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Updated: Jan 12, 2026

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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
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Beyond the bugs: why toxin detection is key in two-tiered C. diff tests
David Goldmeier1, Michael Parry2, Marina Mirkovic3
1George Washington University Hospital, Washington, DC, USA.
Antimicrobial Stewardship & Healthcare Epidemiology : ASHE
|November 3, 2025
Summary
A two-tier C. diff testing strategy accurately identifies active infections, improving antibiotic stewardship. Clinical judgment remains essential for toxin-negative patients with symptoms.
Area of Science:
- Infectious Diseases
- Microbiology
- Clinical Diagnostics
Background:
- Clostridioides difficile (C. diff) infection is a significant healthcare concern.
- Distinguishing active infection from colonization is crucial for appropriate treatment.
- Current diagnostic methods may not always differentiate between infection and colonization.
Purpose of the Study:
- To evaluate a two-tier diagnostic algorithm combining C. diff toxin assay with polymerase chain reaction (PCR).
- To determine if this approach improves patient outcomes and antibiotic stewardship.
- To assess the clinical characteristics and outcomes of toxin-positive versus toxin-negative patients.
Main Methods:
- Retrospective chart review of inpatients positive for C. diff by PCR.
- Implementation of a two-tier testing algorithm (PCR followed by toxin assay).
- Analysis of patient demographics, clinical features, outcomes, and antibiotic initiation.
Main Results:
- Toxin-positive patients exhibited more severe colitis symptoms, higher white blood cell counts, and increased fatality rates.
- Antibiotic prescription was significantly higher in toxin-positive patients (98%) compared to toxin-negative patients (56%).
- A notable percentage of toxin-negative patients (44%) did not receive antibiotics.
Conclusions:
- The two-tier testing strategy effectively identifies active C. diff infections, aiding antibiotic stewardship.
- This approach helps differentiate infection from colonization.
- Clinical judgment is still necessary for managing toxin-negative patients with colitis symptoms.
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