A scalable aptamer-based electrochemical biosensor for rapid detection of SARS-CoV-2 from saliva

一种基于适配体的可扩展电化学生物传感器，用于快速检测唾液中的 SARS-CoV-2

• 批准号: 10320990
• 负责人: Jeffrey Ly
• 金额: $ 49.04万
• 依托单位: MPOD, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-12-21 至 2023-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10320990
• 关键词: 2019-nCoV; Affinity; Antibodies; Binding; Biosensor; Businesses; CLIA certified; COVID-19; COVID-19 detection; COVID-19 intervention; COVID-19 pandemic; COVID-19 point of care; COVID-19 test; COVID-19 testing; Cells; Cellular Phone; Communication; Communities; Contracts; Country; Custom; Data; Data Collection; Databases; Detection; Development; Devices; Diagnosis; Diagnostic; Diagnostic Procedure; Diagnostic tests; Disease; Disease Outbreaks; Electrodes; Electronics; Ensure; Enzyme-Linked Immunosorbent Assay; Family; Future; Goals; Gold; Health Personnel; Health Professional; Healthcare Systems; Immobilization; Individual; Institution; Manufacturer Name; Methods; Noise; Nucleic Acids; Oligonucleotides; Patients; Performance; Periodicity; Phase; Population; Process; Production; Proteins; Public Health; Reagent; Reporting; Reverse Transcriptase Polymerase Chain Reaction; Saliva; Sampling; Schools; Security; Sensitivity and Specificity; Signal Transduction; Site; Specificity; Swab; System; Tablets; Technology; Test Result; Testing; Time; Viral Proteins; Virus; antigen diagnostic; aptamer; base; cloud storage; cost; data infrastructure; density; design; detector; digital; education resources; encryption; follow-up; high risk; improved; miniaturize; mobile application; novel; novel diagnostics; pandemic disease; pathogen; point of care; point-of-care detection; public health emergency; rapid detection; rapid diagnosis; rapid technique; response; saliva sample; test strip; wireless

Abstract The COVID-19 pandemic is a critical global public health emergency and many countries are failing to contain the virus's spread due to slow and insufficient testing. While several diagnostic methods are now available, most tests are either reagent-intensive and must be done in CLIA-approved labs, making them expensive and slow to report results, or rapid and inexpensive, but potentially lacking in sensitivity. In the U.S., seriously ill and high- risk patients have been prioritized for testing, causing states to miss mild and asymptomatic cases, some of which are the most effective spreaders of the virus. However, expanding testing has been a challenge due to shortages of sampling swabs and key reagents for nucleic acid amplification-based tests, which are the most popular option. Testing capabilities must be expanded exponentially to enable mass population-level testing of all patients, healthcare workers and their families, other critical key workers, and the wider community in order to bring the pandemic under control. mPOD proposes to expand testing capabilities through a novel biosensor that will use oligonucleotide molecules called aptamers to bind to unique sites on the SARS-CoV-2 virus. Aptamers have similar binding affinities to antibodies, but due to their smaller size, they are more agile, making them particularly suited for high-specificity binding. To complete the test, a saliva sample will be loaded onto a test strip containing aptamers immobilized onto gold electrodes. The gold-electrode test strip will be inserted into the mPOD DTCT, a proprietary electrochemical test platform where virus-bound aptamers will be detected via cyclic voltammetry, triggering a positive result. The result is sent wirelessly via a mobile app, which sends encrypted data on to the cloud for storage and to public health agencies for enhanced data collection, tracking, and tracing of COVID-19. The app will also include a backend database to help businesses, manufacturers, schools, and large institutions track tested individuals' results and tailor specific public health responses. In order to further develop this technology and enable rapid deployment for timely COVID-19 intervention, mPOD plans to 1) Select SARS-CoV-2-specific aptamers for use in electrode test strips with an optimized signal-to-noise ratio performance, 2) Demonstrate sensitivity and specificity of a low-cost, miniaturized potentiostat test strip for use as a COVID-19 POC or OTC diagnostic, 3) Complete and test a fully-fledged digital infrastructure for data collection, tracking, and tracing of COVID-19 test results via the mPOD mobile app. This non-traditional approach will provide new testing capabilities with the potential to report results faster than standard RT-PCR tests and with greater accuracy and sensitivity compared to existing antigen-based diagnostics. Furthermore, once the system is developed, test strips with customized aptamers can be developed for rapid diagnosis of other pathogens, including future emerging pandemics, via routine POC and OTC testing.

抽象的 COVID-19大流行是全球关键的全球公共卫生紧急事件，许多国家未能遏制 由于测试缓慢和不足，该病毒的蔓延。虽然现在有几种诊断方法，但大多数 测试要么是强度的，因此必须在CLIA批准的实验室中进行，使其昂贵而慢。 报告结果，或迅速且价格便宜，但可能缺乏灵敏度。在美国，生病和高 风险患者已优先进行测试，导致州错过轻度和无症状的病例，其中一些 这是病毒中最有效的散布器。但是，由于 基于核酸扩增的测试的抽样拭子和关键试剂的短缺，这是最多的 流行选择。测试功能必须成倍扩展，以实现大众人口水平的测试 所有患者，医疗保健工作者及其家人，其他关键关键工作者以及更广泛的社区 使大流行受到控制。 MPOD建议通过新型生物传感器扩展测试功能 这将使用称为Aptamer的寡核苷酸分子与SARS-COV-2病毒上的独特位点结合。 适体具有与抗体相似的结合亲和力，但由于其尺寸较小，它们更敏捷，使其产生 它们特别适合于高特异性结合。为了完成测试，将加载唾液样本 测试条含有固定在金电极上的适体。金电极测试条将插入 MPOD DTCT是一个专有的电化学测试平台，可以通过病毒结合的适体通过 循环伏安法，触发阳性结果。结果是通过移动应用程序无线发送的，该应用程序发送 加密到云的数据以进行存储和公共卫生机构，以增强数据收集，跟踪， 并追踪Covid-19。该应用程序还将包括一个后端数据库，以帮助企业，制造商， 学校和大型机构跟踪了测试人员的成果，并量身定制了特定的公共卫生反应。为了 为了进一步开发这项技术，并为及时的Covid-19干预提供快速部署，MPOD计划 至1）选择具有优化信号噪声比的电极测试条中的SARS-COV-2特异性适体 性能，2）表现出低成本，微型电位的测试条的灵敏度和特异性 作为COVID-19 POC或OTC诊断，3）完成并测试符合数据的数字基础架构的数据 通过MPOD移动应用程序收集，跟踪和跟踪COVID-19测试结果。这种非传统方法 将提供新的测试功能，具有比标准RT-PCR测试更快的报告结果的潜力 与现有的基于抗原的诊断相比，具有更高的准确性和灵敏度。此外，曾经 开发系统，可以开发具有自定义适体的测试条，以快速诊断其他 通过常规POC和OTC测试，病原体，包括未来的新兴流程。