- Multiplexed qualitative assay that allows determining the presence of 3 SARS-CoV-2 targets and one human endogenous target by studying two multiplexed rRT-PCR reactions.
- 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: 20 copies (FDA Acceptance Criteria)
- Genomic inclusiveness: In silico design based on 3,123 genomes (GISAID)
- 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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