| Zugriffsnummer | 50353 |
| Dokumenttyp | Zeitschriftenartikel |
| Peer Review | mit Peer Review |
| Sprache | Englisch |
| Titel | Results of German external quality assessment schemes for SARS-CoV-2 antigen detection |
| Autor(in); Institution |
Vierbaum, L.; INSTAND e.V., Society for Promoting Quality Assurance in Medical Laboratories, Duesseldorf, North Rhine-Westphalia, GERMANY
Wojtalewicz, N.; INSTAND e.V., Society for Promoting Quality Assurance in Medical Laboratories, Duesseldorf, North Rhine-Westphalia, GERMANY
Grunert, H.-P.; GBD Gesellschaft fuer Biotechnologische Diagnostik mbH, Berlin, GERMANY
Zimmermann, A.; INSTAND e.V., Society for Promoting Quality Assurance in Medical Laboratories, Duesseldorf, North Rhine-Westphalia, GERMANY
Gosenberg, S.; NSTAND e.V., Society for Promoting Quality Assurance in Medical Laboratories, Duesseldorf, North Rhine-Westphalia, GERMANY
Kaiser, P.; Institute of Virology, Charite' - University Medicine Berlin, GERMANY
Duehring, U.; GBD Gesellschaft für Biotechnologische Diagnostik mbH, Berlin, GERMANY
Drosten, C.; Institute of Virology, Charite' - University Medicine Berlin, GERMANY
Corman, V.; Institute of Virology, Charite' - University Medicine Berlin, GERMANY
Niemeyer, D.; Institute of Virology, Charite' - University Medicine Berlin, GERMANY
Rabenau, H.; University Hospital, Goethe University Frankfurt, GERMANY
Obermeier, M.; Medizinisches Infektiologiezentrum Berlin, GERMANY
Nitsche, A.; Robert Koch-Institute, Centre for Biological Threats and Special Pathogens, Berlin, GERMANY
Michel, J.; Robert Koch-Institute, Centre for Biological Threats and Special Pathogens, Berlin, GERMANY
Pyskens, 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
Huggett, J.; Faculty of Health & Medical Science, School of Biosciences & Medicine, University of Surrey, Guildford, UK
O’Sullivan, D.; National Measurement Laboratory, LGC, Teddington, Middlesex, UK
Busby, E.; National Measurement Laboratory, LGC, Teddington, Middlesex, UK
Cowen, S.; National Measurement Laboratory, LGC, Teddington, Middlesex, UK
Vallone, P.; NIST, National Institute of Standards and Technology, Applied Genetics Group, Biomolecular Measurement Division, Materials Measurement Laboratory, Gaithersburg, MD, USA
Megan, H.; NIST, National Institute of Standards and Technology, Applied Genetics Group, Biomolecular Measurement Division, Materials Measurement Laboratory, Gaithersburg, MD, USA
Falak, Samreen; 8.3, Biomedizinische Optik, PTB-Berlin
Kummrow, Andreas; 8.3, Biomedizinische Optik, PTB-Berlin
Schellenberg, I.; Institute of Bioanalytical Sciences, Center of Life Sciences, Anhalt University of Applied Sciences, Bernburg, Saxony-Anhalt, GERMANY
Zeichhardt, H.; IQVD GmbH, Institut fuer Qualitaetssicherung in der Virusdiagnostik, Berlin, GERMANY
Kammel, M.; INSTAND e.V., Society for Promoting Quality Assurance in Medical Laboratories, Duesseldorf, North Rhine-Westphalia, GERMANY
|
| Quelle/Jahr | Scientific Reports: 13 (2023), 1 - 11 |
| Artikelnummer | 13206 |
| Availability | [online only] |
| ISSN | 2045-2322 (online) |
| DOI | |
| Verlag | [London]: Springer Nature |
| Freie Schlagworte | COVID-19, ; SARS-CoV-2 ; antigen, quantification ; INSTAND ; Proficiency testing schemes |
| Zusammenfassung | The COVID-19 pandemic illustrated the important role of diagnostic tests, including lateral flow tests (LFTs), in identifying patients and their contacts to slow the spread of infections. INSTAND performed external quality assessments (EQA) for SARS-CoV-2 antigen detection with lyophilized and chemically inactivated cell culture supernatant of SARS-CoV-2 infected Vero cells. A pre-study demonstrated the suitability of the material. Participants reported qualitative and/or quantitative antigen results using either LFTs or automated immunoassays for five EQA samples per survey. 711 data sets were reported for LFT detection in three surveys in 2021. This evaluation focused on the analytical sensitivity of different LFTs and automated immunoassays. The inter-laboratory results showed at least 94% correct results for non-variant of concern (VOC) SARS-CoV-2 antigen detection for viral loads of ≥ 4.75 × 106 copies/mL and SARS-CoV-2 negative samples. Up to 85% had success for a non-VOC viral load of ~ 1.60 × 106 copies/mL. A viral load of ~ 1.42 × 107 copies/mL of the Delta VOC was reported positive in > 96% of results. A high specificity was found with almost 100% negative SARS-CoV-2 antigen results for HCoV 229E and HCoV NL63 positive samples. Quantitative results correlated with increasing SARS-CoV-2 viral load but showed a broad scatter. This study shows promising SARS-CoV-2 antigen test performance of the participating laboratories, but further investigations with the now predominant Omicron VOC are needed. |
| Kostenfreier Zugang | Open Access Gold |
| Rechteinformation | CC BY 4.0 ; Creative Commons Attribution 4.0 License |
| Themenbereich der Metrologie | Metrologie in der Medizin |
| Forschungsprojekt | 18HLT03: SEPTIMET: Metrology to enable rapid and accurate clinical measurements in acute management of sepsis |
| Förderinformationen (1) |
Förderername: European Commission (EC)
Förderer ID: 0000 0001 2242 8989 Förderer ID Typ: ISNI Förderprogramm: EMPIR 2018 Health Titel der Förderung: 18HLT03: SEPTIMET: Metrology to enable rapid and accurate clinical measurements in acute management of sepsis Förderungsnummer: 18HLT03 |
Zitierung
Vierbaum, L., Wojtalewicz, N., Grunert, H.-P., Zimmermann, A., Gosenberg, S., Kaiser, P., Duehring, U., Drosten, C., Corman, V., Niemeyer, D., Rabenau, H., Obermeier, M., Nitsche, A., Michel, J., Pyskens, A., Huggett, J., O’Sullivan, D., Busby, E., Cowen, S., Vallone, P., Megan, H., Falak, S., Kummrow, A., Schellenberg, I., Zeichhardt, H., & Kammel, M. (2023). Results of German external quality assessment schemes for SARS-CoV-2 antigen detection. Scientific Reports, 13, 1–11. https://doi.org/10.1038/s41598-023-40330-2