RAPID DETECTION OF C. DIFFICILE TOXINS FROM HUMAN FECAL SPECIMENS

The C DIFFICILE TOX A/B II® test is an enzyme immunoassay (ELISA) that uses antibodies specific for toxins A and B of C. difficile in fresh or frozen human fecal specimens. Toxins A and B are produced by toxigenic strains of C. difficile and cause the symptoms of the infection. Toxin results more closely correlate to disease state and clinical outcomes than other testing options, but testing is not sensitive enough to be used as a standalone test.

TECHLAB® C DIFFICILE TOX A/B II®

• Results in approximately 60 minutes
• Rapid test procedure results in approximately 30 minutes
• Detects both Toxin A and Toxin B

• Performance Characteristics compared to tissue culture
  • Sensitivity 92.2%
  • Specificity 100%
• Limit of Detection (LOD)
  • 0.8 ng/ml toxin A
  • 2.5 ng/ml toxin B

Clostridium difficile infection usually occurs when the normal microflora of the intestinal tract is altered or killed by antibiotics. Once toxigenic C. difficile growth begins, toxins are produced, causing diarrhea and colitis. Toxigenic strains of C. difficile carry the genes encoding the toxins. The disease results from the toxins that the organism produces.

C. difficile produces two main toxins, toxin A and toxin B, toxigenic C. difficile strains may produce both toxins or only toxin B. Toxin A is a weakly cytotoxic enterotoxin. C. difficile also produces toxin B, which is a cytotoxin and can be detected by the tissue culture assay.

Glutamate dehydrogenase (GDH) is the protein produced by all C. difficile bacteria, regardless of their toxin-producing ability. Testing for GDH is a good screening marker for C. difficile infection, but follow-up testing  for toxin production is necessary because we cannot tell from a GDH result alone if the strain can produce toxin, which makes patients sick.

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Product Code: TLI-30397                      C. DIFFICILE TOX A/B II™ (96 wells)