Antigen Detection Assay for the Diagnosis of Visceral Leismaniasis

描述（由申请人提供）：抗原检测试验与常规血清学试验相比，检测疾病状态，而不是宿主对疾病病原的抗体反应。因此，它可以用于诊断和疾病治疗的后续目的。抗原检测试验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喉咙痛、肝炎、肺炎链球菌或嗜肺军团菌引起的肺炎、阿米巴病等。尽管抗原检测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，这种检测方法尚未完全用于这种严重疾病。利用超灵敏质谱技术，我们最近在患者尿液中鉴定出了VL（婴儿利什曼原虫）病原的蛋白质。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质以及其他待鉴定的蛋白质开发一种高灵敏度和特异性的抗原检测方法，以准确诊断活动性VL。

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.