Bacterial infectious disease IVDs

Intended purpose

The Revogene® C. difficile assay performed on the Revogene® instrument is a qualitative in vitro diagnostic test that utilizes automated sample processing and real-time polymerase chain reaction (PCR) to detect the toxin B (tcdB) gene of toxigenic Clostridium difficile (C. difficile) in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection (CDI). The Revogene C. difficile assay is intended to aid in the diagnosis of CDI.