ViroReal® Kit SARS Coronavirus & Influenza A/B

Detection of RNA of the nucleocapsid protein gene of coronavirus SARS-CoV-2, SARS-CoV and SARS-like CoV and influenza A/B virus.

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. 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 SARS Coronavirus & Influenza A/B is an in vitro diagnostic test, based on one-step reverse transcription real-time PCR, for the detection of the N gene of SARS-CoV-2, SARS-CoV and SARS-related coronavirus (Sarbecovirus), of the matrix protein gene of influenza A virus and of the hemagglutinin gene of influenza B virus of patients with or without a suspected SARS-CoV or influenza virus infection. Proper specimens are samples 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.

Product Features:
- Amplification and detection: N gene of SARS-CoV and hemagglutinin/matrix protein gene of influenza A/B virus
- 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
- Available formats: Kit (with reaction mix)