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Evaluation of the Cepheid Xpert C. difficile/Epi and meridian bioscience illumigene C. difficile assays for detecting

Grace O Androga1, Alan M McGovern1, Briony Elliott1

  • 1School of Pathology and Laboratory Medicine, The University of Western Australia, Crawley, Western Australia, Australia.

Journal of Clinical Microbiology
|December 19, 2014
PubMed

Insights

Clostridium difficile PCR ribotype 033 (RT033) is a prevalent pathogen in animals. Current diagnostic assays, illumigene and Xpert, failed to detect RT033, despite the presence of binary toxin genes.

Area of Science:

  • Microbiology
  • Infectious Diseases
  • Diagnostic Science

Background:

  • Clostridium difficile PCR ribotype 033 (RT033) is frequently identified in the gastrointestinal tracts of production animals and sporadically in humans.
  • RT033 strains possess binary toxin genes, a characteristic often associated with increased virulence.

Purpose of the Study:

  • To evaluate the performance of two common diagnostic assays, illumigene C. difficile and Xpert C. difficile/Epi, in detecting Clostridium difficile RT033 isolates.
  • To identify potential limitations in current diagnostic methods for specific C. difficile strains.

Main Methods:

  • Testing of 52 Clostridium difficile RT033 isolates using the illumigene C. difficile assay.
  • Testing of the same 52 RT033 isolates using the Xpert C. difficile/Epi assay.
  • Confirmation of binary toxin gene presence in all tested RT033 isolates.

Main Results:

  • The illumigene C. difficile assay failed to detect any of the 52 Clostridium difficile RT033 isolates.
  • The Xpert C. difficile/Epi assay reported all 52 RT033 isolates as negative for C. difficile, despite the presence of binary toxin genes.
  • All tested RT033 isolates were confirmed to harbor binary toxin genes.

Conclusions:

  • Current diagnostic assays, illumigene and Xpert, demonstrate a failure to detect Clostridium difficile PCR ribotype 033.
  • The presence of binary toxin genes in RT033 warrants further investigation into its clinical significance and diagnostic challenges.
  • There is a critical need for improved diagnostic strategies to accurately identify all C. difficile strains, including RT033.

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