Serological tests are essential for the control and management of COVID-19 pandemic (diagnostics and surveillance, and epidemiological and immunity studies). We introduce a direct serological biosensor assay employing proprietary technology based on plasmonics, which offers rapid (<15 min) identification and quantification of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies in clinical samples, without signal amplification. The portable plasmonic device employs a custom-designed multiantigen (RBD peptide and N protein) sensor biochip and reaches detection limits in the low ng mL –1 range employing polyclonal antibodies. It has also been implemented employing the WHO-approved anti-SARS-CoV-2 immunoglobulin standard. A clinical validation with COVID-19 positive and negative samples ( n = 120) demonstrates its excellent diagnostic sensitivity (99%) and specificity (100%). This positions our biosensor as an accurate and easy-to-use diagnostics tool for rapid and reliable COVID-19 serology to be employed both at laboratory and decentralized settings for the disease management and for the evaluation of immunological status during vaccination or treatment.
【초록키워드】 COVID-19, Treatment, serological test, SARS-CoV-2, coronavirus, vaccination, Immunity, serology, antibody, COVID-19 pandemic, diagnostic, peptide, severe acute respiratory syndrome Coronavirus, anti-SARS-CoV-2, diagnostics, Laboratory, amplification, clinical samples, sensitivity, specificity, Serological tests, Immunoglobulin, Surveillance, RBD, diagnostic sensitivity, management, N protein, polyclonal antibodies, epidemiological, respiratory, serological, quantification, Detection limit, acute respiratory syndrome, acute respiratory syndrome coronavirus, acute respiratory syndrome coronavirus 2, positive, offer, immunological, negative sample, the disease, with COVID-19, 【제목키워드】 COVID-19, biosensor, validation, clinical, Rapid, sensitive,