Accuracy and ease-of-use of seven point-of-care SARS-CoV-2 antigen-detecting tests: a multi-centre clinical evaluation
Background - Antigen-detecting rapid diagnostic tests (Ag-RDTs) for SARS-CoV-2 are important diagnostic tools. We assessed clinical performance and ease-of-use of seven Ag-RDTs in a prospective, manufacturer-independent, multi-centre cross-sectional diagnostic accuracy study to inform global decisio...
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
2022
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| In: |
EBioMedicine
Year: 2022, Jahrgang: 75, Pages: 1-12 |
| ISSN: | 2352-3964 |
| DOI: | 10.1016/j.ebiom.2021.103774 |
| Online-Zugang: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1016/j.ebiom.2021.103774 Verlag, lizenzpflichtig, Volltext: https://www.sciencedirect.com/science/article/pii/S2352396421005685 
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| Verfasserangaben: | Lisa J. Krüger, Amilcar Tanuri, Andreas K. Lindner, Mary Gaeddert, Lisa Köppel, Frank Tobian, Lukas E. Brümmer, Julian A.F. Klein, Federica Lainati, Paul Schnitzler, Olga Nikolai, Frank P. Mockenhaupt, Joachim Seybold, Victor M. Corman, Terence C. Jones, Christian Drosten, Claudius Gottschalk, Stefan F. Weber, Stephan Weber, Orlando C. Ferreira, Diana Mariani, Erika Ramos dos Santos Nascimento, Terezinha M. Pereira Pinto Castineiras, Rafael Mello Galliez, Debora Souza Faffe, Isabela de Carvalho Leitão, Claudia dos Santos Rodrigues, Thiago Silva Frauches, Keity J. Chagas Vilela Nocchi, Natalia Martins Feitosa, Sabrina Santana Ribeiro, Nira R. Pollock, Britta Knorr, Andreas Welker, Margaretha de Vos, JilianA. Sacks, Stefano Ongarello, and Claudia M. Denkinger, for the study team |
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| 245 | 1 | 0 | |a Accuracy and ease-of-use of seven point-of-care SARS-CoV-2 antigen-detecting tests |b a multi-centre clinical evaluation |c Lisa J. Krüger, Amilcar Tanuri, Andreas K. Lindner, Mary Gaeddert, Lisa Köppel, Frank Tobian, Lukas E. Brümmer, Julian A.F. Klein, Federica Lainati, Paul Schnitzler, Olga Nikolai, Frank P. Mockenhaupt, Joachim Seybold, Victor M. Corman, Terence C. Jones, Christian Drosten, Claudius Gottschalk, Stefan F. Weber, Stephan Weber, Orlando C. Ferreira, Diana Mariani, Erika Ramos dos Santos Nascimento, Terezinha M. Pereira Pinto Castineiras, Rafael Mello Galliez, Debora Souza Faffe, Isabela de Carvalho Leitão, Claudia dos Santos Rodrigues, Thiago Silva Frauches, Keity J. Chagas Vilela Nocchi, Natalia Martins Feitosa, Sabrina Santana Ribeiro, Nira R. Pollock, Britta Knorr, Andreas Welker, Margaretha de Vos, JilianA. Sacks, Stefano Ongarello, and Claudia M. Denkinger, for the study team |
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| 520 | |a Background - Antigen-detecting rapid diagnostic tests (Ag-RDTs) for SARS-CoV-2 are important diagnostic tools. We assessed clinical performance and ease-of-use of seven Ag-RDTs in a prospective, manufacturer-independent, multi-centre cross-sectional diagnostic accuracy study to inform global decision makers. - Methods - Unvaccinated participants suspected of a first SARS-CoV-2 infection were recruited at six sites (Germany, Brazil). Ag-RDTs were evaluated sequentially, with collection of paired swabs for routine reverse transcription polymerase chain reaction (RT-PCR) testing and Ag-RDT testing. Performance was compared to RT-PCR overall and in sub-group analyses (viral load, symptoms, symptoms duration). To understandusability a System Usability Scale (SUS) questionnaire and ease-of-use (EoU) assessment were performed. - Findings - 7471 participants were included in the analysis. Sensitivities across Ag-RDTs ranged from 70·4%-90·1%, specificities were above 97·2% for all Ag-RDTs but one (93·1%).Ag-RDTs, Mologic, Bionote, Standard Q, showed diagnostic accuracy in line with WHO targets (> 80% sensitivity, > 97% specificity). All tests showed high sensitivity in the first three days after symptom onset (≥87·1%) and in individuals with viral loads≥ 6 log10SARS-CoV2 RNA copies/mL (≥ 88·7%). Usability varied, with Rapigen, Bionote and Standard Q reaching very good scores; 90, 88 and 84/100, respectively. - Interpretation - Variability in test performance is partially explained by variable viral loads in population evaluated over the course of the pandemic. All Ag-RDTs reach high sensitivity early in the disease and in individuals with high viral loads, supporting their role in identifying transmission relevant infections. For easy-to-use tests, performance shown will likely be maintained in routine implementation. - Funding - Ministry of Science, Research and Arts, State of Baden-Wuerttemberg, Germany, internal funds from Heidelberg University Hospital, University Hospital Charité − Universitätsmedizin Berlin, UK Department of International Development, WHO, Unitaid. | ||
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| 650 | 4 | |a COVID-19 | |
| 650 | 4 | |a SARS-CoV-2 | |
| 650 | 4 | |a Sensitivity | |
| 650 | 4 | |a Specificity | |
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