RADx-rad: A Rapid, Sensitive, Point-of-care, Antigen-based Diagnostics for SARS-CoV-2

Abstract Text:

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 antigenbased 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 (<30 minutes) and sensitive (LoD=100 – 1000 copies/ml) detection of intact SARS-CoV-2 in small volume (<100 μL) of COVID-19 patient samples such as nasopharyngeal/oropharyngeal swab and saliva/sputum samples using an inexpensive (<$5 material cost), disposable, and mass-producible microfluidic cartridge.