关键词： Resonance frequency shift   Antibody   Human serum   ME biosensor   RAPID DETECTION   SARS-COV-2   VIRUS  

摘要： This study proposes a new efficient wireless biosensor based on magnetoelastic waves for antibody detection in human plasma, aiming at the serological diagnosis of COVID-19. The biosensor underwent functionalization with the N antigen - nucleocapsid phosphoprotein of the SARS-CoV-2 virus. Validation analyses by sodium dodecylsulfate polyacrylamide gel electrophoresis (SDS-PAGE), Western blotting (WB), atomic force microscopy (AFM), scanning electron microscopy (SEM), energy-dispersive X-ray (EDX) microanalysis and micro-Raman spectroscopy confirmed the selectivity and effective surface functionalization of the biosensor. The research successfully obtained, expressed and purified the recombinant antigen, while plasma samples from COVID-19 positive and negative patients were applied to test the performance of the biosensor. A performance comparison with the enzyme-linked immunosorbent assays (ELISA) method revealed equivalent diagnostic capacity. These results indicate the robustness of the biosensor in reliably differentiating between positive and negative samples, highlighting its potential as an efficient and low-cost tool for the serological diagnosis of COVID-19. In addition to being fast to execute and having the potential for automation in large-scale diagnostic studies, the biosensor fills a significant gap in existing SARS-CoV-2 detection approaches.