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

  1. Puyskens, Andreas ORCID logo
  2. Krause, Eva
  3. Michel, Janine ORCID logo
  4. Nübling, Claudius Micha ORCID logo
  5. Scheiblauer, Heinrich ORCID logo
  6. Bourquain, Daniel ORCID logo
  7. Grossegesse, Marica ORCID logo
  8. Valusenko, Roman
  9. Corman, Victor Max ORCID logo
  10. Drosten, Christian ORCID logo
  11. Zwirglmaier, Katrin ORCID logo
  12. Wölfel, Roman
  13. Lange, Constanze
  14. Kramer, Jan
  15. Friesen, Johannes ORCID logo
  16. Ignatius, Ralf ORCID logo
  17. Müller, Michael
  18. Schmidt-Chanasit, Jonas ORCID logo
  19. Emmerich, Petra ORCID logo
  20. Schaade, Lars ORCID logo
  21. Nitsche, Andreas ORCID logo

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1000 Titel
  • 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
1000 Autor/in
  1. Puyskens, Andreas |
  2. Krause, Eva |
  3. Michel, Janine |
  4. Nübling, Claudius Micha |
  5. Scheiblauer, Heinrich |
  6. Bourquain, Daniel |
  7. Grossegesse, Marica |
  8. Valusenko, Roman |
  9. Corman, Victor Max |
  10. Drosten, Christian |
  11. Zwirglmaier, Katrin |
  12. Wölfel, Roman |
  13. Lange, Constanze |
  14. Kramer, Jan |
  15. Friesen, Johannes |
  16. Ignatius, Ralf |
  17. Müller, Michael |
  18. Schmidt-Chanasit, Jonas |
  19. Emmerich, Petra |
  20. Schaade, Lars |
  21. Nitsche, Andreas |
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2021-11-04
1000 Erschienen in
1000 Quellenangabe
  • 26(44):pii=2100442
1000 FRL-Sammlung
1000 Copyrightjahr
  • 2021
1000 Lizenz
1000 Verlagsversion
  • https://doi.org/10.2807/1560-7917.ES.2021.26.44.2100442 |
  • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8569922/ |
1000 Ergänzendes Material
  • https://www.eurosurveillance.org/content/10.2807/1560-7917.ES.2021.26.44.2100442#supplementary_data |
1000 Publikationsstatus
1000 Begutachtungsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • INTRODUCTION: The 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. AIM: We aimed to establish a comprehensive specimen panel for the decentralised technical evaluation of SARS-CoV-2 antigen rapid diagnostic tests. METHODS: While 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. RESULTS: Our 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%. CONCLUSIONS: Sensitive RDT can be applied to identify infectious individuals with high viral loads but not to identify all infected individuals.
1000 Sacherschließung
gnd 1206347392 COVID-19
1000 Fächerklassifikation (DDC)
1000 Liste der Beteiligten
  1. https://orcid.org/0000-0002-6492-9463|https://frl.publisso.de/adhoc/uri/ICBLcmF1c2UsIEV2YSAgICAg|https://orcid.org/0000-0001-6227-3125|https://orcid.org/0000-0002-5892-4105|https://orcid.org/0000-0003-1624-8310|https://orcid.org/0000-0001-5075-8870|https://orcid.org/0000-0002-9369-8203|https://frl.publisso.de/adhoc/uri/IFZhbHVzZW5rbywgUm9tYW4gICAg|https://orcid.org/0000-0002-3605-0136|https://orcid.org/0000-0001-7923-0519|https://orcid.org/0000-0001-8598-9572|https://frl.publisso.de/adhoc/uri/ICBXw7ZsZmVsLCBSb21hbiAg|https://frl.publisso.de/adhoc/uri/ICAgTGFuZ2UsIENvbnN0YW56ZSAgIA==|https://frl.publisso.de/adhoc/uri/ICBLcmFtZXIsIEphbiAgIA==|https://orcid.org/0000-0002-8632-2988|https://orcid.org/0000-0001-9020-8312|https://frl.publisso.de/adhoc/uri/ICAgTcO8bGxlciwgTWljaGFlbCAgICA=|https://orcid.org/0000-0003-4433-0231|https://orcid.org/0000-0001-5093-4539|https://orcid.org/0000-0001-6577-5139|https://orcid.org/0000-0001-8185-3176
1000 Label
1000 Förderer
  1. Bundesministerium für Gesundheit |
1000 Fördernummer
  1. -
1000 Förderprogramm
  1. Maßnahmepaket 1&2
1000 Dateien
1000 Förderung
  1. 1000 joinedFunding-child
    1000 Förderer Bundesministerium für Gesundheit |
    1000 Förderprogramm Maßnahmepaket 1&2
    1000 Fördernummer -
1000 Objektart article
1000 Beschrieben durch
1000 @id frl:6432138.rdf
1000 Erstellt am 2022-03-11T09:20:21.831+0100
1000 Erstellt von 323
1000 beschreibt frl:6432138
1000 Bearbeitet von 25
1000 Zuletzt bearbeitet Thu Mar 31 08:05:06 CEST 2022
1000 Objekt bearb. Thu Mar 31 08:04:50 CEST 2022
1000 Vgl. frl:6432138
1000 Oai Id
  1. oai:frl.publisso.de:frl:6432138 |
1000 Sichtbarkeit Metadaten public
1000 Sichtbarkeit Daten public
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