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CLOSTRIDIUM DIFFICILE

The gram-positive anaerobic Clostridium difficile is the leading causative agent of antibiotic-associated diarrhea and pseudomembranous colitis. This pathogen is capable of causing diseases that could be severe or fatal if not diagnosed and treated on time. The exposure to antibiotics is the major risk factor for C. difficile infection. The infection can develop if the normal gastrointestinal flora is disrupted by an antibiotic therapy and a person acquires toxin-producing C. difficile, typically via fecal-oral route. C. difficile’s key virulence factors are toxin A and toxin B. These toxins show high sequence and functional homology.
All strains of C. difficile produce high levels of GDH. Therefore, C. difficile’s GDH enzyme is considered a very good antigen marker for the detection of this organism.
The Chorus Clostridium difficile GDH test is a highly specific and sensitive diagnostic kit for the determination of GDH in stool specimens. The presence of toxins in the GDH positive samples is confirmed by using the Chorus Clostridium difficile A/B Toxins.
Immunoassay detection of toxins A and B in stool specimen is commonly used as a diagnostic aid.

Methods:

Immunoenzymatic method for the qualitative determination of toxins A and B or GDH antigen of C.difficile in stools samples, using a disposable device applied on the Chorus and Chorus TRIO instruments.The test is based on the ELISA principle (Enzyme linked Immunosorbent Assay). The monoclonal antibodies are bound to the solid phase. Antigen is bound to the solid phase through incubation with the extract of faeces. The disposable devices contain all the reagents to perform the test in the Chorus/Chorus TRIO instruments. The results are expressed in index.

Chorus CLOSTRIDIUM DIFFICILE GDH

Coated with monoclonal antibodies specific for C. difficile

Code 81168
Quantity 12 tests
METHOD Sandwich
TYPE Qualitative Test
DIAGNOSTIC SENSITIVITY 100% CI95%: 85.7-99.8
DIAGNOSTIC SPECIFITY 100% CI95%: 86.7-99.8
INCUBATION TIME < 90 min
SHELF LIFE 12 months from the date of preparation
STORAGE AND STABILITY 0°/28°C

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IFU

SDS

CoA

Chorus CLOSTRIDIUM DIFFICILE A/B TOXINS

Coated with monoclonal antibodies specific for C. difficile

Code 81170
Quantity 12 tests
METHOD Sandwich
TYPE Qualitative Test
DIAGNOSTIC SENSITIVITY 87.5% CI95%: 63.7-96.5
DIAGNOSTIC SPECIFITY 100% CI95%: 89.0-99.9
INCUBATION TIME < 90 min
SHELF LIFE 9 months from the date of preparation
STORAGE and STABILITY 2°/8°C

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IFU

SDS

CoA