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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Autores principales: Sung Jin Jo, Sang-Hyun Shin, Jungrok Kim, Seungok Lee, Jehoon Lee
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Publicado: Public Library of Science (PLoS) 2021
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spelling 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)
institution DOAJ
collection DOAJ
language EN
topic Medicine
R
Science
Q
spellingShingle 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
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