Comparative evaluation of Panbio and SD Biosensor antigen rapid diagnostic tests for COVID-19 diagnosis
© 2021 Wiley Periodicals LLC..
The aim of our study was to evaluate the diagnostic performance of two antigen rapid diagnostic tests (Ag-RDTs) to diagnose severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. We evaluated Panbio and SD-Biosensor Ag-RDTs. We employed 186 polymerase chain reaction (PCR) negative samples to evaluate the specificity and 170 PCR positive samples to assess the sensitivity. We evaluated their sensitivity according to Cycle threshold (C t ) values and days post onset of symptoms (d.p.o.). Tests were compared using the McNemar's test. Agreement was evaluated using the kappa score. Specificity was 100% for Panbio and 97.3% for SD-Biosensor. Sensitivity for samples with C t ≤ 20 was 100% for both assays and for samples with C t = 20-25 was 93.0% (Panbio) and 95.3% (SD-Biosensor) (p = 1.000). Sensitivity decreased for samples wit C t = 25-30 (Panbio: 41.3%, SD-Biosensor: 52.2%, p = 0.125) and samples with C t ≥ 30 (Panbio: 5.0%, SD-Biosensor: 17.5%, p = 0.063). Sensitivity within seven d.p.o. was 87.7% for Panbio and 90.4% for SD-Biosensor and notably decreased after seven d.p.o. Agreement with PCR was excellent for high viral load samples (C t ≤ 25): Panbio, 98.9%, kappa = 0.974; SD-Biosensor, 97.4%, kappa = 0.940. Agreement between Ag-RDTs was excellent (94.9%, kappa = 0.882). Panbio and SD-Biosensor Ag-RDTs showed excellent agreement and diagnostic performance results for samples with high viral loads (C t ≤ 25) or samples within seven d.p.o.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:93 |
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| Enthalten in: |
Journal of medical virology - 93(2021), 9 vom: 15. Sept., Seite 5650-5654 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Pérez-García, Felipe [VerfasserIn] |
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| Links: |
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| Themen: |
Antigen rapid diagnostic test |
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| Anmerkungen: |
Date Completed 02.08.2021 Date Revised 05.10.2022 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1002/jmv.27089 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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NLM325540330 |
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| 520 | |a The aim of our study was to evaluate the diagnostic performance of two antigen rapid diagnostic tests (Ag-RDTs) to diagnose severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. We evaluated Panbio and SD-Biosensor Ag-RDTs. We employed 186 polymerase chain reaction (PCR) negative samples to evaluate the specificity and 170 PCR positive samples to assess the sensitivity. We evaluated their sensitivity according to Cycle threshold (C t ) values and days post onset of symptoms (d.p.o.). Tests were compared using the McNemar's test. Agreement was evaluated using the kappa score. Specificity was 100% for Panbio and 97.3% for SD-Biosensor. Sensitivity for samples with C t ≤ 20 was 100% for both assays and for samples with C t = 20-25 was 93.0% (Panbio) and 95.3% (SD-Biosensor) (p = 1.000). Sensitivity decreased for samples wit C t = 25-30 (Panbio: 41.3%, SD-Biosensor: 52.2%, p = 0.125) and samples with C t ≥ 30 (Panbio: 5.0%, SD-Biosensor: 17.5%, p = 0.063). Sensitivity within seven d.p.o. was 87.7% for Panbio and 90.4% for SD-Biosensor and notably decreased after seven d.p.o. Agreement with PCR was excellent for high viral load samples (C t ≤ 25): Panbio, 98.9%, kappa = 0.974; SD-Biosensor, 97.4%, kappa = 0.940. Agreement between Ag-RDTs was excellent (94.9%, kappa = 0.882). Panbio and SD-Biosensor Ag-RDTs showed excellent agreement and diagnostic performance results for samples with high viral loads (C t ≤ 25) or samples within seven d.p.o | ||
| 650 | 4 | |a Comparative Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a COVID-19 | |
| 650 | 4 | |a Panbio COVID-19 Ag | |
| 650 | 4 | |a SARS-CoV-2 | |
| 650 | 4 | |a SD biosensor COVID-19 Ag FIA | |
| 650 | 4 | |a antigen rapid diagnostic test | |
| 650 | 4 | |a lateral flow immunoassay | |
| 650 | 7 | |a Antigens, Viral |2 NLM | |
| 700 | 1 | |a Romanyk, Juan |e verfasserin |4 aut | |
| 700 | 1 | |a Moya Gutiérrez, Helena |e verfasserin |4 aut | |
| 700 | 1 | |a Labrador Ballestero, Andrea |e verfasserin |4 aut | |
| 700 | 1 | |a Pérez Ranz, Inés |e verfasserin |4 aut | |
| 700 | 1 | |a González Arroyo, Javier |e verfasserin |4 aut | |
| 700 | 1 | |a González Ventosa, Victoria |e verfasserin |4 aut | |
| 700 | 1 | |a Pérez-Tanoira, Ramón |e verfasserin |4 aut | |
| 700 | 1 | |a Domingo Cruz, Concepción |e verfasserin |4 aut | |
| 700 | 1 | |a Cuadros-González, Juan |e verfasserin |4 aut | |
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