Highly Sensitive and Specific MSD Multiplexed Autoimmune Disease Panel

 描述(由申请人提供)：自身免疫性疾病是一种慢性衰弱疾病，总共影响5%至8%的美国人口。自身免疫性疾病的高度流行，以及认识到患有器官特异性自身免疫性疾病的人很有可能患上额外的自身免疫性疾病(S)，要求开发能够在小样本量中同时测量多种免疫反应的新技术。在发病前或早期发现这些疾病有助于做出有效的治疗决定。尽管已经实现了对系统性自身免疫性疾病的多达13种相关检测的多路复用，但还没有开发出更广泛的小组来评估器官特异性自身免疫性疾病的范围，如1型糖尿病和腹腔疾病。此外，不存在使用桥接免疫分析格式的多路分析小组，与经典的血清学分析格式相比，桥接免疫分析格式提供了更高的分析特异性。该计划的目标是开发一种新颖、高灵敏度和特定溶液的多重桥接免疫分析小组，该小组可以同时检测与至少12种主要器官特异性自身免疫性疾病相关的25种不同自身免疫反应的患者自身抗体。多重自身抗体检测小组将使用敏感的中尺度诊断，LLC。(MSD)多阵列技术。我们在佛罗里达大学的合作者W.E.温特博士和D.皮特曼博士将提供与肥胖、糖尿病和代谢综合征相关的自身免疫性疾病的临床实验室评估方面的广泛专业知识，并将提供高质量的病例和对照样本，用于小组开发、测试和验证。

 DESCRIPTION (provided by applicant): Autoimmune diseases are chronic debilitating conditions that collectively affect 5 to 8 % of the US population. The high prevalence of autoimmune diseases and the recognition that individuals who develop organ-specific autoimmune conditions have a high likelihood of developing additional autoimmune disorder(s) calls for the development of new technologies that can measure multiple immune reactivities simultaneously in a small sample volume. Detection of these diseases before onset or at early stages can help in making effective treatment decisions. Although multiplexing of up to 13 relevant assays for systemic autoimmune diseases has been achieved, broader panels have not been developed to assess the range of organ-specific autoimmune diseases such as Type 1 Diabetes and Celiac disease. Furthermore, no multiplexed assay panels exist that use a bridging immunoassay format, which provides higher assay specificity as compared to classical serological assay formats. The goal of the proposed program is to develop a novel, highly sensitive, and specific solution-based multiplexed bridging immunoassay panel that can simultaneously detect patient autoantibodies for 25 different autoimmune reactivities relevant to at least 12 major organ-specific autoimmune diseases. The multiplexed autoantibody detection panel will use sensitive Meso Scale Diagnostics, LLC. (MSD) MULTI-ARRAY technology. Our collaborators at the University of Florida, Dr. W.E. Winter and D. Pittmann, will provide their extensive expertise in clinical laboratory assessment of autoimmune diseases related to obesity, diabetes and the metabolic syndrome, and will provide high quality case and control samples for use in panel development, testing, and validation.