试剂盒，进一步增强体外方法的经济优势。 变态反应性接触性皮炎，体外试验，浆细胞样树突状细胞。与公共健康相关：一种用于评估化学品的过敏性接触性皮炎潜力的预测测试系统将在化妆品、个人卫生和局部药物产品涉及的行业中具有深远的应用。过敏性评估对于将职业和公众暴露于化学品和产品的危害降至最低很重要。拟议的基于人类细胞的分析将提供一种敏感和特异的过敏原筛选方法，无需使用实验室动物，而且成本较低。

DESCRIPTION (provided by applicant): Allergic contact dermatitis (ACD) is one of the most common and costly health problems in industrialized countries. Currently, more than 100,000 chemicals are in commercial use and another 2,000 new chemicals and numerous new-product formulations are tested or marketed every year. All of these materials must be screened for allergenicity. During Phase I, a human dendritic cell based assay was developed which gives sensitive and specific responses to allergens. The non-optimized assay is approximately a factor of 10 less expensive than current animal based tests. In addition, the assay avoids animal welfare issues and uncertainty related to species extrapolation. During Phase II, the database of materials tested will be expanded and the in vitro assay method and prediction model will be finalized. The reproducibility of the assay will be assessed and, after demonstration of interlaboratory transferability, a multi-lab GLP validation study will be performed. Finally, an optimized assay kit which further enhances the economic advantages of the in vitro method will be developed. Allergic contact dermatitis, in vitro testing, plasmacytoid DC. PUBLIC HEALTH RELEVANCE: A predictive test system for assessing the allergic contact dermatitis potential of chemicals will have far reaching application in industries involved in cosmetic, personal hygiene and topical pharmaceutical products. Evaluation of allergenicity is important to minimize the hazards of occupational and public exposure to chemicals and products. The proposed human cell based assay will provide a sensitive and specific method of allergen screening without the use of laboratory animals and at a reduced cost.