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IMDx™ C. difficile for Abbott m2000

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View Ordering Information
Product Name Quantity Order # Additional Information
IMDx C. difficile for Abbott m2000 Assay

Box 1
- Amplification Reagent Kit, 4 packs, 24 tests/pack
- Process Control-A, 4 vials

Box 2
- Control Kit, 6 negative controls and 6 positive controls

 06N51-085
IMDx C. difficile for Abbott m2000 System ROW Combined Application CD-ROM 1 CD-ROM 06N51-001

Robust and accurate detection of toxigenic C. difficile on the m2000 platform

The IMDx C. difficile for Abbott m2000 assay is an in vitro polymerase chain
reaction (PCR) assay for the qualitative detection of toxigenic C. difficile toxin A
and B genes in human liquid or soft stool specimens from patients with symptoms
of C. difficile associated disease.

Pioneering Science

• Targets conserved regions within toxin A and toxin B genes of the C. difficile
genome for robust and accurate detection of toxigenic C. difficile, including
NAP1/027 hypervirulent strain and A-B+ strain 1470

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

 

Assay Specifications

Specimen
Human liquid or soft stool
Internal Control Added to each specimen and control
Sample Preparation m2000sp
Amplification and Detection m2000rt
C. difficile Target Genes toxin A (tcdA), toxin B (tcdB) and toxin B-variant (tcdBv)
Limit of Detection

toxin A (tcdA) 21.2 CFU/mL in NAP1 strain
toxin B (tcdB) 21.9 CFU/mL in NAP1 strain
toxin A (tcdA) 7.7 CFU/mL in 1470 strain
toxin B (tcdB) 7.9 CFU/mL in 1470 strain
Reactivity Reactive with 16 strains of C. difficile tested
Analytical Specificity No positive results when tested against 58 related viruses and microorganisms commonly found in clinical specimens
Potentially Interfering Substances No interference from elevated levels of 22 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

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