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Updated: May 18, 2026

A Protein Microarray Assay for Serological Determination of Antigen-specific Antibody Responses Following Clostridium difficile Infection
Published on: June 15, 2018
Outcomes in patients tested for Clostridium difficile toxins
Christopher R Polage1, David L Chin, Jhansi L Leslie
1Department of Pathology and Laboratory Medicine, UC Davis Medical Center, Sacramento, CA 95817, USA. christopher.polage@ucdmc.ucdavis.edu
Patients testing negative for Clostridium difficile toxins generally experience less severe symptoms and complications. Further research is needed to understand the clinical significance of detecting C. difficile in toxin-negative individuals.
Area of Science:
- Medical Microbiology
- Infectious Diseases
- Clinical Diagnostics
Background:
- Clostridium difficile testing is transitioning from toxin detection to direct C. difficile detection.
- A significant proportion of patients (up to 60%) test negative for toxins despite positive C. difficile cultures, creating diagnostic uncertainty regarding infection versus carrier status.
Purpose of the Study:
- To compare the duration of diarrhea, complication rates, and mortality between toxin-positive and toxin-negative patients.
- To assess the clinical significance of C. difficile detection in toxin-negative individuals.
Main Methods:
- Retrospective review of medical records for 7046 inpatients tested for C. difficile toxins between 2005 and 2009.
- Analysis of diarrhea duration, complication rates (including pseudomembranous colitis, megacolon, colectomy), and mortality.
Main Results:
- Toxin-negative patients exhibited significantly less severe diarrhea, fewer diarrhea days, and lower mortality compared to toxin-positive patients (P < 0.001).
- Pseudomembranous colitis was rare in toxin-negative patients (0.02%), with no cases of fulminant C. difficile infection complications like megacolon or colectomy.
Conclusions:
- C. difficile-associated complications appear infrequent in patients who test negative for C. difficile toxins.
- Further investigation is warranted to clarify the clinical implications of detecting C. difficile in toxin-negative patient populations.
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