Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection

Julien Favresse, Constant Gillot, Maxime Oliveira, Julie Cadrobbi, Marc Elsen, Christine Eucher, Kim Laffineur, Catherine Rosseels, Sandrine Van Eeckhoudt, Jean-Baptiste Nicolas, Laure Morimont, Jean-Michel Dogné, Jonathan Douxfils

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Résumé

(1) Background: The detection of SARS-CoV-2 RNA in nasopharyngeal samples through real-time reverse transcription-polymerase chain reaction (RT-PCR) is considered the standard gold method for the diagnosis of SARS-CoV-2 infection. Antigen detection (AD) tests are more rapid, less laborious, and less expensive alternatives but still require clinical validation. (2) Methods: This study compared the clinical performance of five AD tests, including four rapid AD (RAD) tests (biotical, Panbio, Healgen, and Roche) and one automated AD test (VITROS). For that purpose, 118 (62.8%) symptomatic patients and 70 (37.2%) asymptomatic subjects were tested, and results were compared to RT-PCR. (3) Results: The performance of the RAD tests was modest and allowed us to identify RT-PCR positive patients with higher viral loads. For Ct values ≤25, the sensitivity ranged from 93.1% (95% CI: 83.3-98.1%) to 96.6% (95% CI: 88.1-99.6%), meaning that some samples with high viral loads were missed. Considering the Ct value proposed by the CDC for contagiousness (i.e., Ct values ≤33) sensitivities ranged from 76.2% (95% CI: 65.4-85.1%) to 88.8% (95% CI: 79.7-94.7%) while the specificity ranged from 96.3% (95% CI: 90.8-99.0%) to 99.1% (95% CI: 95.0-100%). The VITROS automated assay showed a 100% (95% CI: 95.5-100%) sensitivity for Ct values ≤33, and had a specificity of 100% (95% CI: 96.6-100%); (4) Conclusions: Compared to RAD tests, the VITROS assay fully aligned with RT-PCR for Ct values up to 33, which might allow a faster, easier and cheaper identification of SARS-CoV-2 contagious patients.

langue originaleAnglais
journalJournal of clinical medicine
Volume10
Numéro de publication2
Les DOIs
Etat de la publicationPublié - 2021

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