The Abbott PanBio WHO emergency use listed, rapid, antigen-detecting point-of-care diagnostic test for SARS-CoV-2-Evaluation of the accuracy and ease-of-use.
<h4>Objectives</h4>Diagnostics are essential for controlling the pandemic. Identifying a reliable and fast diagnostic device is needed for effective testing. We assessed performance and ease-of-use of the Abbott PanBio antigen-detecting rapid diagnostic test (Ag-RDT).<h4>Methods<...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Public Library of Science (PLoS)
2021-01-01
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| Series: | PLoS ONE |
| Online Access: | https://doi.org/10.1371/journal.pone.0247918 |
| _version_ | 1818891813487902720 |
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| author | Lisa J Krüger Mary Gaeddert Frank Tobian Federica Lainati Claudius Gottschalk Julian A F Klein Paul Schnitzler Hans-Georg Kräusslich Olga Nikolai Andreas K Lindner Frank P Mockenhaupt Joachim Seybold Victor M Corman Christian Drosten Nira R Pollock Britta Knorr Andreas Welker Margaretha de Vos Jilian A Sacks Claudia M Denkinger study team |
| author_facet | Lisa J Krüger Mary Gaeddert Frank Tobian Federica Lainati Claudius Gottschalk Julian A F Klein Paul Schnitzler Hans-Georg Kräusslich Olga Nikolai Andreas K Lindner Frank P Mockenhaupt Joachim Seybold Victor M Corman Christian Drosten Nira R Pollock Britta Knorr Andreas Welker Margaretha de Vos Jilian A Sacks Claudia M Denkinger study team |
| author_sort | Lisa J Krüger |
| collection | DOAJ |
| description | <h4>Objectives</h4>Diagnostics are essential for controlling the pandemic. Identifying a reliable and fast diagnostic device is needed for effective testing. We assessed performance and ease-of-use of the Abbott PanBio antigen-detecting rapid diagnostic test (Ag-RDT).<h4>Methods</h4>This prospective, multi-centre diagnostic accuracy study enrolled at two sites in Germany. Following routine testing with reverse-transcriptase polymerase chain reaction (RT-PCR), a second study-exclusive swab was performed for Ag-RDT testing. Routine swabs were nasopharyngeal (NP) or combined NP/oropharyngeal (OP) whereas the study-exclusive swabs were NP. To evaluate performance, sensitivity and specificity were assessed overall and in predefined sub-analyses accordingly to cycle-threshold values, days after symptom onset, disease severity and study site. Additionally, an ease-of-use assessment (EoU) and System Usability Scale (SUS) were performed.<h4>Results</h4>1108 participants were enrolled between Sept 28 and Oct 30, 2020. Of these, 106 (9.6%) were PCR-positive. The Abbott PanBio detected 92/106 PCR-positive participants with a sensitivity of 86.8% (95% CI: 79.0% - 92.0%) and a specificity of 99.9% (95% CI: 99.4%-100%). The sub-analyses indicated that sensitivity was 95.8% in Ct-values <25 and within the first seven days from symptom onset. The test was characterized as easy to use (SUS: 86/100) and considered suitable for point-of-care settings.<h4>Conclusion</h4>The Abbott PanBio Ag-RDT performs well for SARS-CoV-2 testing in this large manufacturer independent study, confirming its WHO recommendation for Emergency Use in settings with limited resources. |
| first_indexed | 2024-12-19T17:46:46Z |
| format | Article |
| id | doaj.art-17c0889f27b042c09c9b2af49f36aedd |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-12-19T17:46:46Z |
| publishDate | 2021-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-17c0889f27b042c09c9b2af49f36aedd2022-12-21T20:12:02ZengPublic Library of Science (PLoS)PLoS ONE1932-62032021-01-01165e024791810.1371/journal.pone.0247918The Abbott PanBio WHO emergency use listed, rapid, antigen-detecting point-of-care diagnostic test for SARS-CoV-2-Evaluation of the accuracy and ease-of-use.Lisa J KrügerMary GaeddertFrank TobianFederica LainatiClaudius GottschalkJulian A F KleinPaul SchnitzlerHans-Georg KräusslichOlga NikolaiAndreas K LindnerFrank P MockenhauptJoachim SeyboldVictor M CormanChristian DrostenNira R PollockBritta KnorrAndreas WelkerMargaretha de VosJilian A SacksClaudia M Denkingerstudy team<h4>Objectives</h4>Diagnostics are essential for controlling the pandemic. Identifying a reliable and fast diagnostic device is needed for effective testing. We assessed performance and ease-of-use of the Abbott PanBio antigen-detecting rapid diagnostic test (Ag-RDT).<h4>Methods</h4>This prospective, multi-centre diagnostic accuracy study enrolled at two sites in Germany. Following routine testing with reverse-transcriptase polymerase chain reaction (RT-PCR), a second study-exclusive swab was performed for Ag-RDT testing. Routine swabs were nasopharyngeal (NP) or combined NP/oropharyngeal (OP) whereas the study-exclusive swabs were NP. To evaluate performance, sensitivity and specificity were assessed overall and in predefined sub-analyses accordingly to cycle-threshold values, days after symptom onset, disease severity and study site. Additionally, an ease-of-use assessment (EoU) and System Usability Scale (SUS) were performed.<h4>Results</h4>1108 participants were enrolled between Sept 28 and Oct 30, 2020. Of these, 106 (9.6%) were PCR-positive. The Abbott PanBio detected 92/106 PCR-positive participants with a sensitivity of 86.8% (95% CI: 79.0% - 92.0%) and a specificity of 99.9% (95% CI: 99.4%-100%). The sub-analyses indicated that sensitivity was 95.8% in Ct-values <25 and within the first seven days from symptom onset. The test was characterized as easy to use (SUS: 86/100) and considered suitable for point-of-care settings.<h4>Conclusion</h4>The Abbott PanBio Ag-RDT performs well for SARS-CoV-2 testing in this large manufacturer independent study, confirming its WHO recommendation for Emergency Use in settings with limited resources.https://doi.org/10.1371/journal.pone.0247918 |
| spellingShingle | Lisa J Krüger Mary Gaeddert Frank Tobian Federica Lainati Claudius Gottschalk Julian A F Klein Paul Schnitzler Hans-Georg Kräusslich Olga Nikolai Andreas K Lindner Frank P Mockenhaupt Joachim Seybold Victor M Corman Christian Drosten Nira R Pollock Britta Knorr Andreas Welker Margaretha de Vos Jilian A Sacks Claudia M Denkinger study team The Abbott PanBio WHO emergency use listed, rapid, antigen-detecting point-of-care diagnostic test for SARS-CoV-2-Evaluation of the accuracy and ease-of-use. PLoS ONE |
| title | The Abbott PanBio WHO emergency use listed, rapid, antigen-detecting point-of-care diagnostic test for SARS-CoV-2-Evaluation of the accuracy and ease-of-use. |
| title_full | The Abbott PanBio WHO emergency use listed, rapid, antigen-detecting point-of-care diagnostic test for SARS-CoV-2-Evaluation of the accuracy and ease-of-use. |
| title_fullStr | The Abbott PanBio WHO emergency use listed, rapid, antigen-detecting point-of-care diagnostic test for SARS-CoV-2-Evaluation of the accuracy and ease-of-use. |
| title_full_unstemmed | The Abbott PanBio WHO emergency use listed, rapid, antigen-detecting point-of-care diagnostic test for SARS-CoV-2-Evaluation of the accuracy and ease-of-use. |
| title_short | The Abbott PanBio WHO emergency use listed, rapid, antigen-detecting point-of-care diagnostic test for SARS-CoV-2-Evaluation of the accuracy and ease-of-use. |
| title_sort | abbott panbio who emergency use listed rapid antigen detecting point of care diagnostic test for sars cov 2 evaluation of the accuracy and ease of use |
| url | https://doi.org/10.1371/journal.pone.0247918 |
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