Identification of Borrelia burgdorferi diagnostic biomarkers in humans and nonhum

描述（由申请人提供）：美国莱姆病病例的数量最近被CDC估计为每年30万例。这是一个重大的公共卫生问题。目前可用的诊断依赖于检测对莱姆病病原体伯氏疏螺旋体的抗体反应（血清学）。然而，在莱姆病的早期阶段，血清学检测并不准确。在患者样本中直接检测伯氏疏螺旋体抗原可能是准确早期诊断的唯一解决方案。本应用侧重于验证患者样品中存在伯氏疏螺旋体VlsE蛋白。VlsE最近被确定在莱姆病的非人类灵长类动物模型中积累。此外，该项目旨在通过使用一种名为体内微生物抗原发现（InMAD）的新型生物标志物发现平台，确定莱姆病的新诊断生物标志物。总体目标是确定多种早期莱姆病生物标志物，可以通过快速和敏感的免疫测定来靶向。

DESCRIPTION (provided by applicant): The number of Lyme disease cases in the US has been recently estimated by the CDC at 300,000 cases/year. This is major public health concern. Currently available diagnostics rely on detection of the antibody response (serology) to Borrelia burgdorferi, the causative agent of Lyme disease. However, serological tests are not accurate during the early stages of Lyme disease. Direct detection of B. burgdorferi antigens within patient samples may be the only solution to an accurate early diagnosis. This application focuses on validating the presence B. burgdorferi VlsE protein in patient samples. VlsE was recently determined to accumulate in a nonhuman primate model of Lyme disease. In addition, the project seeks to identify new diagnostic biomarkers for Lyme disease by utilizing a novel biomarker discovery platform termed, In vivo Microbial Antigen Discovery or InMAD. The overall goal is to identify multiple early Lyme disease biomarkers that can be targeted by a rapid and sensitive immunoassay.