Savyon CoproELISA™ C. difficile Toxin A/B

Clostridium difficile (C.difficile) is an anaerobic, Gram-positive bacterium that can cause symptoms ranging from diarrhea to life-threatening inflammation of the colon. C.difficle infection most commonly affects older adults in hospitals and typically occurs after use of antibiotic medications as it competes with the normal, antibiotic sensitive gut flora. Early diagnosis and appropriate changes to the antibiotic treatment regimen are vital for managing and controlling this hospital associated infection.

Diagnosis

Laboratory diagnosis of C.difficile infection is most commonly performed in a two-step algorithm; (i) screening of C.difficile presence using an immunoasay for the detection of C.difficile glutamate dehydrogenase (GDH) followed by (ii) assaying the presence of toxins A/B using either an immuoassay or by PCR based techniques. Although not common, the gold standard method is considered to be the cytotoxin assay. This functional test is based on the notion that C.difficile toxins have a cytopathic effect in cell culture that can be neutralized with specific anti-sera. The need for animal cell culture and the prolgonged time to result vastly limit the use of this method.

Sensitivity: 100%  Specificity: 97.9%  Accuracy: 100%

PPV: 90%  NPV: 100%

Savyon’s CoproELISA™ C. difficile Toxin A/B  is an ELISA-based test for the detection of C.difficile toxins A and B in fecal specimens and is used for confirmation of toxigenic CDAD in suspected patients . The test is compatible with fresh stool specimens.