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

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningfagfællebedømt

Dokumenter

  • Fulltext

    Forlagets udgivne version, 1,03 MB, PDF-dokument

  • Thomas Daell Leineweber
  • Khaled Ghathian
  • Jan Gorm Lisby
  • Friis-Hansen, Lennart Jan
  • Afzal, Shoaib
  • Svend Ellermann-Eriksen
  • Chih Man German Ma
  • Arieh S. Cohen
  • Rikke Lind Jørgensen
  • Matilde Bøgelund Hansen
  • Pia Rørbæk Kamstrup
  • Helene Larsen
  • Nina Steenhard
  • Christel Barker Jensen
  • Thomas Kallemose
  • Maria Wendelboe Forsberg
  • Nikolai Søren Kirkby
  • Schneider, Uffe Vest
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.
OriginalsprogEngelsk
Artikelnummer105472
TidsskriftJournal of Clinical Virology
Vol/bind164
Antal sider6
ISSN1386-6532
DOI
StatusUdgivet - 2023

Bibliografisk note

Funding Information:
The study was funded by a participant fee for each test and by the Danish Regions .

Publisher Copyright:
© 2023 The Author(s)

Antal downloads er baseret på statistik fra Google Scholar og www.ku.dk


Ingen data tilgængelig

ID: 369352506