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Open AccessArticle

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

1
Department of Laboratory Medicine, Clinique St-Luc Bouge, 5004 Namur, Belgium
2
Department of Pharmacy, Namur Research Institute for Life Sciences, University of Namur, 5000 Namur, Belgium
3
Department of Internal Medicine, Clinique St-Luc Bouge, 5004 Namur, Belgium
4
Qualiblood S.A., 5000 Namur, Belgium
*
Author to whom correspondence should be addressed.
J. Clin. Med. 2021, 10(2), 265; https://doi.org/10.3390/jcm10020265
Received: 10 December 2020 / Revised: 4 January 2021 / Accepted: 11 January 2021 / Published: 13 January 2021
(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. View Full-Text
Keywords: COVID-19; SARS-CoV-2; antigen testing; manual assay; automated assay COVID-19; SARS-CoV-2; antigen testing; manual assay; automated assay
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MDPI and ACS Style

Favresse, J.; Gillot, C.; Oliveira, M.; Cadrobbi, J.; Elsen, M.; Eucher, C.; Laffineur, K.; Rosseels, C.; Van Eeckhoudt, S.; Nicolas, J.-B.; Morimont, L.; Dogné, J.-M.; Douxfils, J. Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection. J. Clin. Med. 2021, 10, 265. https://doi.org/10.3390/jcm10020265

AMA Style

Favresse J, Gillot C, Oliveira M, Cadrobbi J, Elsen M, Eucher C, Laffineur K, Rosseels C, Van Eeckhoudt S, Nicolas J-B, Morimont L, Dogné J-M, Douxfils J. Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection. Journal of Clinical Medicine. 2021; 10(2):265. https://doi.org/10.3390/jcm10020265

Chicago/Turabian Style

Favresse, Julien; Gillot, Constant; Oliveira, Maxime; Cadrobbi, Julie; Elsen, Marc; Eucher, Christine; Laffineur, Kim; Rosseels, Catherine; Van Eeckhoudt, Sandrine; Nicolas, Jean-Baptiste; Morimont, Laure; Dogné, Jean-Michel; Douxfils, Jonathan. 2021. "Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection" J. Clin. Med. 10, no. 2: 265. https://doi.org/10.3390/jcm10020265

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