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

• Published in: PloS one Vol. 16; no. 5; p. e0247918
• Main Authors: Krüger, Lisa J, Gaeddert, Mary, Tobian, Frank, Lainati, Federica, Gottschalk, Claudius, Klein, Julian A F, Schnitzler, Paul, Kräusslich, Hans-Georg, Nikolai, Olga, Lindner, Andreas K, Mockenhaupt, Frank P, Seybold, Joachim, Corman, Victor M, Drosten, Christian, Pollock, Nira R, Knorr, Britta, Welker, Andreas, de Vos, Margaretha, Sacks, Jilian A, Denkinger, Claudia M
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 27-05-2021; Public Library of Science (PLoS)
• Subjects: Accuracy; Adult; Antigens; Bags; Biology and Life Sciences; Computer and Information Sciences; Computer programs; COVID-19; COVID-19 - diagnosis; COVID-19 - epidemiology; COVID-19 - immunology; COVID-19 Serological Testing; Diagnostic tests; Drafting software; Editing; Ethics; Evaluation; Female; Germany - epidemiology; Hospitals; Humans; Infections; Laboratories; Male; Medical diagnosis; Medical tests; Medicine; Medicine and Health Sciences; Methodology; Middle Aged; Nucleic acids; People and places; Point-of-Care Testing; Polymerase chain reaction; Public health; Research and Analysis Methods; Reviews; SARS-CoV-2 - immunology; Sensitivity and Specificity; Severe acute respiratory syndrome; Severe acute respiratory syndrome coronavirus 2; Software; Virology; Visualization; World Health Organization; Germany; Switzerland
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0247918

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).
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.
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.
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.