Xpert Carba-R QC Panel M219
The Xpert Carba-R QC Panel M219 is designed for in vitro use as quality control to monitor the detection and differentiation of 5 beta-lactamase gene sequences (blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP-1) when tested with the Cepheid Xpert Carba-R Assay in the GeneXpert instrument.
Gene sequences are associated with non-susceptibility to carbapenems. in gram-negative bacteria. The worldwide spread of bacteria not susceptible to carbapenems is a critical public health problem. 1,2 These bacteria are often resistant to all beta-lactam agents and are often co-resistant to multiple classes of other antimicrobial agents, leaving very few treatment options.
Xpert Carba-R QC Panel M219 cannot be cloned, sold or transferred without the explicit written consent of MMQCI.
PRODUCT SUMMARY and PRINCIPLE:
Xpert Carba-R QC Panel M219 contains Xpert Carba-R Positive Control and Negative Control Xpert Carba-R. Xpert Carba-R Positive Control carries all 5 detected beta-lactamase gene sequences by the Xpert Carba-R test. The Xpert Carba-R Negative Control does not carry any beta-lactamase gene sequence.
The best practice is to establish a quality control program for each trial. performed by the laboratory. 4.5 Routine use of quality controls that are consistent batch to batch help the laboratory to identify changes, trends, and higher frequency of random errors caused by variations in the test system, such as faulty reagents. Early research can prevent failed trial runs.
The Xpert Carba-R QC Panel M219 consists of 12 tubes, 50 µL each of synthetic DNA encapsulated in non-pathogenic, chemically dead, and fixed bacterial cells, suspended in buffer and preservative.
Six (6) of the tubes are Xpert Carba-R Positive Control, which carries the 5 beta-lactamase gene sequences. The other 6 tubes are Xpert Carba-R A negative control that does not carry any beta-lactamase gene sequences.
Table 1 lists the beta-lactamase gene sequences that are monitored by the Xpert Carba-R QC Panel M219 when tested by the Cepheid Xpert Carba-R Assay on the GeneXpert instrument.
INSTRUCTIONS FOR USE:
- Allow the control to come to room temperature. (18-25 ° C).
- Use control as provided. DO NOT THIN.
- Immediately before use, mix control by vortexing at maximum. speed for 10 to 15 seconds and then shake the tube down firmly to remove droplets trapped in the cap.
- Transfer 50 µL of Control to a Sample Reagent vial using a quantitative pipette.
- Close the sample reagent cap and vortex at high speed for 10 seconds.
- Analyze the control as you would a sample from a patient.
- Dispose of after use in accordance with local and federal regulations.