Urine Diagnostics for Aspergillosis

 描述(申请人提供)：曲霉病是一种严重的真菌感染，最常见的是因癌症、化疗和/或移植而导致免疫缺陷的人的肺部。尽管有很好的药物可用，但确定诊断是困难的，而且延迟治疗限制了我们在降低发病率和死亡率方面的进展。我们在动物模型和人类疾病模型中观察到曲霉多糖抗原从尿液中排出。使用一种新型的检测尿液中含有半乳呋喃糖曲霉菌抗原的单抗，我们已经开发出一种依靠横向流动技术的诊断测试，使其能够在接近护理点的地方使用。概念验证研究的结果表明，该设备在疾病过程中早期检测抗原。开发这一第一阶段应用程序是为了解决两个目标：1.确定该原型检测方法在用于辅助诊断可疑感染时的性能特征；以及2.确定该检测方法在用于筛查高危患者早期疾病时的性能特征。该检测的成功验证将使这一新检测方法在筛查和早期治疗策略中的使用进入第二阶段开发。

 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.