Ann Lab Med.  2014 May;34(3):235-239. 10.3343/alm.2014.34.3.235.

Evaluation of a Rapid Membrane Enzyme Immunoassay for the Simultaneous Detection of Glutamate Dehydrogenase and Toxin for the Diagnosis of Clostridium difficile Infection

• Kim H
• Kim WH
• Kim M
• Jeong SH
• Lee K

• KMID: 1791926
• DOI: http://doi.org/10.3343/alm.2014.34.3.235

Abstract

We evaluated the new C. DIFF QUIK CHEK COMPLETE (CD COMPLETE; TechLab, USA), which is a rapid membrane enzyme immunoassay that uses a combination of glutamate dehydrogenase (GDH) antigen and toxin A and B detection. A total of 608 consecutive loose stool specimens collected from the patients with suspected Clostridium difficile infection (CDI) from August to December 2012 were subjected to the CD COMPLETE and VIDAS Clostridium difficile A & B (VIDAS CDAB; bioMerieux, France). Their performances were compared with a toxigenic culture as a reference. Stool specimens that were culture-negative and CD COMPLETE- or VIDAS CDAB-positive were analyzed by using an enrichment procedure. In comparison to the toxigenic cultures, sensitivity, specificity, positive predictive values (PPV), and negative predictive values (NPV) were 63.6%, 98.0%, 76.1%, and 96.4%, respectively, for the CD COMPLETE-toxin and 75.5%, 97.4%, 72.5%, and 97.8%, respectively, for the VIDAS CDAB. In comparison to the enriched C. difficile cultures, the sensitivity, specificity, PPV, and NPV for the CD COMPLETE-GDH were 91.0%, 92.4%, 70.5%, and 98.1%, respectively. The CD COMPLETE is a reliable method for the diagnosis of CDI and provides greater sensitivity than toxin enzyme immunoassay alone. Furthermore, the CD COMPLETE-GDH has advantages over direct culture in detecting C. difficile.

Keyword

Glutamate dehydrogenase; Toxin A; Toxin B; Clostridium difficile; Enzyme immunoassays; Culture

MeSH Terms

Bacterial Proteins/*analysis
Bacterial Toxins/*analysis
Clostridium Infections/*diagnosis/microbiology
Clostridium difficile/enzymology/*isolation & purification/metabolism
Enterotoxins/*analysis
Feces/microbiology
Glutamate Dehydrogenase/*analysis
Humans
*Immunoenzyme Techniques
Reagent Kits, Diagnostic
Sensitivity and Specificity
Bacterial Proteins
Bacterial Toxins
Enterotoxins
Glutamate Dehydrogenase
Reagent Kits, Diagnostic

Figure

• 

  Fig. 1 Flow chart for the two-step testing algorithm to detect toxigenic Clostridium difficile and their simulation results.Abbreviations: GDH, C. DIFF QUIK CHEK COMPLETE-GDH; tox, C. DIFF QUIK CHEK COMPLETE-toxin; VIDAS, VIDAS Clostridium difficile A & B; ND, not done; TP, true positive; FP, false positive; TN, true negative; FN, false negative.

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