3 years ago

Evaluation of the cobas® Cdiff test for the Detection of Toxigenic Clostridium difficile in Stool Samples.

Peterson, Liesenfeld, Duncan, Wang, Davis, Young, Lewinski, Osiecki, Noutsios
Nucleic acid amplification tests are reliable tools for the detection of toxigenic Clostridium difficile from unformed (liquid or soft) stool samples. The objective of this study was to evaluate performance of the cobas® Cdiff Test on the cobas® 4800 System using prospectively collected stool specimens from patients suspected of C. difficile infection (CDI). Performance of the cobas® Cdiff Test was compared to the combined results of direct and broth enriched toxigenic culture in a large, multicenter clinical trial. Additional discrepant analysis was performed using the Xpert® C. difficile Epi Test. Sample storage was evaluated on contrived and fresh samples before and after storage at -20°C. Testing was from 683 subjects (306 males and 377 females); 113 (16.5%) of 683 were positive for toxigenic C. difficile by direct toxigenic culture and 141 of 682 were positive using the combined direct and enriched toxigenic culture (reference method), for a prevalence rate of 20.7%. The sensitivity and specificity of the cobas® Cdiff Test compared to combined direct and enriched culture was 92.9% (131/141; 95% CI: 87.4% to 96.1%) and 98.7% (534/541; 95% CI: 97.4% to 99.4%), respectively. Discrepancy analysis using a retested sample results from a second NAAT (Xpert® C. difficile/Epi test (Cepheid, Sunnyvale, CA) found no false negative and 4 false positive cobas® Cdiff Test results. There was no difference in positive and negative results when comparing fresh and stored samples. These results support the use of the cobas® Cdiff Test as a robust aid in the diagnosis of CDI.

Publisher URL: http://doi.org/10.1128/JCM.01135-17

DOI: 10.1128/JCM.01135-17

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