A multimodal platform for Oral screening of COVID-19

从现成的口腔标本中开发快速可靠的传感器系统对于 SARS-CoV-2感染的筛查和管理。除了需要实验室规模的测试 通过使用仪器，快速检测的发展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在侧流格式检测病毒蛋白质成分 并且取决于实现，可能导致相对高程度的误差。在伙伴关系与 麻省理工学院，InnoTech提出开发一种基于纳米材料的多路传感器平台， 分子结合和随后的报告。我们将开发和商业化的多路传感器 使用能够快速同时检测多个组分的纳米材料报告物的平台 病毒颗粒在可现场应用的电化学装置中的应用。在第一阶段-目标1，我们将重点关注 用于SARS-CoV-2病毒蛋白精确检测的合成生物传感器的开发和优化 和核酸。我们的里程碑是发现和验证了一系列分子识别生物传感器 针对SARS-CoV-2的蛋白质和核酸片段。我们将在4个月内完成这一阶段。 在第二阶段-目标1中，我们将开发和验证电化学检测器。我们将利用合成的 目标1中鉴定和验证的生物传感器转化为电化学平台，用于快速检测 活动性SARS-CoV-2感染，使用感染的多种生物标志物。我们会特别雇佣 市售的一次性电极平台和现有的恒电位仪 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， 具有多重生物传感器芯片和具有多重生物传感器芯片和恒电位仪的α原型 我们将根据现有的COVID-19对该阅读器的敏感性和定量准确性进行基准测试 诊断在第二阶段-目标2中，我们将通过回顾性临床试验验证原型芯片和探测器。 准备提交EUA-FDA的样本。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 记录了至少两种蛋白质和两种核酸的SARS-CoV-2生物传感器的多重， 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%。

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.