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

• 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
• 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

 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）： 莱姆病由伯氏疏螺旋体感染引起，是北美和欧洲最常见的媒介传播传染病。早期疾病可以用抗生素有效治愈；然而，未经治疗的晚期播散性感染可能会对神经和肌肉骨骼系统造成永久性损害。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依赖于伯氏疏螺旋体抗体的血清学检测。然而，当前 IgM 和 IgG 莱姆病血清诊断检测的敏感性很少超过 50%，用于检测早期疾病 (5, 8-14)。需要更有效的诊断测定。利用合成肽的血清诊断已证明早期莱姆病检测的敏感性和特异性显着提高。该应用的重点是开发一种快速护理点 (POC) 设备，该设备利用由高度特异性的合成肽混合物组成的检测目标。 伯氏疏螺旋体在早期感染期间表达的蛋白质。多肽 POC 检测具有高特异性（通过使用伯氏疏螺旋体特有的肽）、提高敏感性（通过使用来自多种 Bb 抗原的肽）和快速诊断等优点。 POC 检测还可以将准确诊断的时间从几天缩短到几分钟，从而改进现有的传统检测。这将通过早期抗生素干预降低发展为潜在的使人衰弱的晚期疾病的可能性，从而改善患者的治疗结果。