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Clinical Trial
. 2021 May 27;16(5):e0247918.
doi: 10.1371/journal.pone.0247918. eCollection 2021.

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

Lisa J Krüger  1 , Mary Gaeddert  1 , Frank Tobian  1 , Federica Lainati  1 , Claudius Gottschalk  1 , Julian A F Klein  1 , Paul Schnitzler  2 , Hans-Georg Kräusslich  2 , Olga Nikolai  3 , Andreas K Lindner  3 , Frank P Mockenhaupt  3 , Joachim Seybold  4 , Victor M Corman  5   6 , Christian Drosten  5   6 , Nira R Pollock  7 , Britta Knorr  8 , Andreas Welker  8 , Margaretha de Vos  9 , Jilian A Sacks  9 , Claudia M Denkinger  1   10 ; study team
Affiliations
Clinical Trial

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

Lisa J Krüger et al. PLoS One. .

Abstract

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.

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Study flow.
Fig 2
Fig 2. Sensitivity of PanBio Ag-RDT compared to viral load for all PCR positive cases (105 participants).
Fig 3
Fig 3. Viral load and Ag-RDT results for asymptomatic participants and by days post symptom onset for all PCR positive cases (105 participants).
See this image and copyright information in PMC

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