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

 描述（由申请方提供）：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。早期的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导致神经和肌肉骨骼系统的永久性损伤。因此，早期诊断对于确保良好的患者结局至关重要。莱姆病的实验室诊断依赖于抗B抗体的血清学检测。burgdorferi。然而，目前IgM和IgG莱姆病血清学诊断检测的灵敏度很少超过50%，用于检测早期疾病（5，8-14）。需要更有效的诊断分析。利用合成肽的血清诊断已证明在检测早期莱姆病的灵敏度和特异性方面有显著改善。本申请的重点是开发快速护理点（POC）装置，其利用由合成肽的混合物组成的测定靶标，所述合成肽对以下物质具有高度特异性： 由B表达的蛋白质。在早期感染中的Burgdorferi。多肽POC测定将提供高特异性的益处（来自于使用B特有的肽。burgdorferi），提高灵敏度（来自多种Bb抗原的肽的使用）和快速诊断。POC测定还将通过将准确诊断的时间减少到几分钟而不是几天来改进现有的常规测定。这将通过早期抗生素干预降低发生潜在衰弱性晚期疾病的可能性来改善患者结局。

 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.