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Related Experiment Video

Updated: Feb 15, 2026

A Purification and In Vitro Activity Assay for a pppGpp Synthetase from Clostridium difficile
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Validation of Active Surveillance Testing for Clostridium difficile Colonization Using the cobas Cdiff Test.

Parul A Patel1, Donna M Schora1, Kamaljit Singh1,2,3

  • 1Department of Laboratory Medicine and Pathology, NorthShore University HealthSystem, Evanston, Illinois, USA.

Journal of Clinical Microbiology
|January 26, 2018
PubMed
Summary

The cobas Cdiff Test reliably detects asymptomatic Clostridium difficile carriers in hospitals. This nucleic acid amplification test (NAAT) is crucial for active surveillance programs aimed at reducing healthcare-associated infections.

Keywords:
Clostridium difficileactive surveillance testingasymptomaticcobas 4800colonizationreal-time PCR

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Area of Science:

  • Microbiology
  • Infectious Diseases
  • Clinical Diagnostics

Background:

  • Clostridium difficile infection (CDI) remains a significant public health concern in the United States, with rates not declining.
  • Active surveillance testing using nucleic acid amplification tests (NAATs) is a key strategy for preventing healthcare-associated CDI.

Purpose of the Study:

  • To validate the cobas Cdiff Test on the cobas 4800 System for detecting asymptomatic Clostridium difficile carriers.
  • To assess the cobas test's performance in a multi-hospital system as part of an infection control program.

Main Methods:

  • Prospective collection of perirectal swabs from asymptomatic patients at admission and during monthly intensive care unit (ICU) screening.
  • Comparison of cobas Cdiff Test results against toxigenic culture.
  • Discrepant analysis using a second NAAT (Xpert C. difficile Epi test) and medical record review for antimicrobial receipt.

Main Results:

  • The cobas Cdiff Test demonstrated high overall agreement (87.6%) with toxigenic culture.
  • Positive percent agreement between cobas and culture was 100%.
  • Discrepant analysis revealed a significant association between cobas-positive/culture-negative results and the use of antimicrobials that inhibit C. difficile growth.

Conclusions:

  • The cobas Cdiff Test is a reliable assay for active surveillance programs.
  • The test effectively identifies asymptomatic carriers of toxigenic Clostridium difficile, aiding in infection control efforts.