Peptide-based Multiplex Assay for Lyme disease Serodiagnosis

基于肽的莱姆病血清学诊断多重检测

• 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
• 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

 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)，莱姆病是美国最常见的媒介传播的传染病，因此它是一种重要的疾病。公共卫生 该疾病影响包括肌肉骨骼、皮肤和神经系统在内的多个器官系统，并被纳入多种疾病的鉴别诊断中。在没有早期 LD 的典型皮肤病变——游走性红斑的情况下，可通过检测以下疾病来确定诊断。客观发现提示该疾病的患者对伯氏疏螺旋体 (Bb) 产生抗体反应，及时诊断非常重要，因为 LD 的早期治疗可以限制或防止对受影响系统的严重损害。血清诊断在早期疾病中缺乏敏感性。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 种适合使用的抗原中鉴定出了特定表位。在基于多肽的检测中，我们将与 Bio-Rad 实验室合作，利用含有特定的多肽来开发一种高度灵敏且特异的 Luminex(r) LD 血清诊断剂。线性表位关键 Bb 抗原 Luminex(r) X-Map 正在成为大多数大型诊断临床实验室的标准技术，目前在美国 200 多个地点使用，包括 Quest Laboratories 等商业临床实验室。 LabCorp、大型医疗集团（例如 Mayo 和克利夫兰诊所）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，特别是在 LD 诊断领域。早期 LD，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 实验室的合作为这一急需的技术的商业化提供了一条明确的成本有效的途径。