PLoS ONE (Jan 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,
  • 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

DOI
https://doi.org/10.1371/journal.pone.0247918
Journal volume & issue
Vol. 16, no. 5
p. e0247918

Abstract

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ObjectivesDiagnostics 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).MethodsThis 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.Results1108 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 ConclusionThe 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.