Highly Sensitive and Specific MSD Multiplexed Autoimmune Disease Panel

高灵敏度和特异性 MSD 多重自身免疫性疾病组合

• 批准号: 9298562
• 负责人: Anu Mathew
• 金额: $ 37.89万
• 依托单位: MESO SCALE DIAGNOSTICS, LLC
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-07-06 至 2020-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9298562
• 关键词: Affect; Antibodies; Antigens; Applications Grants; Autoantibodies; Autoantigens; Autoimmune Diseases; Autoimmune Process; Autoimmune Responses; Binding; Bioinformatics; Biological Assay; Biological Markers; Blinded; Blood Tests; Celiac Disease; Clinical; Communities; Comorbidity; Data; Data Set; Detection; Development; Diabetes Mellitus; Diagnostic; Diagnostic tests; Disease; Evaluation; Florida; Goals; Government; Graves' Disease; High Prevalence; Human; Immobilization; Immune; Immunoassay; Immunoglobulins; Individual; Insulin-Dependent Diabetes Mellitus; Label; Laboratories; Measures; Metabolic syndrome; Methods; National Institute of Allergy and Infectious Disease; Obesity; Organ; Patients; Performance; Persons; Phase; Plasma; Population; Procedures; Protocols documentation; Radioactivity; Reagent; Research; Sampling; Sensitivity and Specificity; Serologic tests; Serological; Serum; Signal Transduction; Solid; Specificity; Support Contracts; Technology; Testing; United States National Institutes of Health; Universities; Validation; assay development; base; case control; chronic autoimmune disease; cohort; effective therapy; immunoreactivity; new technology; novel; programs; public health relevance; systemic autoimmune disease

 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.

 描述（由申请人提供）：自身免疫性疾病是一种慢性衰弱性疾病，共同影响5%至8%的美国人口。自身免疫性疾病的高患病率和认识到发展器官特异性自身免疫性病症的个体具有发展另外的自身免疫性病症的高可能性，这要求开发可以在小样本体积中同时测量多种免疫反应性的新技术。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。尽管已经实现了多达13种系统性自身免疫性疾病相关检测的多重检测，但尚未开发更广泛的检测组来评估器官特异性自身免疫性疾病（如1型糖尿病和乳糜泻）的范围。此外，不存在使用桥接免疫测定形式的多重测定组，其与经典血清学测定形式相比提供更高的测定特异性。该项目的目标是开发一种新型、高灵敏度和特异性的基于溶液的多重桥接免疫测定组，该免疫测定组可以同时检测与至少12种主要器官特异性自身免疫疾病相关的25种不同自身免疫反应性的患者自身抗体。多重自身抗体检测组将使用灵敏的Meso Scale Diagnostics，LLC。(MSD)多阵列技术。我们在佛罗里达大学的合作者，W.E. Winter和D. Pittmann将在与肥胖、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提供广泛的专业知识，并将提供高质量的病例和对照样本，用于面板开发、测试和验证。