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  11. Comparative Evaluation Of Standard™ M10 Flu/rsv/sars-cov-2 And Savanna® Respiratory Viral Panel-4 Assays For The Rapid Molecular Diagnosis Of Influenza A/b Virus, Respiratory Syncytial Virus And Sars-cov-2

Comparative evaluation of STANDARD™ M10 Flu/RSV/SARS-CoV-2 and Savanna® Respiratory Viral Panel-4 assays for the rapid molecular diagnosis of influenza A/B virus, respiratory syncytial virus and SARS-CoV-2

Juulia Suominen1, Raisa Loginov1, Hannimari Kallio-Kokko1

  • 1Department of Clinical Microbiology, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.

Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology
|June 13, 2025

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View abstract on PubMed

Summary
This summary is machine-generated.

The STANDARD™ M10 Flu/RSV/SARS-CoV-2 test demonstrated superior performance for RSV and SARS-CoV-2 detection compared to the Savanna® Respiratory Viral Panel-4 assay. Both assays showed high accuracy for influenza A/B, with M10 being more reliable overall.

Area of Science:

  • Clinical diagnostics
  • Virology
  • Molecular assays

Background:

  • Rising incidence of respiratory infections (influenza A/B, RSV, SARS-CoV-2) necessitates rapid diagnostic tools.
  • Comparative performance data for point-of-care assays is crucial for clinical decision-making.

Purpose of the Study:

  • To compare the diagnostic performance of the STANDARD™ M10 Flu/RSV/SARS-CoV-2 test and the Savanna® Respiratory Viral Panel-4 test.
  • To evaluate these assays against the Xpert® Xpress SARS-CoV-2/Flu/RSV reference test.

Main Methods:

  • Retrospective analysis of 141 clinical samples using RT-PCR assays.
  • Testing with STANDARD™ M10 and Savanna® assays, with Xpert® Xpress as reference.
  • Retesting of discordant Savanna® results and serial dilution testing for sensitivity assessment.
Keywords:
Influenza A/BPoint-of-care-testRSVRT-PCR

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Main Results:

  • M10 assay showed high sensitivity for influenza A (100%), B (95.7%), RSV (97.1%), and SARS-CoV-2 (97.0%).
  • Savanna® assay demonstrated lower sensitivity for SARS-CoV-2 (90.9%) and RSV (100%, but with lower specificity at 94.2%).
  • Both assays had high specificity (≥99%), except for Savanna®'s lower specificity for RSV and SARS-CoV-2. Xpert® showed superior detection of low viral loads.

Conclusions:

  • The M10 assay is superior for RSV and SARS-CoV-2 detection compared to Savanna®, which exhibited false positives.
  • Both assays performed well for influenza A/B detection.
  • Further studies are needed to validate the new Savanna® protocol, while Xpert® remains the most sensitive for low viral quantities.
Respiratory infections
SARS-CoV-2
STANDARD M10
Savanna