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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Bibliographic Details
Main Authors: Nicolas Yin, Cyril Debuysschere, Valery Daubie, Marc Hildebrand, Charlotte Martin, Sonja Curac, Fanny Ponthieux, Marie-Christine Payen, Olivier Vandenberg, Marie Hallin
Format: Article
Language:English
Published: MDPI AG 2022-02-01
Series:Diagnostics
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Online Access:https://www.mdpi.com/2075-4418/12/2/447
Description
Summary: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.
ISSN:2075-4418