A multimodal platform for Oral screening of COVID-19

用于 COVID-19 口腔筛查的多模式平台

基本信息

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
项目类别：
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

项目摘要

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.

原始摘要用于 COVID-19 口腔筛查的多模式平台利用现成的口腔标本开发快速可靠的传感器系统对于筛查和诊断至关重要。 SARS-CoV-2 感染的管理。除了需要实验室规模仪器的测试之外，快速检测可以在疫情管理中发挥及时作用。目前的快速测试通常涉及抗体侧流格式检测病毒蛋白成分，并且根据实施情况，可能会导致相对较高的误差程度。 InnoTech 与 MIT 合作，提议开发基于能够进行分子结合和后续报告的纳米材料。我们将开发并商业化多路复用使用纳米材料报告器的传感器平台能够快速同时检测病毒的多种成分现场适用的电化学装置中的颗粒。对于我们的第一阶段——目标 1，我们将重点关注开发和优化合成生物传感器以准确检测 SARS-CoV-2 病毒蛋白和核酸。我们的里程碑是针对蛋白质和核酸片段的一系列分子识别生物传感器的发现和验证 SARS-CoV-2。我们将在 4 个月内完成这个阶段。在第二阶段目标 1 中，我们将开发并验证电化学检测器。我们将利用目标 1 中识别和验证的合成生物传感器来构建电化学传感器使用感染的多种生物标志物快速检测活动性 SARS-CoV-2 感染的平台。我们将特别采用市售的一次性电极平台和现有的万通恒电位仪 DropSens 可简化规模扩大和商业化。我们的里程碑是在第二阶段的第一年完成多重生物传感器芯片和带有多重生物传感器芯片和恒电位仪读取器的 alpha 原型，我们将针对现有 COVID-19 诊断的灵敏度和定量准确性的基准。在第二阶段目标 2 中，我们将使用回顾性临床样本验证原型芯片和探测器，为 EUA-FDA 提交做准备。我们将确定 LOD、临床表现以及与其他呼吸道病原体和正常菌群的交叉反应性。该目标的里程碑是记录至少两种蛋白质和两种核酸生物传感器的多重检测 SARS- CoV-2 将在口腔样本中提供每微升 5-20 个病毒的 LOD，并将通过以下方法进行临床验证 30 个阳性样本和 30 个阴性样本与 RT-PCR 的一致性大于 95%。