CONVENIENT and EFFICIENT SOLUTION
PRINCIPLE of the TEST
The VitaPCRTM SARS-CoV-2 Assay performed on the VitaPCRTM Instrument is a rapid molecular in vitro diagnostic test utilizing a real-time reverse transcription polymerase chain reaction (RT-PCR) amplification technology. It is used for the qualitative detection and discrimination of SARS-CoV-2 viral RNAs in direct nasopharyngeal (NP) or oropharyngeal (OP) swabs from patients with signs and symptoms of respiratory infection who are suspected of COVID-19.
br> The detection target of SARS-CoV-2 RNA is located in the region of the virus nucleocapsid (N) gene.
The assay is designed for specific detection of the SARS-CoV-2 RNA. In addition, detection of SARSlike (including SARS-CoV-2, SARS-CoV, bat SARS-like coronavirus) conserved region also located in N gene is provided as additional information for reference. An additional primer/probe set to detect human Beta-globin (HBB), which is also used as a sample adequacy control (SAC), is included in the reagent for ensuring adequate addition of sample and monitoring the presence of inhibition factors in the PCR process.