Urine Diagnostics for Aspergillosis

 描述（由申请人提供）：曲霉菌病是一种严重的真菌感染，最常见于癌症化疗和/或移植引起的免疫缺陷患者的肺部。虽然有好的药物，但诊断很困难，治疗过晚限制了我们在降低发病率和死亡率方面的进展。我们观察到曲霉多糖抗原在动物模型和人类疾病中排泄到尿液中。使用一种新的单克隆抗体，检测尿液中含半乳糖呋喃糖的曲霉菌抗原，我们已经开发出一种诊断测试，依赖于侧流技术，使在附近的护理点使用。概念验证研究的结果表明，该设备可以在疾病过程的早期检测抗原。这个第一阶段的应用程序是为了解决两个目标：1。确定该原型测定在用作诊断疑似感染的辅助时的性能特征;以及2.确定该检测试剂盒用于筛查早期疾病高危患者时的性能特征。该检测方法的成功验证将使II期开发能够在筛选和早期治疗策略中使用这种新的检测方法。

 DESCRIPTION (provided by applicant): Aspergillosis is a severe fungal infection that most frequently involves the lungs in people who have immune deficiency caused by cancer chemotherapy and/or transplantation. Although good drugs are available, establishing a diagnosis is difficult, and late treatment has limited our progress in decreasing morbidity and mortality. We observed that Aspergillus polysaccharide antigens are excreted in urine in animal models and humans with disease. Using a novel monoclonal Ab that detects galactofuranose-containing Aspergillus antigens in urine, we have developed a diagnostic test that relies on lateral flow technology, enabling use at near point-of- care. Results of proof-of-concept studies suggest that this device detects antigens early during the course of disease. This phase I application is developed to address two aims: 1. To determine the performance characteristics of this prototype assay when used as an aid to diagnose suspected infection; and 2. To determine the performance characteristics of this assay when used to screen high-risk patients for early disease. Successful validation of the assay will enable phase II development for use of this novel assay in screening and early treatment strategies.