The CMV DNA Quantitation (QT) 2nd Generation Real-Time PCR kit coded CMVDNAQT.2G.CE is intended for the quantitative detection of Cytomegalovirus DNA in human sample (blood, plasma, amniotic fluid) with a simultaneous control of the extraction/amplification reaction through an Internal Control (IC). CMVDNAQT.2G.CE assay was standardised against the 1st WHO International Standard for HCMV (NIBSC code 09/162) to express samples concentration also in International Unit (IU/ml).
NTRODUCTION
Human cytomegalovirus (HCMV) is a a ubiquitous member of the human herpesvirus family of viruses.
Clinical data indicate that HCMV infects various tissue and cell types and, hence, is responsible for a myriad of clinical complications. Depending on the tissue type and the host’s immune state, HCMV engages in three different modes of infection: acute infections with highly productive growth, persistent infections with low levels of replication, and latent infections where no viral progeny are produced. The mechanism of reactivation is largely unknown but appears to be strongly related to impaired immune control of the virus. For this reason, CMV is one of the most common opportunistic pathogens complicating the care of transplant recipients; potentially it is a major cause of morbidity and mortality.
RINCIPLE OF THE TEST
The CMVDNAQT.2G.CE Kit is based on a Real Time chemistry which uses specific Primers and Probes.
CMV DNA, recovered from the biological sample under investigation through an extraction step, is amplified using Real Time amplification system. The amplified product is detected and quantitated, against the standard curve using a fluorescent reporter dye probe specific for a CMV unique genomic sequence. An Heterologous Internal Control (IC) serves as an Extraction/Amplification control for each individually processed specimen aiming to the identification of reaction inhibitors.
A standard curve is supplied allowing the determination of the viral load.
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