Lisa J Krüger1, Mary Gaeddert1, Frank Tobian1, Federica Lainati1, Claudius Gottschalk1, Julian A F Klein1, Paul Schnitzler2, Hans-Georg Kräusslich2, Olga Nikolai3, Andreas K Lindner3, Frank P Mockenhaupt3, Joachim Seybold4, Victor M Corman5,6, Christian Drosten5,6, Nira R Pollock7, Britta Knorr8, Andreas Welker8, Margaretha de Vos9, Jilian A Sacks9, Claudia M Denkinger1,10. 1. Division of Clinical Tropical Medicine, Heidelberg University Hospital, Heidelberg, Germany. 2. Virology, Heidelberg University Hospital, Heidelberg, Germany. 3. Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Tropical Medicine and International Health, Berlin, Germany. 4. Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Medical Directorate, Berlin, Germany. 5. Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Virology, Berlin, Germany. 6. German Centre for Infection Research (DZIF), Partner Site Charité, Berlin, Germany. 7. Department of Laboratory Medicine, Boston Children's Hospital, Boston, Massachusetts, United States of America. 8. Department of Public Health Rhein Neckar Region, Heidelberg, Germany. 9. Foundation for Innovative New Diagnostics, Geneva, Switzerland. 10. German Centre for Infection Research (DZIF), Partner Site Heidelberg University Hospital, Heidelberg, Germany.
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.
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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Authors: Andreas K Lindner; Lisa J Krüger; Olga Nikolai; Julian A F Klein; Heike Rössig; Paul Schnitzler; Victor M Corman; Terry C Jones; Frank Tobian; Mary Gaeddert; Susen Burock; Jilian A Sacks; Joachim Seybold; Frank P Mockenhaupt; Claudia M Denkinger Journal: Microbiol Spectr Date: 2022-01-05
Authors: Ginette A Okoye; Haja I Kamara; Michelle Strobeck; Thomas Alan Mellman; John Kwagyan; Ava Sullivan; Angel S Byrd; Babak Shokrani; Hugh E Mighty Journal: J Clin Virol Date: 2021-10-28 Impact factor: 3.168
Authors: Lukas E Brümmer; Stephan Katzenschlager; Mary Gaeddert; Christian Erdmann; Stephani Schmitz; Marc Bota; Maurizio Grilli; Jan Larmann; Markus A Weigand; Nira R Pollock; Aurélien Macé; Sergio Carmona; Stefano Ongarello; Jilian A Sacks; Claudia M Denkinger Journal: PLoS Med Date: 2021-08-12 Impact factor: 11.069