Performance of the Sofia SARS-CoV-2 rapid antigen test as frontline test in a university hospital, Germany

• Published in: Diagnostic microbiology and infectious disease 2022-05, Vol.103 (1), p.115663-115663, Article 115663
• Main Authors: Bornemann, Linus, Dähne, Theo, Fomenko, Alexey, Kaup, Olaf, Kleideiter, Johannes, Kulis-Horn, Robert, Ruprecht, Bertram, Wehmeier, Michael, Panning, Marcus
• Format: Article
• Language: English
• Subjects: Antigens, Viral; Clinical performance; COVID-19 - diagnosis; Cross-Sectional Studies; Hospitals, University; Humans; Prospective Studies; Rapid antigen testing; Real-world data; RT-PCR; SARS-CoV-2; SARS-CoV-2 - genetics; Sensitivity and Specificity
• ISSN: 0732-8893; 1879-0070
• DOI: 10.1016/j.diagmicrobio.2022.115663

•We evaluated the performance of the Sofia SARS-CoV-2 rapid antigen test (Ag-RDT)•A total of 7877 patients were included in a prospective and monocentric study•Overall sensitivity of Ag-RDT compared to RT-PCR was 62.9% and specificity 99.4%•In a subset of symptomatic and RT-PCR positive patients sensitivity was 72.1%•The Ag-RDT proved to be a rapid tool to detect patients with high viral loads (Ct-value ≤25) 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.