Urine Diagnostics for Aspergillosis

曲霉菌病的尿液诊断

• 批准号: 9409049
• 负责人: Kieren A. Marr
• 金额: $ 100.42万
• 依托单位: MYCOMED TECHNOLOGIES, LLC
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-02-01 至 2019-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9409049
• 关键词: Academic support; Address; Adopted; Aftercare; Animal Model; Animals; Antigens; Aspergillosis; Aspergillus; Award; Binding; Biological Assay; Blood; Breathing; Bronchoalveolar Lavage Fluid; Bronchoscopy; Cancer Etiology; Cessation of life; Characteristics; Clinical; Clinical Microbiology; Consent; Contracts; Development; Devices; Diagnosis; Diagnostic; Diagnostic tests; Disease; Early Diagnosis; Engineering; Environment; Freezing; Fungal Spores; Goals; Gold; Hematologic Neoplasms; Hematology; Human; Immobilization; Immune; Immune system; Industry Collaboration; Infection; Laboratories; Lateral; Lung; Lung diseases; Medical; Monoclonal Antibodies; Morbidity - disease rate; Mycoses; National Institute of Allergy and Infectious Disease; Organ Transplantation; Outcome; Patients; Performance; Phase; Pneumonia; Procedures; Production; Protocols documentation; Publishing; Quality Control; Reader; Reproducibility; Research Personnel; Resources; Risk; Sampling; Sensitivity and Specificity; Small Business Technology Transfer Research; Specificity; Technology; Test Result; Testing; Time; Training; United States National Institutes of Health; Universities; Urine; Work; base; cancer transplantation; cost; design; fungus; galactomannan; high risk; improved; killings; meetings; mortality; new technology; novel; performance tests; point of care; polyglucosan; pre-clinical; public-private partnership; success; tool development

Invasive aspergillosis (IA) continues to cause morbidity and death in medically immune compromised patients, largely because we lack sensitive diagnostic tests that are easy to use during high-risk periods. We discovered that fungal galactofuranose–containing antigens are excreted in urine of infected animals and people, using a novel monoclonal antibody (mAb476). In a phase I STTR, we engineered a lateral flow device (LFD) called AspUTest, and performance was tested using urine samples obtained from patients with suspected and confirmed IA. Results showed >90% sensitivity and specificity, meeting predefined metrics for continued development. This Phase II application is designed to meet the following Specific Aims: 1.To optimize production of the AspUTest device; 2. To determine performance characteristics of AspUTest as an aid to diagnose invasive aspergillosis using batched samples obtained from patients with hematological malignancies; and 3. To validate and test the performance of AspUTest in clinical microbiology laboratories. Meeting these aims will enable submission for FDA clearance of AspUTest, marking an important advance towards decreasing IA morbidity with expanded availability of a low cost, easy to use urine diagnostic.

侵袭性曲霉病（IA）继续在医学免疫领域引起发病和死亡。 妥协的病人，主要是因为我们缺乏敏感的诊断测试，很容易 在高风险时期使用。我们发现真菌中的含呋喃半乳糖 使用一种新的单克隆抗体， 抗体（mAb 476）。在第一阶段STTR中，我们设计了一种侧流装置（LFD）， AspUTest，并使用从患有以下疾病的患者获得的尿样测试性能： 怀疑和确认的IA。结果显示>90%的灵敏度和特异性，符合 预定义的指标，以持续发展。此第二阶段应用程序旨在 满足以下具体目标：1.优化AspUTest装置的生产; 2.到 确定AspUTest的性能特征，以辅助诊断侵入性 使用从血液病患者获得的批量样品， 恶性肿瘤;和3.验证和测试AspUTest在临床中的性能 微生物实验室满足这些目标将能够提交FDA批准 的AspUTest，标志着减少IA发病率的重要进展， 扩大了低成本、易于使用的尿液诊断的可用性。