Evaluation and Modelling of the Performance of an Automated SARS-CoV-2 Antigen Assay According to Sample Type, Target Population and Epidemic Trends
The Lumipulse<sup>®</sup> <i>G</i> SARS-CoV-2 Ag assay performance was evaluated on prospectively collected saliva and nasopharyngeal swabs (NPS) of recently ill in- and outpatients and according to the estimated viral load. Performances were calculated using RT-PCR positive...
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-02-01
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| Series: | Diagnostics |
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| Online Access: | https://www.mdpi.com/2075-4418/12/2/447 |
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| author | Nicolas Yin Cyril Debuysschere Valery Daubie Marc Hildebrand Charlotte Martin Sonja Curac Fanny Ponthieux Marie-Christine Payen Olivier Vandenberg Marie Hallin |
| author_facet | Nicolas Yin Cyril Debuysschere Valery Daubie Marc Hildebrand Charlotte Martin Sonja Curac Fanny Ponthieux Marie-Christine Payen Olivier Vandenberg Marie Hallin |
| author_sort | Nicolas Yin |
| collection | DOAJ |
| description | The Lumipulse<sup>®</sup> <i>G</i> SARS-CoV-2 Ag assay performance was evaluated on prospectively collected saliva and nasopharyngeal swabs (NPS) of recently ill in- and outpatients and according to the estimated viral load. Performances were calculated using RT-PCR positive NPS from patients with symptoms ≤ 7 days and RT-PCR negative NPS as gold standard. In addition, non-selected positive NPS were analyzed to assess the performances on various viral loads. This assay yielded a sensitivity of 93.1% on NPS and 71.4% on saliva for recently ill patients. For NPS with a viral load > 10<sup>3</sup> RNA copies/mL, sensitivity was 96.4%. A model established on our daily routine showed fluctuations of the performances depending on the epidemic trends but an overall good negative predictive value. Lumipulse<sup>®</sup> <i>G</i> SARS-CoV-2 assay yielded good performance for an automated antigen detection assay on NPS. Using it for the detection of recently ill patients or to screen high-risk patients could be an interesting alternative to the more expensive RT-PCR. |
| first_indexed | 2024-03-09T22:10:04Z |
| format | Article |
| id | doaj.art-1545ccad29c64dfe9a193c3bdb58bd6f |
| institution | Directory Open Access Journal |
| issn | 2075-4418 |
| language | English |
| last_indexed | 2024-03-09T22:10:04Z |
| publishDate | 2022-02-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Diagnostics |
| spelling | doaj.art-1545ccad29c64dfe9a193c3bdb58bd6f2023-11-23T19:32:12ZengMDPI AGDiagnostics2075-44182022-02-0112244710.3390/diagnostics12020447Evaluation and Modelling of the Performance of an Automated SARS-CoV-2 Antigen Assay According to Sample Type, Target Population and Epidemic TrendsNicolas Yin0Cyril Debuysschere1Valery Daubie2Marc Hildebrand3Charlotte Martin4Sonja Curac5Fanny Ponthieux6Marie-Christine Payen7Olivier Vandenberg8Marie Hallin9Department of Microbiology, Laboratoire Hospitalier Universitaire de Bruxelles-Universitair Laboratorium Brussel (LHUB-ULB), Université Libre de Bruxelles (ULB), 1000 Brussels, BelgiumDepartment of Microbiology, Laboratoire Hospitalier Universitaire de Bruxelles-Universitair Laboratorium Brussel (LHUB-ULB), Université Libre de Bruxelles (ULB), 1000 Brussels, BelgiumDepartment of Microbiology, Laboratoire Hospitalier Universitaire de Bruxelles-Universitair Laboratorium Brussel (LHUB-ULB), Université Libre de Bruxelles (ULB), 1000 Brussels, BelgiumDepartment of Internal Medicine, Erasme University Hospital, Université Libre de Bruxelles (ULB), 1070 Brussels, BelgiumDepartment of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles (ULB), 1000 Brussels, BelgiumEmergency Department, Erasme University Hospital, Université Libre de Bruxelles (ULB), 1070 Brussels, BelgiumDepartment of Microbiology, Laboratoire Hospitalier Universitaire de Bruxelles-Universitair Laboratorium Brussel (LHUB-ULB), Université Libre de Bruxelles (ULB), 1000 Brussels, BelgiumDepartment of Infectious Diseases, Saint-Pierre University Hospital, Université Libre de Bruxelles (ULB), 1000 Brussels, BelgiumCentre for Environmental Health and Occupational Health, School of Public Health, Université Libre de Bruxelles (ULB), 1050 Brussels, BelgiumDepartment of Microbiology, Laboratoire Hospitalier Universitaire de Bruxelles-Universitair Laboratorium Brussel (LHUB-ULB), Université Libre de Bruxelles (ULB), 1000 Brussels, BelgiumThe Lumipulse<sup>®</sup> <i>G</i> SARS-CoV-2 Ag assay performance was evaluated on prospectively collected saliva and nasopharyngeal swabs (NPS) of recently ill in- and outpatients and according to the estimated viral load. Performances were calculated using RT-PCR positive NPS from patients with symptoms ≤ 7 days and RT-PCR negative NPS as gold standard. In addition, non-selected positive NPS were analyzed to assess the performances on various viral loads. This assay yielded a sensitivity of 93.1% on NPS and 71.4% on saliva for recently ill patients. For NPS with a viral load > 10<sup>3</sup> RNA copies/mL, sensitivity was 96.4%. A model established on our daily routine showed fluctuations of the performances depending on the epidemic trends but an overall good negative predictive value. Lumipulse<sup>®</sup> <i>G</i> SARS-CoV-2 assay yielded good performance for an automated antigen detection assay on NPS. Using it for the detection of recently ill patients or to screen high-risk patients could be an interesting alternative to the more expensive RT-PCR.https://www.mdpi.com/2075-4418/12/2/447SARS-CoV-2COVID-19modeldiagnostictestassay |
| spellingShingle | Nicolas Yin Cyril Debuysschere Valery Daubie Marc Hildebrand Charlotte Martin Sonja Curac Fanny Ponthieux Marie-Christine Payen Olivier Vandenberg Marie Hallin Evaluation and Modelling of the Performance of an Automated SARS-CoV-2 Antigen Assay According to Sample Type, Target Population and Epidemic Trends Diagnostics SARS-CoV-2 COVID-19 model diagnostic test assay |
| title | Evaluation and Modelling of the Performance of an Automated SARS-CoV-2 Antigen Assay According to Sample Type, Target Population and Epidemic Trends |
| title_full | Evaluation and Modelling of the Performance of an Automated SARS-CoV-2 Antigen Assay According to Sample Type, Target Population and Epidemic Trends |
| title_fullStr | Evaluation and Modelling of the Performance of an Automated SARS-CoV-2 Antigen Assay According to Sample Type, Target Population and Epidemic Trends |
| title_full_unstemmed | Evaluation and Modelling of the Performance of an Automated SARS-CoV-2 Antigen Assay According to Sample Type, Target Population and Epidemic Trends |
| title_short | Evaluation and Modelling of the Performance of an Automated SARS-CoV-2 Antigen Assay According to Sample Type, Target Population and Epidemic Trends |
| title_sort | evaluation and modelling of the performance of an automated sars cov 2 antigen assay according to sample type target population and epidemic trends |
| topic | SARS-CoV-2 COVID-19 model diagnostic test assay |
| url | https://www.mdpi.com/2075-4418/12/2/447 |
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