Pathogen information: 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 of the cases a mild course of infection can be observed, while more severe courses are observed in about 15%-20% of the cases, with a mortality rate of up to 3%.
Description: ViroReal® Kit SARS-CoV-2 & SARS is an in vitro diagnostic test based on one-step reverse transcription real-time PCR. It allows rapid and sensitive detection of SARS-CoV-2 and SARS-CoV RNA in samples purified from the respiratory tract. The test is intended to cover possible future changes in the virus sequence, therefore a highly conserved region in all SARS coronavirus clusters of the N gene was chosen as target region. This approach allows universal detection of all so far known SARS-CoV strains including SARS-CoV-2 and SARS-like CoV without discriminating between strains.
PCR-platforms: ViroReal® Kit SARS-CoV-2 & SARS has been developed for the Applied Biosystems® 7500 instrument (Thermo Fisher Scientific), LightCycler® 480 (Roche), cobas Z 480 Analyzer (Roche) and Mx3005P® QPCR System (Agilent), but is compatible with other real-time PCR instruments detecting and differentiating fluorescence in FAM and Cy5 channel.
Sensitivity and specificity: At least 1 target copies/reaction can be detected. The limit of detection (LoD95 = smallest number of copies of target RNA which can be detected in 95% of cases) is 13 target copies/reaction.
ViroReal® Kit SARS-CoV-2 & SARS is specific for SARS-CoV-2 as well as SARS-CoV and SARS-like coronavirus. Other beta coronaviruses are not detected with this kit.
ViroReal® Kit SARS-CoV-2 & SARS - 500rx
CE-IVD diagnistic test, based on real-time PCR by one-step transverse transciptase for the detection of the N gene in SARS-CoV-2 and SARS-CoV.
This test allows to detect false negatives (with the presence of the internal positive control in the Cy5 channel), while the target is detected in the FAM channel.
The detection limit is one copy per reaction. The kit is ready-to-use, with all the necessary componets to do the real-time PCR deteaction, including reverse transcriptase.