Multicenter clinical evaluation of the portrait toxigenic C. difficile assay for detection of toxigenic Clostridium difficile strains in clinical stool specimens. J Clin Microbiol 2012 Dec;50(12):3932-6
Date
09/28/2012Pubmed ID
23015667Pubmed Central ID
PMC3502949DOI
10.1128/JCM.02083-12Scopus ID
2-s2.0-84869217890 (requires institutional sign-in at Scopus site) 36 CitationsAbstract
We compared the Portrait Toxigenic C. difficile Assay, a new semiautomated sample-to-result molecular test, to a toxigenic bacterial culture/cell cytotoxin neutralization assay (TBC/CCNA) for the detection of toxigenic Clostridium difficile in 549 stool specimens. Stool specimens were also tested by one of three alternative FDA-cleared molecular tests for toxigenic C. difficile (Xpert C. difficile, Illumigene C. difficile, or GeneOhm Cdiff). The sensitivities and specificities of the molecular tests compared to TBC/CCNA were as follows: 98.2% and 92.8% for the Portrait assay, 100% and 91.7% for the Xpert assay, 93.3% and 95.1% for the Illumigene assay, and 97.4% and 98.5% for the GeneOhm assay, respectively. The majority of Portrait false-positive results (20/31; 64.5%) were also positive for C. difficile by an alternative molecular test, suggesting an increased sensitivity compared to the culture-based "gold standard" method. The Portrait test detected an assay input of 30 CFU in 100% of spiked samples and detected an input of 10 CFU in 96.7% of samples tested.
Author List
Buchan BW, Mackey TL, Daly JA, Alger G, Denys GA, Peterson LR, Kehl SC, Ledeboer NAAuthors
Blake W. Buchan PhD Professor in the Pathology department at Medical College of WisconsinNathan A. Ledeboer PhD Vice Chair, Professor in the Pathology department at Medical College of Wisconsin
MESH terms used to index this publication - Major topics in bold
AdolescentAutomation
Child
Child, Preschool
Clinical Laboratory Techniques
Clostridium Infections
Feces
Female
Humans
Male
Molecular Diagnostic Techniques
Sensitivity and Specificity
