Products
The artus CMV RGQ MDx Kit is intended for in vitro diagnostic use.
artus CMV RGQ MDx Kit (96) US
Cat. No. / ID: 4503245
For 96 reactions: Master, Mg Solution, 4 Quantitation Standards, 2 Positive Controls (CMV High Positive Control and Low Positive Control), Internal Control, Water (PCR grade)
Features
- Quantifiable results as low as 159 IU/ml
- Accurate quantitation over a broad linear range
- Standardization using the 1st WHO International Standard for CMV
- Direct detection of the target region of the CMV MIE gene
Product Details
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.
Principle
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.
Procedure
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.
Applications
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.
Supporting data and figures
In vitro diagnostic medical device.
In vitro diagnostic medical device.
Resources
Kit Handbooks (1)
Safety Data Sheets (1)
Certificates of Analysis (1)