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: 10688240
• 负责人: PAUL YAGER
• 金额: $ 72.07万
• 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/10688240
• 关键词: Acute; Atopobium vaginae; Biological Assay; Biological Markers; Blood; Blood specimen; Cellular Phone; Collaborations; Collection; Couples; Cytolysis; Data; Daughter; Detection; Development; Devices; Diagnosis; Diagnostic; Disease; Dryness; 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; Sexual Partners; Source; Specificity; Swab; Technology; Testing; Time; United States; Unsafe Sex; Vagina; Validation; Viral; Virion; Virus; Woman; Work; amplification detection; antiretroviral therapy; clinical trial readiness; clinically relevant; commercial prototype; commercialization; design; detection test; ergonomics; home test; men; operation; point of care; prevent; prototype; public-private partnership; sample archive; self testing; success; tool; transmission process; 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努力阻止该病毒的传播。 最早可用于诊断艾滋病毒的生物标志物是艾滋病毒病毒粒子本身的成分，包括其 核糖核酸基因组。为了增加对艾滋病毒早期检测的可及性，该项目将开发HIV急性，一种 基于恒温RNA扩增的HIV RNA快速自我检测方法 这个家。该设备将允许采集手指棒状血样，从任何USB端口获取电力，以及 在30分钟内提供自动诊断。这项工作建立在微流体学的新发展基础上 和纸质诊断，扩大了可在 护理点。长期目标是生产一种用于家庭测试的商业产品。具体目标 是：1.开发和验证与护理点兼容的样本采集和制备策略，以快速 从50微米L指棒血样中至少提供25-125份HIV RNA，其形式支持ISDA- 基于检测的。2.建立和优化用于HIV敏感检测的等温实时RT-ISDA检测方法 RNA和对照。3.设计和构建包含AIMS输出的MD-NAAT平台原型 1和2用于家庭艾滋病毒检测。4.开发近产品样品到结果的HIV原型，并验证 与实验室标准相比，样机的用户可接受性、人体工程学和灵敏度。5.发展 HIVAlert，HIV急性的一种改进，可以使用自我给药的拭子来检测HIV+精液中的 无保护措施的性接触后的阴道。