artus CMV QS-RGQ MDx Kit
For detection and quantitation of human cytomegalovirus (CMV) DNA in human EDTA plasma
The artus CMV QS-RGQ MDx Kit gives you CMV detection as low as 77 IU/ml (LOD) and accurate quantification over a broad linear range, from 159 IU/ml to 7.94 × 107 IU/ml, standardized using the 1st WHO International Standard for Human Cytomegalovirus reporting. Accurate quantitation is provided by direct detection of a 105 bp, highly-conserved region of the CMV MIE gene. An internal control is included to identify potential loss of DNA during the extraction or a possible PCR inhibition. A low positive control monitors for substantial reagent failure and a high positive control verifies that calibration status of the assay is maintained within acceptable limits.
The artus CMV QS-RGQ MDx Kit is intended for in vitro diagnostic use.
The artus CMV QS-RGQ MDx Kit constitutes a ready-to-use system for the detection and quantitation of CMV DNA using PCR on Rotor-Gene Q MDx, analysis via Rotor-Gene AssayManager, with sample preparation and assay setup using QIAsymphony SP/AS. The CMV RG Master provided in the artus CMV QS-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 Rotor-Gene Q MDx. In addition, the artus QS-CMV RGQ MDx Kit contains a second heterologous amplification system as an internal control to identify possible inhibition in the PCR.
Two positive controls are provided with the artus CMV QS-RGQ MDx Kit. The low positive control contains non-infectious CMV nucleic acid fragments at a concentration near the limit of quantitation. The low positive control is used to monitor for substantial reagent failure. The high positive control contains non-infectious CMV nucleic acid fragments at a concentration that is in the middle of the linear range of the artus CMV QS-RGQ MDx Kit. The high positive control is used to verify that the calibration status of the assay is maintained within acceptable limits. The quantitative results of the low and high positive controls must fall within a specified range for the assay to be valid. PCR-grade water (H2O) is provided as a negative control (no template control, NTC). The NTC is used to check a possible contamination with target nucleic acid during the PCR setup.
The artus CMV QS-RGQ MDx Kit is configured for use with the QIAsymphony Rotor-Gene Q MDx system (QS-RGQ MDx) in conjunction with the QIAsymphony DSP Virus/Pathogen Midi Kit for DNA extraction, Rotor-Gene AssayManager 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 human EDTA plasma.
The artus CMV QS-RGQ MDx Kit is intended for use as an aid 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. The results from the artus CMV QS-RGQ MDx Kit must be interpreted within the context of all relevant clinical and laboratory findings.
The artus CMV QS-RGQ MDx Kit is not intended for use as a screening test for blood or blood products.
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