An HIV Self-Test

项目摘要 本项目旨在开发和验证一种无需设备的床旁（POC）设备， 灵敏和定量的艾滋病毒检测。尽管在艾滋病毒检测和 艾滋病毒/艾滋病仍然是一个全球性的健康问题。一种简单但高度灵敏和定量的 在接受抗逆转录病毒治疗（ART）的患者中进行自我检测以监测HIV病毒载量（VL）将有助于识别 早期治疗失败，以避免耐药性的发展，这是维持 因此，我们需要确保抗逆转录病毒疗法的有效性和可持续性，特别是在资源匮乏的环境中。此外，A 检测急性HIV感染的自我检测不仅可以改善这些患者的临床结果， 还能减少艾滋病毒在人群中的传播。 现有的用于VL监测的基于核酸的POC测试需要昂贵的设备和集中的操作。 因此，实验室无法进行自我检测。此外，当前的快速自我检测分析基于 检测艾滋病毒抗体，这是不够敏感，以检测急性艾滋病毒感染之前， HIV抗体的出现。因此，目前没有POC自检测定可用于监测 HIV VL或用于检测急性HIV感染。 我们最近开发了一种自数字化（SD）微流控芯片， 将水溶液样品浓缩到数万纳升的体积。使用这个SD平台，我们有 开发并报道了第一个数字等温核酸扩增检测方法：数字LAMP 环介导等温扩增（Loop-Mediated Isothermal Amplification）另外，第一次按下按钮自行采血 Tasso公司和Seventh Sense生物系统公司正在推出这种设备。结合这两 创新技术-数字化核酸检测和血液自我采集-我们建议开发 一种自我检测HIV的装置，具有以下特点：1）高度敏感和定量， 检测血浆中的HIV-1的VL低至50拷贝/mL; 2）非专业人员易于使用，无需特殊 培训; 3）快速，最佳在20分钟内提供结果; 4）不需要制冷和电力。 为了验证这种自我检测，我们建议在塞内加尔进行自我检测设备的临床研究， 非洲当成功完成后，我们预计我们提出的设备将取得重大进展。 为实现联合国艾滋病毒/艾滋病联合规划署制定的宏伟目标作出贡献 （联合国艾滋病规划署）为结束艾滋病流行病所作的努力。

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.