Institute of Virology, University Medical Centre and Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Institute of Laboratory Medicine, Microbiology and Transfusion Medicine, University Hospital OWL, Campus Bielefeld Hospital, Bielefeld, Germany.
Diagn Microbiol Infect Dis. 2022 May;103(1):115663. doi: 10.1016/j.diagmicrobio.2022.115663. Epub 2022 Feb 26.
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.
快速可靠地检测严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）对于个体患者护理和医院感染预防至关重要。我们旨在评估 Sofia SARS-CoV-2 抗原快速诊断检测（Ag-RDT）与实时逆转录聚合酶链反应（RT-PCR）相比的性能。我们在 2020 年 11 月至 2021 年 3 月期间在德国一所大学医院的急诊部门进行了一项前瞻性、单中心横断面研究。我们使用 Sofia SARS-CoV-2 Ag-RDT 和实时 RT-PCR 对所有样本进行了测试。共纳入 7877 例患者。Ag-RDT 的总体敏感性为 62.9%，特异性为 99.4%。敏感性在研究月份之间存在差异，而特异性保持较高。在 Ct 值≤25 的样本中，敏感性增加到 94.2%。Sofia Ag-RDT 被证明是一种快速检测高病毒载量（Ct 值≤25）样本的工具，因此可能有助于识别传染性患者。
