MycoMEIA - Urine Diagnostic for Aspergillosis

曲霉病导致医学免疫受损患者的发病和死亡， 尤其是在癌症化疗和移植后。最近，我们见证了 流感相关曲霉病和COVID-19相关 曲霉病，使病毒感染重症患者的有效治疗复杂化。 结果很差，部分原因是我们缺乏容易检测的敏感诊断测试。 在高风险时期使用。在我们努力开发更简单的诊断测试的过程中，我们 发现含真菌呋喃半乳糖（galf）的抗原可从尿液中排出 被感染的动物和人，使用新的单克隆抗体。我们设计了一个 原型酶免疫测定称为MycoMEIA，并使用 从疑似和确诊IA患者中获得的尿样。结果表明 >80%的灵敏度和特异性，满足临床研究的预定指标。的一部分 这项提案，这项设计锁定的测定将进入临床研究，在三个临床 微生物实验室支持FDA 510 k申请。建议开展更多工作， 了解如何优化尿液分析以检测非血液学中的曲霉菌病 高危患者，包括重症监护室的COVID-19患者。成功实现里程碑 所描述的将导致第一种快速、易于使用的尿液诊断试剂的商业可用性， 检测这种重要的真菌感染，有可能降低疾病的患病率， 改善成果。

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.