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. 2021 Jan 13;10(2):265.
doi: 10.3390/jcm10020265.

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

Julien Favresse  1   2 , Constant Gillot  2 , Maxime Oliveira  2 , Julie Cadrobbi  1 , Marc Elsen  1 , Christine Eucher  1 , Kim Laffineur  1 , Catherine Rosseels  1 , Sandrine Van Eeckhoudt  3 , Jean-Baptiste Nicolas  3 , Laure Morimont  2   4 , Jean-Michel Dogné  2 , Jonathan Douxfils  2   4
Affiliations

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

Julien Favresse et al. J Clin Med. .

Abstract

(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.

Keywords: COVID-19; SARS-CoV-2; antigen testing; automated assay; manual assay.

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Conflict of interest statement

Among the authors, J.D. is CEO and founder of QUALIblood s.a., a contract research organization manufacturing the DP-Filter, is co-inventor of the DP-Filter (patent application number: PCT/ET2019/052903) and reports personal fees from Daiichi-Sankyo, Gedeon Richter, Mithra Pharmaceuticals, Stago, Roche and Roche Diagnostics outside the submitted work. The other authors have no conflict of interest to disclose.

Figures

Figure 1
Figure 1
Graphical representation of positive and negative antigen results according to RT-PCR Ct values. A significant difference in the Ct value is observed between the positive and negative tests for each antigen method. Importantly, only the automated antigen shows no overlap between Ct values obtained for positive and negative samples. Samples from asymptomatic subjects are highlighted in red.
Figure 2
Figure 2
Linear regression of Ct values obtained by RT-PCR versus the amount of antigen (log10 transformed S/C results) obtained on the VITROS assay. Samples from asymptomatic subjects are highlighted in red.
See this image and copyright information in PMC

Comment in

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