An HIV Self-Test

艾滋病毒自检

• 批准号: 10242940
• 负责人: Daniel T Chiu
• 金额: $ 46.63万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-01 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10242940
• 关键词: AIDS clinical trial group; AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Acute; Africa; Aluminum; Antibody Response; Appearance; Archives; Area; Benchmarking; Biological Assay; Blood; Blood Plasma Volume; Cellular Phone; Characteristics; Clinical; Clinical Research; Cold Chains; Collaborations; Collection; Data; Data Analyses; Detection; Devices; Drug resistance; Effectiveness; Electricity; Epidemic; Equipment; Failure; Feasibility Studies; Feedback; Freeze Drying; Freezing; Goals; HIV; HIV Antibodies; HIV Infections; HIV-1; Heating; Hour; Human immunodeficiency virus test; Infrastructure; Joints; Laboratories; Measures; Mediating; Methods; Microfluidic Microchips; Monitor; NASBA Analysis; Nucleic Acids; Outcome; Patients; Performance; Persons; Phase; Plasma; Population; Preparation; Process; RNA; Reagent; Recombinants; Refrigeration; Reporting; Resources; Run-On Assays; Sampling; Self-Sustained Sequence Replication; Senegal; Services; Site; Technology; Temperature; Time; Touch sensation; Training; Treatment Failure; Tube; United Nations; United States National Institutes of Health; Validation; Viral; Viral Load result; Viremia; Withdrawal; World Health Organization; antiretroviral therapy; aqueous; base; chromatin immunoprecipitation; clinical research site; design; digital; drug development; field study; global health; high risk population; improved; individual patient; innovative technologies; isothermal amplification; nanolitre; phase change; point of care; point of care testing; programs; response; sample collection; self testing; single molecule; transmission process; virology

Project Summary This project proposes to develop and validate an equipment-free point-of-care (POC) device for highly sensitive and quantitative HIV detection. Despite significant progresses made in both HIV detection and treatment, HIV/AIDS remains a global health issue. A simple but highly sensitive and quantitative self-test for monitoring HIV Viral Load (VL) in patients on antiretroviral therapy (ART) will help identify treatment failure earlier to avoid the development of drug resistance, which is key to maintaining the effectiveness and sustainability of ART therapy, especially in resource-poor settings. Additionally, a self-test to detect acute HIV infection will not only improve clinical outcome for these individual patients but also reduce HIV transmission at the population level. Existing nucleic-acid based POC tests for VL monitoring require expensive equipment and centralized laboratories, thus are not feasible for self-testing. In addition, current rapid self-testing assays are based on detecting HIV antibodies, which are not sensitive enough to detect acute HIV infection before the appearance of HIV antibodies. Thus, no POC self-testing assays are currently available for monitoring HIV VL or for the detection of acute HIV infection. We recently developed a self-digitizing (SD) microfluidic chip, which spontaneously partitions an aqueous sample into tens of thousands of nanoliter volumes. Using this SD platform, we have developed and reported the first digital-isothermal-nucleic-acid-amplification assay: digital LAMP (Loop-Mediated Isothermal Amplification). Separately, the first push-button blood self-collection devices are being launched by both Tasso Inc and Seventh Sense Biosystems. Combining these two innovative technologies – Digital Nucleic Acid Assay and Blood Self-Collection – we propose to develop a self-testing HIV device with the following characteristics: 1) Highly sensitive and quantitative for detecting HIV-1 in plasma at VL as low as 50 copies/mL; 2) Easy to use by lay person without special training; 3) Fast, optimally providing results in 20 minutes; 4) Requires no refrigeration and electricity. To validate this self-test, we propose to conduct clinical studies of the self-testing device in Senegal, Africa. When successfully completed, we anticipate our proposed device will make a significant contribution on reaching the ambitious goals laid out by the Joint United Nations Program on HIV/AIDS (UNAIDS) towards ending of the AIDS epidemic.

项目摘要 该项目的提案旨在开发和验证无设备的护理点（POC）设备高度 灵敏和定量的HIV检测。尽管在两个HIV检测中都取得了重大进展 和治疗，艾滋病毒/艾滋病仍然是一个全球健康问题。简单但高度敏感和定量的 用于监测抗逆转录病毒疗法（ART）患者的HIV病毒负荷（VL）的自我测试将有助于识别 治疗较早未能避免耐药性的发展，这是维持耐药性的关键 艺术疗法的有效性和可持续性，尤其是在资源贫乏的环境中。另外， 自我测试以检测急性HIV感染不仅会改善这些个别患者的临床结果 但也会减​​少人口水平的艾滋病毒传播。 现有的基于核酸的VL监控的POC测试需要昂贵的设备和集中式设备 因此，实验室对于自我测试是不可行的。此外，当前的快速自我测试测定是基于 检测HIV抗体，该抗体的灵敏度不足以检测到急性HIV感染 HIV抗体的外观。那是目前没有POC自我测试测定法进行监视 HIV VL或用于检测急性HIV感染。 我们最近开发了一种自数化（SD）微流体芯片，它赞助将 水样样品成千上万的纳米素体积。使用此SD平台，我们有 开发和报道了第一个数字含量核酸酸性扩增测定法：数字灯 （循环介导的等温扩增）。另外，第一个按钮血液自我收集 Tasso Inc和第七Sense Biosystems都启动了设备。结合这两个 创新技术 - 数字核酸测定和血液自我收集 - 我们建议开发 具有以下特征的自我测试的HIV设备：1）高度敏感和定量 在VL处检测血浆中的HIV-1低至50份/ml； 2）外行人易于使用，没有特别 训练; 3）快速，最佳地提供20分钟的结果； 4）不需要制冷和电力。 为了验证这种自我测试，我们建议对塞内加尔进行自测装置进行临床研究， 非洲。成功完成后，我们预计我们的拟议设备将成为重要的 联合国艾滋病毒/艾滋病联合国计划实现雄心勃勃的目标的贡献 （UNAID）终结艾滋病流行病。