Background: Influenza is an acute infectious disease caused by influenza virus A, B or, to a much lesser extent, influenza virus C. Influenza viruses are enveloped viruses with single-stranded, segmented RNA with negative polarity as genome. These viruses can be found worldwide. Epidemics and pandemics are mainly caused by influenza virus A, due to antigenic drift of the hemagglutinin and neuraminidase molecules. Type B and C influenza viruses are isolated almost exclusively from humans, while influenza A viruses infect a wide variety of warm-blooded animals.

Description: ViroReal® Kit Influenza A/B is a non-automated IVD test, based on one-step reverse transcription real-time PCR (RT-PCR), for the qualitative detection of RNA of the matrix protein gene of influenza A virus and the hemagglutinin gene of influenza B virus. Proper specimens are RNA extracts of samples from the human upper respiratory tract (nasal swabs, nasopharyngeal swabs and oropharyngeal swabs). This test is suitable for patients of all ages with suspected influenza A or B virus infection and is intended as an aid in the diagnosis of these pathogens in combination with patient history and additional clinical information. The test is for professional use only and the use is limited to qualified personnel instructed in real-time PCR and in vitro diagnostic procedures. A probe-specific amplification-curve in the FAM channel (530 nm) indicates the amplification of influenza A virus specific RNA. A probe-specific amplification-curve in the VIC channel (554 nm) indicates the amplification of influenza B virus specific RNA. An internal RNA positive control (RNA IPC) is detected in Cy5 channel and is used as RNA extraction as well as RT-PCR inhibition control. The target for the RNA IPC (artificial target RNA) is added during extraction of the sample.


Declaration of Conformity  

ViroReal® Kit Influenza A/B
OrdernumberReactionsChannel PathogenChannel IPCTarget
DHUV0025350FAM & VIC/HEXCY5matrix protein gene & hemagglutinin gene
For in vitro diagnostic use.
Shipping Temperature: -20°C dry ice
Product Features:
  • Amplification and detection: matrix protein gene of Influenza A and hemagglutinin gene of Influenza B
  • Transcription with thermostable MMLV Reverse Transcriptase (M-MLV)
  • contains RNase Inhibitor to block RNA degradation
  • Real-time PCR with rapid hot-start Taq DNA polymerase
  • ROX™ dye as passive reference
  • Internal Positive Control System to exclude false-negative results
  • Optimized to handle PCR inhibitors
  • PCR- platforms: runs on all established standard real-time PCR- platforms
  • Harmonized thermal profiles to run RNA and DNA samples simultaneously

PCR platforms: This test has been validated with the ABI® 7500 instrument (fast cycle parameters are not supported, Thermo Fisher Scientific) and was also tested with QuantStudioTM 7 Pro (Thermo Fisher Scientific), MIC instrument (bio molecular systems) and LightCycler® 480 II (Roche Diagnostics). It is also compatible with other real-time PCR instruments which detect and differentiate fluorescence in FAM, VIC and Cy5 channel (e.g., QuantStudio™ 5, Mx3005P® (Agilent), qTOWER3G (Analytik Jena), cobas z 480 Analyzer (Roche)). When using PCR-platforms not tested by ingenetix, an evaluation of the multiplex-PCR shall be done. Keep in mind that some PCR-platforms first have to be calibrated with the corresponding dye before performing multiplex-PCR.