A critical path to solving the SARS-CoV-2 pandemic, without further socioeconomic impact, is to stop its spread. For this to happen, pre- or asymptomatic individuals infected with the virus need to be detected and isolated opportunely. Unfortunately, there are no current ubiquitous (i.e., ultra-sensitive, cheap, and widely available) rapid testing tools capable of early detection of SARS-CoV-2 infections. In this article, we introduce an accurate, portable, and low-cost medical device and bio-nanosensing electrode dubbed SenSARS and its experimental validation. SenSARS' device measures the electrochemical impedance spectra of a disposable bio-modified screen-printed carbon-based working electrode (SPCE) to the changes in the concentration of SARS-CoV-2 antigen molecules ("S" spike proteins) contained within a sub-microliter fluid sample deposited on its surface. SenSARS offers real-time diagnostics and viral load tracking capabilities. Positive and negative control tests were performed in phosphate-buffered saline (PBS) at different concentrations (between 1 and 50 fg/mL) of SARS-CoV-2(S), Epstein-Barr virus (EBV) glycoprotein gp350, and Influenza H1N1 M1 recombinant viral proteins. We demonstrate that SenSARS is easy to use, with a portable and lightweight (< 200 g) instrument and disposable test electrodes (<U.S. [Formula: see text]5), capable of fast diagnosis (~10 min), with high analytical sensitivity (low limits of detection, LOD = 1.065 fg/mL, and quantitation, LOQ = 3.6 fg/mL) and selectivity to SARS-CoV-2(S) antigens, even in the presence of structural proteins from the other pathogens tested. SenSARS provides a potential path to pervasive rapid diagnostics of SARS-CoV-2 in clinical, point-of-care, and home-care settings, and to breaking the transmission chain of this virus. Medical device compliance testing of SenSARS to EIC-60601 technical standards is underway.
Keywords: Biosensors; SARS-CoV-2; electrochemical biosensors; electrochemical impedance spectroscopy (EIS).