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Highly Sensitive HIV Viral Load Assay for Point-of-Care Settings

适用于护理点环境的高灵敏度 HIV 病毒载量测定

基本信息

批准号：
9909411
负责人：
Waseem Asghar
金额：
$ 37.8万
依托单位：
FLORIDA ATLANTIC UNIVERSITY
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：
2019-05-24 至 2020-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9909411
关键词：
Acquired Immunodeficiency Syndrome Antibodies Antigens Area Binding Biological Assay Biological Markers Biosensing Techniques Blood Plasma Volume CD4 Antigens CD4 Lymphocyte Count CD4 Positive T Lymphocytes Care Technology Points Caring Cell Count Cessation of life Clinical Communicable Diseases Complex Country Dengue Infection Developed Countries Developing Countries Development Devices Diagnostic Disease Disease Management Disease Progression Drug resistance Ensure Epidemic Failure Glass Goals Gold Guidelines HIV HIV Envelope Protein gp120 HIV Infections HIV-1 Hepatitis Image Image Enhancement Imaging technology Individual Infant Laboratories Lymphocyte Count Malaria Methods Microfluidics Modernization Monitor Patients Plasma Prevalence RNA RNA-Directed DNA Polymerase Refrigeration Reporting Resources Reverse Transcriptase Polymerase Chain Reaction Running Sampling Savings Serum Surface Symptoms System Technology Testing Training Training and Infrastructure Treatment Efficacy Treatment outcome Tuberculosis Viral Viral Load result Virion Virus Whole Blood World Health Organization antiretroviral therapy base cost equipment training imaging system improved low and middle-income countries medication compliance microchip patient response point of care portability rapid diagnosis resistant strain rural area virology

项目摘要

PROJECT SUMMARY: More than 36.7 million people are living with AIDS as reported by World Health Organization (WHO) recently. HIV caused over 35 million deaths so far. The epidemic continues to grow with nearly 2.1 million new cases of HIV in 2015 including over 47,000 new cases of HIV infection in US. Currently, only 34% of HIV infected people are getting antiretroviral therapy (ART) treatment in developing world despite ART being affordable or even freely available. The fundamental challenges to reduce HIV burden and its prevalence include the lack of point-of-care assays for viral load in rural areas having limited access to basic laboratory infrastructure and trained technicians. In developed countries, HIV-1 viral load is regularly used to closely monitor and assess the patient response to ART, to ensure drug adherence and to stage disease progression. In contrast, developing countries are using CD4+ T lymphocyte count and clinical symptoms to guide ART following the WHO guidelines with the exception of infants, where viral load assays are required. However, studies have shown that CD4+ T cell counting strategy cannot detect early virological failure which leads to accumulation of drug-resistant strains in infected individuals and reduces ART efficacy. Thus, a rapid, inexpensive, disposable, and simple viral load test is urgently needed. Current viral load technologies are based on the quantification of HIV-1 RNA, p24 antigen, and reverse transcriptase activity. These HIV-1 viral load assays are expensive ($50-200 per test), and technically complex, thus requiring trained technicians to run the assays. Here, we will use our expertise in microchip fabrication, microfluidics, surface functionalization, lensless imaging, and biosensing to create a disposable HIV-1 viral load chip that can (i) selectively capture HIV from whole blood/plasma, (ii) be highly sensitive (can detect <1000 viral copies/mL), inexpensive (~$1), and rapid (within 45 minutes), (iii) can handle small volume of plasma/whole blood (1mL) and (iv) be highly stable (refrigeration free) to aid in HIV quantification and treatment at POC settings. We envision that the proposed technology will aid in rapid viral load quantification benefiting millions of patients around the world. !

项目总结：据世界卫生组织(WHO)报道，目前有超过3670万人患有艾滋病最近。到目前为止，艾滋病毒造成了超过3500万人的死亡。疫情继续增长，近2.1 2015年新增艾滋病毒病例100万例，其中美国新增艾滋病毒感染病例超过4.7万例。目前，在发展中国家，只有34%的艾滋病毒感染者正在接受抗逆转录病毒疗法(ART)治疗。尽管艺术品是负担得起的，甚至是免费提供的。减少艾滋病毒的根本挑战负担及其流行率包括在农村地区缺乏对病毒载量的定点检测，获得基本实验室基础设施和训练有素的技术人员的机会有限。在发达国家，艾滋病毒-1 病毒载量经常被用来密切监测和评估患者对抗逆转录病毒治疗的反应，以确保药物坚持和分期疾病进展。相比之下，发展中国家正在使用CD4+T细胞淋巴细胞计数和临床症状指导抗逆转录病毒治疗遵循世界卫生组织指南，但例外需要进行病毒载量分析的婴儿。然而，研究表明，CD4+T细胞计数策略无法检测到导致耐药积累的早期病毒学失败并降低抗逆转录病毒治疗的疗效。因此，一种快速、廉价、一次性和迫切需要简单的病毒载量测试。目前的病毒载量技术是基于量化的 HIV-1RNA、p24抗原和逆转录酶活性。这些HIV-1病毒载量分析是昂贵(每次测试50-200美元)，技术复杂，因此需要训练有素的技术人员来运行化验。在这里，我们将利用我们在微芯片制造、微流体、表面功能化、无透镜成像和生物传感，以创建一次性HIV-1病毒负载芯片，该芯片可以(I)选择性地从全血/血浆中捕获艾滋病毒，(Ii)高度敏感(可检测到1000份病毒拷贝/毫升)，价格低廉(约1美元)，快速(45分钟内)，(Iii)可以处理少量的血浆/全血 (1毫升)和(Iv)高度稳定(无需冷藏)，以协助POC的艾滋病毒定量和治疗设置。我们预计，拟议的技术将有助于快速量化病毒载量，从而受益世界各地数以百万计的患者。好了！