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The PrimeraDx ICEPlex® C. difficile Assay is for the qualitative detection of the Clostridium difficile toxin B gene (tcdB gene) in nucleic acids purified from unpreserved liquid or soft human stool specimens from patients suspected of having C. difficile infection (CDI). The ICEPlex C. difficile Assay is intended to be used only on the ICEPlex® System, which integrates PCR-based amplification with capillary electrophoresis (CE) for the detection of amplification products. The assay is intended to aid in the diagnosis of CDI. Results should be considered in conjunction with patient clinical history.

PrimeraDx's ICEPlex C. difficile Assay kit is intended to be used only on the ICEPlex System. The ICEPlex C. difficile Assay kit incorporates several universal features and approaches developed at PrimeraDx for the ICEPlex System. The ICEPlex C. difficile Assay kit includes a PCR enzyme and the appropriate PCR buffer system developed, optimized, verified and validated for ideal performance in multiplex PCR with subsequent capillary electrophoresis. The ICEPlex C. difficile assay kit includes a primer mix for detection of the Clostridium difficile toxin B gene (tcdB gene) in human stool specimen from patients suspected of having C. difficile infection (CDI). The ICEPlex C. difficile assay kit is comprised of a PCR enzyme, primer mix, PCR buffer, calibrators mix, injection buffer, internal control, and a positive control. The ICEPlex System combines two functional modules: an amplification module - PCR (Polymerase Chain Reaction) thermal cycler - and an analysis module -CE (Capillary Electrophoresis) system with fluorescent detection. Individual fluorescent PCR products from multiplexed PCR reactions are analyzed by CE through direct electrokinetic injection into the separating capillaries. The labeled amplicons are separated by size and the dyes are excited by two lasers within the system.