Clinical performance evaluation of the Fluorecare® SARS-CoV-2 & Influenza A/B & RSV rapid antigen combo test in symptomatic individuals
Copyright © 2023 Elsevier B.V. All rights reserved..
BACKGROUND: A SARS-CoV-2+Flu A/B+RSV Combo Rapid test may be more relevant than Rapid Antigen Diagnostic (RAD) tests targeting only SARS-CoV-2 since we are facing a concurrent circulation of these viruses during the winter season.
OBJECTIVES: To assess the clinical performance of a SARS-CoV-2+Flu A/B+RSV Combo test in comparison to a multiplex RT-qPCR.
STUDY DESIGN: Residual nasopharyngeal swabs issued from 178 patients were included. All patients, adults and children, were symptomatic and presented at the emergency department with flu-like symptoms. Characterization of the infectious viral agent was done by RT-qPCR. The viral load was expressed as cycle threshold (Ct). Samples were then tested using the multiplex RAD test Fluorecare®ฏ SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test. Data analysis was carried out using descriptive statistics.
RESULTS: The sensitivity of the test varies according to the virus, with the highest sensitivity observed for Influenza A (80.8.% [95%CI: 67.2 - 94.4]) and the lowest sensitivity observed for RSV (41.5% [95%CI: 26.2 - 56.8]). Higher sensitivities were observed for samples with high viral loads (Ct < 20) and decrease with low viral loads. The specificity for SARS-CoV-2, RSV and Influenza A and B was >95%.
CONCLUSIONS: The Fluorecare® combo antigenic presents satisfying performance in real-life clinical setting for Influenza A and B in samples with high viral load. This could be useful to allow a rapid (self-)isolation as the transmissibility of these viruses increase with the viral load. According to our results, its use to rule-out SARS-CoV-2 and RSV infection is not sufficient.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:161 |
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| Enthalten in: |
Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology - 161(2023) vom: 01. Apr., Seite 105419 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Bayart, Jean-Louis [VerfasserIn] |
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| Links: |
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| Themen: |
Antigen |
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| Anmerkungen: |
Date Completed 04.04.2023 Date Revised 21.05.2023 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.jcv.2023.105419 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM35411431X |
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| 100 | 1 | |a Bayart, Jean-Louis |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Clinical performance evaluation of the Fluorecare® SARS-CoV-2 & Influenza A/B & RSV rapid antigen combo test in symptomatic individuals |
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| 500 | |a Date Completed 04.04.2023 | ||
| 500 | |a Date Revised 21.05.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023 Elsevier B.V. All rights reserved. | ||
| 520 | |a BACKGROUND: A SARS-CoV-2+Flu A/B+RSV Combo Rapid test may be more relevant than Rapid Antigen Diagnostic (RAD) tests targeting only SARS-CoV-2 since we are facing a concurrent circulation of these viruses during the winter season | ||
| 520 | |a OBJECTIVES: To assess the clinical performance of a SARS-CoV-2+Flu A/B+RSV Combo test in comparison to a multiplex RT-qPCR | ||
| 520 | |a STUDY DESIGN: Residual nasopharyngeal swabs issued from 178 patients were included. All patients, adults and children, were symptomatic and presented at the emergency department with flu-like symptoms. Characterization of the infectious viral agent was done by RT-qPCR. The viral load was expressed as cycle threshold (Ct). Samples were then tested using the multiplex RAD test Fluorecare®ฏ SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test. Data analysis was carried out using descriptive statistics | ||
| 520 | |a RESULTS: The sensitivity of the test varies according to the virus, with the highest sensitivity observed for Influenza A (80.8.% [95%CI: 67.2 - 94.4]) and the lowest sensitivity observed for RSV (41.5% [95%CI: 26.2 - 56.8]). Higher sensitivities were observed for samples with high viral loads (Ct < 20) and decrease with low viral loads. The specificity for SARS-CoV-2, RSV and Influenza A and B was >95% | ||
| 520 | |a CONCLUSIONS: The Fluorecare® combo antigenic presents satisfying performance in real-life clinical setting for Influenza A and B in samples with high viral load. This could be useful to allow a rapid (self-)isolation as the transmissibility of these viruses increase with the viral load. According to our results, its use to rule-out SARS-CoV-2 and RSV infection is not sufficient | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Antigen | |
| 650 | 4 | |a Combo | |
| 650 | 4 | |a Influenza | |
| 650 | 4 | |a Multiplex | |
| 650 | 4 | |a RAD | |
| 650 | 4 | |a RSV | |
| 650 | 4 | |a SARS-CoV-2 | |
| 700 | 1 | |a Gillot, Constant |e verfasserin |4 aut | |
| 700 | 1 | |a Dogné, Jean-Michel |e verfasserin |4 aut | |
| 700 | 1 | |a Roussel, Gatien |e verfasserin |4 aut | |
| 700 | 1 | |a Verbelen, Valérie |e verfasserin |4 aut | |
| 700 | 1 | |a Favresse, Julien |e verfasserin |4 aut | |
| 700 | 1 | |a Douxfils, Jonathan |e verfasserin |4 aut | |
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