HIVAcute: rapid sample-to-result self-testing for HIV RNA

HIVAcute：快速从样本到结果的 HIV RNA 自我检测

• 批准号: 10663626
• 负责人: PAUL YAGER
• 金额: $ 73.84万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-08-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10663626
• 关键词: Acute; Atopobium vaginae; Biological Assay; Biological Markers; Blood; Blood specimen; Cellular Phone; Clinical Trials; Collaborations; Collection; Couples; Cytolysis; Data; Daughter; Detection; Development; Devices; Diagnosis; Diagnostic; Disease; Early Diagnosis; Elements; Ensure; Exposure to; Fingers; Fluorescence; Gene Targeting; Genome; HIV; HIV Antibodies; HIV Infections; HIV Seropositivity; HIV diagnosis; HIV-1; Heating; Home; Human; Human immunodeficiency virus test; Image; Infection; Laboratories; Lateral; Liquid substance; Measures; Methods; Microfluidics; Modification; Monitor; Optics; Output; Paper; Persons; Phase; Pregnancy Tests; Preparation; Public Health; RNA; RNA amplification; Reagent; Reporting; Sampling; Self Administration; Seminal fluid; Sensitivity and Specificity; Sexual Partners; Source; Swab; Technology; Testing; Time; United States; Unsafe Sex; Vagina; Validation; Viral; Virion; Virus; Woman; Work; amplification detection; antiretroviral therapy; base; clinically relevant; commercialization; design; detection test; ergonomics; home test; men; operation; point of care; prevent; prototype; public-private partnership; sample archive; self testing; success; tool; user-friendly; viral RNA

Abstract Thirty percent of new HIV infections are transmitted by people unaware of their HIV status. Early detection of the presence of infectious levels of HIV virus could support public health efforts to stop the spread of the virus. The earliest biomarkers that can be used to diagnose HIV are elements of the HIV virion itself, including its RNA genome. In order to increase accessibility to early HIV testing, this project will develop the HIVAcute, a rapid self-test for the detection of HIV RNA based on isothermal RNA amplification that can be administered in the home. This device will allow collection of a finger-stick blood sample, gain power from any USB port, and deliver an automated diagnosis within 30 minutes. The work builds upon new developments in microfluidics and paper-based diagnostics, expanding the range of human samples that can be prepared and tested at the point of care. The long-term objective is to produce a commercial product for home testing. The specific aims are: 1. Develop and validate point-of-care-compatible sample acquisition and preparation strategies that rapidly deliver at least 25-125 copies of HIV RNA from a 50 µL finger-stick blood sample in a form that supports iSDA- based detection. 2. Create and optimize isothermal real-time RT-iSDA assays for sensitive detection of HIV RNA and controls. 3. Design and build prototypes of the MD-NAAT platform that incorporate the output of Aims 1 and 2 for home HIV testing. 4. Develop near-product sample-to-result HIVAcute prototype and validate the prototype's user acceptability, ergonomics, and sensitivity as compared to laboratory standards. 5. Develop HIVAlert, a modification of HIVAcute that could use self-administered swabs to detect HIV+ semen in the vagina after unprotected sexual contact.

摘要 30%的新艾滋病毒感染是由不知道自己艾滋病毒状况的人传播的。早期发现 艾滋病毒感染水平的存在可以支持公共卫生工作，以阻止病毒的传播。 可用于诊断HIV的最早生物标志物是HIV病毒体本身的元素，包括其 RNA基因组。为了增加早期艾滋病毒检测的可及性，该项目将开发HIVAcute，一种 基于等温RNA扩增的HIV RNA快速自检， 家中该设备将允许收集手指针刺血液样本，从任何USB端口获得电源， 在30分钟内提供自动诊断。这项工作建立在微流体技术的新发展之上 和基于纸张的诊断，扩大了可以在医院制备和测试的人类样本的范围。 护理点。长期目标是生产用于家庭测试的商业产品。具体目标 是：1.制定并验证与医疗点兼容的样本采集和制备策略， 从50 µL手指针刺血液样本中以支持iSDA的形式提供至少25-125个HIV RNA拷贝， 基于检测。2.创建并优化等温实时RT-iSDA检测试剂盒，用于灵敏检测HIV RNA和对照。3.设计和构建MD-NAAT平台的原型，其中包含Aims的输出 1和2用于家庭艾滋病毒检测。4.开发接近产品的样本到结果的HIVAcute原型并验证 与实验室标准相比，原型的用户可接受性、人体工程学和灵敏度。5.发展 HIVAlert是对HIVAcute的修改，可以使用自我管理的拭子来检测 无保护的性接触后的阴道。