@article{3029729, title = "Clinical Application of the Novel Cell-Based Biosensor for the Ultra-Rapid Detection of the SARS-CoV-2 S1 Spike Protein Antigen: A Practical Approach", author = "Mavrikou, Sophie and Tsekouras, Vasileios and Hatziagapiou, Kyriaki and and Paradeisi, Foteini and Bakakos, Petros and Michos, Athanasios and and Koutsoukou, Antonia and Konstantellou, Elissavet and Lambrou, I, George and and Koniari, Eleni and Tatsi, Elizabeth-Barbara and Papaparaskevas, and Joseph and Iliopoulos, Dimitrios and Chrousos, George P. and Kintzios, and Spyridon", journal = "BIOSENSORS-BASEL", year = "2021", volume = "11", number = "7", publisher = "MDPI", doi = "10.3390/bios11070224", keywords = "Bioelectric Recognition Assay (BERA); membrane engineering; public health surveillance; Point-of-Care (POC); S1 spike protein; rapid antigen test; screening; serological assay; severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2)", abstract = "The availability of antigen tests for SARS-CoV-2 represents a major step for the mass surveillance of the incidence of infection, especially regarding COVID-19 asymptomatic and/or early-stage patients. Recently, we reported the development of a Bioelectric Recognition Assay-based biosensor able to detect the SARS-CoV-2 S1 spike protein expressed on the surface of the virus in just three minutes, with high sensitivity and selectivity. The working principle was established by measuring the change of the electric potential of membrane-engineered mammalian cells bearing the human chimeric spike S1 antibody after attachment of the respective viral protein. In the present study, we applied the novel biosensor to patient-derived nasopharyngeal samples in a clinical set-up, with absolutely no sample pretreatment. More importantly, membrane-engineered cells were pre-immobilized in a proprietary biomatrix, thus enabling their long-term preservation prior to use as well as significantly increasing their ease-of-handle as test consumables. The plug-and-apply novel biosensor was able to detect the virus in positive samples with a 92.8% success rate compared to RT-PCR. No false negative results were recorded. These findings demonstrate the potential applicability of the biosensor for the early, routine mass screening of SARS-CoV-2 on a scale not yet realized." }