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

被引：4
作者：
Bornemann, Linus [1 ,2 ]
Daehne, Theo [1 ,2 ]
Fomenko, Alexey [1 ,2 ]
Kaup, Olaf [3 ]
Kleideiter, Johannes [4 ]
Kulis-Horn, Robert [5 ]
Ruprecht, Bertram [6 ]
Wehmeier, Michael [3 ]
Panning, Marcus [1 ,2 ]
机构：
[1] Univ Freiburg, Inst Virol, Univ Med Ctr, Freiburg, Germany
[2] Univ Freiburg, Fac Med, Freiburg, Germany
[3] Campus Bielefeld Hosp, Univ Hosp OWL, Inst Lab Med Microbiol & Transfus Med, Bielefeld, Germany
[4] Campus Bielefeld Hosp, Dept Clin Hyg, Bielefeld, Germany
[5] MVZ Lab Krone GbR, Bad Salzuflen, Germany
[6] Campus Bielefeld Hosp, Dept Pneumol & Resp Med, Bielefeld, Germany
来源：
DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE | 2022年 / 103卷 / 01期
关键词：
SARS-CoV-2; Rapid antigen testing; RT-PCR; Clinical performance; Real-world data;
D O I：
10.1016/j.diagmicrobio.2022.115663
中图分类号：
R51 [传染病];
学科分类号：
100401 ;
摘要：
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 realtime 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.@ 2022 Elsevier Inc. All rights reserved.
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页数：5
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