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

 Heejung Kim  ;  Wan Hee Kim  ;  Myungsook Kim  ;  Seok Hoon Jeong  ;  Kyungwon Lee 
 ANNALS OF LABORATORY MEDICINE, Vol.34(3) : 1-5, 2014 
Journal Title
Issue Date
Bacterial Proteins/analysis* ; Bacterial Toxins/analysis* ; Clostridium Infections/diagnosis* ; Clostridium Infections/microbiology ; Clostridium difficile/enzymology ; Clostridium difficile/isolation & purification* ; Clostridium difficile/metabolism ; Enterotoxins/analysis* ; Feces/microbiology ; Glutamate Dehydrogenase/analysis* ; Humans ; Immunoenzyme Techniques* ; Reagent Kits, Diagnostic ; Sensitivity and Specificity
Clostridium difficile ; Culture ; Enzyme immunoassays ; Glutamate dehydrogenase ; Toxin A ; Toxin B
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; bioMérieux, 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.
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1. College of Medicine (의과대학) > Dept. of Laboratory Medicine (진단검사의학교실) > 1. Journal Papers
Yonsei Authors
Kim, Heejung(김희정) ORCID logo https://orcid.org/0000-0002-0190-703X
Lee, Kyungwon(이경원) ORCID logo https://orcid.org/0000-0003-3788-2134
Jeong, Seok Hoon(정석훈) ORCID logo https://orcid.org/0000-0001-9290-897X
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