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

NCT02968758 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2461

Last updated 2021-05-03

Study results available
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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.

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.

Sponsors & Collaborators

  • Meridian Bioscience, Inc.

    lead INDUSTRY

Principal Investigators

  • Patrice Allibert · Meridian Bioscience, Inc.

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-06
Primary Completion
2017-08-02
Completion
2017-08-10
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02968758 on ClinicalTrials.gov