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 perf...
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2021
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oai:doaj.org-article:23ec1e4069504683a6bf735e80d289dc2021-11-25T05:54:12ZEvaluation of the clinical performance of a magnetic force-assisted electrochemical immunoassay for the detection of SARS-CoV-2 antigens.1932-620310.1371/journal.pone.0258394https://doaj.org/article/23ec1e4069504683a6bf735e80d289dc2021-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0258394https://doaj.org/toc/1932-6203Rapid 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.Sung Jin JoSang-Hyun ShinJungrok KimSeungok LeeJehoon LeePublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 10, p e0258394 (2021) |
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Medicine R Science Q Sung Jin Jo Sang-Hyun Shin Jungrok Kim Seungok Lee Jehoon Lee Evaluation of the clinical performance of a magnetic force-assisted electrochemical immunoassay for the detection of SARS-CoV-2 antigens. |
description |
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. |
format |
article |
author |
Sung Jin Jo Sang-Hyun Shin Jungrok Kim Seungok Lee Jehoon Lee |
author_facet |
Sung Jin Jo Sang-Hyun Shin Jungrok Kim Seungok Lee Jehoon Lee |
author_sort |
Sung Jin Jo |
title |
Evaluation of the clinical performance of a magnetic force-assisted electrochemical immunoassay for the detection of SARS-CoV-2 antigens. |
title_short |
Evaluation of the clinical performance of a magnetic force-assisted electrochemical immunoassay for the detection of SARS-CoV-2 antigens. |
title_full |
Evaluation of the clinical performance of a magnetic force-assisted electrochemical immunoassay for the detection of SARS-CoV-2 antigens. |
title_fullStr |
Evaluation of the clinical performance of a magnetic force-assisted electrochemical immunoassay for the detection of SARS-CoV-2 antigens. |
title_full_unstemmed |
Evaluation of the clinical performance of a magnetic force-assisted electrochemical immunoassay for the detection of SARS-CoV-2 antigens. |
title_sort |
evaluation of the clinical performance of a magnetic force-assisted electrochemical immunoassay for the detection of sars-cov-2 antigens. |
publisher |
Public Library of Science (PLoS) |
publishDate |
2021 |
url |
https://doaj.org/article/23ec1e4069504683a6bf735e80d289dc |
work_keys_str_mv |
AT sungjinjo evaluationoftheclinicalperformanceofamagneticforceassistedelectrochemicalimmunoassayforthedetectionofsarscov2antigens AT sanghyunshin evaluationoftheclinicalperformanceofamagneticforceassistedelectrochemicalimmunoassayforthedetectionofsarscov2antigens AT jungrokkim evaluationoftheclinicalperformanceofamagneticforceassistedelectrochemicalimmunoassayforthedetectionofsarscov2antigens AT seungoklee evaluationoftheclinicalperformanceofamagneticforceassistedelectrochemicalimmunoassayforthedetectionofsarscov2antigens AT jehoonlee evaluationoftheclinicalperformanceofamagneticforceassistedelectrochemicalimmunoassayforthedetectionofsarscov2antigens |
_version_ |
1718414387820101632 |