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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.
Puyskens, Andreas; Krause, Eva; Michel, Janine; Nübling, C Micha; Scheiblauer, Heinrich; Bourquain, Daniel; Grossegesse, Marica; Valusenko, Roman; Corman, Victor M; Drosten, Christian; Zwirglmaier, Katrin; Wölfel, Roman; Lange, Constanze; Kramer, Jan; Friesen, Johannes; Ignatius, Ralf; Müller, Michael; Schmidt-Chanasit, Jonas; Emmerich, Petra; Schaade, Lars; Nitsche, Andreas.
  • 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, Robert Koch Institute, 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, Robert Koch Institute, 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, Robert Koch Institute, Berlin, Germany.
  • Nübling CM; Testing Laboratory for In-vitro Diagnostic Medical Devices, Paul-Ehrlich-Institute, Langen, Germany.
  • Scheiblauer H; Testing Laboratory for In-vitro Diagnostic Medical Devices, Paul-Ehrlich-Institute, Langen, 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, Robert Koch Institute, Berlin, Germany.
  • Grossegesse M; 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, Robert Koch Institute, Berlin, Germany.
  • Valusenko R; 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, Robert Koch Institute, Berlin, Germany.
  • Corman VM; Charité - Universitätsmedizin Berlin, Institute of Virology and German Centre for Infection Research (DZIF), Associated Partner Site, Berlin, Germany.
  • Drosten C; Labor Berlin, Charité - Vivantes GmbH, Berlin, Germany.
  • Zwirglmaier K; Charité - Universitätsmedizin Berlin, Institute of Virology and German Centre for Infection Research (DZIF), Associated Partner Site, Berlin, Germany.
  • Wölfel R; Bundeswehr Institute of Microbiology and German Centre for Infection Research (DZIF), Partner Site Munich, Munich, Germany.
  • Lange C; Bundeswehr Institute of Microbiology and German Centre for Infection Research (DZIF), Partner Site Munich, Munich, Germany.
  • Kramer J; LADR Central Laboratory Dr. Kramer & Colleagues, Geesthacht, Germany.
  • Friesen J; LADR Central Laboratory Dr. Kramer & Colleagues, Geesthacht, Germany.
  • Ignatius R; MVZ Labor28 GmbH, Berlin, Germany.
  • Müller M; MVZ Labor28 GmbH, Berlin, Germany.
  • Schmidt-Chanasit J; MVZ Labor28 GmbH, Berlin, Germany.
  • Emmerich P; Bernhard Nocht Institute for Tropical Medicine, Arbovirology Department, Hamburg, Germany.
  • Schaade L; Bernhard Nocht Institute for Tropical Medicine, Arbovirology Department, Hamburg, Germany.
  • Nitsche A; Department of Tropical Medicine and Infectious Diseases, Center of Internal Medicine II, University of Rostock, Rostock, Germany.
Euro Surveill ; 26(44)2021 11.
Article in English | MEDLINE | ID: covidwho-1504591
ABSTRACT
IntroductionThe detection of SARS-CoV-2 with rapid diagnostic tests (RDT) has become an important tool to identify infected people and break infection chains. These RDT are usually based on antigen detection in a lateral flow approach.AimWe aimed to establish a comprehensive specimen panel for the decentralised technical evaluation of SARS-CoV-2 antigen rapid diagnostic tests.MethodsWhile for PCR diagnostics the validation of a PCR assay is well established, there is no common validation strategy for antigen tests, including RDT. In this proof-of-principle study we present the establishment of a panel of 50 pooled clinical specimens that cover a SARS-CoV-2 concentration range from 1.1 × 109 to 420 genome copies per mL of specimen. The panel was used to evaluate 31 RDT in up to six laboratories.ResultsOur results show that there is considerable variation in the detection limits and the clinical sensitivity of different RDT. We show that the best RDT can be applied to reliably identify infectious individuals who present with SARS-CoV-2 loads down to 106 genome copies per mL of specimen. For the identification of infected individuals with SARS-CoV-2 loads corresponding to less than 106 genome copies per mL, only three RDT showed a clinical sensitivity of more than 60%.ConclusionsSensitive RDT can be applied to identify infectious individuals with high viral loads but not to identify all infected individuals.
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Full text: Available Collection: International databases Database: MEDLINE Document Type: Article Main subject: SARS-CoV-2 / COVID-19 Subject: SARS-CoV-2 / COVID-19 Type of study: Diagnostic study Language: English Clinical aspect: Diagnosis Year: 2021

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Full text: Available Collection: International databases Database: MEDLINE Document Type: Article Main subject: SARS-CoV-2 / COVID-19 Subject: SARS-CoV-2 / COVID-19 Type of study: Diagnostic study Language: English Clinical aspect: Diagnosis Year: 2021
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