The Food and Drug Administration has cleared DiaSorin’s Simplexa C. difficile Direct assay for the qualitative detection of Clostridium difficile. The assay runs on the Liaison MDx instrument, a scalable bench-top integrated cycler that provides real-time polymerase chain reaction results. Using fluorescently labeled, bifunctional primer-probes, the Simplexa C. difficile Direct test amplifies and detects a well conserved region of the C. difficile toxin B gene in liquid or unformed stool samples. For the C. difficile strain ATCC 43255, the test’s limit of detection (LoD) is 0.95 CFU/mL, and for the strain NAP1A, the LoD is 0.43. In addition, the test detects 32 other toxigenic C. difficile strains. The Simplexa C. difficile Direct kit includes sufficient reagents for 24 reactions, as well as the Simplexa C. difficile Positive Control Pack, which is intended for use as a control with the assay.