Performance of the Sofia SARS-CoV-2 rapid antigen test as frontline test in a university hospital, Germany.
Clinical performance
RT-PCR
Rapid antigen testing
Real-world data
SARS-CoV-2
Journal
Diagnostic microbiology and infectious disease
ISSN: 1879-0070
Titre abrégé: Diagn Microbiol Infect Dis
Pays: United States
ID NLM: 8305899
Informations de publication
Date de publication:
May 2022
May 2022
Historique:
received:
17
11
2021
revised:
09
02
2022
accepted:
19
02
2022
pubmed:
26
3
2022
medline:
14
4
2022
entrez:
25
3
2022
Statut:
ppublish
Résumé
The rapid and reliable detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is of high importance for individual patient care and hospital infection prevention. We aimed to evaluate the performance of the Sofia SARS-CoV-2 antigen rapid diagnostic test (Ag-RDT) in comparison to real-time reverse-transcription polymerase chain reaction (RT-PCR). We conducted a prospective, monocentric cross-sectional study in an emergency department of a German university hospital from November 2020 to March 2021. We tested all samples using both Sofia SARS-CoV-2 Ag-RDT and real-time RT-PCR. A total of 7877 patients were included. Overall sensitivity of the Ag-RDT was 62.9% and specificity was 99.4%. Sensitivity varied across study months, whereas specificity remained high. Sensitivity increased to 94.2% in samples with a cycle threshold (Ct)-value ≤25. The Sofia Ag-RDT proved to be a rapid tool to detect samples with high viral loads (Ct-value ≤25) and might thus help to identify infectious patients.
Identifiants
pubmed: 35331603
pii: S0732-8893(22)00031-1
doi: 10.1016/j.diagmicrobio.2022.115663
pmc: PMC8881221
pii:
doi:
Substances chimiques
Antigens, Viral
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
115663Informations de copyright
Copyright © 2022 Elsevier Inc. All rights reserved.
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