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Comparative sensitivity evaluation for 122 CE-marked rapid diagnostic tests for SARS-CoV-2 antigen, Germany, September 2020 to April 2021.
Scheiblauer, Heinrich; Filomena, Angela; Nitsche, Andreas; Puyskens, Andreas; Corman, Victor M; Drosten, Christian; Zwirglmaier, Karin; Lange, Constanze; Emmerich, Petra; Müller, Michael; Knauer, Olivia; Nübling, C Micha.
  • Scheiblauer H; Testing Laboratory for In-vitro Diagnostic Medical Devices, Paul-Ehrlich-Institute, Langen, Germany.
  • Filomena A; Testing Laboratory for In-vitro Diagnostic Medical Devices, Paul-Ehrlich-Institute, Langen, 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, Robert Koch Institute, Berlin, Germany.
  • 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.
  • 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.
  • Lange C; Bundeswehr Institute of Microbiology, and German Centre for Infection Research (DZIF), Partner Site, Munich, Germany.
  • Emmerich P; LADR Central Laboratory Dr. Kramer & Colleagues, Geesthacht, Germany.
  • Müller M; Bernhard-Nocht Institute, Department of Virology, Hamburg, and Department of Tropical Medicine and Infectious Diseases, Center of Internal Medicine II, University of Rostock, Rostock, Germany.
  • Knauer O; MVZ Labor 28 GmbH, Berlin, Germany.
  • Nübling CM; Testing Laboratory for In-vitro Diagnostic Medical Devices, Paul-Ehrlich-Institute, Langen, Germany.
Euro Surveill ; 26(44)2021 Nov.
Article in English | MEDLINE | ID: covidwho-1504717
ABSTRACT
IntroductionNumerous CE-marked SARS-CoV-2 antigen rapid diagnostic tests (Ag RDT) are offered in Europe, several of them with unconfirmed quality claims.AimWe performed an independent head-to-head evaluation of the sensitivity of SARS-CoV-2 Ag RDT offered in Germany.MethodsWe addressed the sensitivity of 122 Ag RDT in direct comparison using a common evaluation panel comprised of 50 specimens. Minimum sensitivity of 75% for panel specimens with a PCR quantification cycle (Cq) ≤ 25 was used to identify Ag RDT eligible for reimbursement in the German healthcare system.ResultsThe sensitivity of different SARS-CoV-2 Ag RDT varied over a wide range. The sensitivity limit of 75% for panel members with Cq ≤ 25 was met by 96 of the 122 tests evaluated; 26 tests exhibited lower sensitivity, few of which failed completely. Some RDT exhibited high sensitivity, e.g. 97.5 % for Cq < 30.ConclusionsThis comparative evaluation succeeded in distinguishing less sensitive from better performing Ag RDT. Most of the evaluated Ag RDT appeared to be suitable for fast identification of acute infections associated with high viral loads. Market access of SARS-CoV-2 Ag RDT should be based on minimal requirements for sensitivity and specificity.
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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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