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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

<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 t...

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Main Authors: Krüger, Lisa (Author) , Gaeddert, Mary (Author) , Köppel, Lisa (Author) , Brümmer, Lukas E. (Author) , Gottschalk, Claudius (Author) , Barreto Miranda, Isabel (Author) , Schnitzler, Paul (Author) , Kräusslich, Hans-Georg (Author) , Lindner, Andreas (Author) , Nikolai, Olga (Author) , Mockenhaupt, Frank Peter (Author) , Seybold, Joachim (Author) , Corman, Victor Max (Author) , Drosten, Christian (Author) , Pollock, Nira (Author) , Cubas-Atienzar, A. I. (Author) , Kontogianni, K. (Author) , Collins, A. (Author) , Wright, A. H. (Author) , Knorr, Britta (Author) , Welker, Andreas (Author) , Vos, Margaretha de (Author) , Sacks, Jilian A. (Author) , Adams, E. R. (Author) , Denkinger, Claudia M. (Author)
Format: Article (Journal) Chapter/Article
Language:English
Published: October 4, 2020
Edition:Preprint
In: medRxiv
Year: 2020, Pages: 1-22
DOI:10.1101/2020.10.01.20203836
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.1101/2020.10.01.20203836
Verlag, kostenfrei, Volltext: https://www.medrxiv.org/content/10.1101/2020.10.01.20203836v1
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Author Notes: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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Summary:<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>
Item Description:Gesehen am 30.04.2021
Physical Description:Online Resource
DOI:10.1101/2020.10.01.20203836

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