Abstract
New diagnostics technologies for the efficient detection and quantification of SARS-CoV-2 antibodies are very crucial to manage the COVID-19 pandemic, especially in the context of emerging vaccination paradigms. Herein, we report on a novel point-of-care Electrochemical ELISA platform with disposable screen printed electrodes functionalized with SARS-CoV-2 Spike Glycoprotein S1, to enable fast and accurate quantitative estimation of total antibody concentration (IgG and IgM) in clinical samples. The quantification is performed with a comparison of electrochemical redox current against the current produced by the spiked monoclonal antibodies with known concentration. The assay is validated through multicentric evaluation against 3 different FDA authorized Laboratory standard techniques, using both EDTA whole blood and serum samples. We demonstrate that the proposed assay has excellent sensitivity and specificity, making it a suitable candidate for epidemiological surveys and quantification of antibodies in COVID-19 vaccination programs.
Keywords: COVID-19; Disposable test strips; Electrochemistry; IgG/IgM antibody; Printed electrodes; SARS-CoV-2.
【저자키워드】 COVID-19, SARS-CoV-2, Disposable test strips, Electrochemistry, IgG/IgM antibody, Printed electrodes, 【초록키워드】 SARS-CoV-2, vaccination, spike, antibody, COVID-19 pandemic, monoclonal antibody, spike glycoprotein, FDA, diagnostics, ELISA, point-of-care, clinical samples, SARS-CoV-2 antibodies, SARS-CoV-2 antibody, COVID-19 vaccination, Sensitivity and specificity, Whole blood, epidemiological survey, quantification, Quantitative, platform, Electrochemistry, Concentration, IgG and IgM, epidemiological surveys, serum samples, IgM antibody, EDTA, current, produced, performed, New, 【제목키워드】 SARS-CoV-2, antibody, point of care, ELISA, platform, IgG and IgM,