Evaluation of the accuracy and ease-of-use of Abbott PanBio - A WHO emergency use listed, rapid, antigen-detecting point-of-care diagnostic test for <i>SARS-CoV-2</i>

Abstract

Abstract Background Diagnostics are essential for controlling the pandemic. Identifying a reliable and fast diagnostic is needed to support 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 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 of symptoms, disease severity and study site. Additionally, an ease-of-use assessment and System Usability Scale (SUS) were performed. Findings 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 &lt;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. Interpretation 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. Funding The Foundation of Innovative New Diagnostics supplied the test kits for the study. The internal funds from the Heidelberg University as well as the Charité Berlin supported this study.