Rapid antigen test as a screening tool for SARS-CoV-2 infection : Head-to-head comparison with qRT-PCR in Ethiopia
© 2023 Published by Elsevier Ltd..
Objective: This study aimed to determine the diagnostic accuracy of the antigen rapid diagnostic test (Ag-RDT) as a screening tool for SARS-CoV-2 infection compared to Quantitative reverse transcription polymerase chain reaction (qRT-PCR).
Methods: This study was conducted at six referral hospitals in Oromia Region, Ethiopia. One thousand seven hundred twenty-one patients who visited the hospitals for various medical conditions were tested with qRT-PCR and/or Ag-RDTs. Qualitative detection of SARS-CoV-2 antigen was performed using the Panbio™ COVID-19 Ag rapid test device.
Results: Compared with qRT-PCR, Ag-RDTs had a sensitivity of 33.3 % (95%CI: 30.9%-35.9 %) and a specificity of 99.3 % (95%CI: 98.8%-99.7 %) to detect active SARS-CoV-2 infection. The area under the receiver operator curve was 0.67 (95%CI: 0.63-0.69). The sensitivity of Ag-RDTs appeared high in patients with shortness of breath (73.3 %) and those presenting with all three symptoms - fever, cough, and dyspnea (71.4 %). In all instances, specificity was more than 98 %. The Ag-RDT positivity rate also correlated well with viral load: 51.7 % in cases with cycle threshold (Ct) < 25 (high viral load) and only 3.4 % when Ct > 25 (low viral load).
Conclusion: Although Ag-RDT for diagnosing SARS-CoV-2 is a good option as a point-of-care screening tool, it has a low sensitivity to detect active infections. Using Panbio™ COVID-19 Ag Rapid test for diagnostic and treatment decisions may lead to a false negative, resulting in patient misdiagnosis, ultimately contributing to disease spread and poor patient outcome.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:10 |
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| Enthalten in: |
Heliyon - 10(2024), 1 vom: 15. Jan., Seite e23518 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Gobena, Dabesa [VerfasserIn] |
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| Links: |
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| Themen: |
Ag-RDT |
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| Anmerkungen: |
Date Revised 05.01.2024 published: Electronic-eCollection Citation Status PubMed-not-MEDLINE |
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| doi: |
10.1016/j.heliyon.2023.e23518 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM366604236 |
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| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a © 2023 Published by Elsevier Ltd. | ||
| 520 | |a Objective: This study aimed to determine the diagnostic accuracy of the antigen rapid diagnostic test (Ag-RDT) as a screening tool for SARS-CoV-2 infection compared to Quantitative reverse transcription polymerase chain reaction (qRT-PCR) | ||
| 520 | |a Methods: This study was conducted at six referral hospitals in Oromia Region, Ethiopia. One thousand seven hundred twenty-one patients who visited the hospitals for various medical conditions were tested with qRT-PCR and/or Ag-RDTs. Qualitative detection of SARS-CoV-2 antigen was performed using the Panbio™ COVID-19 Ag rapid test device | ||
| 520 | |a Results: Compared with qRT-PCR, Ag-RDTs had a sensitivity of 33.3 % (95%CI: 30.9%-35.9 %) and a specificity of 99.3 % (95%CI: 98.8%-99.7 %) to detect active SARS-CoV-2 infection. The area under the receiver operator curve was 0.67 (95%CI: 0.63-0.69). The sensitivity of Ag-RDTs appeared high in patients with shortness of breath (73.3 %) and those presenting with all three symptoms - fever, cough, and dyspnea (71.4 %). In all instances, specificity was more than 98 %. The Ag-RDT positivity rate also correlated well with viral load: 51.7 % in cases with cycle threshold (Ct) < 25 (high viral load) and only 3.4 % when Ct > 25 (low viral load) | ||
| 520 | |a Conclusion: Although Ag-RDT for diagnosing SARS-CoV-2 is a good option as a point-of-care screening tool, it has a low sensitivity to detect active infections. Using Panbio™ COVID-19 Ag Rapid test for diagnostic and treatment decisions may lead to a false negative, resulting in patient misdiagnosis, ultimately contributing to disease spread and poor patient outcome | ||
| 650 | 4 | |a Journal Article | |
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| 700 | 1 | |a Mekonnen, Zeleke |e verfasserin |4 aut | |
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