Development of a plasmonic-based multiplexed platform for Diagnosis and Screening of Type 1 Diabetes and related Auto-Immune Diseases

开发基于等离子体的多重平台，用于 1 型糖尿病和相关自身免疫性疾病的诊断和筛查

• 批准号: 8981968
• 负责人: Joshua Tucker Robinson
• 金额: $ 20.7万
• 依托单位: NIRMIDAS BIOTECH, INC.
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-08-15 至 2016-08-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8981968
• 关键词: Accounting; Adult; Antibodies; Antigens; Autoantibodies; Autoimmune Diabetes; Autoimmune Diseases; Autoimmune Process; Biological Assay; Biological Markers; Celiac Disease; Child; Clinic; Clinical Research; Collaborations; Data; Detection; Developing Countries; Development; Diabetes Mellitus; Diagnosis; Diagnostic tests; Disease; Early Diagnosis; Effectiveness; Enzyme-Linked Immunosorbent Assay; Epidemic; Epidemiology; Fluorescence; Foundations; Generations; Goals; Gold; Health; High Prevalence; Hour; Immune; Immune System Diseases; Immunoassay; Immunoglobulin G; Insulin; Insulin-Dependent Diabetes Mellitus; Intervention; Legal patent; Link; Morbidity - disease rate; Non-Insulin-Dependent Diabetes Mellitus; Obesity; Patients; Performance; Phase; Pilot Projects; Population; Production; Protocols documentation; Radioimmunoassay; Radioisotopes; Resources; Risk; Sampling; Sensitivity and Specificity; Serum; Signal Transduction; Standardization; Surface Plasmon Resonance; Technology; Testing; Time; World Health Organization; autoimmune thyroid disease; base; clinical Diagnosis; commercialization; disease diagnosis; electric field; fluorophore; improved; instrumentation; islet; nano; nanocoating; nanostructured; plasmonics; prevent; programs; prototype; public health relevance; rapid detection; scale up; screening; type I and type II diabetes

 DESCRIPTION (provided by applicant): The World Health Organization projects that the global diabetes cases will increase from 217 million in 2005 to 366 million by 2030 [1]. The rate of type-1 or autoimmune diabetes (T1D) in children is rising by 3% annually with a projected 70% increase between 2004 and 2020, while the rate of type-2 diabetes (T2D) has also been increasing exponentially in children partly due to the global obesity epidemic. Diagnosis of these diseases has become increasingly difficult. Currently, T1D diagnosis and screening tests for new, on-set patients are done by slow and costly radioimmunoassay (RIA), delaying definitive diagnosis and timely treatment. The RIA test may take up to two weeks to deliver a diagnosis, but clinical intervention is needed for T1D diagnosis in 24 hours or less in some cases. Due to the need for radioisotope generation and detection, the T1D test is inaccessible to developing countries and regions of the world with limited resources. Also, latent autoimmune diabetes adults (LADA) cases with positive autoantibodies are common, accounting for a non-trivial fraction of adult type-2 diabetes patients. Antibodies testing and screening for adult diabetes patients would also provide valuable information and guidance to LADA patient management and treatment. Of note, with T1D there is a markedly higher prevalence of Celiac Disease and Autoimmune Thyroid Disease (ATD), which are considered linked diseases. In US, autoimmune thyroid disease occurs in ~ 15 - 30% T1D patients and Celiac Disease occurs in 4 - 9% of T1d patients. We propose to develop and clinically test a multiplexed auto-immune antibody chip with simultaneous diagnosis of T1D, Celiac Disease, and ATD. The chip will provide a rapid, fluorescence-based diagnostic test using existing instrumentation found in the clinic, made possible by the unique signal-enhancing technology, pGOLD, available to Nirmidas Biotech. The pGOLD chip will detect autoantibodies in a patient's serum that indicate T1D, Celiac Disease, and ATD with the same performance as RIA in just 1-2 hours. This project will test the pGOLD chip with 150 patient serum samples as a pilot study as the initial step towards gaining regulatory approval and commercialization of the chip.

 描述（申请人提供）：世界卫生组织预测全球糖尿病病例将从2005年的2.17亿增加到2030年的3.66亿[1]。儿童1型或自身免疫性糖尿病（T1 D）的发病率每年上升3%，预计2004年至2020年期间将增加70%，而儿童2型糖尿病（T2 D）的发病率也呈指数级增长，部分原因是全球肥胖流行。这些疾病的诊断变得越来越困难。目前，T1 D的诊断和筛查测试新的，发病的患者是通过缓慢和昂贵的放射免疫测定（RIA），延迟明确的诊断和及时治疗。RIA测试可能需要长达两周的时间才能做出诊断，但在某些情况下，需要在24小时或更短时间内进行T1 D诊断的临床干预。由于需要放射性同位素的产生和检测，T1 D测试对于世界上资源有限的发展中国家和地区来说是无法实现的。此外，具有阳性自身抗体的潜伏性自身免疫性糖尿病成人（LADA）病例是常见的，占成人2型糖尿病患者的非微不足道的部分。对成年糖尿病患者进行抗体检测和筛查也将为旱地退化评估患者的管理和治疗提供宝贵的信息和指导。值得注意的是，与T1 D有一个显着更高的患病率乳糜泻和自身免疫性甲状腺疾病（ATD），这被认为是相关的疾病。在美国，自身免疫性甲状腺疾病发生在约15 - 30%的T1 D患者中，乳糜泻发生在4 - 9%的T1 D患者中。我们建议开发和临床测试多重自身免疫抗体芯片，同时诊断T1 D，乳糜泻和ATD。该芯片将提供一个快速的，基于荧光的诊断测试使用现有的仪器在临床上发现，使独特的信号增强技术，pGOLD，提供给Nirmidas生物技术。pGOLD芯片将在1-2小时内检测患者血清中指示T1 D、乳糜泻和ATD的自身抗体，其性能与RIA相同。该项目将使用150份患者血清样本测试pGOLD芯片，作为获得监管批准和芯片商业化的第一步。