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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

Objectives 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). Methods This prospective, multi-centre...

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Main Authors: Krüger, Lisa (Author) , Gaeddert, Mary (Author) , Tobian, Frank (Author) , Lainati, Federica (Author) , Gottschalk, Claudius (Author) , Klein, Julian (Author) , Schnitzler, Paul (Author) , Kräusslich, Hans-Georg (Author) , Nikolai, Olga (Author) , Lindner, Andreas K. (Author) , Mockenhaupt, Frank P. (Author) , Seybold, Joachim (Author) , Corman, Victor M. (Author) , Drosten, Christian (Author) , Pollock, Nira R. (Author) , Knorr, Britta (Author) , Welker, Andreas (Author) , Vos, Margaretha de (Author) , Sacks, Jilian A. (Author) , Denkinger, Claudia M. (Author)
Format: Article (Journal)
Language:English
Published: May 27, 2021
In: PLOS ONE
Year: 2021, Volume: 16, Issue: 5, Pages: 1-11
ISSN:1932-6203
DOI:10.1371/journal.pone.0247918
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1371/journal.pone.0247918
Verlag, lizenzpflichtig, Volltext: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0247918
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Author Notes: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, for the study team
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Summary:Objectives 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). Methods 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. Results 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. Conclusion 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.
Item Description:Gesehen am 22.09.2021
Physical Description:Online Resource
ISSN:1932-6203
DOI:10.1371/journal.pone.0247918

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