Development of an automated HIV self-testing assay

自动化 HIV 自检检测的开发

• 批准号: 10539345
• 负责人: Waseem Asghar
• 金额: $ 44.34万
• 依托单位: FLORIDA ATLANTIC UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-01-01 至 2024-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10539345
• 关键词: 2019-nCoV; Acquired Immunodeficiency Syndrome; Acute; Address; Antibody Response; Automation; Biological Assay; Biological Markers; Blood specimen; Cessation of life; Communicable Diseases; Contracts; Country; Detection; Development; Devices; Diagnostic; Disease Management; Dryness; Fingers; Flavivirus; Goals; HIV; HIV Infections; HIV Seropositivity; HIV-1; Heating; Hepatitis; Human immunodeficiency virus test; Image; Individual; Infection; Intervention; Magnetism; Malaria; Mediating; Methods; Microfluidic Microchips; Microfluidics; Monitor; Patients; Persons; Phase; Prevalence; Protocols documentation; RNA; Reaction; Reagent; Refrigeration; Reverse Transcriptase Polymerase Chain Reaction; Sampling; Sensitivity and Specificity; Specificity; Speed; System; Technology; Testing; Time; Treatment Failure; Treatment outcome; Tuberculosis; Validation; Viral; Viral Genome; Virus; Whole Blood; acute infection; antiretroviral therapy; commercialization; design; fabrication; glucose monitor; improved; isothermal amplification; microchip; microelectronics; novel; rapid detection; rapid diagnosis; self testing; statistics; viral rebound; virus culture

Project Summary Although antiretroviral therapy (ART) is effective in saving AIDS patients' lives, the implementation of ART worldwide has been drastically hampered by the lack of treatment monitoring diagnostics and disease management. According to the recent statistics by USAIDS, the coverage of ART is still only 59%, despite ART being affordable or freely available in most countries. In addition, worldwide, about 1 in 4 of the people that contracted the virus are unaware of their HIV status. One of the fundamental challenges to reduce HIV burden and its prevalence is the absence of HIV self-testing assays which are sensitive enough to detect new HIV infections during the first two-weeks (acute phase) post-infection and viral rebound in virally supressed patients receiving ART. Current self-testing technologies only detect the host antibody response to HIV infection, which usually arises 3-4 weeks after the initial infection and it is not an indicator of therapy failure and viral rebound. No self-testing technologies have yet been commercialized that are able to detect HIV during the early stages of acute infection or viral rebound in suppressed patients on ART. To increase access to HIV testing and to improve treatment outcomes, there is an urgent need to develop reliable and affordable HIV self-testing technologies. To address these challenges, we propose to develop a disposable self-testing HIV-1 chip that can (i) selectively detect HIV from whole blood samples, (ii) be highly sensitive to detect HIV during the acute infection, treatment and viral rebound (<1000 copies/ml), (iii) be rapid (within 40 minutes), (iv) be highly stable (refrigeration-free), and (v) be fully automated (true sample-in-answer- out).

项目摘要 尽管抗逆转录病毒疗法（ART）有效地挽救了艾滋病患者的生命，但ART的实施 缺乏治疗监测诊断和疾病，全世界都受到了极大的阻碍 管理。根据美国国际开发署最近的统计数据，尽管 大多数国家 /地区的艺术价格合理或免费。此外，全球，大约有四分之一的人 该病毒的感染不知道其艾滋病毒状况。减少艾滋病毒的基本挑战之一 负担及其患病率是缺乏艾滋病毒自我测试测定，这些测定足以检测到足以检测到 感染后第一个两周（急性期）的新艾滋病毒感染和病毒反弹 饱食患者接受艺术。当前的自我测试技术仅检测宿主抗体响应 艾滋病毒感染通常是在初次感染后3-4周产生的，这不是治疗的指标 失败和病毒反弹。尚无自我测试技术的商业化，能够检测到 急性感染或抑制ART患者的病毒反弹的早期艾滋病毒。增加 获得艾滋病毒测试并改善治疗结果，迫切需要发展可靠和 负担得起的艾滋病毒自我测试技术。为了应对这些挑战，我们建议开发一次性 可以自我测试的HIV-1芯片可以（i）从全血样品中选择性检测HIV，（ii）高度敏感 为了在急性感染中检测HIV，治疗和病毒反弹（<1000份/ml），（iii）很快（在内 40分钟），（iv）高度稳定（无制冷），并且（v）是完全自动化的（真正的样本中的样本 - 出去）。