At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prospective Multi-Center Study for Clinical Validation of the Molecular-Based GenePOC CDiff System for the Detection of Toxin B Gene From Toxigenic Clostridium Difficile Strains in Unformed (Soft or Liquid) Human Stool Specimens
In Brief
A clinical study evaluating Comparison between GenePOC PCR and Reference Method for Clostridium Difficile Infection. Completed, enrolled 2,461 participants across 7 sites in 2 countries.
Detailed Summary
The primary purpose of this clinical investigation is to verify the performance of the GenePOC CDiff test on the GenePOC instrument. This will be achieved by comparing the GenePOC CDiff test to the Toxigenic Culture (TC) and cell cytotoxicity neutralisation assay (CCNA), a conventional method considered as gold standard for detection of toxigenic Clostridium difficile in stool specimens.
Study Details
Timeline
Interventions
Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain.