Evaluation of the clinical performance of a magnetic force-assisted electrochemical immunoassay for the detection of SARS-CoV-2 antigens

Rapid antigen (Ag) tests for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) provide quick results, do not require specialized technical skills or infrastructure, and can be used as a point-of-care method to prevent the spread of coronavirus disease (COVID-19). The performance of a magnetic force-assisted electrochemical immunoassay-based test, namely the MARK-B COVID-19 Ag test (BBB, Sungnam, Republic of Korea), was evaluated using 170 nasopharyngeal swab specimens and compared to that of RT-PCR and commercial rapid Ag test (STANDARD Q COVID-19 Ag Test, SD Biosensor, Suwon-si, Republic of Korea). The overall sensitivity and specificity of the MARK-B test were 90.0% (95% CI 79.4%–96.2%) and 99.0% (95% CI 95.0%–99.9%), respectively, with a kappa coefficient of 0.908. The correlations between the electrical current values of MARK-B and the Ct values of RT-PCR were −0.898 (E gene, 95% CI −0.938 to −0.834) and −0.914 (RdRp gene, 95% CI −0.948 to −0.860), respectively. The limit of detection of the MARK-B was measured using the viral culture reference samples and found to be 1 x 102 pfu/mL. The magnetic force-assisted electrochemical immunoassay-based Ag test can be used to rapidly detect SARS-CoV-2 infections, and the corresponding fully automated portable device can provide easy readability and semi-quantitative results.

A Novel Method for the Detection of SARS-CoV-2 Based on Graphene-Impedimetric Immunosensor

Due to the SARS-CoV-2 pandemic, there has been an increase in the search for affordable healthcare devices for mass testing and rapid diagnosis. In this context, this work described a new methodology for SARS-CoV-2 detection based on an impedimetric immunosensor developed using the advantageous immobilization of antibodies in the reduced graphene oxide (rGO). The rGO was obtained by chemical synthesis from the commercial graphene oxide (GO), and the materials were morphologically, electrochemically and visually characterized. The cyclic voltammetry (CV) and electrochemical impedance spectroscopy (EIS) techniques were used to evaluate the fabrication steps of the immunosensor. The electrochemical immunoassay was considered for SARS-CoV-2 spike protein RBD detection using a impedimetric immunosensor and redox couple ([(Fe(CN)6)]3−/4−) as a probe. The immunosensor was effectively developed and applied in the detection of SARS-CoV-2 spike protein RBD in saliva samples.