Validation of the GenePOC CDiff Assay for the Detection of the Toxin B Gene From Toxigenic Clostridium Difficile Strains

NACompletedINTERVENTIONAL
Enrollment

2,461

Participants

Timeline

Start Date

February 6, 2017

Primary Completion Date

August 2, 2017

Study Completion Date

August 10, 2017

Conditions
Clostridium Difficile Infection
Interventions
DEVICE

Comparison between GenePOC PCR and Reference Method

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.

Trial Locations (7)

21287

John Hopkins University School of Medicine, Baltimore

46202

Wishard Health Services, Indianapolis

48201

Detroit Medical Center University Laboratories, Detroit

53226

Medical College of Wisconsin, Milwaukee

87102

Tricore Laboratory University of New Mexico, Albuquerque

M5G 1X5

Mount Sinai Hospital Joseph and Wolf Lebovic Health Complex, Toronto

H4A 3J1

McGill University Health Centre, Montreal

Sponsors
All Listed Sponsors
lead

Meridian Bioscience, Inc.

INDUSTRY

NCT02968758 - Validation of the GenePOC CDiff Assay for the Detection of the Toxin B Gene From Toxigenic Clostridium Difficile Strains | Biotech Hunter | Biotech Hunter