Evaluation of the DiaSorin LIAISON SARS-CoV-2 antigen assay on nasopharyngeal swabs in two different SARS-CoV-2 pandemic waves in Switzerland: The impact of the Omicron variant on its performance
Background: SARS-CoV-2 antigen tests reliably detect individuals with high viral loads and provide an efficient diagnostic tool to manage the current SARS-CoV-2 pandemic. However, mutations in SARS-CoV-2 variants of concerns that appeared after validation of most antigen tests might impact their dia...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2022-08-01
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| Series: | Journal of Clinical Virology Plus |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2667038022000345 |
| _version_ | 1811284232620736512 |
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| author | Stephanie Uster Zana Topalli Thomas Sasse Franziska Suter-Riniker Maria Teresa Barbani |
| author_facet | Stephanie Uster Zana Topalli Thomas Sasse Franziska Suter-Riniker Maria Teresa Barbani |
| author_sort | Stephanie Uster |
| collection | DOAJ |
| description | Background: SARS-CoV-2 antigen tests reliably detect individuals with high viral loads and provide an efficient diagnostic tool to manage the current SARS-CoV-2 pandemic. However, mutations in SARS-CoV-2 variants of concerns that appeared after validation of most antigen tests might impact their diagnostic performance. Objectives: To assess the impact of the Omicron variant on the performance of the DiaSorin LIAISON SARS-CoV-2 antigen test, we evaluated its sensitivity and specificity on nasopharyngeal swabs (NPS) compared to rRT-PCR in the second and the Omicron pandemic wave in Switzerland. Study design: A random selection of NPS from patients undergoing SARS-CoV-2 diagnostics by rRT-PCR were collected during the second and the Omicron pandemic wave and further analyzed by the LIAISON antigen test. Sensitivity and specificity compared to rRT-PCR were calculated. Results: Test performance did not change in the two investigated periods. The overall sensitivity of 75.8% in the second and 76.5% in the Omicron wave increased to 87.1% and 88.4%, excluding samples with rRT-PCR Ct-value >30. By lowering the cut-off from 200 TCID50/ml to 62 TCID50/ml to discriminate between negative and positive samples using a ROC-curve, the sensitivity resulted in 88.8% for the second and 93.3% for the Omicron pandemic wave. The specificity of the LIAISON antigen test was 100% in both collectives. Conclusion: Omicron variant does not seem to affect the performance of the LIAISON antigen test. The WHO recommended sensitivity of ≥80% for antigen testing was fulfilled during both pandemic periods in samples with Ct-value <30 or by optimizing the assay cut-off. |
| first_indexed | 2024-04-13T02:25:33Z |
| format | Article |
| id | doaj.art-42a6274a56a149849562ead65a4cfeed |
| institution | Directory Open Access Journal |
| issn | 2667-0380 |
| language | English |
| last_indexed | 2024-04-13T02:25:33Z |
| publishDate | 2022-08-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Journal of Clinical Virology Plus |
| spelling | doaj.art-42a6274a56a149849562ead65a4cfeed2022-12-22T03:06:48ZengElsevierJournal of Clinical Virology Plus2667-03802022-08-0123100095Evaluation of the DiaSorin LIAISON SARS-CoV-2 antigen assay on nasopharyngeal swabs in two different SARS-CoV-2 pandemic waves in Switzerland: The impact of the Omicron variant on its performanceStephanie Uster0Zana Topalli1Thomas Sasse2Franziska Suter-Riniker3Maria Teresa Barbani4Institute for Infectious Diseases, University of Bern, Friedbühlstrasse 51, 3001 Bern, SwitzerlandInstitute for Infectious Diseases, University of Bern, Friedbühlstrasse 51, 3001 Bern, SwitzerlandInstitute for Infectious Diseases, University of Bern, Friedbühlstrasse 51, 3001 Bern, SwitzerlandInstitute for Infectious Diseases, University of Bern, Friedbühlstrasse 51, 3001 Bern, SwitzerlandCorresponding authorFriedbühlstrasse 51, 3001 Bern, Switzerland.; Institute for Infectious Diseases, University of Bern, Friedbühlstrasse 51, 3001 Bern, SwitzerlandBackground: SARS-CoV-2 antigen tests reliably detect individuals with high viral loads and provide an efficient diagnostic tool to manage the current SARS-CoV-2 pandemic. However, mutations in SARS-CoV-2 variants of concerns that appeared after validation of most antigen tests might impact their diagnostic performance. Objectives: To assess the impact of the Omicron variant on the performance of the DiaSorin LIAISON SARS-CoV-2 antigen test, we evaluated its sensitivity and specificity on nasopharyngeal swabs (NPS) compared to rRT-PCR in the second and the Omicron pandemic wave in Switzerland. Study design: A random selection of NPS from patients undergoing SARS-CoV-2 diagnostics by rRT-PCR were collected during the second and the Omicron pandemic wave and further analyzed by the LIAISON antigen test. Sensitivity and specificity compared to rRT-PCR were calculated. Results: Test performance did not change in the two investigated periods. The overall sensitivity of 75.8% in the second and 76.5% in the Omicron wave increased to 87.1% and 88.4%, excluding samples with rRT-PCR Ct-value >30. By lowering the cut-off from 200 TCID50/ml to 62 TCID50/ml to discriminate between negative and positive samples using a ROC-curve, the sensitivity resulted in 88.8% for the second and 93.3% for the Omicron pandemic wave. The specificity of the LIAISON antigen test was 100% in both collectives. Conclusion: Omicron variant does not seem to affect the performance of the LIAISON antigen test. The WHO recommended sensitivity of ≥80% for antigen testing was fulfilled during both pandemic periods in samples with Ct-value <30 or by optimizing the assay cut-off.http://www.sciencedirect.com/science/article/pii/S2667038022000345SARS-CoV-2Antigen testLIAISONVOCOmicron |
| spellingShingle | Stephanie Uster Zana Topalli Thomas Sasse Franziska Suter-Riniker Maria Teresa Barbani Evaluation of the DiaSorin LIAISON SARS-CoV-2 antigen assay on nasopharyngeal swabs in two different SARS-CoV-2 pandemic waves in Switzerland: The impact of the Omicron variant on its performance Journal of Clinical Virology Plus SARS-CoV-2 Antigen test LIAISON VOC Omicron |
| title | Evaluation of the DiaSorin LIAISON SARS-CoV-2 antigen assay on nasopharyngeal swabs in two different SARS-CoV-2 pandemic waves in Switzerland: The impact of the Omicron variant on its performance |
| title_full | Evaluation of the DiaSorin LIAISON SARS-CoV-2 antigen assay on nasopharyngeal swabs in two different SARS-CoV-2 pandemic waves in Switzerland: The impact of the Omicron variant on its performance |
| title_fullStr | Evaluation of the DiaSorin LIAISON SARS-CoV-2 antigen assay on nasopharyngeal swabs in two different SARS-CoV-2 pandemic waves in Switzerland: The impact of the Omicron variant on its performance |
| title_full_unstemmed | Evaluation of the DiaSorin LIAISON SARS-CoV-2 antigen assay on nasopharyngeal swabs in two different SARS-CoV-2 pandemic waves in Switzerland: The impact of the Omicron variant on its performance |
| title_short | Evaluation of the DiaSorin LIAISON SARS-CoV-2 antigen assay on nasopharyngeal swabs in two different SARS-CoV-2 pandemic waves in Switzerland: The impact of the Omicron variant on its performance |
| title_sort | evaluation of the diasorin liaison sars cov 2 antigen assay on nasopharyngeal swabs in two different sars cov 2 pandemic waves in switzerland the impact of the omicron variant on its performance |
| topic | SARS-CoV-2 Antigen test LIAISON VOC Omicron |
| url | http://www.sciencedirect.com/science/article/pii/S2667038022000345 |
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