MycoMEIA - Urine Diagnostic for Aspergillosis

曲霉病会导致医学免疫受损患者的发病率和死亡率， 尤其是在癌症化疗和移植之后。最近，我们目睹了 流感相关曲霉病和新冠肺炎相关病例增加 曲霉病，使病毒感染的危重患者的有效治疗复杂化。 结果很差，部分原因是我们缺乏敏感的诊断测试，这些测试很容易 在高风险时期使用。在我们努力开发更简单的诊断测试期间，我们 发现含有真菌半乳呋喃糖(GALF)的抗原会从尿液中排出 利用新的单抗，对受感染的动物和人进行检测。我们设计了一个 称为MycoMEIA的原型酶免疫分析，并使用 从疑似和确诊的IA患者身上采集尿样。结果显示 &gt；80%的敏感度和特异度，满足临床研究的预定义指标。作为以下内容的一部分 这项提议，这项设计锁定的试验将进入临床研究，在三个临床 微生物实验室支持FDA 510k应用。建议进行更多工作以 了解如何优化尿液化验以检测非血液病患者的曲霉菌病 有风险的患者，包括患有新冠肺炎的ICU患者。成功实现里程碑 介绍了将导致商业化的第一种快速、易用的尿液诊断方法 对这种重要的真菌感染进行检测，有可能降低疾病患病率和 改善结果。

Aspergillosis causes morbidity and death in medically immune compromised patients, especially after cancer chemotherapy and transplant. Recently, we have witnessed increased cases of influenza-associated aspergillosis and COVID-19-associated aspergillosis, complicating effective treatment in those critically ill with viral infections. Outcomes are poor in part because we lack sensitive diagnostic tests that are easy to use during high-risk periods. During our efforts to develop easier diagnostic tests, we discovered that fungal galactofuranose (galf)– containing antigens are excreted in urine of infected animals and people, using novel monoclonal antibodies. We engineered a prototype enzyme immunoassay called MycoMEIA, and performance was tested using urine samples obtained from patients with suspected and confirmed IA. Results showed >80% sensitivity and specificity, meeting predefined metrics for clinical study. As part of this proposal, this design-locked assay will move into clinical study, in three clinical microbiology laboratories to support FDA 510k application. Additional work is proposed to understand how the urine assay can be optimized to detect aspergillosis in non-hematology patients at risk, including ICU patients with COVID-19. Success in meeting the milestones described will lead to commercial availability of the first rapid, easy to use urine diagnostic assay for this important fungal infection, with potential to reduce disease prevalence and improve outcomes.