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.

项目总结 目前的SARS-CoV-2疫情已经开始重塑我们思考和使用诊断化验方法的方式 防止传染病的传播。针对SARS的早期诊断工作几乎完全集中在 用核酸扩增试验检测病毒；最近检测循环抗体 用酶联免疫吸附试验完成血清学筛查。虽然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，造成采样和结果之间的严重延迟。快速 以侧向流动分析为形式的诊断试验是最近出现的，但到目前为止还缺乏 敏感度和选择性有助于减缓疾病传播。当前方法的另一个挑战是 他们需要不同的分子方法来处理不同的标记，从而创造出一种可以 确定一个人是否被感染是一件具有挑战性的事情。因此，有一种明确而紧迫的需求。 建立单一传感平台，定量检测两种病毒抗原的ng/m L水平 在感染期间产生，在护理地点从血液、唾液或鼻拭子中产生循环抗体 基本上任何很少或根本没有受过培训的人都可以使用它。该项目的目标是创建一个简单、 用于检测SARS-CoV-2的廉价、可部署的电化学纸基分析设备(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的 组件：无标记电化学生物传感器、一次性近场通信(NFC) 恒电位器，以及一种自供电微流控装置，其执行复杂的样品制备步骤而无需 用户干预。这个名为NFC-ePad的系统将允许用户直接添加样品并按下按钮 传感器，然后将他们的手机放在单元上以启动测量。手机会激活传感器 并将结果报告给用户。为了实现我们的目标，我们正在与朱拉隆功的同事合作 泰国的大学和硅工艺™。我们的目标是1)展示一种灵敏的无标记生物传感器 循环SARS-CoV-2核衣壳蛋白和抗刺受体结合域抗体，2) 创建用于样品处理的自力式微流控装置，以及3)使用DEIDENTED， 储存了临床样本。一旦开发完成，该系统将提供一个快速、简单和易于使用的平台 医疗保健提供者和个人一样，可以快速确定潜在的感染和免疫状态 新冠肺炎患者。