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

共 28 条

[1] Comparison of the Quidel Sofia SARS FIA Test to the Hologic Aptima SARS-CoV-2 TMA Test for Diagnosis of COVID-19 in Symptomatic Outpatients [J].

Beck, Eric T. ;

Paar, Wendy ;

Fojut, Lara ;

Serwe, Jordan ;

Jahnke, Renee R. .

JOURNAL OF CLINICAL MICROBIOLOGY, 2021, 59 (02)

[2] Real-life evaluation of the Sofia SARS-CoV-2 antigen assay in a large tertiary care hospital [J].

Bornemann, Linus ;

Kaup, Olaf ;

Kleideiter, Johannes ;

Panning, Marcus ;

Ruprecht, Bertram ;

Wehmeier, Michael .

JOURNAL OF CLINICAL VIROLOGY, 2021, 140

[3] A SARS-CoV-2 Nucleocapsid Variant that Affects Antigen Test Performance [J].

Bourassa, Lori ;

Perchetti, Garrett A. ;

Phung, Quynh ;

Lin, Michelle J. ;

Mills, Margaret G. ;

Roychoudhury, Pavitra ;

Harmon, Kimberly G. ;

Reed, Jonathan C. ;

Greninger, Alexander L. .

JOURNAL OF CLINICAL VIROLOGY, 2021, 141

[4] Diagnostic Performance of an Antigen Test with RT-PCR for the Detection of SARS-CoV-2 in a Hospital Setting - Los Angeles County, California, June-August 2020 [J].

Brihn, Auguste ;

Chang, Jamie ;

OYong, Kelsey ;

Balter, Sharon ;

Terashita, Dawn ;

Rubin, Zach ;

Yeganeh, Nava .

MMWR-MORBIDITY AND MORTALITY WEEKLY REPORT, 2021, 70 (19) :702-706

[5] Predicting Infectious Severe Acute Respiratory Syndrome Coronavirus 2 From Diagnostic Samples [J].

Bullard, Jared ;

Dust, Kerry ;

Funk, Duane ;

Strong, James E. ;

Alexander, David ;

Garnett, Lauren ;

Boodman, Carl ;

Bello, Alexander ;

Hedley, Adam ;

Schiffman, Zachary ;

Doan, Kaylie ;

Bastien, Nathalie ;

Li, Yan ;

Van Caeseele, Paul G. ;

Poliquin, Guillaume .

CLINICAL INFECTIOUS DISEASES, 2020, 71 (10) :2663-2666

[6] Rapid Diagnostic Testing for SARS-CoV-2 [J].

Drain, Paul K. .

NEW ENGLAND JOURNAL OF MEDICINE, 2022, 386 (03) :264-272

[7] Multidisciplinary assessment of the Abbott BinaxNOW SARS-CoV-2 point-of-care antigen test in the context of emerging viral variants and self-administration [J].

Frediani, Jennifer K. ;

Levy, Joshua M. ;

Rao, Anuradha ;

Bassit, Leda ;

Figueroa, Janet ;

Vos, Miriam B. ;

Wood, Anna ;

Jerris, Robert ;

Van Leung-Pineda ;

Gonzalez, Mark D. ;

Rogers, Beverly B. ;

Mavigner, Maud ;

Schinazi, Raymond F. ;

Schoof, Nils ;

Waggoner, Jesse J. ;

Kempker, Russell R. ;

Rebolledo, Paulina A. ;

O'Neal, Jared W. ;

Stone, Cheryl ;

Chahroudi, Ann ;

Morris, Claudia R. ;

Suessmith, Allie ;

Sullivan, Julie ;

Farmer, Sarah ;

Foster, Amanda ;

Roback, John D. ;

Ramachandra, Thanuja ;

Washington, CaDeidre ;

Le, Kristie ;

Cordero, Maria C. ;

Esper, Annette ;

Nehl, Eric J. ;

Wang, Yun F. ;

Tyburski, Erika A. ;

Martin, Greg S. ;

Lam, Wilbur A. .

SCIENTIFIC REPORTS, 2021, 11 (01)

[8]

Ghulam A, 2021, BIOSCI RES, V18, P47

[9] Surveillance testing for SARS-COV-2 infection in an asymptomatic athlete population: a prospective cohort study with 123 362 tests and 23 463 paired RT-PCR/antigen samples [J].

Harmon, Kimberly ;

de St Maurice, Anabelle M. ;

Brady, Adam C. ;

Swaminathan, Sankar ;

Aukerman, Doug F. ;

Rueda, Miguel A. ;

Terrell, Kim ;

Cohen, Randall P. ;

Gamradt, Seth C. ;

Henry, Sunday D. ;

Huston, Lindsay M. ;

McAllister, David R. ;

McCarty, Kenneth M. ;

Pass, Anthony N. ;

Paul, Stephen R. ;

Petron, David J. ;

Kliethermes, Stephanie A. .

BMJ OPEN SPORT & EXERCISE MEDICINE, 2021, 7 (02)

[10] Comparison of commercial realtime reverse transcription PCR assays for the detection of SARS-CoV-2 [J].

Igloi, Zsofia ;

Leven, Margareta ;

Abou-Nouar, Zain Abdel-Karem ;

Weller, Babette ;

Matheeussen, Veerle ;

Coppens, Jasmine ;

Koopmans, Marion ;

Molenkamp, Richard .

JOURNAL OF CLINICAL VIROLOGY, 2020, 129

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