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

 描述(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，晚期播散性感染如果得不到治疗，可能会对神经和肌肉骨骼系统造成永久性损害。因此，早期诊断对于确保良好的患者预后至关重要。莱姆病的实验室诊断依赖于对伯氏杆菌抗体的血清学检测。然而，目前的IgM和IgG莱姆病血清诊断试验对早期疾病的检测灵敏度很少超过50%(5，8-14)。需要更有效的诊断分析方法。利用合成肽的血清诊断方法在检测早期莱姆病方面的敏感性和特异性已有显著提高。本申请的重点是开发一种快速护理点(POC)设备，该设备利用由具有高度特异性的合成多肽的混合物组成的检测靶点 伯氏杆菌在感染早期表达的蛋白质。多肽POC分析将提供高特异性(通过使用伯氏杆菌特有的多肽)、提高灵敏度(通过使用来自多个BB抗原的多肽)和快速诊断的好处。POC检测还将改进现有的传统检测方法，将准确诊断的时间减少到几分钟，而不是几天。这将通过早期抗生素干预降低发生可能使人衰弱的晚期疾病的可能性，从而改善患者的预后。

 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.