Standardization using the 1st WHO International Standard for CMV
Direct detection of the target region of the CMV MIE gene
The artus CMV RGQ MDx Kit is the only FDA-approved PCR-based assay optimized for low- to mid-throughput testing of CMV DNA and is intended for use as an aid in the management of solid organ transplant patients who are undergoing anti-CMV therapy.
The artus CMV RGQ MDx Kit constitutes a ready-to-use system for the detection and quantitation of CMV DNA using PCR on the Rotor-Gene Q MDx instrument. The CMV RG Master provided in the artus CMV RGQ MDx Kit contains reagents and enzymes for the specific amplification of a 105 bp region of the CMV Major Immediate Early Gene (MIE) DNA within the CMV genome. Oligonucleotide probes that are linked to fluorescent dyes specifically bind to the amplified PCR product and permit the direct detection of CMV DNA by the Rotor-Gene Q MDx instrument. In addition, the artus CMV RGQ MDx Kit contains a second heterologous amplification system as an internal control to identify possible inhibition in the PCR.
The artus CMV RGQ MDx workflow solution for the measurement of CMV DNA levels comprises the EZ1 DSP Virus System (EZ1 DSP Virus Kit and EZ1 Advanced instruments) for DNA extraction and the Rotor-Gene Q MDx instrument for CMV DNA amplification and quantitation. The system enables sensitive and specific measurement of CMV DNA levels in EDTA plasma.
The artus CMV RGQ MDx Kit assists in the management of solid organ transplant patients who are undergoing anti-CMV therapy. The test measures CMV DNA levels in EDTA plasma and can be used to assess CMV viral load response to antiviral drug therapy.