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.

引用

页数：5

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