A Rapid Point-of-Care Assay for the Diagnosis of Lyme Disease

诊断莱姆病的快速护理点检测

基本信息

批准号：
9135755
负责人：
Paul Michael Arnaboldi
金额：
$ 15.18万
依托单位：
BIOPEPTIDES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-06-10 至 2017-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9135755
关键词：
Address Adjustment Disorders Antibiotics Antibodies Antigen Targeting Antigens B-Lymphocyte Epitopes Bacteria Bedside Testings Binding Proteins Biological Assay Borrelia burgdorferi Centers for Disease Control and Prevention (U.S.)Clinical Collaborations DBL Oncoprotein Detection Development Devices Diagnosis Diagnostic Disease Disease Progression Early Diagnosis Early treatment Ensure Enzyme-Linked Immunosorbent Assay Epitopes Europe Generations Goals Human Immune response Immunoglobulin G Immunoglobulin M Individual Infection Integrin Binding Intervention Laboratories Laboratory Diagnosis Left Legal patent Link Lyme Arthritis Lyme Disease Maps Musculoskeletal System Nervous system structure North America OspC protein Patient-Focused Outcomes Patients Peptides Performance Phase Physicians Proteins Rheumatoid Arthritis Sensitivity and Specificity Serodiagnoses Serological Serum Small Business Innovation Research Grant Specificity Speed Staging Syphilis Technology Testing Time United States Vector-transmitted infectious disease Western Blotting Work accurate diagnosis base cross reactivity decorin binding protein B diagnostic assay efficacy testing erythema migrans human disease improved individual patient linear transformation point of care prevent prototype public health relevance rapid diagnosis response synthetic peptide

项目摘要

DESCRIPTION (provided by applicant): Lyme disease, caused by infection with Borrelia burgdorferi, is the most common vector borne infectious disease in North America and Europe. Early disease can be effectively cured with antibiotics; however, untreated late disseminated infection can result in permanent damage to the nervous and musculoskeletal systems. Therefore, early diagnosis is critical for ensuring good patient outcomes. The laboratory diagnosis of Lyme disease is dependent upon the serological detection of antibodies against B. burgdorferi. However, the sensitivity of current IgM and IgG Lyme disease serodiagnostic assays seldom exceeds 50% for the detection of early disease (5, 8-14). More effective diagnostic assays are needed. Serodiagnostics utilizing synthetic peptides have demonstrated significant improvements in sensitivity and specificity for the detection of early Lyme disease. The focus of this application is the development of a rapid point of care (POC) device that utilizes an assay target consisting of a mixture of synthetic peptides that are highly specific for proteins expressed by B. burgdorferi during early infection. A multi-peptide POC assay would offer the benefits of high specificity (from the use of peptides unique to B. burgdorferi), elevate sensitivity (from the use of peptides from multiple Bb antigens), and rapid diagnosis. A POC assay would also improve upon existing conventional assays by reducing the time of accurate diagnosis to a few minutes rather than several days. This would improve patient outcome by reducing the likelihood of developing potentially debilitating late stage disease through early antibiotic intervention.

描述（由申请人提供）：莱姆病是由伯氏疏螺旋体感染引起的，是北美和欧洲最常见的媒介传播的传染病，早期疾病可以用抗生素有效治愈；然而，未经治疗的晚期传播感染可能会导致永久性感染。因此，早期诊断对于确保患者良好的治疗效果至关重要，莱姆病的实验室诊断取决于针对布鲁氏菌的血清学检测。然而，目前莱姆病 IgM 和 IgG 血清诊断检测的灵敏度很少超过 50%（5, 8-14），需要使用合成肽的更有效的血清诊断检测来显着提高灵敏度。该应用的重点是开发一种快速护理点 (POC) 设备，该设备利用由合成混合物组成的检测目标。具有高度特异性的肽伯氏疏螺旋体在早期感染期间表达的蛋白质将具有高特异性（通过使用伯氏疏螺旋体独特的肽）、提高敏感性（通过使用来自多种 Bb 抗原的肽）的优点， POC 检测还可以将准确诊断的时间缩短到几分钟而不是几天，从而改进现有的常规检测，这将通过减少早期抗生素发展为潜在的使人衰弱的晚期疾病的可能性来改善患者的治疗结果。干涉。