TY - JOUR
T1 - Evaluation of four laboratory-based high-throughput SARS-CoV-2 automated antigen tests compared to RT-PCR on nasal and oropharyngeal samples
AU - Leineweber, Thomas Daell
AU - Ghathian, Khaled
AU - Lisby, Jan Gorm
AU - Friis-Hansen, Lennart
AU - Afzal, Shoaib
AU - Ellermann-Eriksen, Svend
AU - Ma, Chih Man German
AU - Cohen, Arieh S
AU - Jørgensen, Rikke Lind
AU - Hansen, Matilde Bøgelund
AU - Kamstrup, Pia Rørbæk
AU - Larsen, Helene
AU - Steenhard, Nina
AU - Jensen, Christel Barker
AU - Kallemose, Thomas
AU - Forsberg, Maria Wendelboe
AU - Kirkby, Nikolai Søren
AU - Schneider, Uffe Vest
N1 - Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.
PY - 2023/7
Y1 - 2023/7
N2 - BACKGROUND: 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.METHODS: 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.RESULTS: 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%.CONCLUSION: 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.
AB - BACKGROUND: 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.METHODS: 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.RESULTS: 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%.CONCLUSION: 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.
UR - http://www.scopus.com/inward/record.url?scp=85158864048&partnerID=8YFLogxK
U2 - 10.1016/j.jcv.2023.105472
DO - 10.1016/j.jcv.2023.105472
M3 - Journal article
C2 - 37178678
SN - 1386-6532
VL - 164
SP - 105472
JO - Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology
JF - Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology
M1 - 105472
ER -