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.
【저자키워드】 real-world data, RT-PCR, SARS-CoV-2., rapid antigen testing, Clinical performance, 【초록키워드】 SARS-CoV-2, coronavirus, cross-sectional, hospital, diagnostic test, real-world data, severe acute respiratory syndrome Coronavirus, RT-PCR, emergency department, Antigen, polymerase chain reaction, sensitivity, specificity, cross-sectional study, Rapid diagnostic test, Viral load, cycle threshold, clinical, Patient, Infection prevention, Rapid, Ct-value, SARS-CoV-2 antigen, infectious, real-time RT-PCR, Ag-RDT, patients, Chain Reaction, Patient care, acute respiratory syndrome, acute respiratory syndrome coronavirus, acute respiratory syndrome coronavirus 2, university hospital, help, polymerase chain, tested, identify, detect, evaluate, remained, conducted, 【제목키워드】 SARS-CoV-2, Antigen, Germany, performance, university hospital,