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IMDx™ VanR for Abbott m2000™

CE Marked

Robust qualitative detection of the presence of the vanA and vanB genes that can be associated with Vancomycin Resistant Enterococcus

The IMDx VanR for Abbott m2000 assay is an in vitro polymerase chain reaction (PCR)
assay for the qualitative detection of nucleic acids encoding vanA and vanB vancomycin
resistance genes directly from human peri-rectal or rectal swabs or stool samples from
patients at risk for Vancomycin Resistant Enterococcus (VRE) colonization.

Pioneering Science

• The selection of conserved regions of vanA and vanB genes provides for the robust and
accurate detection of vanA and vanB vancomycin resistance genes in human peri-rectal
or rectal swabs or stool samples

Advanced Automation

• Flexible sample preparation options of 24, 48, 72 or 96 samples per run
• Extensive m2000 system test menu for infectious disease allowing for platform consolidation

Confident Results

• Assay design philosophy optimizes probe technology and cycling parameters to produce
robust results
maxRatio data analysis performs multiple validity checks on each patient result for
improved confidence in sample reporting

IMDx VanR for Abbott m2000

• Detects the two most clinically significant genotypes: vanA and vanB.
• Quick sample preparation reduces hands-on time.
• Automated sample processing using the Abbott m2000sp allows for higher throughput capability.

 

Assay Specifications

Specimen

Human peri-rectal, rectal swabs, or stool samples
Internal Control Added to each specimen and control
Sample Preparation m2000sp
Amplification and Detection m2000rt
VanR Target Genes vanA
vanB
Limit of Detection

95 CFU/mL for vanA in E. faecium strain MMC4
170.3 CFU/mL for vanB in E. faecalis strain in V583

Analytical Reactivity Reactive with 5 different strains of Vancomycin Resistant Enterococcus
Analytical Specificity No positive results when tested against 60 viruses and microorganisms commonly found in clinical specimens
Potentially Interfering Substances No interference from elevated levels of endogenous and exogenous substances

IMDx is a trademark of Intelligent Medical Devices, Inc.

For more information on Intelligent Medical Devices, Inc., please visit www.intelligentmdx.com

CE Marked