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Novel Quantitative Cost-effective Assay for the Diagnosis and Monitoring of HIV viral loads

用于诊断和监测 HIV 病毒载量的新型定量成本效益分析

基本信息

批准号：
10414134
负责人：
Karin Chumbimuni-Torres
金额：
$ 7.14万
依托单位：
UNIVERSITY OF CENTRAL FLORIDA
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-06-01 至 2024-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10414134
关键词：
AIDS/HIV problem Acquired Immunodeficiency Syndrome Awareness Bathing Biological Assay Biosensor COVID-19 pandemic Cessation of life Counseling Country DNA Data Detection Developing Countries Diagnosis Economics Ensure Epidemic Equipment Exclusion Free Energy Funding Goals HIV HIV Genome HIV Infections HIV diagnosis HIV-1 HIV-2 Hand Hour Human Human immunodeficiency virus test Hybrids Individual Infection Joints Methodology Methods Monitor Nucleic Acid Amplification Tests Nucleotides Oligonucleotides Patients Performance Persons Polymerase Chain Reaction Procedures Protocols documentation RNA RNA amplification Reaction Research Resource-limited setting Retroviridae Reverse Transcription Self-Sustained Sequence Replication Signal Transduction Stretching Structure T7 RNA polymerase Techniques Technology Temperature Time United Nations Validation Variant Viral Genome Viral Load result Viral load measurement Virus Visit Water amplification detection base cold temperature cost effective design detection platform falls income disparities infection rate isothermal amplification low and middle-income countries new technology novel pandemic disease point of care point of care testing point-of-care diagnostics programs promoter rapid detection treatment services user-friendly viral RNA viral detection

项目摘要

PROJECT SUMMARY Since the start of the AIDS epidemic, according to the United Nations Joint Programme on HIV/AIDS (UNAIDS), a total of 75.7 million people have been infected with HIV, and of which 32.7 million have died due to AIDS- related illnesses. In 2016, UNAIDS defined several targets for HIV testing and treatment to be achieved by 2020 to end the AIDS epidemic by 2030. Such milestones include the reduction of the yearly infection rate to 500,000 new infections per year, the reduction of yearly AIDS-related deaths to 5000,000 deaths per year, and the 90- 90-90 goal, requiring that 90% of HIV-infected individuals be aware of their status, of which 90% are receiving treatment, and of which 90% have undetectable viral loads. We have now reached the goal year, and, based on data from 2019, we are not projected to meet any of these milestones. Although the targets were reached in a handful of countries, most low- and middle-income countries continue to fall behind the global goal in part due to decreases in funding and income disparities. To achieve these goals, extensive HIV testing is required, not only to diagnose new cases but in order to monitor the viral loads of those living with HIV. Therefore, there is an urgent need for a specific virus detection platform that can be used in low-resources settings. Here, we propose to develop a new technology for the specific, sensitive, and rapid detection of HIV-1 and HIV-2, using a universal recognition point-of-care testing platform. This unique platform integrates electrochemical detection of specific viral genome sequences using four-way junction (4WJ) probes following a modify isothermal amplification of the viral RNA fragments using Nucleic Acid Sequence Based Amplification (NASBA). The complete analysis (RNA amplification and detection) is expected to be executed in less than one hour, which is comparable with a regular visit to the doctor’s office. In the proposed research we will: 1) Optimized the modified-tag isothermal amplification using NASBA; 3) Design an electrochemical biosensor by selecting appropriate fragments of the amplicons to be interrogated by the 4WJ probes; 4) Optimize and characterize the biosensor for virus direct detection of amplicons; 5) Study variable parameters for single- and multiplex biosensor analysis; 6) Apply the developed biosensors for virus detection of commercially available reference material; and 7) Validate our methodology using a reference method (RT-qPCR). The proposed technology promises to be a user-friendly point-of-care testing at limited-resource settings for timely diagnosis of HIV infection and monitoring to help stopping the proliferation of AIDS infection by 2030.

项目摘要据联合国艾滋病毒/艾滋病联合规划署（艾滋病规划署）称，自艾滋病流行病开始以来，共有7570万人感染艾滋病毒，其中3270万人死于艾滋病- 相关疾病。2016年，联合国艾滋病规划署确定了到2020年实现艾滋病毒检测和治疗的几个目标。到2030年结束艾滋病的流行。这些里程碑包括将年感染率降至50万每年新感染人数减少，每年与艾滋病有关的死亡人数减少到500万人， 90-90目标，要求90%的艾滋病毒感染者了解自己的状况，其中90%正在接受治疗，其中90%的病毒载量检测不到。我们现在已经达到了目标年，根据从2019年的数据来看，我们预计不会达到这些里程碑中的任何一个。虽然这些目标是在一个少数国家，大多数低收入和中等收入国家继续落后于全球目标，部分原因是减少资金和收入差距。为了实现这些目标，需要进行广泛的艾滋病毒检测，只是为了诊断新病例，但为了监测艾滋病毒感染者的病毒载量。因此，有一个迫切需要一个特定的病毒检测平台，可用于低资源设置。在这里，我们建议开发一种特异、灵敏、快速检测HIV-1和HIV-2的新技术，识别点护理测试平台。这种独特的平台集成了特定的电化学检测使用四向连接（4 WJ）探针，在改良的等温扩增后，使用基于核酸序列的扩增（NASBA）的病毒RNA片段。完整的分析（RNA扩增和检测）预计将在不到一个小时的时间内完成，与定期去看医生的效果相当。在拟议的研究中，我们将：1）优化利用NASBA进行修饰标签等温扩增; 3）通过选择将通过4 WJ探针询问的扩增子的适当片段; 4）优化和表征扩增子的合适片段。用于病毒直接检测扩增子的生物传感器; 5）研究单和多重生物传感器的可变参数 6）将所开发的生物传感器应用于市售参考材料的病毒检测;以及 7)使用参考方法（RT-qPCR）验证方法学。拟议的技术有望成为一个用户友好的护理点测试在有限的资源设置，及时诊断和监测艾滋病毒感染，以帮助到2030年阻止艾滋病感染的扩散。