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来诊断莱姆病（LD）。 LD 是美国最常见的媒介传播传染病，因此它是一个重要的公共卫生问题 关心。该病累及肌肉骨骼、皮肤、神经系统等多个器官系统，被纳入多种疾病的鉴别诊断。在不存在游走性红斑（早期 LD 的典型皮肤病变）的情况下，通过检测患者体内对伯氏疏螺旋体 (Bb) 的抗体反应来确定诊断，客观结果提示该疾病。及时诊断很重要，因为 LD 的早期治疗可以限制或防止受影响系统的严重损害。目前的血清诊断方法对早期疾病缺乏敏感性。我们通过绘制和定义早期感染中表达的关键 Bb 抗原的特定线性 B 细胞表位，为新一代血清测定奠定了基础。我们从 19 种抗原中鉴定出适合用于基于多肽的测定的特定表位。我们将与 Bio-Rad Laboratories 合作，利用含有关键 Bb 抗原的特定线性表位的多种肽来开发高度敏感和特异的 Luminex(r) LD 血清诊断剂。 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 BioPlex 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、Mayo 和 Cleveland Clinics 等大型医疗集团以及许多大学医疗中心。我们新颖且高度创新的方法将填补 LD 诊断的空白，特别是早期 LD，并且与当前 LD 所有阶段的检测相比，将提供卓越的特异性和灵敏度。此外，我们与 Bio-Rad Laboratories 的合作为这一急需的技术的商业化提供了一条明确的、具有成本效益的途径。

 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.