Diagnostic value of five commercial tests for the rapid diagnosis of Clostridium difficile-associated disease

Clin Lab. 2008;54(1-2):9-13.

Abstract

We compared five commercial immunoassays (Biostar OIA CdTOX AB, ImmunoCard Toxins A&B - Meridian, Xpect C. difficile toxin A/B -Remel, C. difficile toxin A test- Oxoid, and TOX A/B QUIK CHEK- Techlab) which allow a rapid diagnosis of C. difficile associated disease. The tests were performed directly on patient's stool specimen submitted for routine investigation of C. difficile infection from two University Hospitals in Brussels. The cell cytotoxicity assay was considered as the gold standard. Of the 100 stool specimens included in the study 23 were positive for C. difficile toxin. The sensitivity, specificity, positive and negative predictive values were respectively, 95.7%, 100%, 100% and 98.7% for TOX A/B QUIK CHEKTM, 91.3%, 100%, 100% and 97.5% for ImmunoCard Toxins A&B and for Xpect C. difficile toxin A/B, 87%, 100%, 100% and 96.3% for OIA CdTOX AB and 87%, 98.7%, 97.2% and 96.3% for C. difficile toxin A test. The differences were not statistically significant (p > 0.05). These data suggest that the tested immunoassays are acceptable for rapid detection of C. difficile toxin.

Publication types

  • Comparative Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Animals
  • Bacterial Toxins / analysis*
  • Cell Survival
  • Chlorocebus aethiops
  • Clostridioides difficile / isolation & purification*
  • Enterocolitis, Pseudomembranous / microbiology*
  • Enterotoxins / analysis*
  • False Positive Reactions
  • Feces / chemistry
  • Feces / microbiology
  • Humans
  • Immunoassay / instrumentation
  • Immunoassay / methods
  • Predictive Value of Tests
  • Sensitivity and Specificity
  • Vero Cells

Substances

  • Bacterial Toxins
  • Clostridium difficile lethal toxin B
  • Enterotoxins
  • tcdA protein, Clostridium difficile