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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.
Puyskens, Andreas; Bayram, Fatimanur; Sesver, Akin; Michel, Janine; Krause, Eva; Bourquain, Daniel; Filomena, Angela; Esser-Nobis, Katharina; Steffanowski, Carla; Nübling, C Micha; Scheiblauer, Heinrich; Schaade, Lars; Nitsche, Andreas.
Afiliação
  • Puyskens A; Robert Koch Institute, Highly Pathogenic Viruses, Centre for Biological Threats and Special Pathogens, WHO Reference Laboratory for SARS-CoV-2 and WHO Collaborating Centre for Emerging Infections and Biological Threats, Berlin, Germany.
  • Bayram F; Robert Koch Institute, Highly Pathogenic Viruses, Centre for Biological Threats and Special Pathogens, WHO Reference Laboratory for SARS-CoV-2 and WHO Collaborating Centre for Emerging Infections and Biological Threats, Berlin, Germany.
  • Sesver A; Robert Koch Institute, Highly Pathogenic Viruses, Centre for Biological Threats and Special Pathogens, WHO Reference Laboratory for SARS-CoV-2 and WHO Collaborating Centre for Emerging Infections and Biological Threats, Berlin, Germany.
  • Michel J; Robert Koch Institute, Highly Pathogenic Viruses, Centre for Biological Threats and Special Pathogens, WHO Reference Laboratory for SARS-CoV-2 and WHO Collaborating Centre for Emerging Infections and Biological Threats, Berlin, Germany.
  • Krause E; Robert Koch Institute, Highly Pathogenic Viruses, Centre for Biological Threats and Special Pathogens, WHO Reference Laboratory for SARS-CoV-2 and WHO Collaborating Centre for Emerging Infections and Biological Threats, Berlin, Germany.
  • Bourquain D; Robert Koch Institute, Highly Pathogenic Viruses, Centre for Biological Threats and Special Pathogens, WHO Reference Laboratory for SARS-CoV-2 and WHO Collaborating Centre for Emerging Infections and Biological Threats, Berlin, Germany.
  • Filomena A; Paul-Ehrlich-Institute, Testing Laboratory for In-vitro Diagnostic Medical Devices, Langen, Germany.
  • Esser-Nobis K; Paul-Ehrlich-Institute, Testing Laboratory for In-vitro Diagnostic Medical Devices, Langen, Germany.
  • Steffanowski C; Paul-Ehrlich-Institute, Testing Laboratory for In-vitro Diagnostic Medical Devices, Langen, Germany.
  • Nübling CM; Paul-Ehrlich-Institute, Division Major Policy Issues, Coordination, Langen, Germany.
  • Scheiblauer H; Paul-Ehrlich-Institute, Testing Laboratory for In-vitro Diagnostic Medical Devices, Langen, Germany.
  • Schaade L; Robert Koch Institute, Highly Pathogenic Viruses, Centre for Biological Threats and Special Pathogens, WHO Reference Laboratory for SARS-CoV-2 and WHO Collaborating Centre for Emerging Infections and Biological Threats, Berlin, Germany.
  • Nitsche A; Robert Koch Institute, Highly Pathogenic Viruses, Centre for Biological Threats and Special Pathogens, WHO Reference Laboratory for SARS-CoV-2 and WHO Collaborating Centre for Emerging Infections and Biological Threats, Berlin, Germany.
Euro Surveill ; 28(16)2023 04.
Article em En | MEDLINE | ID: mdl-37078884
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.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Teste Sorológico para COVID-19 / SARS-CoV-2 / COVID-19 Tipo de estudo: Diagnostic_studies Limite: Humans País/Região como assunto: Europa Idioma: En Revista: Euro Surveill Assunto da revista: DOENCAS TRANSMISSIVEIS Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Alemanha

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Teste Sorológico para COVID-19 / SARS-CoV-2 / COVID-19 Tipo de estudo: Diagnostic_studies Limite: Humans País/Região como assunto: Europa Idioma: En Revista: Euro Surveill Assunto da revista: DOENCAS TRANSMISSIVEIS Ano de publicação: 2023 Tipo de documento: Article País de afiliação: Alemanha