Peptide-based Multiplex Assay for Lyme disease Serodiagnosis

 描述（由申请人提供）：我们建议开发一种更灵敏、更特异的多重血清学检测方法，用于诊断莱姆病（LD）。LD是美国最常见的媒介传播的传染病，因此它是一个重要的公共卫生问题。 关心该疾病影响多个器官系统，包括肌肉骨骼、皮肤和神经系统，并包括在多种疾病的鉴别诊断中。在没有游走性红斑（早期LD的经典皮肤病变）的情况下，诊断是通过检测患者对伯氏疏螺旋体（Bb）的抗体反应来确定的，这些患者的客观结果提示了该疾病。及时诊断非常重要，因为LD的早期治疗限制或防止了对受影响系统的严重损害。目前的血清学诊断缺乏早期疾病的敏感性。我们通过绘制和定义在早期感染中表达的关键BB抗原的特异性线性B细胞表位，为新一代血清测定奠定了基础。我们从19种抗原中鉴定了适合用于基于多肽的测定的特异性表位。在与Bio-Rad实验室的合作中，我们将开发一种高灵敏度和特异性的Luminex（r）LD血清学诊断，该血清学诊断利用含有关键Bb抗原的特异性线性表位的多种肽。Luminex（r）X-Map正在成为大多数大型临床诊断实验室的标准技术。Bio-Rad的BioRad 2200目前在美国200多个地点使用，包括Quest Laboratories和LabCorp等商业临床实验室、马约和克利夫兰诊所等大型医疗集团以及许多大学医疗中心。我们的新颖和高度创新的方法将填补LD诊断的空白，特别是在早期LD，并将提供上级的特异性和灵敏度相比，目前的测定在LD的所有阶段。此外，我们与Bio-Rad实验室的合作为这项急需的技术的商业化提供了一条明确的成本效益途径。

 DESCRIPTION (provided by applicant): We propose to develop a more sensitive, specific multiplex serologic assay for the diagnosis of Lyme disease (LD). LD is the most common vector borne infectious disease in the United States, and as such it is a significant public health concern. The disease affects multiple organ systems including musculoskeletal, skin and nervous system, and is included in the differential diagnosis of multiple diseases. In the absence of Erythema migrans, the classic skin lesion of early LD, the diagnosis is established by the detection of an antibody response to Borrelia burgdorferi (Bb) in patients with objective findings suggestive of the disease. Prompt diagnosis is important because early treatment of LD limits or prevents serious damage to the systems affected. Current serodiagnostics lack sensitivity in early disease. We laid the ground work for a new generation of seroassays by mapping and defining the specific linear B cell epitopes of key Bb antigens expressed in early infection. We identified specific epitopes from 19 of antigens that are suited for use in multi- peptide-based assays. In collaboration with Bio-Rad Laboratories, we will develop a highly sensitive and specific Luminex(r) LD serodiagnostic utilizing multiple peptides containing specific linear epitopes key Bb antigens. Luminex(r) X-Map is becoming a standard technology in most large clinical diagnostic labs. Bio-Rad's BioPlex 2200 is currently used at over 200 locations in the US, including commercial clinical labs such as Quest Laboratories and LabCorp, large medical groups, such as the Mayo and Cleveland Clinics, and many University-based medical centers. Our novel and highly innovative approach will fill the void in LD diagnostics, especially in early LD, and will provide superior specificity and sensitivity compared to current assays in all phases of LD. In addition, our collaboration with Bio-Rad Laboratories offers a clear cost effective path to the commercialization of this much needed technology.