This test detects the presence of the SARS-CoV-2 coronavirus and influenza A and B viruses as well as respiratory syncytial virus (RSV-A and RSV-B) in respiratory samples through the detection of specific genes and an endogenous human gene by real-time reverse transcription PCR (RT-qPCR).
Assay Features:
- Multiplexed qualitative assay that allows determining the presence of two SARS-CoV-2 targets, including the ORF1ab and S genes, and specific targets for influenza A and B viruses and for respiratory syncytial virus (RSV)
- The endogenous human gene, RNaseP, allows assessing the respiratory sample collection process, the quality of the sample, and the nucleic acid extraction process
- Limit of detection: LoD <50 copies for the analyzed human viruses (FDA acceptance criterion)
- Cross-reactivity: diagnostic evaluation with pathological human samples confirm kit specificity against human enterovirus, bocavirus, adenovirus, rhinovirus, and metapneumovirus
- Genomic inclusivity: in silico design based on 4,115 SARS-CoV-2 genomes (GISAID database)
- Detection of viral sequences of SARS-CoV-2, influenza, and RSV reported between 2016 and 2020
- Number of reactions per sample: 1
- Number of targets: 6
- 1 h 20 min turnaround time
- CE-IVD marked
- Made in EU