Clinical performance evaluation of the Fluorecare® SARS-CoV-2 & Influenza A/B & RSV rapid antigen combo test in symptomatic individuals

Jean-Louis Bayart, Constant Gillot, Jean-Michel Dogné, Gatien Roussel, Valérie Verbelen, Julien Favresse, Jonathan Douxfils

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Abstract

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.

Original languageEnglish
Article number105419
Pages (from-to)105419
JournalJournal of Clinical Virology
Volume161
Early online date28 Feb 2023
DOIs
Publication statusPublished - Apr 2023

Keywords

  • Antigen
  • Combo
  • Influenza
  • Multiplex
  • RAD
  • RSV
  • SARS-CoV-2

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