title: Evaluation of a simultaneous detection kit for the glutamate dehydrogenase antigen and toxin A/B in feces for diagnosis of Clostridium difficile infection.
abstract: Rapid detection kits for toxin A/B in feces are widely used as a diagnostic tool for Clostridium difficile infection (CDI). Their low sensitivity, however, has been considered a problem. In this study, we evaluated a new rapid diagnostic kit for simultaneous detection of the glutamate dehydrogenase (GDH) antigen and toxin A/B, C. DIFF QUIK CHEK COMPLETE. A total of 60 stool specimens from 60 patients with antibiotic-associated diarrhea were examined. Using C. difficile culture as the reference method, the GDH portion of this kit indicated a sensitivity, specificity, and negative predictive value of 100, 93.3, and 100%, respectively. The toxin A/B portion showed a sensitivity and specificity of 78.6 and 96.9%, respectively, compared to the culture results of toxin B-positive C. difficile (toxigenic culture). Of the 23 specimens that showed "dual positives" for GDH and toxin A/B, 22 were toxigenic culture positive, whereas C. difficile culture was negative in all the 28 specimens that showed "dual negatives" for GDH and toxin A/B. Of the nine "GDH-positive and toxin A/B-negative" specimens, six exhibited positive results by toxigenic culture. Results showing "dual positives" and "dual negatives" for GDH and toxin A/B can be reported as "true positive" and "true negative," respectively, whereas additional testing for confirmation, such as toxigenic culture, is required for specimens with discrepant results. Diagnostic algorithms, utilizing the simultaneous detection kit for GDH and toxin A/B as an initial screening test, may be useful for accurate and efficient diagnosis of CDI as well as the control of healthcare-associated infections.
authors: Department of Infectious Diseases, Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology, Tokyo, Japan. mkawada-tky@umin.ac.jp
authors: Miki
authors: M
authors: Kawada
authors: Megumi
authors: M
authors: Annaka
authors: Haru
authors: H
authors: Kato
authors: Sumie
authors: S
authors: Shibasaki
authors: Keiko
authors: K
authors: Hikosaka
authors: Hiroshi
authors: H
authors: Mizuno
authors: Yoshishige
authors: Y
authors: Masuda
authors: Takashi
authors: T
authors: Inamatsu
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000942:Antigens, Bacterial / Q000032:analysis*; D001426:Bacterial Proteins / Q000032:analysis*; D001427:Bacterial Toxins / Q000032:analysis*; D016360:Clostridioides difficile / Q000737:chemistry / Q000201:enzymology / Q000302:isolation & purification*; D004761:Enterocolitis, Pseudomembranous / Q000175:diagnosis / Q000382:microbiology*; D004768:Enterotoxins / Q000032:analysis*; D005243:Feces / Q000737:chemistry* / Q000382:microbiology; D005260:Female; D005969:Glutamate Dehydrogenase / Q000276:immunology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity
chemical_list: D000942:Antigens, Bacterial; D001426:Bacterial Proteins; D001427:Bacterial Toxins; D004768:Enterotoxins; D011933:Reagent Kits, Diagnostic; C041348:tcdA protein, Clostridium difficile; C031815:toxB protein, Clostridium difficile; D005969:Glutamate Dehydrogenase