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.
Description: ViroReal® Kit SARS-CoV-2 Multiplex 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) and of the RdRp gene of SARS-CoV-2 of patients with or without a suspected SARS-CoV 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.
- Amplification and detection: N gene of SARS-CoV and RdRp gene of SARS-CoV-2
- 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
- Kits format: 500 reactions or 100 reactions
- Channel Target: FAM and VIC/HEX; Channel IPC: Cy5