ViroKey® Flu A/B & RSV RT-PCR Extension Kit (for use with ViroKey SARS-CoV-2 RT-PCR Test v2.0) (CE-IVD)

Integrated workflow for Influenza A, Influenza B, RSV and SARS-CoV-2 detection

PURPOSE

The ViroKey Flu A/B & RSV RT-PCR Extension Kit (For use only with ViroKey SARS-CoV-2 RT-PCR Test v2.0), is used in conjunction with the ViroKey SARS-CoV-2 RT-PCR Test v2.0, is a triplex, real-time polymerase chain reaction (PCR) test. This test is intended for the qualitative detection of RNA from SARS-CoV-2, Influenza A, Influenza B, and Respiratory Syncytial Virus (RSV) in nasopharyngeal and oropharyngeal swabs from individuals. 

The ViroKey Flu A/B & RSV RT-PCR Extension Kit is configured only for use together with the ViroKey SARS-CoV-2 RT-PCR Test v2.0 on the Sentosa®  SX101 instrument, with either the ViroKey SX Virus Total Nucleic Acid Kit or Sentosa SX Virus Total Nucleic Acid Kit v2.0, in conjunction with Sentosa SA201 Real-Time PCR system.

Results are for the identification of SARS-CoV-2, Influenza A, Influenza B, and Respiratory Syncytial Virus (RSV) RNA. Positive results are indicative of the presence of SARS-CoV-2, Influenza A and B, or Respiratory Syncytial Virus (RSV) RNA. Negative results do not preclude the absence of SARS-CoV-2, Influenza A and B or RSV RNA. Mutations that arise within the highly conserved regions of the viral genome covered by both kits’ primers and / or probes may result in failure to detect the presence of the virus. 

CE-IVD: For in vitro diagnostic use. Not for distribution in U.S.

 

FEATURES AND BENEFITS

Supporting Clinical Research

  • Sensitive and robust
  • Differentially detect SARS-CoV-2, Influenza A, Influenza B & RSV
    (when used with ViroKey SARS-CoV-2 RT-PCR Test v2.0)

Maximising Laboratory Efficiency

  • Only 30 minutes to 1 hour of hands-on time
  • Automation from sample to result with automated PCR result analysis
  • Test up to 46 samples (plus two controls) per automated run

Increasing Cost Effectiveness

  • Differentiate four pathogens in one run to save reagents and consumables cost
  • Comprehensive and fast result call-out to reduce patient management cost

WORKFLOW

SPECIFICATIONS

 

AttributeValue
Sample Types

Nasopharyngeal and oropharyngeal swabs

Targets
  • SARS-CoV-2: ORF1a and N gene
  • Influenza A: Matrix Protein
  • Influenza B: Matrix Protein
  • RSV: Matrix Protein
Limit of Detection (LoD)

ViroKey SX Virus Total Nucleic Acid Kit

  • SARS-CoV-2: 200 GE/mL (9.2 GE/reaction)
  • Influenza A: 2.5 TCID50/mL (0.12 TCID50/reaction)
  • Influenza B: 10 TCID50/mL (0.46 TCID50/reaction)
  • RSV: 2.5 TCID50/mL (0.12 TCID50/reaction)

Sentosa SX Virus Total Nucleic Acid Kit v2.0

  • SARS-CoV-2: 150 GE/mL (6.9 GE/reaction)
  • Influenza A: 0.94 TCID50/mL (0.04 TCID50/reaction)
  • Influenza B: 5 TCID50/mL (0.23 TCID50/reaction)
  • RSV: 2.5 TCID50/mL (0.12 TCID50/reaction)
Analytical Specificity

No cross reactivity with 27 pathogens tested

Analytical Reactivity
  • Able to detect all analysed SARS-CoV-2 sequences in GenBank and GISAID databases*
  • Able to detect all analysed Influenza A, B, and RSV sequences in GenBank database*(*As of 10 November, 2020)
Clinical Sensitivity

ViroKey SX Virus Total Nucleic Acid Kit

  • SARS-CoV-2: 100% (95% CI: 88.6, 100)
  • Influenza A: 98% (95% CI: 89.5, 99.6) 
  • Influenza B: 96.8% (95% CI: 83.8, 99.4)
  • RSV: 96.7% (95% CI: 83.3, 99.4)

Sentosa SX Virus Total Nucleic Acid Kit v2.0

  • SARS-CoV-2: 100% (95% CI: 88.6, 100)
  • Influenza A: 98% (95% CI: 89.5, 99.6) 
  • Influenza B: 96.7% (95% CI: 83.8, 99.4)
  • RSV: 100% (95% CI: 88.6, 100)

Clinical Specificity

ViroKey SX Virus Total Nucleic Acid Kit

  • SARS-CoV-2: 100% (95% CI: 92.9, 100)
  • Influenza A: 98% (95% CI: 89.5, 99.6)
  • Influenza B: 100% (95% CI: 92.9, 100)
  • RSV: 100% (95% CI: 92.9, 100)

Sentosa SX Virus Total Nucleic Acid Kit v2.0

  • SARS-CoV-2: 100% (95% CI: 88.6, 100)
  • Influenza A: 100% (95% CI: 88.6, 100)
  • Influenza B: 100% (95% CI: 88.6, 100)
  • RSV: 100% (95% CI: 88.6, 100)

 

PRODUCT FLYERS

ORDERING INFORMATION

ProductPack SizeItem Number
Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24) CE-IVD 4x24 300042
ViroKey Flu A/B & RSV RT-PCR Extension Kit (8x48) CE-IVD 8x48 301074
ViroKey SARS-CoV-2 RT-PCR Test v2.0 (8x48) CE-IVD 8x48 301069
ViroKey SX Virus Total Nucleic Acid Kit (4x48) CE-IVD 4x48 300678

For availability in your country, please contact your Vela Diagnostics sales representative.