Peptide-based Multiplex Assay for Lyme disease Serodiagnosis

基于肽的莱姆病血清学诊断多重检测

基本信息

批准号：
9045060
负责人：
Paul Michael Arnaboldi
金额：
$ 17.63万
依托单位：
BIOPEPTIDES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-01-01 至 2016-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9045060
关键词：
Acute Address Affect Antibodies Antibody Formation Antibody Response Antigen Targeting Antigens Area B-Lymphocyte Epitopes Bacteria Binding Binding Proteins Bioinformatics Biological Assay Blinded Blood donor Borrelia burgdorferi Centers for Disease Control and Prevention (U.S.)Clinic Clinical Collaborations DBL Oncoprotein Data Detection Development Diagnosis Diagnostic Differential Diagnosis Disease Early treatment Enzyme-Linked Immunosorbent Assay Epitopes Generations Goals Human Immune response Immunoglobulin G Immunoglobulin M Individual Infection Integrin Binding Knowledge Laboratories Lasers Lateral Legal patent Link Location Lyme Arthritis Lyme Disease Maps Measures Medical Medical center Musculoskeletal Nervous system structure Neurologic OspC protein Patients Peptides Phase Proteins Public Health Recombinant Proteins Recombinants Running Sampling Sensitivity and Specificity Series Serodiagnoses Serological Serum Site Skin Small Business Innovation Research Grant Specificity System Systemic Lupus Erythematosus Technology Testing Time United States Universities Vector-transmitted infectious disease Visit Weight Western Blotting Work base body system commercialization cost effective decorin binding protein B disease diagnosis erythema migrans improved innovation novel prevent prospective public health relevance research study response skin lesion synthetic polymer Bioplex

项目摘要

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.

描述（由适用提供）：我们建议开发一种更敏感的，具体的多重血清学测定法，以诊断莱姆病（LD）。 LD是美国最常见的媒介传染病，因此是重要的公共卫生忧虑。该疾病会影响多个器官系统，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。在缺乏红斑偏移的情况下，早期LD的经典皮肤病变是通过发现对该疾病的客观发现的患者的抗体反应来确定诊断的。及时诊断很重要，因为早期治疗LD限制或防止对受影响系统的严重损害。当前的血清诊断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细胞表位来为新一代的血清测量奠定了基础工作。我们确定了适合用于基于多肽的测定法中的19种抗原的特定表位。通过与Bio-Rad实验室合作，我们将利用包含特定线性表位关键BB抗原的多个宠物来开发高度敏感和特定的Luminex（R）LD血清诊断。在大多数大型临床诊断实验室中，Luminex（R）X-MAP已成为一种标准技术。 Bio-Rad的Bioplex 2200目前在美国的200多个地点使用，包括Quest Laboratories和Labcorp等商业临床实验室，大型医疗团体，例如Mayo和Cleveland诊所，以及许多基于大学的医疗中心。我们的新颖和高度创新的方法将填补LD诊断的空隙，尤其是在早期LD中，并且与LD的所有阶段相比，与当前的Assas相比，将提供更高的特异性和敏感性。此外，我们与Bio-Rad Laboratories的合作为这项急需的技术的商业化提供了清晰的成本效益途径。