30-Seconds Sars-Cov-2 Human Sample Diagnosis and Analytical Specificity Analysis Using Disposable Strips on a Metal-Oxide-Semiconductor Field-Effect Transistor Platform

Abstract

A SARS-CoV-2 rapid detection technology employed commercially available test strips similar to the blood glucose test strips were developed with a detection time of 30 sec and the sensitivity as good as polymerase chain reaction (PCR). The analytical specificity of this technology was also investigated by testing the cross-reactivity and microbial interference on this biosensor platform using FDA suggested 31 different contaminants. Variants of SARS-CoV-2 have mutated along with the worldwide spread of the pandemic. Currently, the most common detection methods are PCR and lateral flow tests. The former takes more than an hour to obtain results and the latter has difficulty detecting the virus at low concentrations (for cycling threshold values, CT values, >25 to 27). Therefore, the demand for a fast, cost-effective, and low detection limit testing method has been significantly increased. In this work, 60 human saliva samples with 30 positive and 30 negative were collected and tested with PCR for SARS-CoV-2 prior to using our disposable strips. For this technology, the test strip was connected to the gate electrode of the MOSFET on the printed circuit board that serves to amplify signals. A synchronous double-pulsed bias voltages (around 1 ms) were sent to both the drain and gate of the MOSFET. The resulting change in drain waveforms was converted to digital readings and compared with cycling threshold (Ct) values of human samples to assess this sensor technology. The result signifies that positive human samples with a range of Ct values from 17.8 to 40 can be differentiated, along with proving none of those high-risk organisms would hinder the sensitivity of our system. Which demonstrated the potential of this system to be developed into a cost-effective and point-of-care rapid detection for SARS-CoV-2.