Streamlined 15-min HIV Viral Load Self-Testing Using Finger-Stick Blood

使用指尖采血进行简化的 15 分钟 HIV 病毒载量自检

• 批准号: 10065791
• 负责人: Yu-Hsiang Hsieh
• 金额: $ 47.51万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 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/10065791
• 关键词: AIDS prevention; Accident and Emergency department; Accreditation; Acquired Immunodeficiency Syndrome; Acute; Baltimore; Biological Assay; Blood; Buffers; Car Phone; Cessation of life; Charge; Chronic Disease; Clinic; Clinic Visits; Clinical; Clinical Management; Cold Chains; Collaborations; Communicable Diseases; Complex; Consent; Consumption; Detection; Development; Devices; Diagnostic; Drug resistance; FDA approved; Filtration; Fingers; Fluorescence; Freeze Drying; Goals; Gold; HIV; HIV Infections; Health Policy; Home environment; Human immunodeficiency virus test; Infection; Institutes; Interruption; Intervention; Laboratories; Lead; Liquid substance; Magnetism; Manuals; Membrane; Methods; Microfluidics; Miniaturization; Monitor; Nucleic Acids; Patients; Performance; Persons; Phase; Plasma; Preparation; Prevention strategy; Process; Protocols documentation; Public Health; RNA; Reaction; Reagent; Recording of previous events; Rehydrations; Resources; Sampling; Schedule; Science; Self Administration; Site; Surveys; Techniques; Technology; Test Result; Testing; Time; Training; Translating; Uganda; Venipunctures; Viral; Viral Load result; Visit; Waxes; Whole Blood; World Health Organization; acute care; acute infection; amplification detection; antiretroviral therapy; base; cost; high risk population; improved; instrument; instrumentation; miniaturize; multidisciplinary; novel; nucleic acid purification; operation; particle; portability; prevent; reconstitution; resistance mutation; response; seal; tool; transmission process; user-friendly; validation studies; viral rebound; virology

The revolutionary advances in human immunodeficiency virus (HIV) antiretroviral therapy (ART) which could reach and maintain viral suppression have gradually transitioned HIV/acquired immunodeficiency syndrome (AIDS) to a manageable, chronic disease in the past 2 decades. However, it is still one of the leading public threats in the world with approximately 37.9 million people living with HIV (PLWHA), 1.7 million new infections, and 770,000 HIV-related deaths in 2018. As a comprehensive strategy for improving the clinical management of HIV, the World Health Organization (WHO) specifically calls for improved accessibility of not only ART, but also HIV testing to reach untested high-risk populations and to help PLWHA ascertain their viral load (VL) and potential for transmission. In response, this project seeks to develop a diagnostic technology for rapid, affordable and easy-to-use HIV VL detection that is amenable for self-testing and even in-home testing. Unlike conventional diagnostic technologies that are impractical for self-testing due to requirements of sophisticated devices and instruments, our platform employs magnetofluidic technology to replace bulk fluid transport with magnetic particle manipulation, enabling the integration of sample processing and PCR without the need for complex fluidic cartridges and supporting instrumentation. Miniaturization of instrumentation and assay facilitated by magnetofluidics minimizes reagent consumption and the thermal mass, leading to >10-fold reduction in cost and assay time. The integrated device facilitates HIV RNA detection from finger-stick blood in a facile “sample-to- answer” manner, promising a rapid, inexpensive and user-friendly strategy for VL self-testing. We have assembled a multi-disciplinary team with complementary expertise and strong track record and history of collaboration in team science. In order to achieve the above goal, we propose (i) to develop a streamlined assay protocol for sample processing and PCR detection of HIV in whole blood, (ii) to develop an inexpensive magnetofluidic cartridge implementing the HIV detection assay as a simple blood-to-result test, (iii) to develop a portable instrument to enable facile HIV self-testing, (iv) to develop a method for ambient cartridge storage, and finally (v) to evaluate performance and patient acceptability of the HIV self-testing platform in both acute care and resource-limited settings. The development of this HIV VL self-testing technology has the potential for dramatically increasing the accessibility of detecting acute infections and monitoring viral suppression in PLWHA, thus presenting a game changer in the global HIV prevention strategy.

人类免疫缺陷病毒（HIV）抗逆转录病毒疗法（ART）的革命进步，可以 接触和维持病毒抑制已逐渐过渡HIV/获得的免疫缺陷综合征 （艾滋病）在过去的20年中，可管理的慢性疾病。但是，它仍然是主要的公众之一 世界上有大约3790万艾滋病毒（PLWHA）的威胁，170万新感染， 2018年与HIV相关的770,000例死亡。作为改善临床管理的综合策略 艾滋病毒，世界卫生组织（WHO）特别要求改善艺术的可及性，而且还要求 HIV测试以达到未经测试的高风险人群，并帮助PLWHA确定其病毒载荷（VL）和 传输的潜力。作为回应，该项目旨在开发一种诊断技术，以快速，负担得起 以及易于使用的HIV VL检测，可用于自我测试甚至在家测试。与传统不同 由于复杂设备的要求和 仪器，我们的平台员工磁性流体技术用磁性粒子代替散装流体运输 操纵，实现样品处理和PCR的整合，而无需复杂的流体 墨盒和辅助仪器。仪器和测定的小型化 磁流失型可最大程度地减少试剂的消耗和热量，从而降低成本约10倍和 测定时间。在轻松的“样品到样品中，综合设备设施的HIV RNA检测 答案”的方式，保证一种快速，廉价且用户友好的VL自我测试策略。 我们已经组建了一个具有完善专业知识和良好往绩和历史的多学科团队 团队科学合作。为了实现上述目标，我们建议（i）开发一个简化的 用于全血中样本处理和PCR检测HIV的测定方案，（ii）开发廉价的 实施HIV检测测定法作为简单的血液到星期测试的磁液墨盒，以开发一个 便携式仪器以启用艾滋病毒自我测试，（iv）开发一种环境弹药库的方法，并且 最后（v）在两个急性护理中评估艾滋病毒自我测试平台的表现和患者的可接受性 和资源有限的设置。这种艾滋病毒VL自我测试技术的开发有可能 急剧增加了检测急性感染和监测PLWHA病毒抑制的可及性， 从而在全球艾滋病毒预防策略中提出了改变游戏规则的人。