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The Journal of the Japanese Society for Clinical Microbiology

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[Vol.28 No.4 contents]
Japanese / English

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Article in Japanese

ArticleTitle Comparison of Two Commercially Available Clostridioides difficile Toxin Detection Assays/Glutamate Dehydrogenase Detection Assay Kits (The C. DIFF QUIK CHEK COMPLETE, GE Test Immunochromato -CD GDH/TOX[Nissui]) to a toxigenic Culture Method
Language J
AuthorList Hiromichi Suzuki1), Yukihiro Toi2), Junichi Chiba3), Morihiko Sato4), Yutaro Ono5), Shigeyuki Notake6), Tadatomo Ohyanagi7), Hiroyuki Kunishima8)
Affiliation 1) Division of Infectious Diseases, Department of Medicine/Departmentof Clinical Laboratory Medicine, Tsukuba Medical Center Hospital
2) Department of Respiratory Medicine, Sendai Kousei Hospital
3) Department of Pathology/Department of Clinical Laboratory, Sendai Kousei Hospital
4) Department of Infection Control, Shonan Kamakura General Hospital
5) Department of Clinical Laboratory, Shonan Kamakura General Hospital
6) Department of Clinical Laboratory, Tsukuba Medical Center Hospital
7) Department of Clinical Laboratory/Department of Infection Control, St. Marianna University School of Medicine Hospital
8) Department of Infectious Diseases, St. Marianna University School of Medicine
Publication J.J.C.M.: 28 (4), 261-268, 2018
Received January 5, 2018
Accepted April 5, 2018
Abstract We prospectively evaluated the performance of two Clostridioides difficile toxin detection assays/glutamate dehydrogenase (GDH) detection assay Kits (The C. DIFF QUIK CHEK COMPLETE; QUIK CHEK, GE Test Immunochromato -CD GDH/TOX [Nissui] ; GE Test) at four facilities in Japan from May 2017 to October 2017. C. difficile was cultivated from 55 of 229 stool samples; toxin producing C. difficile was detected in 39 stool samples (71%). In comparison to the culture method, the positive concordance rate, negative concordance rate, positive predictive value, negative predictive value of GDH test were 91% (50/55), 99% (172/174), 96% (50/52), 97% (172/177) for QUIK CHEK, and 93% (51/55), 95% (166/174), 86% (51/59), 98% (166/170) for GE Test, respectively. As for the detection of toxigenic C. difficile, the positive concordance rate, negative concordance rate, positive predictive value, negative predictive value of the two toxin kits were same: 49% (19/39), 100% (190/190), 100% (19/19), 90% (190/210). Binary toxin gene (cdt) were detected in 4 stool samples and a tcdC mutation was detected in one stool sample. In conclusion, the GDH tests using the two kits showed high rates of concordance with the cultivation of C. difficile; however, the two toxin kits only detected the presence of toxigenic C. difficile in approximately half of the samples.
Keywords Clostridioides difficile, Clostridium difficile, GDH
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