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. 2021 Aug:141:104874.
doi: 10.1016/j.jcv.2021.104874. Epub 2021 May 29.

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

Andreas K Lindner  1 , Olga Nikolai  2 , Chiara Rohardt  2 , Franka Kausch  2 , Mia Wintel  2 , Maximilian Gertler  2 , Susen Burock  3 , Merle Hörig  2 , Julian Bernhard  2 , Frank Tobian  4 , Mary Gaeddert  4 , Federica Lainati  4 , Victor M Corman  5 , Terry C Jones  6 , Jilian A Sacks  7 , Joachim Seybold  8 , Claudia M Denkinger  9 , Frank P Mockenhaupt  2
Affiliations

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

Andreas K Lindner et al. J Clin Virol. 2021 Aug.

Abstract

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.

Keywords: Antigen-detecting rapid diagnostic test; COVID-19; SARS-CoV-2; Self-swab; Self-testing.

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Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

References

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    1. Lindner A.K., Nikolai O., Kausch F., et al. Head-to-head comparison of SARS-CoV-2 antigen-detecting rapid test with self-collected nasal swab versus professional-collected nasopharyngeal swab. Eur. Respir. J. 2020 doi: 10.1183/13993003.03961-2020. - DOI - PMC - PubMed
    1. Lindner A.K., Nikolai O., Rohardt C., et al. Head-to-head comparison of SARS-CoV-2 antigen-detecting rapid test with professional-collected nasal versus nasopharyngeal swab. Eur. Respir. J. 2021 doi: 10.1183/13993003.04430-2020. - DOI - PMC - PubMed
    1. Nikolai O., Rohardt C., Tobian F., et al. Anterior nasal versus nasal mid-turbinate sampling for a SARS-CoV-2 antigen-detecting rapid test: does localisation or professional collection matter? medRxiv. 2021 doi: 10.1101/2021.02.09.21251274. 2021.02.09. - DOI - PMC - PubMed
    1. Federal Institute for Drugs and Medical Devices. Antigen Tests For SARS-CoV-2. https://www.bfarm.de/EN/MedicalDevices/AntigenTests/_node.html. Date last accessed: March 20 2021.

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