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

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ClinicalTrials.gov Identifier: NCT02968758
Recruitment Status : Completed
First Posted : November 21, 2016
Last Update Posted : August 14, 2017
Sponsor:
Information provided by (Responsible Party):
GenePOC

November 15, 2016
November 21, 2016
August 14, 2017
February 6, 2017
August 2, 2017   (Final data collection date for primary outcome measure)
Performance characteristics : clinical sensitivity (true positive rate) and clinical specificity (true negative rate) in comparison to the Reference Method [ Time Frame: At the time of the results with Reference Method is confirmed, up to 3 months ]
To establish the performance characteristics of the GenePOC CDiff System for its use in determining the presence of CDiff in liquid/unformed stool specimen obtained from patients suspected of having C. difficile infection (CDI). Sensitivity will be established as the proportion of positives that are correctly identified by the GenePOC CDiff System, when compared to the Reference Method. Specificity will be established as the proportion of negatives that are correctly identified by the GenePOC CDiff System, when compared to the Reference Method.
Not Provided
Complete list of historical versions of study NCT02968758 on ClinicalTrials.gov Archive Site
  • Positive and Negative Predictive Values (PPV and NPV) [ Time Frame: At the time of the results with Reference Method is confirmed, up to 3 months ]
    To estimate the Positive and Negative Predictive Values (PPV and NPV) of the GenePOC CDiff System. PPV will be calculated as the proportion of positive results with the GenePOC CDiff System that are true positive results, when compared to the Reference Method. PNV will be calculated as the proportion of negative results with the GenePOC CDiff System that are true negative results, when compared to the Reference Method.
  • Unresolved sample results [ Time Frame: At the time of the results with Reference Method is confirmed, up to 3 months ]
    To estimate the rate of unresolved results for the GenePOC CDiff System due to Sample Processing control failure (unresolved sample results).
  • Indeterminate sample results [ Time Frame: At the time of the results with Reference Method is confirmed, up to 3 months ]
    To estimate the rate of indeterminate results for the GenePOC CDiff Test due to an Instrument failure (indeterminate sample results).
  • Reproducibility of positive and negative results [ Time Frame: 3 months ]
    To determine the reproducibility between sites of the GenePOC CDiff System. Reproducibility of positive and negative results will be measured between days, operators, runs and laboratories.
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Validation of the GenePOC CDiff Assay for the Detection of the Toxin B Gene From Toxigenic Clostridium Difficile Strains
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
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.

The GenePOC CDiff test performed on the GenePOC™ instrument is a qualitative in vitro diagnostic (IVD) test that utilizes automated sample preparation and real-time polymerase chain reaction (rtPCR) to detect the toxin B (tcdB) gene of toxigenic Clostridium difficile (C. difficile) in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection (CDI).

The GenePOC CDiff system comprises the GenePOC instrument and the GenePOC CDiff test, which consists of:

  1. Transfer Loop (TL)
  2. CDiff disposable microfluidic cartridges (PIE) (described in this document as PIEs because of the shape of the cartridge)
  3. CDiff Sample Buffer Tube (SBT)
  4. Disposable Transfer Tool (DTT).

The GenePOC Instrument is fully automated and integrates sample lysis, dilution, amplification and detection of the target sequence in complex samples using real-time Polymerase chain reaction (rtPCR). User intervention is only required for discharging the patient sample into the SBT (sample Buffer Tube), transferring the sample into the PIE and for loading/unloading the PIEs into the instrument. The GenePOC instrument consists of a rotor to spin the PIEs, temperature control, fluorescence detection, a tactile user-friendly interface, two barcode readers, and integrated firmware and software to deliver results to the user. The PIE is a closed system that prevents the risk of contamination.

An unformed (soft or liquid) stool specimen is collected using standard stool collection device. Using a disposable 5µL inoculating loop (transfer loop) dipped into the homogenized stool specimen, stool material is transferred into SBT and vortexed. Sample is then transferred to the GenePOC CDiff PIE. The GenePOC CDiff PIE is then automatically processed by the GenePOC Instrument. On completion of a run, the user removes the processed PIEs from the instrument and discards them according to local biological waste management procedures.

One GenePOC instrument per site will be allocated. The purpose of the clinical investigation is to enroll sufficient specimens from up to 7 Clinical Centers to obtain a total of 150 specimens positive for CDiff based on the Reference Method final result.

Subject Informed consent is not required for this clinical trial as the testing will be performed on excess de-identified specimens only.

Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Clostridium Difficile Infection
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.
Experimental: Accuracy Testing
Comparison between GenePOC PCR and Reference Method
Intervention: Device: Comparison between GenePOC PCR and Reference Method
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2581
Not Provided
August 10, 2017
August 2, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT02968758
GenePOC CDiff_clinical-01
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Plan to Share IPD: No
GenePOC
GenePOC
Not Provided
Study Director: Patrice Allibert GenePOC
GenePOC
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP