- Multiplexed qualitative assay that allows to determine the presence of 2 targets of SARS-CoV-2, including the ORF1ab and S genes (both marked with the FAM fluorophore) and specific targets of Influenza A and B, and the respiratory syncytial virus RSV. The assay allows to identify the presence of SARS-Cov-2, Influenzas, RSV and the human endogenous control RNAseP by studying multiplex rRT-PCR.
- The human endogenous gene, RNaseP, allows evaluating the process of obtaining the respiratory sample, the quality of the sample and the process of extracting nucleic acids.
- Detection Limit: Less than 50 copies per reaction for all human viruses tested (FDA Acceptance Criteria)
- Cross-reactivity: Diagnostic evaluation with human pathological samples confirm the specificity of the Kit against human respiratory viruses Enterovirus, Bocavirus, Adenovirus and Entero/Rhinovirus.
- Genomic inclusivity: In silico design based on 4,115 SARS-CoV-2 genomes (GISAID). Detection of viral sequences of SARS-CoV-2, Influenza and RSV described between 2016 – 2020.
- It complies with the quality requirements specified by ISO 13485 and ISO 14001 in relation to the materials used in its manufacturing process.
- For in vitro diagnostic use.
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