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Related Experiment Video

Updated: Jun 17, 2026

A Protein Microarray Assay for Serological Determination of Antigen-specific Antibody Responses Following Clostridium difficile Infection
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A Protein Microarray Assay for Serological Determination of Antigen-specific Antibody Responses Following Clostridium difficile Infection

Published on: June 15, 2018

Clostridium difficile testing in the clinical laboratory by use of multiple testing algorithms.

Susan M Novak-Weekley1, Elizabeth M Marlowe, John M Miller

  • 1Southern California Permanente Medical Group, North Hollywood, California 91605, USA. Susan.M.Novak@kp.org

Journal of Clinical Microbiology
|January 15, 2010
PubMed
Summary

The Cepheid Xpert C. difficile assay offers a rapid and accurate diagnostic for Clostridium difficile infection (CDI). It demonstrated superior sensitivity and negative predictive value compared to other methods, providing results in under an hour.

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Area of Science:

  • Clinical Microbiology
  • Infectious Diseases
  • Diagnostic Assays

Background:

  • Rising incidence of Clostridium difficile infection (CDI) necessitates improved diagnostic tools.
  • Current diagnostic methods for CDI can be time-consuming or lack optimal accuracy.
  • The Cepheid Xpert C. difficile assay is a novel integrated system for automated sample preparation and real-time PCR detection.

Purpose of the Study:

  • To evaluate the performance of the Cepheid Xpert C. difficile assay for diagnosing CDI.
  • To compare the Xpert assay's accuracy and speed against existing diagnostic methods and algorithms.

Main Methods:

  • 432 stool specimens from symptomatic patients were tested using glutamate dehydrogenase (GDH) assay, toxin A and B enzyme immunoassay (EIA), Xpert C. difficile assay, and cell culture cytotoxicity neutralization assay (CCCN).
  • Results were compared against toxigenic culture as the gold standard.
  • Statistical analysis, including Fisher's exact test, was used to compare assay performance.

Main Results:

  • The Xpert C. difficile assay showed high sensitivity (94.4%), specificity (96.3%), and negative predictive value (98.8%).
  • The Xpert assay was statistically superior to EIA and a GDH-EIA-CCCN algorithm (P < 0.001 and P = 0.0363, respectively).
  • Xpert assay testing was completed in under 1 hour, significantly faster than the 2-day average for the GDH-EIA-CCCN algorithm.

Conclusions:

  • The Cepheid Xpert C. difficile assay is a highly sensitive and specific diagnostic tool for CDI.
  • The Xpert assay provides rapid results, significantly reducing turnaround time compared to conventional methods.
  • This assay represents a significant advancement in the timely and accurate diagnosis of Clostridium difficile infection.