As a consequence of the progress of the global vaccination against the COVID-19 disease, fast, accurate and affordable assays are needed for monitoring the efficiency of developing immunity against the coronavirus at the population level. In this context, we herewith report the proof-of-concept development of an innovative bioelectric biosensor for the ultra-detection (in less than three minutes) of IgG antibodies against the SARS-CoV-2 S1 spike antigen. The biosensor comprises a disposable set of screen-printed electrodes upon which are immobilized cells engineered to bear the S1 protein on their surface. When anti-S1 antibodies are presented to the engineered cell population, a rapid, specific, and selective change of the cell membrane potential occurs; this is in turn recorded by a bespoke portable potentiometer. End results are communicated via Bluetooth to a smartphone equipped with a customized user interface. By using the novel biosensor, anti-S1 antibodies could be detected at concentrations as low as 5 ng/mL. In a preliminary clinical trial, positive results were derived from patients vaccinated or previously infected by the virus. Selectivity over other respiratory viruses was demonstrated by the lack of cross-reactivity to antibodies against rhinovirus. After further clinical validation and extension to also screen IgM, IgA and possible neutralizing antibodies, our approach is intended to facilitate the mass and reliable detection of antibodies in the early stages following vaccination and to monitor the duration and level of acquired immunity both in a clinical and self-testing environment.
