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

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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • COVID-19 Serological Testing*
  • COVID-19* / diagnosis
  • COVID-19* / epidemiology
  • COVID-19* / immunology
  • Female
  • Germany / epidemiology
  • Humans
  • Male
  • Middle Aged
  • Point-of-Care Testing*
  • SARS-CoV-2 / immunology*
  • Sensitivity and Specificity
  • World Health Organization

Grant support

The study was supported by Heidelberg and Charité University Hospital internal funds awarded to CD, as well as a grant of the Ministry of Science, Research and the Arts of Baden-Württemberg, Germany awarded to CD. Foundation of Innovative New Diagnostics (FIND) reports grants from UK Department of International Development (DFID, recently replaced by FCMO - UK Foreign, Commonwealth & Development Office) (Grant No. 300341-102) awarded to JS, grants from World Health Organization (WHO) awarded to JS, and grants from Unitaid (No. 2019-32-FIND MDR) awarded to JS to conduct of the study.