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 |
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Jazyk: | angličtina |
Rok vydání: | 2021 |
Předmět: |
medicine.medical_specialty
2019-20 coronavirus outbreak Coronavirus disease 2019 (COVID-19) Head to head Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) lcsh:Medicine Automated assay Gastroenterology Asymptomatic Manual assay 03 medical and health sciences 0302 clinical medicine Antigen Internal medicine parasitic diseases medicine 030212 general & internal medicine automated assay 0303 health sciences 030306 microbiology business.industry SARS-CoV-2 Antigen testing lcsh:R manual assay Clinical performance COVID-19 antigen testing General Medicine medicine.symptom business Viral load |
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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