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Krüger, Lisa
[VerfasserIn];
Gaeddert, Mary
[VerfasserIn];
Köppel, Lisa
[VerfasserIn];
Brümmer, Lukas E.
[VerfasserIn];
Gottschalk, Claudius
[VerfasserIn];
Barreto Miranda, Isabel
[VerfasserIn];
Schnitzler, Paul
[VerfasserIn];
Kräusslich, Hans-Georg
[VerfasserIn];
Lindner, Andreas
[VerfasserIn];
Nikolai, Olga
[VerfasserIn];
Mockenhaupt, Frank Peter
[VerfasserIn];
Seybold, Joachim
[VerfasserIn];
Corman, Victor Max
[VerfasserIn];
Drosten, Christian
[VerfasserIn];
Pollock, Nira
[VerfasserIn];
Cubas-Atienzar, A. I.
[VerfasserIn];
Kontogianni, K.
[VerfasserIn];
Collins, A.
[VerfasserIn];
Wright, A. H.
[VerfasserIn];
Knorr, Britta
[VerfasserIn];
Welker, Andreas
[VerfasserIn];
Vos, Margaretha de
[VerfasserIn];
Sacks, Jilian A.
[VerfasserIn];
Adams, E. R.
[VerfasserIn];
Evaluation of the accuracy, ease of use and limit of detection of novel, rapid, antigen-detecting point-of-care diagnostics for SARS-CoV-2
- [Preprint]
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- Medientyp: E-Artikel
- 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
- Beteiligte: Krüger, Lisa [VerfasserIn]; Gaeddert, Mary [VerfasserIn]; Köppel, Lisa [VerfasserIn]; Brümmer, Lukas E. [VerfasserIn]; Gottschalk, Claudius [VerfasserIn]; Barreto Miranda, Isabel [VerfasserIn]; Schnitzler, Paul [VerfasserIn]; Kräusslich, Hans-Georg [VerfasserIn]; Lindner, Andreas [VerfasserIn]; Nikolai, Olga [VerfasserIn]; Mockenhaupt, Frank Peter [VerfasserIn]; Seybold, Joachim [VerfasserIn]; Corman, Victor Max [VerfasserIn]; Drosten, Christian [VerfasserIn]; Pollock, Nira [VerfasserIn]; Cubas-Atienzar, A. I. [VerfasserIn]; Kontogianni, K. [VerfasserIn]; Collins, A. [VerfasserIn]; Wright, A. H. [VerfasserIn]; Knorr, Britta [VerfasserIn]; Welker, Andreas [VerfasserIn]; Vos, Margaretha de [VerfasserIn]; Sacks, Jilian A. [VerfasserIn]; Adams, E. R. [VerfasserIn]; Denkinger, Claudia M. [VerfasserIn]
- Erschienen: October 4, 2020
- Erschienen in: medRxiv ; (2020), Artikel-ID 2020.10.01.20203836
- Ausgabe: Preprint
- Sprache: Englisch
- DOI: 10.1101/2020.10.01.20203836
- Identifikator:
- Entstehung:
- Anmerkungen:
- Beschreibung: <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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