Simplexa C. Difficile Direct Kit

Simplexa C. Difficile Direct Kit

Background

The European Centre for Disease Prevention and Control (ECDC) reports that the burden of healthcare-associated C. difficile infection (CDIs) in acute care hospitals in the EU/EEA was estimated at 123.997 cases annually. In the ECDC point prevalence survey of healthcare-associated infections (HAIs) and antimicrobial use in European acute care hospitals 2011-2012, C. difficile was the 8th most frequently detected microorganism among HAIs. Using a conservative figure of 3% attributable mortality, the number of deaths occurring as the direct consequence of healthcare-associated CDI can be estimated at 3.700 per year in the EU/EEA.

Why to choose it

A CLIA moderate complexity assay with greater than 4.4X fewer invalid rates that fits into any testing algorithm. The assay allows you to improve your efficiency with a true sample-to-answer workflow without DNA extraction and provides results in about an hour.

For use on

LIASION MDX

Benefits

Low Invalid Rates

Simplexa C. difficile Direct has shown greater than 4.4X fewer invalids than other commercial NAATs.


Highly Specific

The Simplexa C. difficile Direct assay delivers diagnostic confidence

In a thorough study of over 2,300 prospective samples, our Simplexa C. difficile Direct assay demonstrated excellent clinical agreement against three US on-market assays.

SIMPLEXA C. DIFFICILE DIRECT CLINICAL AGREEMENT SUMMARY

Method

N

Positive % agreement 

Negative % agreement 

NAAT 1 

829

93.4%

96.6%

NAAT 2

776

93.9%

94.0%

NAAT 3

721

84.8%

99.2%

Direct Culture 

2330

98.7%

92.1%

Ordering Info

PRODUCTCODEREACTIONS

Simplexa C. difficile Direct Assay 

*Direct Amplification Discs included in kit

MOL2950

24

Simplexa C. difficile Direct Positive Control Pack

MOL2960

10 x 100µL

Please click below for more information

SIMPLEXA BROCHURE




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