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Rapid and Low- cost POC Assay for Zika Virus Diagnosis

用于寨卡病毒诊断的快速、低成本 POC 检测

基本信息

批准号：
9254690
负责人：
SEASON S-S WONG
金额：
$ 22.5万
依托单位：
AI BIOSCIENCES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-01-01 至 2017-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9254690
关键词：
Americas Arboviruses Area Attention Biological Assay Cellular Phone Centers for Disease Control and Prevention (U.S.)Central America Collection Congenital Abnormality Congresses Consult Country Culicidae Data Detection Development Devices Diagnosis Diagnostic Diagnostic tests Disease Outbreaks Emergency Situation Environmental Wind Flavivirus Fluorescence Friction Funding Goals Gold Guillain-Barré Syndrome Health Health Personnel Healthcare Image Infection Injection of therapeutic agent International Laboratories Latin America Learning Lifting Link Magnetism Medical Metals Methods Microcephaly Microfluidics Modernization Molds Molecular Molecular Diagnostic Testing Monitor Motion Music Nucleic Acids Patients Phase Plasticizers Point-of-Care Systems Polymerase Polymerase Chain Reaction Population Positioning Attribute Pregnancy Preparation Prevention Printing Procedures Process Public Health Pump RNA Reaction Reporting Research Research Personnel Resources Reverse Transcriptase Polymerase Chain Reaction Reverse Transcription Saliva Sampling Sensitivity and Specificity Series Serum Signal Transduction Small Business Innovation Research Grant South America Speed System Techniques Technology Testing Texas Time Training United States United States National Institutes of Health Universities Urine Virus Virus Diseases Visit Wireless Technology Work Zika Virus authority base combat commercialization cost cost effective design diagnostic assay global health innovation instrument interest molecular diagnostics novel operation particle point of care point-of-care diagnostics portability professor recombinase response screening tool viral RNA viral detection wireless fidelity

项目摘要

PROJECT SUMMARY The aim of this proposal is to develop a rapid, low-cost, and easy-to-use POC diagnostic test for Zika virus (ZIKV). ZIKV is an emerging mosquito-borne Flavivirus that has gained global attention due to new evidence that it is linked to birth defect microcephaly. Additionally, health experts are also concerned about the link between the virus and Guillain-Barré syndrome (GBS). President Obama announced in early February of 2016 that he is asking Congress for more than $1.8 billion in emergency funding to expand the United States’ efforts to combat Zika. One of the most vital tools necessary to confront an outbreak like the Zika virus is a reliable, accurate, and easily accessible diagnostic test. The issue with existing tests is that they often fail to distinguish between Zika and similar viruses to which people living in Central and South America are frequently exposed. The CDC has recommended the use of molecular detection (e.g., reverse transcription polymerase chain reaction or RT-PCR) to identify Zika virus in suspected cases. While CDC and qualified state health department labs can perform the RT-PCR ZIKV test, these labs use highly sophisticated instruments and turnaround times are typically weeks. To this end, we will collaborate with internationally known arboviruses expert and leading US ZIKV researcher Professor Scott Weaver at the University of Texas Medical Branch (UTMB) to develop a low-cost POC system for testing ZIKVs infection in non-traditional healthcare settings in the US and Americas. This device uses a wind-up music box to drive an innovatively designed plastic gear set to automate nucleic acid extraction in pre-filled cartridges and to elute the purified RNA directly into real-time master mix of amplification assays such as reverse transcription recombinase polymerase amplification reaction (RT-RPA) or polymerase chain reactions (RT-PCR). The gear set and the disposable cartridge can be enclosed for biosafety and contamination prevention. This portable system lacks complicated microfluidics, pumps or other sensitive/high cost components, thus making it suitable for resource-limited countries. The simple sample-to-answer process requires minimal training and informs healthcare workers of patients’ diagnostic statuses. In Phase I, we will first demonstrate quality RNA extraction from spiked serum and urine samples in 10 min using pre-filled cartridges and the gear set. We will also demonstrate that the eluted RNA samples can be rapidly amplified to confirm the presence of ZIKV RNA using isothermal real-time RT-RPA assay. We aim to complete real-time RT-RPA amplification reactions in less than 15 min. The fluorescent signal produced from amplification will be monitored using LEDs for excitation and a smartphone camera for emission monitoring and analysis. Near the end of Phase I, our collaborator will validate our device for ZIKV detection. The successful development and commercialization of our technology will lead to molecular diagnostics being implemented in non-laboratory settings and will assist resource-limited populations to get tested for Zika. In short, our portable system will be pertinent to the ongoing ZIKV global health emergency.

项目摘要该提案的目的是开发一种快速、低成本、易于使用的寨卡病毒POC诊断测试（ZIKV）. ZIKV是一种新出现的蚊媒黄病毒，由于新的证据，它与先天性小头畸形有关此外，健康专家也对这种联系感到担忧。格林-巴利综合征（Guillain-Barré syndrome，GBS）奥巴马总统在2016年2月初宣布，他要求国会提供超过18亿美元的紧急资金，以扩大美国的努力来对抗寨卡病毒应对寨卡病毒等疫情最重要的工具之一是可靠的，准确、方便的诊断测试。现有测试的问题在于，它们通常无法区分寨卡病毒与生活在中美洲和南美洲的人们经常接触的类似病毒之间的关系。 CDC建议使用分子检测（例如，逆转录聚合酶链寨卡病毒是一种常见的寨卡病毒。疾控中心和合格的州卫生部部门实验室可以进行RT-PCR ZIKV测试，这些实验室使用高度复杂的仪器，周转时间通常为数周。为此，我们将与国际知名虫媒病毒合作德克萨斯大学医学分支的专家和美国ZIKV研究的领先者斯科特·韦弗教授说（UTMB）开发一种低成本的POC系统，用于在非传统医疗环境中测试ZIKV感染，美国和美洲。这个装置使用一个发条音乐盒来驱动一个创新设计的塑料齿轮组自动化预填充盒中的核酸提取，并将纯化的RNA直接进行实时定量分析，扩增测定的主混合物，例如逆转录重组酶聚合酶扩增反应（RT-RPA）或聚合酶链反应（RT-PCR）。齿轮组和一次性盒可为了生物安全和防止污染，应将其封闭。这种便携式系统缺乏复杂的微流体，泵或其他敏感/高成本组件，因此适用于资源有限的国家。的简单的采样到回答过程需要最少的培训，并告知医护人员患者的诊断状态。在第一阶段，我们将首先证明从加标的血清和尿液中提取高质量的RNA 使用预充式检测盒和齿轮组，在10分钟内完成采样。我们还将证明洗脱的RNA 可以使用等温实时RT-RPA快速扩增样品以确认ZIKV RNA的存在比色法我们的目标是在不到15分钟内完成实时RT-RPA扩增反应。将使用LED激发和智能手机摄像头监测扩增产生的信号，排放监测和分析。接近第一阶段结束时，我们的合作者将验证我们的ZIKV设备侦测我们的技术的成功开发和商业化将导致分子在非实验室环境中实施诊断，并将帮助资源有限的人群获得寨卡病毒检测简而言之，我们的便携式系统将与正在进行的ZIKV全球卫生紧急情况有关。