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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

基本信息

批准号：
10214460
负责人：
PAUL YAGER
金额：
$ 43.22万
依托单位：
UNIVERSITY OF WASHINGTON
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-08-01 至 2022-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10214460
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 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

项目摘要

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

项目成果

期刊论文数量（6）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Disposable platform for bacterial lysis and nucleic acid amplification based on a single USB-powered printed circuit board.

DOI：
10.1371/journal.pone.0284424
发表时间：
2023
期刊：
PLOS ONE
影响因子：
3.7
作者：
Shah, Kamal G.;Roller, Mike;Kumar, Sujatha;Bennett, Steven;Heiniger, Erin;Looney, Katriel;Buser, Joshua;Bishop, Joshua D.;Yager, Paul
通讯作者：
Yager, Paul

Two-Fluorophore Mobile Phone Imaging of Biplexed Real-Time NAATs Overcomes Optical Artifacts in Highly Scattering Porous Media.

DOI：
10.1021/acs.analchem.0c02000
发表时间：
2020-10-06
期刊：
ANALYTICAL CHEMISTRY
影响因子：
7.4
作者：
Shah, Kamal G.;Kumar, Sujatha;Singh, Vidhi;Hansen, Louise;Heiniger, Erin;Bishop, Joshua D.;Lutz, Barry;Yager, Paul
通讯作者：
Yager, Paul

Near-digital amplification in paper improves sensitivity and speed in biplexed reactions.