A Rapid, Sensitive, Point-of-Care, Antigen-Based Diagnostics for SARS-CoV-2

A rapid, sensitive, low-cost diagnostic device for early detection of novel Coronavirus Disease (COVID-19) can significantly change the paradigm in real-time and efficient management of patients and available healthcare resources specifically during this time of increased demand for hospital services. The quantitative real-time polymerase chain reaction (qPCR) represents the most important method for the diagnosis of COVID-19 at its early stage of infection and before the appearance of clinical symptoms. However, qPCR-based molecular diagnostics are bulky, expensive, or lab-based, or require trained personnel for system operation. The majority of the FDA EUA-approved COVID diagnostics are PCR-based which require nucleic acid extraction and amplification and thermal cycling. Such systems also require relatively expensive/bulky equipment for sample processing. Recent studies have shown large variations up to 10,000 fold variations in limit of detection (LoD) of some of the nucleic acid-based and antigen-based COVID-19 diagnostics currently approved under emergency use authorization (EUA). Therefore, there is still a need in developing POC diagnostics and particularly antigen-based SARS-CoV-2 detection devices with LoD comparable to PCR-based assays. The main goal of this interdisciplinary project is developing a portable diagnostic system for rapid and sensitive detection of intact SARS-CoV-2 in small volume of COVID-19 patient samples such as anterior/nasopharyngeal/oropharyngeal swab samples using an inexpensive, disposable, and mass-producible microfluidic cartridge.