TY - JOUR
T1 - A nationwide analytical and clinical evaluation of 44 rapid antigen tests for SARS-CoV-2 compared to RT-qPCR
AU - Schneider, Uffe Vest
AU - Forsberg, Maria Wendelboe
AU - Leineweber, Thomas Daell
AU - Jensen, Christel Barker
AU - Ghathian, Khaled
AU - Agergaard, Charlotte Nielsen
AU - Mortensen, Kasper Kjersgaard
AU - Cohen, Arieh
AU - Jørgensen, Charlotte Sværke
AU - Larsen, Helene
AU - Hansen, Matilde Bøgelund
AU - Saleme, Ulla
AU - Koch, Anders
AU - Kirkby, Nikolai Søren
AU - Kallemose, Thomas
AU - Schaadt, Marie Louise
AU - Jensen, Frederikke Holm
AU - Jørgensen, Rikke Lind
AU - Ma, Chih Man German
AU - Steenhard, Nina
AU - Knudsen, Jenny Dahl
AU - Lisby, Jan Gorm
AU - The National Danish RAT testing group
N1 - Publisher Copyright:
© 2022 The Author(s)
PY - 2022
Y1 - 2022
N2 - Background: The SARS-CoV-2 pandemic has resulted in massive testing by Rapid Antigen Tests (RAT) without solid independent data regarding clinical performance being available. Thus, decision on purchase of a specific RAT may rely on manufacturer-provided data and limited peer-reviewed data. Methods: This study consists of two parts. In the retrospective analytical part, 33 RAT from 25 manufacturers were compared to RT-PCR on 100 negative and 204 positive deep oropharyngeal cavity samples divided into four groups based on RT-PCR Cq levels. In the prospective clinical part, nearly 200 individuals positive for SARS-CoV-2 and nearly 200 individuals negative for SARS-CoV-2 by routine RT-PCR testing were retested within 72 h for each of 44 included RAT from 26 manufacturers applying RT-PCR as the reference method.Results: The overall analytical sensitivity differed significantly between the 33 included RAT; from 2.5% (95% CI 0.5–4.8) to 42% (95% CI 35–49). All RAT presented analytical specificities of 100%. Likewise, the overall clinical sensitivity varied significantly between the 44 included RAT; from 2.5% (95% CI 0.5–4.8) to 94% (95% CI 91–97). All RAT presented clinical specificities between 98 and 100%. Conclusion: The study presents analytical as well as clinical performance data for 44 commercially available RAT compared to the same RT-PCR test. The study enables identification of individual RAT that has significantly higher sensitivity than other included RAT and may aid decision makers in selecting between the included RAT. Funding: The study was funded by a participant fee for each test and the Danish Regions.
AB - Background: The SARS-CoV-2 pandemic has resulted in massive testing by Rapid Antigen Tests (RAT) without solid independent data regarding clinical performance being available. Thus, decision on purchase of a specific RAT may rely on manufacturer-provided data and limited peer-reviewed data. Methods: This study consists of two parts. In the retrospective analytical part, 33 RAT from 25 manufacturers were compared to RT-PCR on 100 negative and 204 positive deep oropharyngeal cavity samples divided into four groups based on RT-PCR Cq levels. In the prospective clinical part, nearly 200 individuals positive for SARS-CoV-2 and nearly 200 individuals negative for SARS-CoV-2 by routine RT-PCR testing were retested within 72 h for each of 44 included RAT from 26 manufacturers applying RT-PCR as the reference method.Results: The overall analytical sensitivity differed significantly between the 33 included RAT; from 2.5% (95% CI 0.5–4.8) to 42% (95% CI 35–49). All RAT presented analytical specificities of 100%. Likewise, the overall clinical sensitivity varied significantly between the 44 included RAT; from 2.5% (95% CI 0.5–4.8) to 94% (95% CI 91–97). All RAT presented clinical specificities between 98 and 100%. Conclusion: The study presents analytical as well as clinical performance data for 44 commercially available RAT compared to the same RT-PCR test. The study enables identification of individual RAT that has significantly higher sensitivity than other included RAT and may aid decision makers in selecting between the included RAT. Funding: The study was funded by a participant fee for each test and the Danish Regions.
KW - Analytical sensitivity and specificity
KW - Clinical sensitivity and specificity
KW - Point of care tests
KW - Rapid antigen tests
KW - Reverse transcriptation polymerase chain reaction
KW - SARS-CoV-2
U2 - 10.1016/j.jcv.2022.105214
DO - 10.1016/j.jcv.2022.105214
M3 - Journal article
C2 - 35738151
AN - SCOPUS:85132754916
SN - 1386-6532
VL - 153
JO - Journal of Clinical Virology
JF - Journal of Clinical Virology
M1 - 105214
ER -