Laboratory Diagnostic Methods for Clostridioides difficile Infection: the First Systematic Review and Meta-analysis

Hae-Sun Chung1, Jeong Su Park2, Bo-Moon Shin3

  • 1Department of Laboratory Medicine, Ewha Womans University College of Medicine, Seoul, Korea.

Abstract

Insights

Glutamate dehydrogenase (GDH) enzyme immunoassays (EIAs) and nucleic acid amplification tests (NAATs) offer high sensitivity for diagnosing Clostridioides difficile infection (CDI). Toxin A and B EIAs are less sensitive but highly specific.

Area of Science:

  • Clinical Microbiology
  • Infectious Diseases
  • Diagnostic Accuracy Studies

Background:

  • Clostridioides difficile infection (CDI) diagnosis relies on various laboratory methods.
  • Accurate and timely diagnosis is crucial for effective patient management and infection control.

Purpose of the Study:

  • To systematically analyze and compare the performance of current laboratory diagnostic methods for CDI.
  • To provide data to inform the selection of optimal diagnostic strategies for CDI.

Main Methods:

  • Systematic review and meta-analysis of studies from major databases (PubMed, Web of Science, Cochrane Library, KoreaMed).
  • Evaluation of glutamate dehydrogenase (GDH) enzyme immunoassays (EIAs), toxin A and B EIAs, and nucleic acid amplification tests (NAATs).
  • Calculation of pooled sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) against toxigenic culture.

Main Results:

  • Pooled sensitivities/specificities: GDH EIAs (92.7%/94.6%), Toxin AB EIAs (57.9%/97.0%), NAATs (90.0%/95.8%).
  • Automated EIAs and specific NAATs (Xpert C. difficile) demonstrated superior sensitivity.
  • Predictive values varied with CDI prevalence; high NPVs at low prevalence, high PPVs at high prevalence.

Conclusions:

  • GDH EIAs and NAATs exhibit high sensitivity for CDI diagnosis.
  • Toxin AB EIAs, while less sensitive, offer the highest specificity.
  • Findings offer valuable insights for optimizing CDI laboratory diagnostics.