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 forthe screening and management of SARS-CoV-2 infection. Other than tests that require laboratory-scaleinstrumentation, 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 componentsand, depending on the implementation, can result in a relatively high degree of error. In partnership withMIT, InnoTech proposes the development of a multiplexed sensor platform based on nanomaterials capableof molecular binding and subsequent reporting. We will develop and commercialize a multiplexed sensorplatform using nanomaterial reporters capable of rapid simultaneous detection of multiple components ofviral particles in a field applicable electrochemical device. For our Phase I- Aim 1 we will focus on thedevelopment and optimization of synthetic biosensors for accurate detection of SARS-CoV-2 viral proteinsand nucleic acid. Our milestone is the discovery and validation an array of molecular recognition biosensorsagainst 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 syntheticbiosensors identified and validated in Aim 1 to an electrochemical platform for the rapid detection of anactive SARS-CoV-2 infection using multiple biomarkers of the infection. We will specifically employcommercially-available, disposable electrode platforms and existing potentiostats from Metrohm DropSensto streamline scale-up and commercialization. Our milestone, to be completed in year 1 of Phase II, is tohave a multiplex biosensor chip and an alpha prototype with a multiplex biosensor chip and a potentiostatreader which we will benchmark for sensitivity and quantitative accuracy against existing COVID-19diagnostics. In Phase II-Aim 2, we will validate the prototype chips and detectors with retrospective clinicalspecimens 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 todocument a multiplex of at least two proteins and two nucleic acid biosensors for SARS-CoV-2 that willprovide a LOD of 5-20 viruses per microliter in an oral specimen and will be clinically validated withgreater than 95% concordance with RT-PCR in 30 positive and 30 negative specimens.