title: Evaluation of 3 automated real-time PCR (Xpert C. difficile assay, BD MAX Cdiff, and IMDx C. difficile for Abbott m2000 assay) for detecting Clostridium difficile toxin gene compared to toxigenic culture in stool specimens.
abstract: We evaluated the performance of the 3 automated systems (Cepheid Xpert, BD MAX, and IMDx C. difficile for Abbott m2000) detecting Clostridium difficile toxin gene compared to toxigenic culture. Of the 254 stool specimens tested, 87 (48 slight, 35 moderate, and 4 heavy growth) were toxigenic culture positive. The overall sensitivities and specificities were 82.8% and 98.8% for Xpert, 81.6% and 95.8% for BD MAX, and 62.1% and 99.4% for IMDx, respectively. The specificity was significantly higher in IMDx than BD MAX (P= 0.03). All stool samples underwent toxin A/B enzyme immunoassay testing, and of the 254 samples, only 29 samples were positive and 2 of them were toxigenic culture negative. Considering the rapidity and high specificity of the real-time PCR assays compared to the toxigenic culture, they can be used as the first test method for C. difficile infection/colonization.
authors.affiliation: Department of Laboratory Medicine, Seoul St Mary's Hospital, Korea, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
authors.forename: Jaeeun
authors.initials: J
authors.lastname: Yoo
authors.affiliation: Department of Laboratory Medicine, Seoul St Mary's Hospital, Korea, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
authors.forename: Hyeyoung
authors.initials: H
authors.lastname: Lee
authors.affiliation: Department of Biostatistics, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
authors.forename: Kang Gyun
authors.initials: KG
authors.lastname: Park
authors.affiliation: Department of Biostatistics, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
authors.forename: Gun Dong
authors.initials: GD
authors.lastname: Lee
authors.affiliation: Department of Biostatistics, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
authors.forename: Yong Gyu
authors.initials: YG
authors.lastname: Park
authors.affiliation: Department of Laboratory Medicine, Seoul St Mary's Hospital, Korea, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea. Electronic address: yjpk@catholic.ac.kr.
authors.forename: Yeon-Joon
authors.initials: YJ
authors.lastname: Park
mesh_terms: D057205:Automation, Laboratory / Q000379:methods*; D001427:Bacterial Toxins / Q000032:analysis* / Q000235:genetics*; D016360:Clostridioides difficile / Q000235:genetics / Q000254:growth & development / Q000302:isolation & purification*; D005243:Feces / Q000382:microbiology*; D006801:Humans; D007124:Immunoenzyme Techniques; D011446:Prospective Studies; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods*; D012680:Sensitivity and Specificity
chemical_list: D001427:Bacterial Toxins
keywords: Culture; Semiquantitative; Sensitivity; Specificity