Assay to detect early neurologic Lyme disease

检测早期神经系统莱姆病的检测

• 批准号: 6441380
• 负责人: STEVEN E SCHUTZER
• 金额: $ 15.89万
• 依托单位: BIOSCIENCE DEVELOPMENT, INC.
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-30 至 2006-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6441380
• 关键词: Lyme disease; antibody; bacterial antigens; central nervous system disorders; cerebrospinal fluid; clinical research; diagnosis design /evaluation; diagnostic tests; early diagnosis; human tissue; immunologic assay /test; nervous system infection; technology /technique development

DESCRIPTION (provided by applicant): Neurologic involvment is one of the most serious and common complications of Lyme disease (LD). Yet there is no reliable test available to detect this at an early stage. LD cases due to Borrelia burgdorferi (Bb) are increasing. Serious consequences can occur when Bb invades the central nervous system(CNS). Early detection of invasion would permit CNS-penetrating antibiotics to reduce sequelae. Our objective is to develop an assay to detect active CNS infection. Preliminary data suggests that Bb immune complexes (IC) analysis in cerebrospinal fluid (CSF) is a potential test. Specific Aim : To determine whether early neurologic LD patients have CSF IC which contain anti-Bb antibodies (Abs) and Bb antigens (Ags). Hypothesis: Early neurologic LD patients form IC in CSF. Rationale: In many infections IC Ab is found bound to its Ag target earlier than free Ab. In contrast to free Ab, specific IC Ab or Ag reflects active infection. Samples are already banked from neurologic LD patients with both erythema migrans AND microbiological confirmation. We will study blinded CSF specimens and compare CSF BbIC to free Bb Ab assays, PCR, and cultures (data already available). BbIC will be isolated by a proven simple technique, polyethylene glycol. BbIC Ab and Ag will be identified. Focus will be towards on specific and in vivo expressed Bb Ags. Results will be statistically analyzed. Phase 2 will be designed for broadscale usage and refinement.

描述（由申请人提供）：神经系统参与是最常见的问题之一 莱姆病（LD）的严重和常见并发症。但目前还没有可靠的 可进行测试以在早期阶段检测到这一点。疏螺旋体引起的 LD 病例 伯氏疏螺旋体 (Bb) 正在增加。 Bb入侵时会产生严重后果 中枢神经系统（CNS）。及早发现入侵将允许 中枢神经系统穿透性抗生素可减少后遗症。我们的目标是开发一个 检测活动性中枢神经系统感染的测定。初步数据表明 Bb 免疫 脑脊液 (CSF) 中的复合物 (IC) 分析是一项潜在的测试。 具体目标 : 确定早期神经性 LD 患者是否患有 CSF IC 其中含有抗 Bb 抗体 (Abs) 和 Bb 抗原 (Ags)。 假设：早期神经性 LD 患者在脑脊液中形成 IC。 理由：在许多感染中，IC Ab 更早地与其 Ag 靶点结合 比游离抗体。与游离 Ab 相比，特异性 IC Ab 或 Ag 反映了活性 感染。 已经从患有两种红斑的神经性 LD 患者中储存了样本 移行症和微生物学确认。我们将研究盲法脑脊液标本 并将 CSF BbIC 与游离 Bb Ab 测定、PCR 和培养物进行比较（数据已 可用的）。 BbIC 将通过一种经过验证的简单技术（聚乙烯）进行分离 乙二醇。将鉴定 BbIC Ab 和 Ag。重点将放在具体的 和体内表达的 Bb Ags。对结果进行统计分析。第二阶段 将被设计用于广泛使用和改进。