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
|Condition or disease||Intervention/treatment||Phase|
|Clostridium Difficile Infection||Device: Comparison between GenePOC PCR and Reference Method||Not Applicable|
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:
- Transfer Loop (TL)
- CDiff disposable microfluidic cartridges (PIE) (described in this document as PIEs because of the shape of the cartridge)
- CDiff Sample Buffer Tube (SBT)
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2581 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||February 6, 2017|
|Actual Primary Completion Date :||August 2, 2017|
|Actual Study Completion Date :||August 10, 2017|
Experimental: Accuracy Testing
Comparison between GenePOC PCR and Reference Method
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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02968758
|United States, Indiana|
|Wishard Health Services|
|Indianapolis, Indiana, United States, 46202|
|United States, Maryland|
|John Hopkins University School of Medicine|
|Baltimore, Maryland, United States, 21287|
|United States, Michigan|
|Detroit Medical Center University Laboratories|
|Detroit, Michigan, United States, 48201|
|United States, New Mexico|
|Tricore Laboratory University of New Mexico|
|Albuquerque, New Mexico, United States, 87102|
|United States, Wisconsin|
|Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Mount Sinai Hospital Joseph and Wolf Lebovic Health Complex|
|Toronto, Ontario, Canada, M5G 1X5|
|McGill University Health Centre|
|Montreal, Quebec, Canada, H4A 3J1|
|Study Director:||Patrice Allibert||GenePOC|