Purpose/Principle

This test is used for early detection of active CMV infection, surveillance of high-risk patients, and monitoring the efficacy of therapy. This assay uses primers and a dual-labeled fluorescent probe directed against a conserved sequence of the CMV glycoprotein B (gB) gene. The amplified product is detected using 5’-nuclease methodology and quantitated by extrapolation to a standard curve of log10 dilutions of a plasmid containing the gB sequence. The assay is linear across six orders of magnitude. A second assay targeting the DNA polymerase gene is run concurrently on each specimen to detect false negatives or inhibition due to mutations under the gB probe region.