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Related Experiment Video

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A Protein Microarray Assay for Serological Determination of Antigen-specific Antibody Responses Following Clostridium difficile Infection
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[Clostridium difficile TOX A/B II TEST evaluation].

Hideko Sugiura1, Takamasa Kaneko, Megumi Sumita

  • 1Clinical Laboratory Department, St. Luke's International Hospital.

Kansenshogaku Zasshi. the Journal of the Japanese Association for Infectious Diseases
|October 29, 2009
PubMed
Summary

The TOX A/B II test shows higher sensitivity and specificity for detecting Clostridioides difficile-associated diarrhea (CDAD) compared to the Uniquick test. TOX A/B II is recommended as a diagnostic aid for CDAD.

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Area of Science:

  • Clinical Microbiology
  • Diagnostic Assay Development
  • Infectious Diseases

Background:

  • Clostridioides difficile-associated diarrhea (CDAD) is a significant healthcare-associated infection.
  • Accurate and rapid toxin detection is crucial for timely diagnosis and treatment of CDAD.
  • Commercial diagnostic kits offer potential for improved CDAD detection.

Purpose of the Study:

  • To compare the performance of two commercial toxin detection kits: C. difficile toxin A/B (TOX A/B II) and C. difficile toxin A (Uniquick).
  • To evaluate kit performance based on toxin detection limits, cross-reactivity, sensitivity, and specificity using clinical specimens.

Main Methods:

  • Purified toxin A solutions were used to determine detection limits.
  • Cross-reactivity was assessed using culture supernatants from various C. difficile strains and other bacteria.
  • Sensitivity, specificity, and predictive values were evaluated using 99 fecal specimens.

Main Results:

  • TOX A/B II detected toxin A at 0.35 ng/mL; Uniquick detected toxin A at 0.7 ng/mL.
  • TOX A/B II specifically detected toxins A and B, while Uniquick detected only toxin A.
  • For clinical specimens, TOX A/B II demonstrated higher sensitivity (95.3% vs 76.7%) and negative predictive value (96.5% vs 84.6%) compared to Uniquick.

Conclusions:

  • The TOX A/B II test is a more suitable diagnostic aid for CDAD than Uniquick due to its superior performance and correlation with toxin B-positive C. difficile.
  • While TOX A/B II shows promise, stool culture for C. difficile remains necessary for comprehensive diagnosis.