Evaluation of 4 molecular assays as part of a 2-step algorithm for the detection of Clostridium difficile in stool specimens

Adam J. Caulfield, Catherine M. Bolster LaSalle, Yu Hui H. Chang, Thomas E. Grys

Research output: Contribution to journalArticle

3 Scopus citations

Abstract

Detection of Clostridium difficile infection is important for clinical laboratories, owing to debilitating disease, severe outcomes, patient awareness, and public reporting of hospital data. This study evaluated the performance of 4 nucleic acid amplification test (NAAT) assays as part of a 2-step algorithm that involves reflexive NAAT following enzyme immunoassay (EIA) testing that is indeterminate for glutamate dehydrogenase (GDH) antigen and toxin A/B (GDH+/toxin or GDH/toxin+). A total of 500 stool specimens from consecutive patients were tested by each of the 5 methods and also evaluated as part of a 2-step algorithm. A specimen was considered positive for presence of C. difficile if it tested positive by 3 of 4 molecular methods or toxigenic culture. The sensitivity and specificity of the GDH-EIA method were each 93%. The toxin EIA had only 48% sensitivity, but it had 99% specificity. Sensitivity and specificity of 2-step algorithmic testing ranged from 88% to 93% and 99% to 100%, respectively, offering similar performance to stand-alone NAAT testing.

Original languageEnglish (US)
Pages (from-to)1-5
Number of pages5
JournalDiagnostic Microbiology and Infectious Disease
Volume91
Issue number1
DOIs
StatePublished - May 2018

Keywords

  • Clostridium difficile
  • Diagnostic assay
  • GDH
  • Glutamate dehydrogenase
  • NAAT
  • Nucleic acid amplification test

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

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