Cytomegalovirus (Human herpesvirus 5) IVDs

Intended purpose

The CMV RNA ELITe MGB® Kit product is an in vitro diagnostic medical device intended to be used by healthcare professionals as quantitative nucleic acids reverse transcription and Real-Time PCR assay for the detection and quantification of the human Cytomegalovirus virion mRNA (CMV RNA) extracted from non-cellular clinical specimens. The assay is validated in association with the ELITe InGenius® instrument, an automated and integrated system for extraction, reverse transcription, Real-Time PCR and results interpretation, using human specimens of plasma collected in EDTA.