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. 2023 Apr;28(16):2200615.
doi: 10.2807/1560-7917.ES.2023.28.16.2200615.

Performance of 20 rapid antigen detection tests to detect SARS-CoV-2 B.1.617.2 (Delta) and B.1.1.529 (Omicron) variants using a clinical specimen panel from January 2022, Berlin, Germany

Andreas Puyskens  1 , Fatimanur Bayram  1 , Akin Sesver  1 , Janine Michel  1 , Eva Krause  1 , Daniel Bourquain  1 , Angela Filomena  2 , Katharina Esser-Nobis  2 , Carla Steffanowski  2 , C Micha Nübling  3 , Heinrich Scheiblauer  2 , Lars Schaade  1 , Andreas Nitsche  1
Affiliations

Performance of 20 rapid antigen detection tests to detect SARS-CoV-2 B.1.617.2 (Delta) and B.1.1.529 (Omicron) variants using a clinical specimen panel from January 2022, Berlin, Germany

Andreas Puyskens et al. Euro Surveill. 2023 Apr.

Abstract

BackgroundThere are conflicting reports on the performance of rapid antigen detection tests (RDT) in the detection of the SARS-CoV-2 Omicron (B.1.1.529) variant; however, these tests continue to be used frequently to detect potentially contagious individuals with high viral loads.AimThe aim of this study was to investigate comparative detection of the Delta (B.1.617.2) and Omicron variants by using a selection of 20 RDT and a limited panel of pooled combined oro- and nasopharyngeal clinical Delta and Omicron specimens.MethodsWe tested 20 CE-marked RDT for their performance to detect SARS-CoV-2 Delta and Omicron by using a panel of pooled clinical specimens collected in January 2022 in Berlin, Germany.ResultsWe observed equivalent detection performance for Delta and Omicron for most RDT, and sensitivity was widely in line with our previous pre-Delta/Omicron evaluation. Some variation for individual RDT was observed either for Delta vs Omicron detection, or when compared with the previous evaluation, which may be explained both by different panel sizes resulting in different data robustness and potential limitation of batch-to-batch consistency. Additional experiments with three RDT using non-pooled routine clinical samples confirmed comparable performance to detect Delta vs Omicron. Overall, RDT that were previously positively evaluated retained good performance also for Delta and Omicron variants.ConclusionOur findings suggest that currently available RDT are sufficient for the detection of SARS-CoV-2 Delta and Omicron variants.

Keywords: B.1.1.529 (Omicron); B.1.617.2 (Delta); SARS-CoV-2; rapid antigen detection test.

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Conflict of interest statement

Conflict of interest: None declared.

Figures

Figure 1
Figure 1
Overview of rapid antigen detection test performance using SARS-CoV-2 Delta and Omicron pooled clinical specimens, Germany, January 2022 (n = 20)
Figure 2
Figure 2
Comparison of rapid antigen detection tests of SARS-CoV-2 Delta and Omicron using non-pooled clinical specimens, Germany, January 2022
See this image and copyright information in PMC

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References

    1. Dinnes J. COVID-19 rapid antigen testing strategies require careful evaluation. EBioMedicine. 2021;70:103491. 10.1016/j.ebiom.2021.103491 - DOI - PMC - PubMed
    1. World Health Organization (WHO). SARS-CoV-2 antigen-detecting rapid diagnostic tests: an implementation guide. Geneva: WHO; 2020. Available from: https://www.who.int/publications/i/item/9789240017740
    1. de Michelena P, Torres I, Ramos-García Á, Gozalbes V, Ruiz N, Sanmartín A, et al. Real-life performance of a COVID-19 rapid antigen detection test targeting the SARS-CoV-2 nucleoprotein for diagnosis of COVID-19 due to the Omicron variant. J Infect. 2022;84(5):e64-6. 10.1016/j.jinf.2022.02.022 - DOI - PMC - PubMed
    1. Stanley S, Hamel DJ, Wolf ID, Riedel S, Dutta S, Contreras E, et al. Limit of detection for rapid antigen testing of the SARS-CoV-2 Omicron and Delta variants of concern using live-virus culture. J Clin Microbiol. 2022;60(5):e0014022. 10.1128/jcm.00140-22 - DOI - PMC - PubMed
    1. Schrom J, Marquez C, Pilarowski G, Wang CY, Mitchell A, Puccinelli R, et al. Comparison of SARS Co-V-2 reverse transcriptase polymerase chain reaction and BinaxNOW rapid antigen tests at a community site during an Omicron surge: a cross-sectional study. Ann Intern Med. 2022;75(5):682-90. 10.7326/M22-0202 - DOI - PMC - PubMed

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