A nationwide analytical and clinical evaluation of 44 rapid antigen tests for SARS-CoV-2 compared to RT-qPCR

Uffe Vest Schneider*, Maria Wendelboe Forsberg, Thomas Daell Leineweber, Christel Barker Jensen, Khaled Ghathian, Charlotte Nielsen Agergaard, Kasper Kjersgaard Mortensen, Arieh Cohen, Charlotte Sværke Jørgensen, Helene Larsen, Matilde Bøgelund Hansen, Ulla Saleme, Anders Koch, Nikolai Søren Kirkby, Thomas Kallemose, Marie Louise Schaadt, Frederikke Holm Jensen, Rikke Lind Jørgensen, Chih Man German Ma, Nina SteenhardJenny Dahl Knudsen, Jan Gorm Lisby, The National Danish RAT testing group

*Corresponding author for this work

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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.

Original languageEnglish
Article number105214
JournalJournal of Clinical Virology
Number of pages8
Publication statusPublished - Aug 2022

Bibliographical note

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  • Analytical sensitivity and specificity
  • Clinical sensitivity and specificity
  • Point of care tests
  • Rapid antigen tests
  • Reverse transcriptation polymerase chain reaction
  • SARS-CoV-2


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