Point-of-care antigen detection assay for early diagnosis of Ebola virus disease (EVD)

用于早期诊断埃博拉病毒病 (EVD) 的即时抗原检测分析

• 批准号: 9910131
• 负责人: David P AuCoin
• 金额: $ 29.91万
• 依托单位: INBIOS INTERNATIONAL, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-03-10 至 2022-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9910131
• 关键词: Address; Affinity; Africa; Antigens; Attention; Authorization documentation; Award; Biological Assay; Burkholderia pseudomallei; Clinical; Collaborations; Communicable Diseases; Containment; Contracts; Democratic Republic of the Congo; Detection; Development; Diagnosis; Diagnostic; Diagnostic tests; Disease; Disease Outbreaks; Early Diagnosis; Ebola; Ebola Hemorrhagic Fever; Ebola virus; Emergency Situation; Emerging Communicable Diseases; Environment; Equipment; Funding; Glycoproteins; Goals; Gold; Health Personnel; Healthcare; Hemorrhage; Human Resources; Immunization; Immunoassay; Individual; International; Interruption; Joints; Laboratories; Lateral; Lead; Letters; Medical Research; Melioidosis; Monoclonal Antibodies; Nevada; Patients; Phase; Plague; Politics; Polymerase Chain Reaction; Positioning Attribute; Preparation; Private Sector; Process; Public Health; Recombinants; Recording of previous events; Research Institute; Resources; Sampling; Secure; Security; Sensitivity and Specificity; Serum; Small Business Technology Transfer Research; Testing; Therapeutic; Time; Training; Training and Infrastructure; Tropical Disease; United States; Universities; Vaccines; Validation; Viral Hemorrhagic Fevers; Viral Load result; Viral Matrix Proteins; Virus; World Health Organization; Zaire Ebola virus; base; biothreat; cost; diagnosis standard; improved; medical countermeasure; medical schools; monoclonal antibody production; mortality; nonhuman primate; pandemic disease; phase 1 study; point of care; prototype; screening; stem; tool; transmission process; viral transmission

Project Summary Ebolavirus spp. cause a severe hemorrhagic fever known as Ebola virus disease (EVD). EVD is a serious public health concern, both as an emerging infectious disease and a potential biothreat. The 2013-2016 Ebola pandemic in West Africa brought global attention to the challenges associated with controlling an Ebola. The ongoing outbreak in the Democratic Republic of Congo, which recently reached over 1000 cases with no signs of slowing, has only confirmed the need for improved Ebola medical countermeasures. To better control Ebola outbreaks, it is imperative for healthcare workers to be able to diagnosis and isolate infected patients at the point-of-care in a timely manner. As such, the World Health Organization and other healthcare agencies have called for development of Ebola rapid diagnostic tests (RDTs). The proposed joint effort, for development a point-of-care antigen detection assay for early diagnosis of EVD, stems from a history of successful collaborations between the academic laboratory of Dr. David AuCoin at the University of Nevada, Reno (UNR) and commercial partner, InBios International, Inc. The two organizations have valuable expertise in RDT development and navigating the FDA approval process. The effort is further bolstered by assistance from collaborators at the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) who will perform all high containment level (BSL4) studies. Preliminary studies for this proposal have resulted in an Ebola RDT prototype that shows a substantial improvement in sensitivity for Zaire ebolavirus. Our goal is to further improve assay sensitivity and expand detection to all EVD causing Ebolavirus spp. A comprehensive approach with clearly defined strategies will be used to support successful development of a pan-Ebola RDT with high sensitivity. Key aspects and milestones include: i) high throughput monoclonal antibody (mAb) production using multiple immunization strategies, ii) mAb characterization and RDT-based mAb screening, iii) commercial optimization and development of multiple assay prototypes, iv) determination of analytical sensitivity and specificity and v) assay validation with samples from Ebola-infected non-human primates.

项目摘要 埃博拉病毒属。引起严重的出血热称为埃博拉病毒疾病（EVD）。 EVD是 严重的公共卫生关注，无论是一种新兴的传染病还是潜力 生物治疗。 2013 - 2016年西非的埃博拉大流行引起了全球的关注 与控制埃博拉病毒相关的挑战。民主党的持续爆发 刚果共和国最近达到1000多个案件，没有放缓的迹象，只有 确认需要改善埃博拉病毒医学对策。更好地控制埃博拉 爆发，医疗保健工人必须能够诊断和隔离感染 及时保健的患者。因此，世界卫生组织和 其他医疗机构呼吁开发埃博拉病毒快速诊断测试（RDTS）。 拟议的联合努力，用于开发早期的护理点抗原检测测定法 EVD的诊断源于学术之间成功合作的历史 内华达大学，里诺（UNR）和商业的戴维·奥科因博士实验室 合作伙伴INBIOS International，Inc.。这两个组织在RDT中具有宝贵的专业知识 开发和导航FDA批准过程。这项努力进一步得到了支持 美国陆军医学研究所的合作者的协助 疾病（USAMRIID）将执行所有高遏制水平（BSL4）研究。 该提案的初步研究导致了埃博拉RDT原型，该原型显示 Zaire Ebolavirus的敏感性的实质性提高。我们的目标是进一步改进测定法 灵敏度并扩大检测到所有EVD，从而导致埃博拉病毒属。一种全面的方法 有明确的策略将用于支持泛欧博拉的成功开发 RDT具有高灵敏度。关键方面和里程碑包括：i）高吞吐量单克隆 使用多种免疫策略的抗体（MAB）生产，ii）mab表征和 基于RDT的mAb筛选，iii）商业优化和多重测定的开发 原型，iv）确定分析灵敏度和特异性以及v）测定验证 来自埃博拉病毒的非人类灵长类动物的样品。