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

基本信息

批准号：
10219140
负责人：
Yu-Hsiang Hsieh
金额：
$ 47.55万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
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/10219140
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 Drug resistance FDA approved Filtration Fingers Fluorescence Freeze Drying Goals Gold HIV HIV Infections Health Policy 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 detection assay detection limit diagnostic technologies high risk population home test improved instrument instrumentation miniaturize multidisciplinary novel nucleic acid purification operation particle portability prevent reconstitution resistance mutation response seal self testing tool transmission process user-friendly validation studies viral rebound virology

项目摘要

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）的革命性进展可以达到并维持病毒抑制已逐渐转变为艾滋病毒/获得性免疫缺陷综合症过去 2 年来，艾滋病已成为一种可控制的慢性疾病，但它仍然是主要的公众疾病之一。全球约有 3790 万艾滋病毒感染者 (PLWHA)、170 万新感染者， 2018 年，有 770,000 例艾滋病毒相关死亡。作为改善临床管理的综合战略针对艾滋病毒，世界卫生组织 (WHO) 特别呼吁不仅要提高抗逆转录病毒治疗的可及性，而且要提高艾滋病治疗的可及性 HIV 检测覆盖未经检测的高危人群，并帮助 PLWHA 确定其病毒载量 (VL) 和作为回应，该项目旨在开发一种快速、经济的诊断技术。与传统检测不同，易于使用的 HIV VL 检测可以进行自我检测，甚至可以进行家庭检测。由于复杂设备的要求，诊断技术对于自测试来说不切实际仪器，我们的平台采用磁流体技术，用磁性颗粒代替大量流体传输操作，实现样品处理和 PCR 的集成，无需复杂的流体试剂盒和支持仪器的小型化促进了仪器和测定。磁流体技术最大限度地减少了试剂消耗和热质量，从而使成本和成本降低了 10 倍以上该集成设备有助于通过简单的“样本到检测”方式从指尖采血中检测 HIV RNA。答案”的方式，承诺一种快速、廉价且用户友好的 VL 自测试策略。我们组建了一支多学科团队，具有互补的专业知识和良好的业绩记录和历史为了实现上述目标，我们建议（i）开发一个简化的团队科学协作。用于样品处理和全血中 HIV 的 PCR 检测的测定方案，(ii) 开发一种廉价的磁流体盒将 HIV 检测分析作为简单的血液结果测试，(iii) 开发便携式仪器，以实现简便的 HIV 自检，(iv) 开发一种环境盒存储方法，以及最后 (v) 评估 HIV 自检平台在急症护理中的表现和患者可接受性这种 HIV VL 自检技术的开发具有潜力。大大提高了感染者中检测急性感染和监测病毒抑制的可及性，从而改变了全球艾滋病毒预防战略的游戏规则。