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Diagnostic accuracy and feasibility of patient self-testing with a SARS-CoV-2 antigen-detecting rapid test

Background - Considering the possibility of nasal self-sampling and the ease of use in performing SARS-CoV-2 antigen-detecting rapid diagnostic tests (Ag-RDTs), self-testing is a feasible option. - Objective - The goal of this study was a head-to-head comparison of diagnostic accuracy of patient sel...

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Main Authors: Lindner, Andreas (Author) , Nikolai, Olga (Author) , Rohardt, Chiara (Author) , Kausch, Franka (Author) , Wintel, Mia (Author) , Gertler, Maximilian (Author) , Burock, Susen (Author) , Hörig, Merle (Author) , Bernhard, Julian (Author) , Tobian, Frank (Author) , Gaeddert, Mary (Author) , Lainati, Federica (Author) , Corman, Victor M. (Author) , Jones, Terry C. (Author) , Sacks, Jilian A. (Author) , Seybold, Joachim (Author) , Denkinger, Claudia M. (Author) , Mockenhaupt, Frank P. (Author)
Format: Article (Journal)
Language:English
Published: 29 May 2021
In: Clinical and diagnostic virology
Year: 2021, Volume: 141, Pages: 1-4
ISSN:1873-4901
DOI:10.1016/j.jcv.2021.104874
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1016/j.jcv.2021.104874
Verlag, lizenzpflichtig, Volltext: https://www.sciencedirect.com/science/article/pii/S1386653221001414
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Author Notes:Andreas K. Lindner, Olga Nikolai, Chiara Rohardt, Franka Kausch, Mia Wintel, Maximilian Gertler, Susen Burock, Merle Hörig, Julian Bernhard, Frank Tobian, Mary Gaeddert, Federica Lainati, Victor M. Corman, Terry C. Jones, Jilian A. Sacks, Joachim Seybold, Claudia M. Denkinger, Frank P. Mockenhaupt
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Summary:Background - Considering the possibility of nasal self-sampling and the ease of use in performing SARS-CoV-2 antigen-detecting rapid diagnostic tests (Ag-RDTs), self-testing is a feasible option. - Objective - The goal of this study was a head-to-head comparison of diagnostic accuracy of patient self-testing with professional testing using a SARS-CoV-2 Ag-RDT. - Study design - We performed a manufacturer-independent, prospective diagnostic accuracy study of nasal mid-turbinate self-sampling and self-testing with symptomatic adults using a WHO-listed SARS-CoV-2 Ag-RDT. Procedures were observed without intervention. For comparison, Ag-RDTs with nasopharyngeal sampling were professionally performed. Estimates of agreement, sensitivity, and specificity relative to RT-PCR on a combined oro-/nasopharyngeal sample were calculated. Feasibility was evaluated by observer and participant questionnaires. - Results - Among 146 symptomatic adults, 40 (27.4%) were RT-PCR-positive for SARS-CoV-2. Sensitivity with self-testing was 82.5% (33/40; 95% CI 68.1-91.3), and 85.0% (34/40; 95% CI 70.9-92.9) with professional testing. At high viral load (≥7.0 log10 SARS-CoV-2 RNA copies/ml), sensitivity was 96.6% (28/29; 95% CI 82.8-99.8) for both self- and professional testing. Deviations in sampling and testing were observed in 25 out of the 40 PCR-positives. Most participants (80.9%) considered the Ag-RDT as easy to perform. - Conclusion - Laypersons suspected for SARS-CoV-2 infection were able to reliably perform the Ag-RDT and test themselves. Procedural errors might be reduced by refinement of the instructions for use or the product design/procedures. Self-testing allows more wide-spread and frequent testing. Paired with the appropriate information of the public about the benefits and risks, self-testing may have significant impact on the pandemic.
Item Description:Gesehen am 08.10.2021
Physical Description:Online Resource
ISSN:1873-4901
DOI:10.1016/j.jcv.2021.104874

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