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 埃博拉病毒属引起一种称为埃博拉病毒病(EVD)的严重出血热。EVD是 严重的公共卫生问题，既是一种新出现的传染病，也是一种潜在的 生物疗法。2013-2016年西非埃博拉大流行使全球关注 与控制埃博拉病毒相关的挑战。民主党正在爆发的疫情 刚果共和国，最近达到1000多例，没有放缓的迹象，只有 确认了改进埃博拉医疗对策的必要性。为了更好地控制埃博拉病毒 对于暴发疫情，医护人员必须能够诊断和隔离受感染的 及时在患者的护理点进行护理。因此，世界卫生组织和 其他医疗机构也呼吁开发埃博拉快速诊断测试(RDT)。 拟议的联合努力，为开发一种早期的护理点抗原检测方法 EVD的诊断，源于学者之间成功合作的历史 内华达大学雷诺分校David Aucoin博士的实验室和商业 InBios International，Inc.合作伙伴。这两个组织在RDT方面拥有宝贵的专业知识 开发和导航FDA的审批流程。这一努力得到了进一步的支持 美国陆军传染病医学研究所合作者的协助 疾病(USAMRIID)，将执行所有高遏制级别(BSL4)研究。 对这一提议的初步研究已经产生了埃博拉RDT原型，该原型显示 扎伊尔埃博拉病毒敏感度大幅提高。我们的目标是进一步提高化验水平 敏感性，并将检测范围扩大到所有导致埃博拉病毒种的埃博拉病毒。一种全面的方法 将使用明确定义的战略来支持泛埃博拉病毒的成功发展 RDT具有较高的灵敏度。主要方面和里程碑包括：i)高通量的单抗 使用多种免疫策略生产抗体(MAb)，ii)mAb特性和 基于RDT的单抗筛选--III)多种检测方法的商业化优化与发展 原型，四)分析灵敏度和特异度的确定和五)分析验证 来自感染埃博拉病毒的非人类灵长类动物的样本。