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 10 2 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.
【초록키워드】 COVID-19, coronavirus disease, SARS-CoV-2, coronavirus, Test, severe acute respiratory syndrome Coronavirus, RT-PCR, Antigen, Spread, Nasopharyngeal swab, point-of-care, Viral, Sensitivity and specificity, limit of detection, Rapid, RdRP, automated, respiratory, correlation, viral culture, SARS-CoV-2 infections, RdRp gene, Nasopharyngeal swab specimens, Ct values, Infrastructure, acute respiratory syndrome, 95% CI, acute respiratory syndrome coronavirus, acute respiratory syndrome coronavirus 2, E gene, correlations, Kappa coefficient, SD Biosensor, MARK, nasopharyngeal swab specimen, Prevent, was measured, detect, evaluated, can be used, electrical, semi-quantitative, 【제목키워드】 immunoassay, SARS-CoV-2 antigen,