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Impact of strain type on detection of toxigenic Clostridium difficile: comparison of molecular diagnostic and enzyme immunoassay approaches.

Publication ,  Journal Article
Tenover, FC; Novak-Weekley, S; Woods, CW; Peterson, LR; Davis, T; Schreckenberger, P; Fang, FC; Dascal, A; Gerding, DN; Nomura, JH; Goering, RV ...
Published in: J Clin Microbiol
October 2010

A multicenter clinical trial assessed the performance of the Cepheid Xpert C. difficile assay on stool specimens collected from patients suspected of having Clostridium difficile infection (CDI). A total of 2,296 unformed stool specimens, collected from seven study sites, were tested by Xpert C. difficile enrichment culture followed by cell culture cytotoxicity testing of the isolates (i.e., toxigenic culture with enrichment) and the study sites' standard C. difficile test methods. The methods included enzyme immunoassay (EIA), direct cytotoxin testing, and two- and three-step algorithms using glutamate dehydrogenase (GDH) screening followed by either EIA or EIA and an in-house PCR assay. All C. difficile strains were typed by PCR-ribotyping. Compared to results for toxigenic culture with enrichment, the sensitivity, specificity, and positive and negative predictive values of the Xpert assay were 93.5, 94.0, 73.0, and 98.8%, respectively. The overall sensitivity of the EIAs compared to that of enrichment culture was 60.0%, and the sensitivity of combined GDH algorithms was 72.9%; both were significantly lower than that of Xpert C. difficile (P < 0.001 and P = 0.03, respectively). The sensitivity of the EIA was significantly lower than that of the Xpert C. difficile assay for detection of ribotypes 002, 027, and 106 (P < 0.0001, P < 0.0001, and P = 0.004, respectively, Fisher's exact test), and the sensitivity of GDH algorithms for ribotypes other than 027 was lower than that for Xpert C. difficile (P < 0.001). The Xpert C. difficile assay is a simple, rapid, and accurate method for detection of toxigenic C. difficile in unformed stool specimens and is minimally affected by strain type compared to EIA and GDH-based methods.

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Published In

J Clin Microbiol

DOI

EISSN

1098-660X

Publication Date

October 2010

Volume

48

Issue

10

Start / End Page

3719 / 3724

Location

United States

Related Subject Headings

  • Young Adult
  • Toxicity Tests
  • Sensitivity and Specificity
  • Ribotyping
  • Molecular Diagnostic Techniques
  • Middle Aged
  • Microbiology
  • Male
  • Immunoenzyme Techniques
  • Humans
 

Citation

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ICMJE
MLA
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Tenover, F. C., Novak-Weekley, S., Woods, C. W., Peterson, L. R., Davis, T., Schreckenberger, P., … Persing, D. H. (2010). Impact of strain type on detection of toxigenic Clostridium difficile: comparison of molecular diagnostic and enzyme immunoassay approaches. J Clin Microbiol, 48(10), 3719–3724. https://doi.org/10.1128/JCM.00427-10
Tenover, Fred C., Susan Novak-Weekley, Christopher W. Woods, Lance R. Peterson, Thomas Davis, Paul Schreckenberger, Ferric C. Fang, et al. “Impact of strain type on detection of toxigenic Clostridium difficile: comparison of molecular diagnostic and enzyme immunoassay approaches.J Clin Microbiol 48, no. 10 (October 2010): 3719–24. https://doi.org/10.1128/JCM.00427-10.
Tenover FC, Novak-Weekley S, Woods CW, Peterson LR, Davis T, Schreckenberger P, et al. Impact of strain type on detection of toxigenic Clostridium difficile: comparison of molecular diagnostic and enzyme immunoassay approaches. J Clin Microbiol. 2010 Oct;48(10):3719–24.
Tenover, Fred C., et al. “Impact of strain type on detection of toxigenic Clostridium difficile: comparison of molecular diagnostic and enzyme immunoassay approaches.J Clin Microbiol, vol. 48, no. 10, Oct. 2010, pp. 3719–24. Pubmed, doi:10.1128/JCM.00427-10.
Tenover FC, Novak-Weekley S, Woods CW, Peterson LR, Davis T, Schreckenberger P, Fang FC, Dascal A, Gerding DN, Nomura JH, Goering RV, Akerlund T, Weissfeld AS, Baron EJ, Wong E, Marlowe EM, Whitmore J, Persing DH. Impact of strain type on detection of toxigenic Clostridium difficile: comparison of molecular diagnostic and enzyme immunoassay approaches. J Clin Microbiol. 2010 Oct;48(10):3719–3724.

Published In

J Clin Microbiol

DOI

EISSN

1098-660X

Publication Date

October 2010

Volume

48

Issue

10

Start / End Page

3719 / 3724

Location

United States

Related Subject Headings

  • Young Adult
  • Toxicity Tests
  • Sensitivity and Specificity
  • Ribotyping
  • Molecular Diagnostic Techniques
  • Middle Aged
  • Microbiology
  • Male
  • Immunoenzyme Techniques
  • Humans