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Abstract

Background

There 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.

Aim

The 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.

Methods

We 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.

Results

We 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.

Conclusion

Our findings suggest that currently available RDT are sufficient for the detection of SARS-CoV-2 Delta and Omicron variants.

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/content/10.2807/1560-7917.ES.2023.28.16.2200615
2023-04-20
2024-04-16
http://instance.metastore.ingenta.com/content/10.2807/1560-7917.ES.2023.28.16.2200615
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References

  1. Dinnes J. COVID-19 rapid antigen testing strategies require careful evaluation. EBioMedicine. 2021;70:103491.  https://doi.org/10.1016/j.ebiom.2021.103491  PMID: 34284175 
  2. 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
  3. 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.  https://doi.org/10.1016/j.jinf.2022.02.022  PMID: 35217106 
  4. 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.  https://doi.org/10.1128/jcm.00140-22  PMID: 35440165 
  5. 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.  https://doi.org/10.7326/M22-0202  PMID: 35286144 
  6. Soni A, Herbert C, Filippaios A, Broach J, Colubri A, Fahey N, et al. Comparison of rapid antigen tests’ performance between Delta and Omicron variants of SARS-CoV-2. Ann Intern Med. 2022;175(12):1685-92.  https://doi.org/10.7326/M22-0760  PMID: 36215709 
  7. Bayart J-L, Degosserie J, Favresse J, Gillot C, Didembourg M, Djokoto HP, et al. Analytical sensitivity of six SARS-CoV-2 rapid antigen tests for Omicron versus Delta variant. Viruses. 2022;14(4):654.  https://doi.org/10.3390/v14040654  PMID: 35458384 
  8. Hardick J, Gallagher N, Sachithanandham J, Fall A, Siddiqui Z, Pekosz A, et al. Evaluation of four point of care (POC) antigen assays for the detection of the SARS-CoV-2 variant Omicron. Microbiol Spectr. 2022;10(3):e0102522.  https://doi.org/10.1128/spectrum.01025-22  PMID: 35616382 
  9. Osterman A, Badell I, Basara E, Stern M, Kriesel F, Eletreby M, et al. Impaired detection of omicron by SARS-CoV-2 rapid antigen tests. Med Microbiol Immunol (Berl). 2022;211(2-3):105-17.  https://doi.org/10.1007/s00430-022-00730-z  PMID: 35187580 
  10. Bekliz M, Adea K, Puhach O, Perez-Rodriguez F, Marques Melancia S, Baggio S, et al. Analytical sensitivity of eight different SARS-CoV-2 antigen-detecting rapid tests for Omicron-BA.1 variant. Microbiol Spectr. 2022;10(4):e0085322.  https://doi.org/10.1128/spectrum.00853-22  PMID: 35938792 
  11. Puyskens A, Krause E, Michel J, Nübling CM, Scheiblauer H, Bourquain D, et al. Establishment of a specimen panel for the decentralised technical evaluation of the sensitivity of 31 rapid diagnostic tests for SARS-CoV-2 antigen, Germany, September 2020 to April 2021. Euro Surveill. 2021;26(44):2100442.  https://doi.org/10.2807/1560-7917.ES.2021.26.44.2100442  PMID: 34738516 
  12. Scheiblauer H, Filomena A, Nitsche A, Puyskens A, Corman VM, Drosten C, et al. Comparative sensitivity evaluation for 122 CE-marked rapid diagnostic tests for SARS-CoV-2 antigen, Germany, September 2020 to April 2021. Euro Surveill. 2021;26(44):2100441.  https://doi.org/10.2807/1560-7917.ES.2021.26.44.2100441  PMID: 34738515 
  13. Michel J, Neumann M, Krause E, Rinner T, Muzeniek T, Grossegesse M, et al. Resource-efficient internally controlled in-house real-time PCR detection of SARS-CoV-2. Virol J. 2021;18(1):110.  https://doi.org/10.1186/s12985-021-01559-3  PMID: 34078394 
  14. Brinkmann A, Ulm SL, Uddin S, Förster S, Seifert D, Oehme R, et al. AmpliCoV: rapid whole-genome sequencing using multiplex PCR amplification and real-time Oxford nanopore MinION sequencing enables rapid variant identification of SARS-CoV-2. Front Microbiol. 2021;12:651151.  https://doi.org/10.3389/fmicb.2021.651151  PMID: 34276587 
  15. US Food and Drug Administration (FDA). SARS-CoV-2 Viral mutations: impact on COVID-19 tests. Silver Spring; FDA. [accessed: 20 Apr 2022]. Available from: https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-viral-mutations-impact-COVID-19-tests#omicronvariantimpact
  16. Bekliz M, Perez-Rodriguez F, Puhach O, Adea K, Melancia SM, Baggio S, et al. Sensitivity of SARS-CoV-2 antigen-detecting rapid tests for Omicron variant. MedRxiv. 2021. 2021.12.18.21268018 Version 2.  https://doi.org/10.1101/2021.12.18.21268018 
  17. Meiners CL, Horn J, Mühlemann B, Schmidt ML, Walper F, Menzel P, et al. SARS-CoV-2 rapid antigen test sensitivity and viral load in freshly symptomatic hospital employees, December 2020 to February 2022. SSRN. 2022 .  https://doi.org/10.2139/ssrn.4099425 
  18. Jones TC, Biele G, Mühlemann B, Veith T, Schneider J, Beheim-Schwarzbach J, et al. Estimating infectiousness throughout SARS-CoV-2 infection course. Science. 2021;373(6551):eabi5273.  https://doi.org/10.1126/science.abi5273  PMID: 34035154 
  19. European Centre for Disease Prevention and Control (ECDC). Weekly epidemiological update: Omicron variant of concern (VOC) – week 2 (data as of 20 January 2022) EU/EEA. Stockholm: ECDC; 2022. Available from: https://www.ecdc.europa.eu/en/news-events/weekly-epidemiological-update-omicron-variant-concern-voc-week-2-data-20-january-2022
  20. European Centre for Disease Prevention and Control (ECDC). Assessment of the further spread and potential impact of the SARS-CoV-2 Omicron variant of concern in the EU/EEA, 19th update. Stockholm: ECDC; 2022. Available from: https://www.ecdc.europa.eu/en/publications-data/covid-19-omicron-risk-assessment-further-emergence-and-potential-impact
  21. European Commission. COVID-19 in vitro diagnostic medical devices. Brussels: European Commission. [Accessed: 4 Jul 2022]. Available from: https://covid-19-diagnostics.jrc.ec.europa.eu/devices
  22. Gangavarapu K, Latif AA, Mullen JL, Alkuzweny M, Hufbauer E, Tsueng G, et al. Outbreak.info genomic reports: scalable and dynamic surveillance of SARS-CoV-2 variants and mutations. MedRxiv. 2022. 2022.01.27.22269965. . https://doi.org/10.1101/2022.01.27.22269965 
  23. Khare S, Gurry C, Freitas L, Schultz MB, Bach G, Diallo A, et al. GISAID’s role in pandemic response. China CDC Wkly. 2021;3(49):1049-51.  https://doi.org/10.46234/ccdcw2021.255  PMID: 34934514 
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