Antigen Detection Assay for the Diagnosis of Visceral Leismaniasis

描述(申请人提供)：抗原检测试验与传统的血清学试验不同，检测的是疾病状态，而不是宿主抗体对疾病病因的反应。因此，它既可用于诊断，也可用于疾病治疗随访。抗原检测方法已成功地用于各种传染病的诊断，包括化脓性链球菌引起的咽喉痛、肝炎、肺炎链球菌或嗜肺军团菌引起的肺炎以及阿米巴病。尽管抗原检测方法具有快速诊断活动性内脏利什曼病(VL)的潜力，但矛盾的是，该检测方法尚未完全用于这一严重疾病。利用超灵敏质谱学技术，我们最近从患者尿液中鉴定出了婴儿利什曼原虫的蛋白质。这些发现构成了本项目的基础，该项目旨在利用这些独特的蛋白以及其他待鉴定的蛋白来开发一种高度敏感和特异的抗原检测方法，用于准确诊断活动性VL。 公共卫生相关性：该SBIR项目旨在开发一种诊断内脏利什曼病(VL)的抗原检测方法。该提案的一般基础是基于支持者小组在内脏利什曼病(VL)患者尿液中发现的婴儿利什曼原虫蛋白。由于婴儿乳杆菌是VL的病原体，这些发现有力地支持了抗原检测方法的发展，用于诊断这种严重的疾病。

DESCRIPTION (provided by applicant): Antigen detection assay in contrast to conventional serological test, detects disease status and not the host antibody response to the disease etiological agent. It can therefore be used for both diagnosis and disease treatment follow-up purposes. Antigen detection assay has been successfully used for the diagnosis of different infectious diseases including sore throat caused by Streptococcus pyogenes, hepatitis, pneumonia caused by Streptococcus pneumoniae or Legionella pneumophilla, and amoebiasis. Although antigen detection assay has the potential to quickly diagnose active visceral leishmaniasis (VL), paradoxically this test has not yet been fully developed for this serious disease. Using the ultra-sensitive mass spectrometry technology we have recently identified proteins from the etiological agent of VL (Leishmania infantum) in the patients' urine. These findings constitute the foundation of the present project, which aims to use these unique proteins as well as other to be identified to develop a highly sensitive and specific antigen detection assay for the accurate diagnosis of active VL. PUBLIC HEALTH RELEVANCE: This SBIR project aims to develop an antigen detection assay for the diagnosis of visceral leishmaniasis (VL). The general foundation of the proposal is based on the proponent's group finding of Leishmania infantum proteins in the urine of patients with visceral leishmaniasis (VL). Because L. infantum is the etiological agent of VL these findings strongly support the development of an antigen detection assay for the diagnosis this serious disease.