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NOT AVAILABLE FOR SALE IN THE U.S.

For use with Sofia 2.

The Sofia 2 C. difficile Fluorescent Immunoassay (FIA) uses advanced immunofluorescence-based lateral-flow technology to provide rapid differential detection of glutamate dehydrogenase (GDH) and Toxin A/B in fecal samples from patients suspected of Clostridioides difficile colonization or infection.

Sofia 2 delivers accurate, objective and automated results in 15 minutes, allowing for rapid treatment decisions.


Features & Benefits

FeatureBenefit

GDH and Toxin A/B results

Detects the presence of C. difficile and toxigenic C. difficile bacteria in one test.

Results in 15 minutes

Faster time to results for truly rapid C. difficile testing.

Compatible with all Infectious Diseases Society of America (IDSA) and European Society of Clinical Microbiology and Infectious Diseases (ESCMID) recommended C. difficile testing algorithms
Compatible with the IDSA and ESCMID C. difficile testing guidelines when used alone or as part of an algorithm with molecular C. difficile testing.

Can be performed with fresh, frozen, Cary Blair or C&S samples or specimens

Flexible sample options allow for easy handling, leading to more accurate results.

Simple easy to use workflow

Simple test workflow follows a similar format to other Sofia 2 assays.

Dual work modes

Adjusts to your volume fluctuations. Allows for significant throughput and batching of samples in READ NOW Mode.

Objective result

Eliminates the subjectivity of a visual result.

All components included in kit

Ready to use with Sofia, no need for additional equipment.

Room temperature storage

No refrigerator space needed. No need to wait for reagents to warm up. Rapid C. difficile tests can be run immediately as needed.

LIS Connectivity and Data Management

Reduced time and opportunity for human error.

Product Specifications

Product Spec NameProduct Spec Data
Sample type

Unformed stool

Time to results

15 minutes

Kit storage conditions

Room temperature (15°C to 30°C / 59°F to 86°F)

Sensitivity*

GDH: 86.4%, Toxin A/B: 84.1%

Specificity*

GDH: 93.0%, Toxin A/B: 98.5%

*Refer to Package Insert for additional performance claims.

Ordering Information

Catalog NumberDescriptionKit Size / Case Size
20329 (XUS)

Test Kit

25/12