Influenza A/B & RSV Real-Time PCR Test CE

The Aridia Influenza A/B & RSV Real-Time PCR Test is based on the real-time amplification and detection of influenza A, influenza B, and respiratory syncytial virus (RSV) in a one-step format.

The test is designed for specific and qualitative detection and differentiation of influenza A, influenza B, and respiratory syncytial virus (RSV) RNA in clinical respiratory specimens as an aid in the diagnosis of influenza A, influenza B, and RSV infections alongside all available clinical and epidemiological data, patient history, and other laboratory test outcomes. The product is intended for use by professionals specifically trained in nucleic acid amplification techniques and in vitro diagnostic procedures.

Any person presenting an upper respiratory tract infection that produces symptoms such as sudden onset fever, myalgia, headache, malaise, cough, sore throat, and runny nose, within a week after symptom onset.

Influenza A, influenza B, and RSV RNA is detectable in clinical respiratory specimens within the first 5 days after illness onset. A positive PCR test during this detection window is confirmatory of infection. A negative PCR test does not exclude infection and should be followed up with additional serological diagnostic testing. All test results should be evaluated by a health care professional in the context of clinical symptoms, epidemiological information, patient history, and other diagnostic test results.

  • Real-time PCR technology
  • Dry formulation in an easy-to-use format provides a stable system
  • Room temperature shipment and storage for up to 24 months
  • Lyophilized components in each reaction well for stability, integrity and convenience
  • Pre-mixed reagents for less test steps and less human errors
  • Open system suitable for most real-time PCR thermocyclers and nucleic acid extraction kits on the market

Clinical performance compared to a CE-marked commercial molecular assay:

  • Sensitivity: 98%, Specificity: 100% for influenza A
  • Sensitivity: 98%, Specificity: 100% for influenza B
  • Sensitivity: 100%, Specificity: 100% for RSV
  • Limit of Detection: ≥50 influenza A, ≥10 influenza B, and ≥10 RSV RNA copies detected as positive ≥ 95% of the time
  • Cross-Reactivity: no cross-reactivity with many common respiratory pathogens (see details in the package insert)
  • Analytical reactivity: 
    • The reactivity for Influenza A was confirmed by real-time amplification with
    • influenza A/California/7/2009(H1N1) virus, influenza A/Perth/16 /2009(H3N2) virus, influenza A/New Caledonia/20/99(H1N1) virus, Influenza A/Switzerland /9715293/2013 virus, and Influenza A/Turkey/Germany R2485+86/2014 virus as templates
    • The reactivity for influenza B was confirmed by real-time amplification with influenza B/Brisbane/60/2008 virus, influenza B/Florida/04/06 virus, and influenza B/Phuket/3073/2013 virus as templates.
    • The reactivity for RSV was confirmed by real-time amplification with respiratory syncytial virus as templates.
  • Aridia Influenza A/B & RSV Real-Time PCR Test Strips (High Profile/Low Profile)
  • Positive Control
  • Negative Control
  • PCR-Grade Water
  • Resuspension Solution (for Reconstitution of the Stabilized Reaction Mix)
  • Optical Caps

Catalog #

Product

Quantity

P0187H/L

Influenza A/B & RSV Real-Time PCR Test

96/kit

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FOR EXPORT ONLY