tetano
Editor, Senior Moderator
Sci Rep
. 2023 Aug 14;13(1):13206.
doi: 10.1038/s41598-023-40330-2. Results of German external quality assessment schemes for SARS-CoV-2 antigen detection
Laura Vierbaum[SUP] #[/SUP][SUP] 1 [/SUP], Nathalie Wojtalewicz[SUP] #[/SUP][SUP] 2 [/SUP], Hans-Peter Grunert[SUP] 3 [/SUP], Anika Zimmermann[SUP] 4 [/SUP], Annemarie Scholz[SUP] 4 [/SUP], Sabine Goseberg[SUP] 2 [/SUP], Patricia Kaiser[SUP] 2 [/SUP], Ulf Duehring[SUP] 3 [/SUP], Christian Drosten[SUP] 5 [/SUP], Victor Corman[SUP] 5 [/SUP], Daniela Niemeyer[SUP] 5 [/SUP], Holger F Rabenau[SUP] 5 [/SUP], Martin Obermeier[SUP] 6 [/SUP], Andreas Nitsche[SUP] 7 [/SUP], Janine Michel[SUP] 8 [/SUP], Andreas Puyskens[SUP] 8 [/SUP], Jim F Huggett[SUP] 9 10 [/SUP], Denise M O'Sullivan[SUP] 9 [/SUP], Eloise Busby[SUP] 9 [/SUP], Simon Cowen[SUP] 9 [/SUP], Peter M Vallone[SUP] 11 [/SUP], Megan H Cleveland[SUP] 11 [/SUP], Samreen Falak[SUP] 12 [/SUP], Andreas Kummrow[SUP] 12 [/SUP], Ingo Schellenberg[SUP] 2 13 [/SUP], Heinz Zeichhardt[SUP] 2 4 3 [/SUP], Martin Kammel[SUP] #[/SUP][SUP] 2 4 [/SUP]
Affiliations
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 × 10[SUP]6[/SUP] copies/mL and SARS-CoV-2 negative samples. Up to 85% had success for a non-VOC viral load of ~ 1.60 × 10[SUP]6[/SUP] copies/mL. A viral load of ~ 1.42 × 10[SUP]7[/SUP] 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.
. 2023 Aug 14;13(1):13206.
doi: 10.1038/s41598-023-40330-2. Results of German external quality assessment schemes for SARS-CoV-2 antigen detection
Laura Vierbaum[SUP] #[/SUP][SUP] 1 [/SUP], Nathalie Wojtalewicz[SUP] #[/SUP][SUP] 2 [/SUP], Hans-Peter Grunert[SUP] 3 [/SUP], Anika Zimmermann[SUP] 4 [/SUP], Annemarie Scholz[SUP] 4 [/SUP], Sabine Goseberg[SUP] 2 [/SUP], Patricia Kaiser[SUP] 2 [/SUP], Ulf Duehring[SUP] 3 [/SUP], Christian Drosten[SUP] 5 [/SUP], Victor Corman[SUP] 5 [/SUP], Daniela Niemeyer[SUP] 5 [/SUP], Holger F Rabenau[SUP] 5 [/SUP], Martin Obermeier[SUP] 6 [/SUP], Andreas Nitsche[SUP] 7 [/SUP], Janine Michel[SUP] 8 [/SUP], Andreas Puyskens[SUP] 8 [/SUP], Jim F Huggett[SUP] 9 10 [/SUP], Denise M O'Sullivan[SUP] 9 [/SUP], Eloise Busby[SUP] 9 [/SUP], Simon Cowen[SUP] 9 [/SUP], Peter M Vallone[SUP] 11 [/SUP], Megan H Cleveland[SUP] 11 [/SUP], Samreen Falak[SUP] 12 [/SUP], Andreas Kummrow[SUP] 12 [/SUP], Ingo Schellenberg[SUP] 2 13 [/SUP], Heinz Zeichhardt[SUP] 2 4 3 [/SUP], Martin Kammel[SUP] #[/SUP][SUP] 2 4 [/SUP]
Affiliations
- PMID: 37580353
- DOI: 10.1038/s41598-023-40330-2
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 × 10[SUP]6[/SUP] copies/mL and SARS-CoV-2 negative samples. Up to 85% had success for a non-VOC viral load of ~ 1.60 × 10[SUP]6[/SUP] copies/mL. A viral load of ~ 1.42 × 10[SUP]7[/SUP] 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.