| |  Online-Ressource |
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| Verfasst von: | Krüger, Lisa [VerfasserIn]  |
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| | Gaeddert, Mary [VerfasserIn] |
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| | Köppel, Lisa [VerfasserIn] |
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| | Brümmer, Lukas E. [VerfasserIn] |
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| | Gottschalk, Claudius [VerfasserIn] |
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| | Barreto Miranda, Isabel [VerfasserIn] |
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| | Schnitzler, Paul [VerfasserIn] |
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| | Kräusslich, Hans-Georg [VerfasserIn] |
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| | Lindner, Andreas [VerfasserIn] |
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| | Nikolai, Olga [VerfasserIn] |
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| | Mockenhaupt, Frank Peter [VerfasserIn] |
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| | Seybold, Joachim [VerfasserIn] |
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| | Corman, Victor Max [VerfasserIn] |
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| | Drosten, Christian [VerfasserIn] |
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| | Pollock, Nira [VerfasserIn] |
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| | Cubas-Atienzar, A. I. [VerfasserIn] |
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| | Kontogianni, K. [VerfasserIn] |
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| | Collins, A. [VerfasserIn] |
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| | Wright, A. H. [VerfasserIn] |
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| | Knorr, Britta [VerfasserIn] |
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| | Welker, Andreas [VerfasserIn] |
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| | Vos, Margaretha de [VerfasserIn] |
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| | Sacks, Jilian A. [VerfasserIn] |
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| | Adams, E. R. [VerfasserIn] |
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| | Denkinger, Claudia M. [VerfasserIn] |
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| Titel: | Evaluation of the accuracy, ease of use and limit of detection of novel, rapid, antigen-detecting point-of-care diagnostics for SARS-CoV-2 |
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| Verf.angabe: | L.J. Krüger, M. Gaeddert, L. Köppel, L.E. Brümmer, C. Gottschalk, I.B. Miranda, P. Schnitzler, H.G. Kräusslich, A.K. Lindner, O. Nikolai, F.P. Mockenhaupt, J. Seybold, V.M. Corman, C. Drosten, N.R. Pollock, A.I. Cubas-Atienzar, K. Kontogianni, A. Collins, A.H. Wright, B. Knorr, A. Welker, M. de Vos, J.A. Sacks, E.R. Adams, C.M. Denkinger, for the study team |
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| Ausgabe: | Preprint |
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| E-Jahr: | 2020 |
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| Jahr: | October 4, 2020 |
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| Umfang: | 22 S. |
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| Fussnoten: | Gesehen am 30.04.2021 |
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| Titel Quelle: | Enthalten in: medRxiv |
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| Ort Quelle: | Cold Spring Harbor : Cold Spring Harbor Laboratory, 2019 |
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| Jahr Quelle: | 2020 |
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| Band/Heft Quelle: | (2020), Artikel-ID 2020.10.01.20203836, Seite 1-22 |
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| Abstract: | <h3>Abstract</h3> <h3>Background</h3> <p>Reliable point-of-care (POC) diagnostics not requiring laboratory infrastructure could be a game changer in the COVID-19 pandemic, particularly in the Global South. We assessed performance, limit of detection and ease-of-use of three antigen-detecting, rapid POC tests (Ag-RDT) for <i>SARS-CoV-2</i>.</p><h3>Methods</h3> <p>This prospective, multi-centre diagnostic accuracy study recruited participants suspected to have <i>SARS-CoV-2</i> in Germany and the UK. Paired nasopharyngeal swabs (NP) or NP and/or oropharyngeal swabs (OP) were collected from participants (one for clinical RT-PCR and one for Ag-RDT). Performance of each of three Ag-RDTs was compared to RT-PCR overall, and according to predefined subcategories e.g. cycle threshold (CT)-value, days from symptoms onset, etc. In addition, limited verification of the analytical limit-of-detection (LOD) was determined. To understand the usability a System Usability Scale (SUS) questionnaire and ease-of-use (EoU) assessment were performed.</p><h3>Results</h3> <p>Between April 17<sup>th</sup> and August 25<sup>th</sup>, 2020, 2417 participants were enrolled, with 70 (3.0%) testing positive by RT-PCR. The best-performing test (SD Biosensor, Inc. STANDARD Q) was 76×6% (95% Confidence Interval (CI) 62×8-86×4) sensitive and 99×3% (CI 98×6-99×6) specific. A sub-analysis showed all samples with RT-PCR CT-values <25 were detectable by STANDARD Q. The test was considered easy-to-use (SUS 86/100) and suitable for POC. Bioeasy and Coris showed specificity of 93×1% (CI 91×0%-94×8%) and 95×8% (CI 93×4%-97×4%), respectively, not meeting the predefined target of ≥98%.</p><h3>Conclusion</h3> <p>There is large variability in performance of Ag-RDT with SD Biosensor showing promise. Given the usability at POC, this test is likely to have impact despite imperfect sensitivity; however further research and modelling are needed.</p> |
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| DOI: | doi:10.1101/2020.10.01.20203836 |
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| URL: | Bitte beachten Sie: Dies ist ein Bibliographieeintrag. Ein Volltextzugriff für Mitglieder der Universität besteht hier nur, falls für die entsprechende Zeitschrift/den entsprechenden Sammelband ein Abonnement besteht oder es sich um einen OpenAccess-Titel handelt.
kostenfrei: Volltext: https://doi.org/10.1101/2020.10.01.20203836 |
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| | kostenfrei: Volltext: https://www.medrxiv.org/content/10.1101/2020.10.01.20203836v1 |
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| | DOI: https://doi.org/10.1101/2020.10.01.20203836 |
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| Datenträger: | Online-Ressource |
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| Sprache: | eng |
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| Bibliogr. Hinweis: | Forschungsdaten: Krüger, Lisa, 1989 - : The Abbott PanBio WHO emergency use listed, rapid, antigen-detecting point-of-care diagnostic test for SARS-CoV-2 |
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| K10plus-PPN: | 1756646171 |
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| Verknüpfungen: | → Sammelwerk |
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Evaluation of the accuracy, ease of use and limit of detection of novel, rapid, antigen-detecting point-of-care diagnostics for SARS-CoV-2 / Krüger, Lisa [VerfasserIn]; October 4, 2020 (Online-Ressource)
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