Are We Moving Toward Diagnostic Stewardship Or Laboratory Retrogress On Clostridioides difficile Testing?

The widespread adoption of PCR-based testing for Clostridioides difficile infection (CDI) has replaced enzyme immunoassays (EIA) in the U.S., increasing sensitivity and reported healthcare-onset CDI (HO-CDI) cases. However, concerns about overdiagnosis persist, as PCR may detect asymptomatic coloniz...

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Publicado en:Sage Open Pathology Vol. 19; pp. 1 - 9
Autores principales: Navarathna, Dhammika H., Cornelius, Lisa, Lukey, Janell, Wiley, Linda K., San Juan, Ma Rowena, Bolin, Sara C.
Formato: research tables/charts Journal Article
Publicado: Sage Publications Inc. 6/16/2026
Acceso en línea:Ver este registro en EBSCOhost
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      dt: 6/16/2026
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      pub: Sage Publications Inc.
      place: Thousand Oaks, California
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        atl: Are We Moving Toward Diagnostic Stewardship Or Laboratory Retrogress On Clostridioides difficile Testing?
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        au:
          Navarathna, Dhammika H.
          Cornelius, Lisa
          Lukey, Janell
          Wiley, Linda K.
          San Juan, Ma Rowena
          Bolin, Sara C.
        affil: Department of Pathology and Laboratory Medicine Services, Central Texas Veterans Health Care System, Temple, TX, USA
      sug:
        subj:
          Clostridium Infections Diagnosis
          Diagnosis, Laboratory Methods
          Sensitivity and Specificity Evaluation
          Health Services Misuse
          Overdiagnosis
          Polymerase Chain Reaction
          Immunoenzyme Techniques
          Incident Reports
          Patient Safety
          Quality Improvement
          Clinical Laboratories, Hospital
          Human
          Microbial Culture and Sensitivity Tests
          Clostridioides Difficile Analysis
          Clostridium Infections Symptoms
          Bacterial Colonization
          Comparative Studies
          Inpatients
          Laboratory Personnel Education
          Diagnostic Reasoning
          Decision Making, Clinical
          Electronic Order Entry
          Algorithms
          Patient Care
          Molecular Biology
          Clinical Research
          Practice Guidelines
          Texas
          Pearson's Correlation Coefficient
          Two-Tailed Test
          Data Analysis Software
      ab: The widespread adoption of PCR-based testing for Clostridioides difficile infection (CDI) has replaced enzyme immunoassays (EIA) in the U.S., increasing sensitivity and reported healthcare-onset CDI (HO-CDI) cases. However, concerns about overdiagnosis persist, as PCR may detect asymptomatic colonization. To mitigate this, some institutions use a 2-step algorithm, confirming positive PCR/GDH results with EIA. Our healthcare system, which exclusively reports PCR results, conducted a process improvement (PI) project to evaluate whether incorporating EIA testing could improve hospital reporting and patient safety. We compared our routine PCR testing with 2 commercial EIA platforms to assess sensitivity and specificity and analyzed PCR cycle threshold (Ct) values in relation to EIA results. EIA tests demonstrated less than 30% sensitivity compared to PCR, artificially reducing HO-CDI cases. Few inpatients tested by PCR despite not meeting CDI testing criteria had positive EIA results, indicating true CDI and highlighting the need for better provider education. Lower PCR Ct values, reflecting higher bacterial loads, correlated with EIA positivity, suggesting that EIA requires higher toxin expression for detection. Implementing decision-making alerts in electronic ordering improved diagnostic stewardship. While multi-step testing algorithms may reduce HO-CDI rates, they risk excluding toxin-negative (false-negative) CDI due to EIA's low sensitivity. This approach offers limited clinical value in CDI management. Instead, reinforcing provider education on appropriate testing criteria is a more effective strategy to reduce unnecessary testing and improve patient care.
      pubtype: Academic Journal
      doctype:
        research
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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