A Multi-Center Study of the Revogene® C. difficile System for Detection of the Toxin B Gene from Unformed Stool Specimens

Clostridioides difficile is the leading cause of diarrhea in hospitalized US patients and results in over 400,000 cases of C. difficile infections (CDI) per year. CDI have a mortality rate of 6-30% and significantly increase healthcare costs due to increased length of stay and increased frequency of readmissions due to recurrences. Therefore, efforts to reduce the spread of C. difficile in hospitals has led to development of rapid, sensitive diagnostic methods . A multi-center study was performed to establish performance characteristics of the Revogene C. difficile test (Cincinnati, Ohio, United States) for use in detection of toxin B gene (tcdB) from toxigenic C. difficile. The Revogene® instrument is a new molecular platform that uses real-time Polymerase Chain Reaction (rtPCR) to detect nucleic acids of up to 8 specimens at a time. A total of 2,461 specimens, submitted for C. difficile testing from symptomatic patients, were enrolled at 7 sites throughout the US and Canada to evaluate the assay. Each stool specimen was tested for the presence of the tcdB gene using the Revogene C. difficile test and results were compared to 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 (CI), 80% to 88%) and a specificity of 97.2% (95% CI, 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.