Background: Coronaviruses are positive single-stranded RNA viruses of the family Coronaviridae. Several different strains of coronaviruses are currently known to infect humans (HCoV-229E, HCoV-NL63, HCoV-OC43, HCoV-HKU1, MERS-CoV, SARS-CoV, SARS-CoV-2, NCoV and HCoV-EMC). Strains HCoV-229E, HCoV-NL63, HCoV-OC43, MERS-CoV and HCoV-HKU1 cause cold, upper respiratory infection, bronchiolitis and pneumonia in humans. SARS-CoV, a beta coronavirus, causes the Severe Acute Respiratory Syndrome (SARS). SARS-CoV-2 is a beta coronavirus that emerged in Wuhan, China in December 2019. The virus is responsible for the disease COVID-19 (corona virus disease 2019). Fever, cough and breathing difficulties are described as the most frequent initial symptoms, later on it can lead to pneumonia. The coronavirus spreads mainly by droplet and contact transmission. In most cases a mild course of infection is observed, while more severe courses are observed in about 15%-20%, with a mortality rate of up to 3%. 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® Assay Influenza A/B is an in vitro diagnostic test, based on one-step reverse transcription real-time PCR, for the detection of the matrix protein gene of influenza A virus and of the hemagglutinin gene of influenza B virus. This test is only intended for use in combination with ViroReal® Kit SARS-CoV-2 & SARS, which detects the N gene of SARS-CoV-2, SARS-CoV and SARS-related coronavirus (Sarbecovirus). Proper specimens are samples of patients with or without a suspected SARS-CoV or influenza virus infection from the upper and lower respiratory tract (throat rinsing fluid, nasopharyngeal and oropharyngeal swabs, anterior nasal swab and mid-turbinate nasal swab specimens, nasopharyngeal wash/aspirate and nasal aspirates, sputa and BAL). Testing of self-collected or healthcare provider-collected anterior and mid-turbinate nasal swabs is limited to patients with symptoms of COVID-19 or influenza.

Declaration of Conformity  

Product Features:
  • Amplification and detection: matrix protein gene of Influenza A and hemagglutinin gene of Influenza B
  • PCR- platforms: runs on all established standard real-time PCR- platforms
  • Harmonized thermal profiles to run RNA and DNA samples simultaneously

PCR platforms: ViroReal® Assay Influenza A/B has been developed for the Applied Biosystems® 7500 instrument (Thermo Fisher Scientific), LightCycler® 480 II (Roche Diagnostics),  qTOWER3G (Analytic Jena), MIC instrument (bio molecular systems) and Mx3005P® QPCR System (Agilent), but is compatible with other real-time PCR instruments detecting and differentiating fluorescence in FAM, VIC/HEX and Cy5 channel.

ViroReal® Assay Influenza A/B
OrdernumberReactionsChannel PathogenChannel IPCTarget
RTGM001RV100VIC/HEXmatrix protein gene & hemagglutinin gene
RTGM002RV500VIC/HEXmatrix protein gene & hemagglutinin gene
For in vitro diagnostic use.
Shipping Temperature: +4°C cool packs