Performance of a Point-of-Care Test for the Rapid Detection of SARS-CoV-2 Antigen

The rapid detection of infections caused by the <i>severe acute respiratory syndrome coronavirus 2</i> (SARS-CoV-2) is necessary in the ongoing pandemic. Antigen-specific point-of-care tests (POCT) may be useful for this purpose. Here, such a POCT (SARS-CoV-2 NADAL<sup>®</sup>...

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Main Authors: Annabelle Strömer, Ruben Rose, Miriam Schäfer, Frieda Schön, Anna Vollersen, Thomas Lorentz, Helmut Fickenscher, Andi Krumbholz
Format: Article
Language:English
Published: MDPI AG 2020-12-01
Series:Microorganisms
Subjects:
Online Access:https://www.mdpi.com/2076-2607/9/1/58
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author Annabelle Strömer
Ruben Rose
Miriam Schäfer
Frieda Schön
Anna Vollersen
Thomas Lorentz
Helmut Fickenscher
Andi Krumbholz
author_facet Annabelle Strömer
Ruben Rose
Miriam Schäfer
Frieda Schön
Anna Vollersen
Thomas Lorentz
Helmut Fickenscher
Andi Krumbholz
author_sort Annabelle Strömer
collection DOAJ
description The rapid detection of infections caused by the <i>severe acute respiratory syndrome coronavirus 2</i> (SARS-CoV-2) is necessary in the ongoing pandemic. Antigen-specific point-of-care tests (POCT) may be useful for this purpose. Here, such a POCT (SARS-CoV-2 NADAL<sup>®</sup> COVID-19 Ag) was compared to a laboratory-developed triplex real-time polymerase chain reaction (RT-PCR) designed for the detection of viral nucleoprotein gene and two control targets. This RT-PCR served as a reference to investigate POCT sensitivity by re-testing upper respiratory tract (URT) samples (<i>n</i> = 124) exhibiting different SARS-CoV-2 loads in terms of RT-PCR threshold cycle (Ct) values. The optical intensities of the antigen bands were compared to the Ct values of the RT-PCR. The infectivity of various virus loads was estimated by inoculating Vero cells with URT samples (<i>n</i> = 64, Ct 17-34). POCT sensitivity varied from 100% (Ct < 25) to 73.1% (Ct ≤ 30); higher SARS-CoV-2 loads correlated with higher band intensities. All samples with a Ct > 30 were negative; among SARS-CoV-2 free samples (<i>n</i> = 10) no false-positives were detected. A head-to-head comparison with another POCT (Abbott, Panbio™ COVID-19 Ag Rapid Test) yielded similar results. Isolation of SARS-CoV-2 in cell-culture was successful up to a Ct value of 29. The POCT reliably detects high SARS-CoV-2 loads and rapidly identifies infectious individuals.
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spelling doaj.art-e86eb821cd0d4dedafd8571fc8a786032023-11-21T02:49:23ZengMDPI AGMicroorganisms2076-26072020-12-01915810.3390/microorganisms9010058Performance of a Point-of-Care Test for the Rapid Detection of SARS-CoV-2 AntigenAnnabelle Strömer0Ruben Rose1Miriam Schäfer2Frieda Schön3Anna Vollersen4Thomas Lorentz5Helmut Fickenscher6Andi Krumbholz7Institute for Infection Medicine, Christian-Albrecht University and University Medical Center Schleswig-Holstein, Brunswiker Str. 4, 24105 Kiel, GermanyInstitute for Infection Medicine, Christian-Albrecht University and University Medical Center Schleswig-Holstein, Brunswiker Str. 4, 24105 Kiel, GermanyLabor Dr. Krause und Kollegen MVZ GmbH, Steenbeker Weg 23, 24106 Kiel, GermanyLabor Dr. Krause und Kollegen MVZ GmbH, Steenbeker Weg 23, 24106 Kiel, GermanyLabor Dr. Krause und Kollegen MVZ GmbH, Steenbeker Weg 23, 24106 Kiel, GermanyLabor Dr. Krause und Kollegen MVZ GmbH, Steenbeker Weg 23, 24106 Kiel, GermanyInstitute for Infection Medicine, Christian-Albrecht University and University Medical Center Schleswig-Holstein, Brunswiker Str. 4, 24105 Kiel, GermanyInstitute for Infection Medicine, Christian-Albrecht University and University Medical Center Schleswig-Holstein, Brunswiker Str. 4, 24105 Kiel, GermanyThe rapid detection of infections caused by the <i>severe acute respiratory syndrome coronavirus 2</i> (SARS-CoV-2) is necessary in the ongoing pandemic. Antigen-specific point-of-care tests (POCT) may be useful for this purpose. Here, such a POCT (SARS-CoV-2 NADAL<sup>®</sup> COVID-19 Ag) was compared to a laboratory-developed triplex real-time polymerase chain reaction (RT-PCR) designed for the detection of viral nucleoprotein gene and two control targets. This RT-PCR served as a reference to investigate POCT sensitivity by re-testing upper respiratory tract (URT) samples (<i>n</i> = 124) exhibiting different SARS-CoV-2 loads in terms of RT-PCR threshold cycle (Ct) values. The optical intensities of the antigen bands were compared to the Ct values of the RT-PCR. The infectivity of various virus loads was estimated by inoculating Vero cells with URT samples (<i>n</i> = 64, Ct 17-34). POCT sensitivity varied from 100% (Ct < 25) to 73.1% (Ct ≤ 30); higher SARS-CoV-2 loads correlated with higher band intensities. All samples with a Ct > 30 were negative; among SARS-CoV-2 free samples (<i>n</i> = 10) no false-positives were detected. A head-to-head comparison with another POCT (Abbott, Panbio™ COVID-19 Ag Rapid Test) yielded similar results. Isolation of SARS-CoV-2 in cell-culture was successful up to a Ct value of 29. The POCT reliably detects high SARS-CoV-2 loads and rapidly identifies infectious individuals.https://www.mdpi.com/2076-2607/9/1/58COVID-19diagnosticPCRantigenPOCTcomparison
spellingShingle Annabelle Strömer
Ruben Rose
Miriam Schäfer
Frieda Schön
Anna Vollersen
Thomas Lorentz
Helmut Fickenscher
Andi Krumbholz
Performance of a Point-of-Care Test for the Rapid Detection of SARS-CoV-2 Antigen
Microorganisms
COVID-19
diagnostic
PCR
antigen
POCT
comparison
title Performance of a Point-of-Care Test for the Rapid Detection of SARS-CoV-2 Antigen
title_full Performance of a Point-of-Care Test for the Rapid Detection of SARS-CoV-2 Antigen
title_fullStr Performance of a Point-of-Care Test for the Rapid Detection of SARS-CoV-2 Antigen
title_full_unstemmed Performance of a Point-of-Care Test for the Rapid Detection of SARS-CoV-2 Antigen
title_short Performance of a Point-of-Care Test for the Rapid Detection of SARS-CoV-2 Antigen
title_sort performance of a point of care test for the rapid detection of sars cov 2 antigen
topic COVID-19
diagnostic
PCR
antigen
POCT
comparison
url https://www.mdpi.com/2076-2607/9/1/58
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