The Evaluation of the Performance of C. Diff Quik Chek Complete and Toxin A + B (Clostridium difficile) DUO Diagnostic Tests Compared with Toxigenic Culture in the Diagnosis of Clostridium difficile Infection

Clin Lab. 2020 Apr 1;66(4). doi: 10.7754/Clin.Lab.2019.190713.

Abstract

Background: Clostridium difficile is an important cause of nosocomial diarrhea and the best standard laboratory method for the diagnosis of C. difficile infection is controversial. In this study, we aimed to investigate the performance of Toxin A + B (Clostridium difficile) DUO kit which detects C. difficile toxin A and B by the immunochromatographic method and C. Diff Quik Chek Complete (QCC) rapid membrane immunoassay kit which determines the presence of glutamate dehydrogenase (GDH) and C. difficile toxin A and B in stool samples, compared with toxigenic culture in the diagnosis of C. difficile infection.

Methods: One hundred ninety-three stool samples from patients suspected of having C. difficile infection were included in the study. The performances of two commercial tests were compared with toxigenic culture which was accepted as the reference method.

Results: The sensitivity and specificity of the GDH component of QCC were 94.4% and 97.7%, the sensitivity and specificity of the toxin component were 92.3% and 100%, respectively. The sensitivity and specificity of Toxin A + B (Clostridium difficile) DUO test were found as 53.8% and 87.8%, respectively.

Conclusions: C. Diff Quik Chek Complete test, which is a rapid test with high sensitivity and specificity, can be used alone for the diagnosis of C. difficile infection while Toxin A + B (Clostridium difficile) DUO test cannot be used for the same purpose due to the low sensitivity and specificity of the test.

Publication types

  • Comparative Study

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Azure Stains*
  • Bacterial Toxins / analysis*
  • Child
  • Child, Preschool
  • Clostridioides difficile / pathogenicity
  • Clostridium Infections / diagnosis*
  • Clostridium Infections / microbiology
  • Diagnostic Tests, Routine / methods
  • Diagnostic Tests, Routine / standards*
  • Feces / microbiology
  • Female
  • Glutamate Dehydrogenase / analysis*
  • Humans
  • Male
  • Methylene Blue*
  • Middle Aged
  • Reagent Kits, Diagnostic / standards
  • Sensitivity and Specificity
  • Virulence
  • Xanthenes*
  • Young Adult

Substances

  • Azure Stains
  • Bacterial Toxins
  • Diff Quik
  • Reagent Kits, Diagnostic
  • Xanthenes
  • Glutamate Dehydrogenase
  • Methylene Blue