A SARS-CoV-2 NFC ePAD Biosensor

SARS-CoV-2 NFC ePAD 生物传感器

• 批准号: 10185040
• 负责人: DAVID S DANDY
• 金额: $ 98.89万
• 依托单位: COLORADO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-13 至 2024-09-12
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10185040
• 关键词: 2019-nCoV; Antibodies; Antigens; Archives; Biological Assay; Biosensor; Blood; Blood specimen; Buffers; COVID-19; COVID-19 detection; COVID-19 diagnostic; COVID-19 outbreak; COVID-19 patient; Cessation of life; Clinical; Collaborations; Communicable Diseases; Communication; Complex; Detection; Development; Devices; Diagnostic; Diagnostic tests; Disease; Disease Outbreaks; Electrodes; Enzyme-Linked Immunosorbent Assay; Generations; Goals; Gold; Guidelines; Health Personnel; Human; Individual; Infection; Infectious Diseases Research; Institutional Review Boards; Intervention; Label; Laboratories; Location; Measurement; Measures; Methods; Microfluidic Microchips; Modification; Molecular; Nucleic Acid Amplification Tests; Nucleocapsid; Nucleocapsid Proteins; Paper; Patients; Performance; Preparation; Procedures; Process; Quarantine; Rapid diagnostics; Reagent; Reporting; Risk; SARS-CoV-2 antigen; Saliva; Sampling; Sensitivity and Specificity; Serology; Severe Acute Respiratory Syndrome; Silicon; Surface; Surface Tension; System; Techniques; Technology; Telephone; Testing; Thailand; Training; Translating; United States; Universities; Viral; Viral Antigens; Virus; antibody detection; base; cost effective; diagnostic assay; diagnostic platform; healthy aging; immunological status; improved; innovation; laboratory equipment; laboratory facility; lateral flow assay; nasal swab; nasopharyngeal swab; point of care; prevent; receptor binding; screening; sensor; waiver

PROJECT SUMMARY The current SARS-CoV-2 outbreak has begun to reshape how we think about and use diagnostic assays for preventing the spread of infectious diseases. Early diagnostic efforts specific to SARS focused almost solely on detecting the virus using nucleic acid amplification tests; more recently detection of circulating antibodies using ELISA to complete serological screening. While these techniques can provide accurate results, they require laboratory facilities and equipment, creating a significant delay between sampling and results. Rapid diagnostic tests in the form of lateral flow assays have appeared more recently but so far have lacked the sensitivity and selectivity to be useful for slowing disease spread. Another challenge with current approaches is that they require different molecular approaches for different markers making creation of a single test that can determine if an individual is or has been infected is challenging. As a result, there is a clear and pressing need to develop a single sensing platform that can quantitatively detect ng/mL levels of both viral antigens produced during infection and circulating antibodies at the point-of-care from blood, saliva, or nasal swabs that can be used by essentially anyone with little or no training. The goal of this project is to create a simple, inexpensive, and deployable electrochemical paper-based analytical device (ePAD) for detecting SARS-CoV-2 antigens and antibodies in blood, saliva, and nasopharyngeal swabs. Our device will combine three innovative components: a label-free electrochemical biosensor, a disposable near field communication (NFC) potentiostat, and a self-powered microfluidic device that performs complex sample preparation steps without user intervention. This system, the NFC-ePAD, will allow a user to literally add sample and press a button on the sensor and then place their phone on the unit to initiate the measurement. The phone activates the sensor and reports the results to the user. To achieve our goal, we are collaborating with colleagues at Chulalongkorn University and Silicon Craft™ in Thailand. Our aims are 1) demonstrate a sensitive label-free biosensor for circulating SARS-CoV-2 nucleocapsid protein and anti-spike receptor binding domain (RBD) antibodies, 2) create a self-power microfluidic device for sample processing, and 3) validate the system using deidentified, banked clinical samples. Once developed, the system will provide a fast, simple, and easy-to-use platform for healthcare providers and individuals alike to rapidly determine the infection and immune status of potential COVID-19 patients.

项目摘要 当前的SARS-COV-2爆发已经开始重塑我们如何看待和使用诊断测定法 防止传染病的传播。几乎完全专门针对SAR的早期诊断工作 使用核酸扩增测试检测病毒；最近检测到循环抗体 使用ELISA完成血清学筛查。尽管这些技术可以提供准确的结果，但它们 需要实验室设施和设备，从而在抽样和结果之间产生重大延迟。迅速的 最近出现了以横向流量测定形式的诊断测试，但到目前为止缺乏 灵敏度和选择性可用于减缓疾病扩散。当前方法的另一个挑战是 他们需要不同的分子方法来进行不同的标记，从而创建一个可以 确定个人是否已感染或已感染。结果，有明确而紧迫的需求 要开发一个可以定量检测两种病毒抗原Ng/ml水平的单个感应平台 在感染和循环抗体期间产生的血液，唾液或鼻拭子的循环抗体 从本质上讲，任何人几乎没有培训的人都可以使用。该项目的目的是创建一个简单的， 用于检测SARS-COV-2的廉价和可部署的电化学分析装置（EPAD） 血液，唾液和鼻咽拭子中的抗原和抗体。我们的设备将结合三个创新 组件：无标签的电化学生物传感器，一次性近距离通信（NFC） Potentiostat和一个自动的微流体设备，可以执行复杂的样品准备步骤，而无需 用户干预。该系统，NFC-EPAD，将允许用户从字面上添加示例，然后按下按钮 传感器，然后将手机放在设备上以启动测量。手机激活传感器 并将结果报告给用户。为了实现我们的目标，我们正在与Chulalongkorn的同事合作 泰国的大学和硅Craft™。我们的目的是1）展示一个无敏感的无标签的生物传感器 循环SARS-COV-2核蛋白蛋白和抗尖峰受体结合结构域（RBD）抗体，2） 创建一个自动微流体设备，用于样品处理，3）使用Deidinified验证系统， 银行临床样本。一旦开发，该系统将为快速，简单且易于使用的平台提供 医疗保健提供者和个人都可以快速确定潜在的感染和免疫学状态 Covid-19患者。