Revogene C. difficile Test Demonstrates 85% Sensitivity for Toxin B Gene Detection in Multicenter Trial
A seven-site evaluation of the Revogene C. difficile real-time PCR test assessed 2,461 stool specimens against direct and enriched toxigenic culture. The assay achieved 85.0% sensitivity and 97.2% specificity for detection of the tcdB gene, with rapid turnaround on a compact platform processing up to 8 specimens simultaneously. While sensitivity was moderate compared to enriched culture, the speed and simplicity of the Revogene system offer practical advantages for routine C. difficile diagnostic workflows.
The original study
A Multicenter Study of the Revogene C. difficile System for Detection of the Toxin B Gene from Unformed Stool Specimens.
- Authors
- Mashock MJ, Faron ML, Carroll KC, Dang C, Lewis S, Salimnia H, et al.
- Journal
- Journal of clinical microbiology
- Type
- Evaluation Study, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't
- PMID
- 31776191
Original abstract
Clostridioides difficile is the leading cause of diarrhea in hospitalized U.S. patients and results in over 400,000 cases of C. difficile infection per year. C. difficile infections have mortality rates of 6 to 30% and significantly increase health care costs, because of increased length of stay and increased frequency of readmissions due to recurrences. Efforts to reduce the spread of C. difficile in hospitals have led to the development of rapid sensitive diagnostic methods. A multicenter study was performed to establish the performance characteristics of the Revogene C. difficile test (Meridian Bioscience, Cincinnati, OH, USA) for use in detection of the toxin B (tcdB) gene from toxigenic C. difficile The Revogene instrument is a new molecular platform that uses real-time PCR to detect nucleic acids in up to 8 specimens at a time. A total of 2,461 specimens from symptomatic patients that had been submitted for C. difficile testing were enrolled at 7 sites throughout the United States and Canada for evaluation of the assay. Each stool specimen was tested for the presence of the tcdB gene using the Revogene C. difficile test, and results were compared with those of the reference method, a combination of direct and enriched culture methods. Overall, the Revogene C. difficile test demonstrated a sensitivity of 85.0% (95% confidence interval, 80% to 88%) and a specificity of 97.2% (95% confidence interval, 96% to 98%). The Revogene C. difficile test, using clinical stool specimens for detection of tcdB in C. difficile, demonstrated acceptable sensitivity and specificity, with a short turnaround time.