Evaluation of four laboratory-based high-throughput SARS-CoV-2 automated antigen tests compared to RT-PCR on nasal and oropharyngeal samples

• Published in: Journal of clinical virology Vol. 164; p. 105472
• Main Authors: Leineweber, Thomas Daell, Ghathian, Khaled, Lisby, Jan Gorm, Friis-Hansen, Lennart, Afzal, Shoaib, Ellermann-Eriksen, Svend, Ma, Chih Man German, Cohen, Arieh S., Jørgensen, Rikke Lind, Hansen, Matilde Bøgelund, Kamstrup, Pia Rørbæk, Larsen, Helene, Steenhard, Nina, Jensen, Christel Barker, Kallemose, Thomas, Forsberg, Maria Wendelboe, Kirkby, Nikolai Søren, Schneider, Uffe Vest
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01.07.2023; The Author(s). Published by Elsevier B.V
• Subjects: Analytical performance; Automated antigen tests; Clinical performance; COVID-19 - diagnosis; COVID-19 Testing; Humans; Prospective Studies; Rapid antigen tests; Retrospective Studies; Reverse Transcriptase Polymerase Chain Reaction; RT-PCR; SARS-CoV-2; SARS-CoV-2 - genetics; Sensitivity and Specificity; Rapid antigen tests; SARS-CoV-2; Automated antigen tests; Analytical performance; Clinical performance; RT-PCR
• ISSN: 1386-6532; 1873-5967
• DOI: 10.1016/j.jcv.2023.105472

•Anterior nasal swabs are significantly more sensitive than deep oropharyngeal swabs.•One automated antigen test for SARS-CoV-2 was significantly less sensitive than three other tests.•Anatomical test location impacted sensitivity more than choice of automated antigen test. The demand for RT-PCR testing has been unprecedented during the SARS-CoV-2 pandemic. Fully automated antigen tests (AAT) are less cumbersome than RT-PCR, but data on performance compared to RT-PCR are scarce. The study consists of two parts. A retrospective analytical part, comparing the performance of four different AAT on 100 negative and 204 RT-PCR positive deep oropharyngeal samples divided into four groups based on RT-PCR cycle of quantification levels. In the prospective clinical part, 206 individuals positive for and 199 individuals negative for SARS-CoV-2 were sampled from either the anterior nasal cavity (mid-turbinate) or by deep oropharyngeal swabs or both. The performance of AATs was compared to RT-PCR. The overall analytical sensitivity of the AATs differed significantly from 42% (95% CI 35–49) to 60% (95% CI 53–67) with 100% analytical specificity. Clinical sensitivity of the AATs differed significantly from 26% (95% CI 20–32) to 88% (95% CI 84–93) with significant higher sensitivity for mid-turbinate nasal swabs compared to deep oropharyngeal swabs. Clinical specificity varied from 97% to 100%. All AATs were highly specific for detection of SARS-CoV-2. Three of the four AATs were significantly more sensitive than the fourth AAT both in terms of analytical and clinical sensitivity. Anatomical test location significantly influenced the clinical sensitivity of AATs.