Advances and required improvements in methods to diagnosing Clostridioides difficile infections in the healthcare setting

Masako Mizusawa, Karen C. Carroll

Research output: Contribution to journalReview articlepeer-review


Introduction: Clostrididioides difficile is associated with adverse clinical outcomes and increased morbidity, mortality, length of hospital stay, and health-care costs. Areas Covered: We searched relevant papers in PubMed for the last 10 years. In major papers, we scanned the bibliographies to ensure that important articles were included. This review addresses the evolving epidemiology of Clostridioides difficile infection (CDI) and discusses novel methods/approaches for improving the diagnosis of this important disease. Expert opinion: No single diagnostic test to date has demonstrated optimum sensitivity and specificity for detection of CDI. Many institutions have developed multi-step algorithms consistent with guidelines established by various professional societies. Some institutions have successfully tried to improve the pretest probability of molecular assays by implementing appropriate sample rejection criteria and establishing best practice alerts at the time of electronic order entry. Others have established PCR cycle threshold cutoffs to attempt to differentiate symptomatic patients from asymptomatic carriers or to make predictions about severity of disease with variable success. As research advances our understanding of C. difficile pathogenesis and pathophysiology, more information on CDI specific biomarkers is emerging. Finally, assessments of the microbiome and metabolome may expand the diagnostic armamentarium with advances in mass spectrometry and sequencing technologies.

Original languageEnglish (US)
Pages (from-to)311-321
Number of pages11
JournalExpert Review of Molecular Diagnostics
Issue number3
StatePublished - 2021


  • Clostridioides difficile
  • Colitis
  • best practice alerts
  • biomarkers
  • glutamate dehydrogenase
  • metabolomics
  • microbiome
  • nucleic acid test
  • toxin enzyme immunoassay
  • two step algorithm

ASJC Scopus subject areas

  • Pathology and Forensic Medicine
  • Molecular Medicine
  • Molecular Biology
  • Genetics


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