tetano
Editor, Senior Moderator
Diagn Microbiol Infect Dis
. 2022 Feb 26;115663.
doi: 10.1016/j.diagmicrobio.2022.115663. Online ahead of print.
Performance of the Sofia SARS-CoV-2 rapid antigen test as frontline test in a university hospital, Germany
Linus Bornemann[SUP] 1 [/SUP], Theo Dähne[SUP] 1 [/SUP], Alexey Fomenko[SUP] 1 [/SUP], Olaf Kaup[SUP] 2 [/SUP], Johannes Kleideiter[SUP] 3 [/SUP], Robert Kulis-Horn[SUP] 4 [/SUP], Bertram Ruprecht[SUP] 5 [/SUP], Michael Wehmeier[SUP] 2 [/SUP], Marcus Panning[SUP] 6 [/SUP]
Affiliations
Abstract
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.
Keywords: Clinical performance; RT-PCR; Rapid antigen testing; Real-world data; SARS-CoV-2.
. 2022 Feb 26;115663.
doi: 10.1016/j.diagmicrobio.2022.115663. Online ahead of print.
Performance of the Sofia SARS-CoV-2 rapid antigen test as frontline test in a university hospital, Germany
Linus Bornemann[SUP] 1 [/SUP], Theo Dähne[SUP] 1 [/SUP], Alexey Fomenko[SUP] 1 [/SUP], Olaf Kaup[SUP] 2 [/SUP], Johannes Kleideiter[SUP] 3 [/SUP], Robert Kulis-Horn[SUP] 4 [/SUP], Bertram Ruprecht[SUP] 5 [/SUP], Michael Wehmeier[SUP] 2 [/SUP], Marcus Panning[SUP] 6 [/SUP]
Affiliations
- PMID: 35331603
- DOI: 10.1016/j.diagmicrobio.2022.115663
Abstract
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.
Keywords: Clinical performance; RT-PCR; Rapid antigen testing; Real-world data; SARS-CoV-2.