An HIV Self-Test

项目摘要 该项目建议开发和验证一种无设备的护理点(POC)设备，用于 灵敏和定量的艾滋病毒检测。尽管在艾滋病毒检测方面取得了重大进展 尽管如此，艾滋病毒/艾滋病仍然是一个全球健康问题。一种简单但高度敏感的定量方法 监测接受抗逆转录病毒治疗(ART)患者的HIV病毒载量(VL)的自我测试将有助于识别 早期治疗失败，避免耐药性的发展，这是维持 艺术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，一个 检测急性艾滋病毒感染的自我检测不仅可以改善这些患者的临床结果 而且还可以减少艾滋病毒在人口层面的传播。 用于VL监测的现有基于核酸的POC测试需要昂贵的设备和集中的 因此，实验室进行自我检测是不可行的。此外，当前的快速自检检测是基于 关于检测艾滋病毒抗体，这些抗体不够敏感，不足以在感染前发现急性艾滋病毒感染 HIV抗体的出现。因此，目前没有PoC自检检测可用于监控 艾滋病毒VL或用于检测急性艾滋病毒感染。 我们最近开发了一种自数字化(SD)微流控芯片，它可以自发地分割和 将水样制成数万纳升的体积。使用这个SD平台，我们有 研制并报道了第一台数字化等温核酸扩增分析仪器：数字灯 (环介导等温扩增)。另外，第一个按钮自采血液按钮 Tasso Inc.和第七感生物系统公司都在推出这些设备。将这两者结合起来 创新技术-数字核酸分析和自采血液-我们建议开发 一种自我检测HIV病毒的装置，具有以下特点：1)高灵敏度和定量检测 以低至50拷贝/毫升的VL检测血浆中的HIV-1；2)外行人无需特殊操作即可使用 培训；3)快速，最好在20分钟内提供结果；4)不需要冷藏和电力。 为了验证这种自我测试，我们建议在塞内加尔进行自我测试设备的临床研究， 非洲。当成功完成后，我们预计我们提出的设备将做出重要的 为实现联合国艾滋病毒/艾滋病联合规划署确定的宏伟目标作出贡献 (艾滋病规划署)朝着结束艾滋病流行的方向前进。

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.