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

Autor: Kim Laffineur, Christine Eucher, Maxime Oliveira, Laure Morimont, Sandrine Van Eeckhoudt, Constant Gillot, Marc Elsen, Julie Cadrobbi, Julien Favresse, Jean-Baptiste Nicolas, Jean-Michel Dogné, Catherine Rosseels, Jonathan Douxfils
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: Journal of Clinical Medicine
Volume 10
Issue 2
Journal of Clinical Medicine, Vol 10, Iss 265, p 265 (2021)
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 2021, ' Head-to-Head Comparison of Rapid and Automated Antigen Detection Tests for the Diagnosis of SARS-CoV-2 Infection ', Journal of clinical medicine, vol. 10, no. 2, 265, pp. 1-10 . https://doi.org/10.3390/jcm10020265
ISSN: 2077-0383
DOI: 10.3390/jcm10020265
Popis: (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 &le
25, the sensitivity ranged from 93.1% (95% CI: 83.3&ndash
98.1%) to 96.6% (95% CI: 88.1&ndash
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 &le
33) sensitivities ranged from 76.2% (95% CI: 65.4&ndash
85.1%) to 88.8% (95% CI: 79.7&ndash
94.7%) while the specificity ranged from 96.3% (95% CI: 90.8&ndash
99.0%) to 99.1% (95% CI: 95.0&ndash
100%). The VITROS automated assay showed a 100% (95% CI: 95.5&ndash
100%) sensitivity for Ct values &le
33, and had a specificity of 100% (95% CI: 96.6&ndash
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.
Databáze: OpenAIRE
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