Validation of the GenePOC CDiff Assay for the Detection of the Toxin B Gene From Toxigenic Clostridium Difficile Strains
Completed · Not applicable
Conditions studied: Clostridium Difficile Infection
In brief
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.
Key facts
- Study ID
- NCT02968758
- Run by
- Meridian Bioscience, Inc.
- People needed
- 2461
- Starts
- 2017-02-06
- Expected to finish
- 2017-08-10
- Last updated by the study team
- 2021-05-03
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Unformed Stool specimens from patients suspected of having CDI for whom diagnostic tests are indicated and ordered;
- At least 1.25mL of unformed stool specimen (defined as specimen assuming the shape of its container);
- Only one (1) specimen per patient will be included in the study;
- Materials use within their expiration date;
- Transport, storage times, and conditions (e.g. room temperature and/or refrigerated) within requested indications.
You may not qualify if…
- Specimens from patients for whom CDI diagnostic tests have not been ordered;
- Transport and storage times and conditions that exceed these Study Protocol requirements;
- Formed or hard stool specimens or rectal swabs.
Where it is running
- Wishard Health Services — Indianapolis, Indiana, United States
- John Hopkins University School of Medicine — Baltimore, Maryland, United States
- Detroit Medical Center University Laboratories — Detroit, Michigan, United States
- Tricore Laboratory University of New Mexico — Albuquerque, New Mexico, United States
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States
- Mount Sinai Hospital Joseph and Wolf Lebovic Health Complex — Toronto, Ontario, Canada
- McGill University Health Centre — Montreal, Quebec, Canada
Full record on ClinicalTrials.gov
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