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Performance of the artus C. difficile QS-RGQ Kit for the detection of toxigenic Clostridium difficile

 Hee-Won Moon  ;  Hyeong Nyeon Kim  ;  Ji-Young Kim  ;  Mina Hur  ;  Heejung Kim  ;  Yeo-Min Yun 
 CLINICAL BIOCHEMISTRY, Vol.50(1~2) : 84-87, 2017 
Journal Title
Issue Date
Clostridium difficile/isolation & purification* ; Feces/microbiology ; Humans ; Limit of Detection ; Nucleic Acid Amplification Techniques* ; Prospective Studies
Clostridium difficile ; Cycle threshold value ; Performance ; Toxigenic culture ; Xpert C. difficile ; artus C. difficile QS-RGQ Kit
OBJECTIVES: Nucleic acid amplification tests are commonly used for the direct detection of toxigenic Clostridium difficile. We evaluated the diagnostic performance of newly launched, artus C. difficile QS-RGQ Kit (artus C. difficile, QIAGEN, Hilden, Germany), in comparison with toxigenic culture (TC) and Xpert C. difficile (Cepheid, Sunnyvale, CA, USA). DESIGN AND METHODS: In prospectively collected 261 diarrheal specimens, the artus C. difficile and the Xpert C. difficile assays were performed. TC using chromogenic agar (chromID CD agar, bioMérieux, Marcy-l'Etoile, France) was used a reference method. RESULTS: Based on TC, the sensitivity and specificity of the artus C. difficile were 98.2% and 93.6%, respectively, and those of the Xpert C. difficile were 94.6% and 94.6%, respectively; there was no statistical difference. The agreement between the artus C. difficile and the Xpert C. difficile was almost perfect (kappa=0.918). In the artus C. difficile, the cycle threshold (Ct) values of tcdA were constantly lower than those of tcdB in all positive specimens (mean Ct, 24.5 vs. 26.4; mean difference of 1.9). Three specimens were considered tcdA+/tcdB- by the difference of Ct cutoffs between tcdA and tcdB (38.3 and 36.5, respectively). CONCLUSIONS: The performance of the artus C. difficile is excellent compared with TC and is comparable to that of the Xpert C. difficile. Both PCR assays could be useful diagnostic options for the direct detection of toxigenic C. difficile in clinical laboratories. The optimal Ct cutoff of tcdA and tcdB for artus C. difficile may be further validated in following studies.
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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
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