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
Sophie Mavrikou,
Vasileios Tsekouras,
Kyriaki Hatziagapiou,
Foteini Paradeisi,
Petros Bakakos,
Athanasios Michos,
Antonia Koutsoukou,
Elissavet Konstantellou,
George I. Lambrou,
Eleni Koniari,
Elizabeth-Barbara Tatsi,
Joseph Papaparaskevas,
Dimitrios Iliopoulos,
George P. Chrousos,
Spyridon Kintzios
Affiliations
Sophie Mavrikou
Laboratory of Cell Technology, Department of Biotechnology, Agricultural University of Athens, EU-CONEXUS European University, 11855 Athens, Greece
Vasileios Tsekouras
Laboratory of Cell Technology, Department of Biotechnology, Agricultural University of Athens, EU-CONEXUS European University, 11855 Athens, Greece
Kyriaki Hatziagapiou
First Department of Pediatrics, National and Kapodistrian University of Athens, “Aghia Sophia” Children’s Hospital, Thivon 1, 11527 Athens, Greece
Foteini Paradeisi
Laboratory of Cell Technology, Department of Biotechnology, Agricultural University of Athens, EU-CONEXUS European University, 11855 Athens, Greece
Petros Bakakos
First University Department of Respiratory Medicine, “Sotiria” Hospital, Medical School, National and Kapodistrian University of Athens, 152 Mesogeion Ave, 11527 Athens, Greece
Athanasios Michos
First Department of Pediatrics, National and Kapodistrian University of Athens, “Aghia Sophia” Children’s Hospital, Thivon 1, 11527 Athens, Greece
Antonia Koutsoukou
First University Department of Respiratory Medicine, “Sotiria” Hospital, Medical School, National and Kapodistrian University of Athens, 152 Mesogeion Ave, 11527 Athens, Greece
Elissavet Konstantellou
First University Department of Respiratory Medicine, “Sotiria” Hospital, Medical School, National and Kapodistrian University of Athens, 152 Mesogeion Ave, 11527 Athens, Greece
George I. Lambrou
First Department of Pediatrics, National and Kapodistrian University of Athens, “Aghia Sophia” Children’s Hospital, Thivon 1, 11527 Athens, Greece
Eleni Koniari
University Research Institute of Maternal and Child Health and Precision Medicine, and UNESCO Chair on Adolescent Health Care, National and Kapodistrian University of Athens, “Aghia Sophia” Children’s Hospital, Thivon & Livadias 8 str, 11527 Athens, Greece
Elizabeth-Barbara Tatsi
University Research Institute of Maternal and Child Health and Precision Medicine, and UNESCO Chair on Adolescent Health Care, National and Kapodistrian University of Athens, “Aghia Sophia” Children’s Hospital, Thivon & Livadias 8 str, 11527 Athens, Greece
Joseph Papaparaskevas
Department of Microbiology, Medical School, National and Kapodistrian University of Athens, Mikras Asias 75, 11527 Athens, Greece
Dimitrios Iliopoulos
Emergency Operations Center, National Public Health Organization (NPHO), Agrafon 3-5, 15123 Athens, Greece
George P. Chrousos
University Research Institute of Maternal and Child Health and Precision Medicine, and UNESCO Chair on Adolescent Health Care, National and Kapodistrian University of Athens, “Aghia Sophia” Children’s Hospital, Thivon & Livadias 8 str, 11527 Athens, Greece
Spyridon Kintzios
Laboratory of Cell Technology, Department of Biotechnology, Agricultural University of Athens, EU-CONEXUS European University, 11855 Athens, Greece
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.