Cost-effectiveness of a modified two-step algorithm using a combined glutamate dehydrogenase/toxin enzyme immunoassay and real-time PCR for the diagnosis of Clostridium difficile infection

J Microbiol Immunol Infect. 2014 Feb;47(1):75-8. doi: 10.1016/j.jmii.2012.07.008. Epub 2012 Aug 24.

Abstract

The analytical performance and cost-effectiveness of the Wampole Toxin A/B EIA, the C. Diff. Quik Chek Complete (CdQCC) (a combined glutamate dehydrogenase antigen/toxin enzyme immunoassay), two RT-PCR assays (Progastro Cd and BD GeneOhm) and a modified two-step algorithm using the CdQCC reflexed to RT-PCR for indeterminate results were compared. The sensitivity of the Wampole Toxin A/B EIA, CdQCC (GDH antigen), BD GeneOhm and Progastro Cd RT-PCR were 85.4%, 95.8%, 100% and 93.8%, respectively. The algorithm provided rapid results for 86% of specimens and the remaining indeterminate results were resolved by RT-PCR, offering the best balance of sensitivity and cost savings per test (algorithm ∼US$13.50/test versus upfront RT-PCR ∼US$26.00/test).

Keywords: BD GeneOhm RT-PCR; C. Diff Quik Check Complete; Clostridium difficile; ProGastro Cd RT-PCR.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • Algorithms
  • Bacterial Toxins / analysis*
  • Bacterial Toxins / genetics
  • Clinical Laboratory Techniques / economics
  • Clinical Laboratory Techniques / methods*
  • Clostridioides difficile / enzymology
  • Clostridioides difficile / genetics
  • Clostridioides difficile / isolation & purification*
  • Clostridium Infections / diagnosis*
  • Clostridium Infections / economics
  • Clostridium Infections / microbiology*
  • Cost-Benefit Analysis
  • Diagnostic Tests, Routine / economics
  • Diagnostic Tests, Routine / methods
  • Glutamate Dehydrogenase / analysis*
  • Glutamate Dehydrogenase / genetics
  • Humans
  • Immunoenzyme Techniques / economics
  • Immunoenzyme Techniques / methods
  • Real-Time Polymerase Chain Reaction / economics
  • Real-Time Polymerase Chain Reaction / methods*
  • Sensitivity and Specificity

Substances

  • Bacterial Toxins
  • Glutamate Dehydrogenase