Evaluation of the rapid antigen detection test STANDARD F COVID-19 Ag FIA for diagnosing SARS-CoV-2 : experience from an Emergency Department
Copyright © 2022 Elsevier Inc. All rights reserved..
The purpose of this study was to assess the clinical performance of STANDARD F COVID-19 Ag FIA (SD Biosensor Inc., Gyeonggi-do, Republic of Korea), a rapid antigen detection test (RADT) for diagnosing SARS-CoV-2, in patients attended at the Emergency Department with signs or symptoms compatible with COVID-19 that had started in the last 5 days. The clinical performance of the antigen test was compared with RT-PCR, the reference standard. We included 663 specimens from non-repetitive patients. Clinical sensitivity and specificity were 84.0% (95% CI 76.1-89.7) and 99.6% (95% CI 98.5-99.9), respectively. The positive and negative predictive values were 98.1% (95% CI 92.7-99.7) and 96.4% (95% CI 94.4-97.7), respectively. The kappa index agreement between RT-PCR and the RADT was 0.89 (95% CI 0.84-0.93). We concluded that STANDARD F COVID-19 Ag FIA is an excellent first-line RADT method to diagnose symptomatic patients in the emergency department.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:103 |
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| Enthalten in: |
Diagnostic microbiology and infectious disease - 103(2022), 2 vom: 15. Juni, Seite 115683 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
García-Fernández, Sergio [VerfasserIn] |
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| Links: |
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| Themen: |
Antigens, Viral |
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| Anmerkungen: |
Date Completed 10.05.2022 Date Revised 21.12.2022 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.diagmicrobio.2022.115683 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM339512296 |
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| 520 | |a The purpose of this study was to assess the clinical performance of STANDARD F COVID-19 Ag FIA (SD Biosensor Inc., Gyeonggi-do, Republic of Korea), a rapid antigen detection test (RADT) for diagnosing SARS-CoV-2, in patients attended at the Emergency Department with signs or symptoms compatible with COVID-19 that had started in the last 5 days. The clinical performance of the antigen test was compared with RT-PCR, the reference standard. We included 663 specimens from non-repetitive patients. Clinical sensitivity and specificity were 84.0% (95% CI 76.1-89.7) and 99.6% (95% CI 98.5-99.9), respectively. The positive and negative predictive values were 98.1% (95% CI 92.7-99.7) and 96.4% (95% CI 94.4-97.7), respectively. The kappa index agreement between RT-PCR and the RADT was 0.89 (95% CI 0.84-0.93). We concluded that STANDARD F COVID-19 Ag FIA is an excellent first-line RADT method to diagnose symptomatic patients in the emergency department | ||
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| 700 | 1 | |a de la Fuente, Silvia Velasco |e verfasserin |4 aut | |
| 700 | 1 | |a Rodríguez, María José Reina |e verfasserin |4 aut | |
| 700 | 1 | |a Gozalo, Mónica |e verfasserin |4 aut | |
| 700 | 1 | |a Rodríguez-Lozano, Jesús |e verfasserin |4 aut | |
| 700 | 1 | |a Méndez-Legaza, José Manuel |e verfasserin |4 aut | |
| 700 | 1 | |a Calvo, Jorge |e verfasserin |4 aut | |
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