A multimodal platform for Oral screening of COVID-19

用于 COVID-19 口腔筛查的多模式平台

• 批准号: 10665346
• 负责人: ROYA KHOSRAVI-FAR
• 金额: $ 50万
• 依托单位: INNOTECH LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2024-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10665346
• 关键词: 2019-nCoV; Antibodies; Antigens; Automobile Driving; Award; Benchmarking; Binding; Biological Assay; Biological Markers; Biosensing Techniques; Biosensor; Businesses; COVID diagnostic; COVID-19 detection; COVID-19 diagnostic; COVID-19 screening; Clinical; Collection; Communicable Diseases; Computer software; Detection; Development; Devices; Diagnostic; Diagnostic tests; Disease; Disease Outbreaks; Electrodes; Elements; FDA Emergency Use Authorization; Future; Hour; Housekeeping; Human; Individual; Infection; Infectious Agent; Influenza; Laboratories; Lateral; Microfluidic Microchips; Microfluidics; Molecular; Nature; Nucleic Acids; Optics; Oral; Patient Care; Patients; Performance; Phase; Play; Preparation; Process; Proteins; Provider; Public Health; RADx Radical; Reader; Readiness; Reporter; Reporting; Reproducibility; Reverse Transcriptase Polymerase Chain Reaction; Role; Running; SARS-CoV-2 B.1.617.2; SARS-CoV-2 infection; Saliva; Sampling; Screening Result; Signal Transduction; Site; Small Business Technology Transfer Research; Specimen; System; Technology; Technology Transfer; Testing; Time; Time Management; United States National Institutes of Health; Validation; Viral; Viral Proteins; Virus; Washington; Work; antibody detection; base; clinical application; combat; commercialization; cost; cross reactivity; design; design verification; detection limit; detector; electrochemical device; emerging pathogen; experience; innovation; instrumentation; manufacturability; miniaturize; molecular array; molecular recognition; multimodality; nanomaterials; nanosensors; normal microbiota; pandemic disease; pandemic preparedness; particle; pathogen; point of care; portability; precision medicine; prototype; rapid detection; rapid test; respiratory pathogen; response; sample collection; scale up; screening; sensor; transmission process; treatment planning

Original Abstract A multimodal platform for Oral screening of COVID-19 The development of a rapid and reliable sensor system from readily available oral specimens is crucial for the screening and management of SARS-CoV-2 infection. Other than tests that require laboratory-scale instrumentation, the development of rapid tests can play a timely role in the management of an outbreak. Current rapid tests often involve the antibodies in a lateral flow format to detect viral protein components and, depending on the implementation, can result in a relatively high degree of error. In partnership with MIT, InnoTech proposes the development of a multiplexed sensor platform based on nanomaterials capable of molecular binding and subsequent reporting. We will develop and commercialize a multiplexed sensor platform using nanomaterial reporters capable of rapid simultaneous detection of multiple components of viral particles in a field applicable electrochemical device. For our Phase I- Aim 1 we will focus on the development and optimization of synthetic biosensors for accurate detection of SARS-CoV-2 viral proteins and nucleic acid. Our milestone is the discovery and validation an array of molecular recognition biosensors against both protein and nucleic acid segments of SARS-CoV-2. We will complete this phase in 4 months. In Phase II-Aim 1, we will develop and validate the electrochemical detectors. We will utilize the synthetic biosensors identified and validated in Aim 1 to an electrochemical platform for the rapid detection of an active SARS-CoV-2 infection using multiple biomarkers of the infection. We will specifically employ commercially-available, disposable electrode platforms and existing potentiostats from Metrohm DropSens to streamline scale-up and commercialization. Our milestone, to be completed in year 1 of Phase II, is to have a multiplex biosensor chip and an alpha prototype with a multiplex biosensor chip and a potentiostat reader which we will benchmark for sensitivity and quantitative accuracy against existing COVID-19 diagnostics. In Phase II-Aim 2, we will validate the prototype chips and detectors with retrospective clinical specimens in preparation for EUA-FDA submission. We will determine the LOD, clinical performance, and cross-reactivity with other respiratory pathogens and normal flora. The milestone for this Aim is to document a multiplex of at least two proteins and two nucleic acid biosensors for SARS- CoV-2 that will provide a LOD of 5-20 viruses per microliter in an oral specimen and will be clinically validated with greater than 95% concordance with RT-PCR in 30 positive and 30 negative specimens.

原始大小电子游戏 用于COVID-19口服筛查的多模式平台 从容易获得的口腔样本中开发快速可靠的传感器系统对于筛选和 SARS-CoV-2感染的管理。除了需要实验室规模仪器的测试外， 快速检测可在控制疾病爆发方面发挥及时作用。目前的快速检测通常涉及抗体， 横向流动形式来检测病毒蛋白组分，并且根据实施方式，可以导致相对高的 误差程度。InnoTech与麻省理工学院合作，提出开发基于 纳米材料能够分子结合和随后的报告。我们将开发一种多路复用的 使用能够快速同时检测病毒的多个组分的纳米材料报告物的传感器平台 在现场可应用的电化学装置中的颗粒。在第一阶段-目标1，我们将专注于发展和 优化合成生物传感器，用于准确检测SARS-CoV-2病毒蛋白和核酸。我们的里程碑 是发现和验证一系列针对蛋白质和核酸片段的分子识别生物传感器 SARS-CoV-2我们将在4个月内完成这一阶段。在第二阶段-目标1，我们将开发和验证 电化学检测器我们将利用目标1中鉴定和验证的合成生物传感器进行电化学分析。 使用多种感染生物标志物快速检测活动性SARS-CoV-2感染的平台。我们将 特别是使用市售一次性电极平台和现有的Metrohm恒电位仪 DropSens将简化规模扩大和商业化。我们的里程碑将在第二阶段的第一年完成， 多路生物传感器芯片和具有多路生物传感器芯片和恒电位仪读取器的α原型，我们将 针对现有COVID-19诊断的灵敏度和定量准确性基准。在第二阶段-目标二，我们会 使用回顾性临床样本验证原型芯片和检测器，为EUA-FDA提交做准备。 我们将确定LOD、临床性能以及与其他呼吸道病原体和正常植物群的交叉反应性。 这一目标的里程碑是记录至少两种蛋白质和两种核酸的SARS生物传感器的复合物， CoV-2将在口腔标本中提供5-20个病毒/微升的LOD，并将通过以下方法进行临床验证： 30例阳性和30例阴性标本与RT-PCR的符合率均大于95%。