An interventional study of Comparison between GenePOC PCR and Reference Method in Clostridium Difficile Infection, sponsored by Meridian Bioscience, Inc.. Completed at 7 sites in 2 countries. Per ClinicalTrials.gov, last updated 2021-05-03.
Sponsored by Meridian Bioscience, Inc. · Not applicable, Interventional, and Diagnostic
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:
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.
310 studies on the registry are indexed under Clostridium Infections; 50 are open to participants now.
This study's enrollment of 2,461 is above the median of 65 across 233 interventional studies indexed under Clostridium Infections.
Browse Clostridium Infections studies →Meridian Bioscience, Inc. is the lead sponsor of 27 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
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.
Time frame: At the time of the results with Reference Method is confirmed, up to 3 months
Positive and Negative Predictive Values (PPV and NPV)
To estimate the Positive and Negative Predictive Values (PPV and NPV) of the GenePOC CDiff System. PPV is the percentage of true positives out of all positive results (true positive/true positive + false positive). NPV is the percentage of true negatives out of all negative results (true negative/true negative +false negative.).
Time frame: At the time of the results with Reference Method is confirmed, up to 3 months
Unresolved Sample Results
To estimate the rate of unresolved results for the GenePOC CDiff System due to Sample Processing control failure (unresolved sample results).
Time frame: At the time of the results with Reference Method is confirmed, up to 3 months
Indeterminate Sample Results
To estimate the rate of indeterminate results for the GenePOC CDiff Test due to an Instrument failure (indeterminate sample results).
Time frame: At the time of the results with Reference Method is confirmed, up to 3 months
| Milestone | Accuracy Testing - Fresh Specimen | Accuracy Testing - Frozen Specimen |
|---|---|---|
| Started | 797 | 1664 |
| Completed | 797 | 1664 |
| Not completed | 0 | 0 |
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.
| percentage of specimens | Accuracy Testing - Fresh Specimen | Accuracy Testing - Frozen Specimen |
|---|---|---|
| Sensitivity | 95.5 (87.3 to 99.1) | 95.2 (90.8 to 97.9) |
| Specificity | 93.4 (91.4 to 95.1) | 95.3 (94.1 to 96.3) |
To estimate the Positive and Negative Predictive Values (PPV and NPV) of the GenePOC CDiff System. PPV is the percentage of true positives out of all positive results (true positive/true positive + false positive). NPV is the percentage of true negatives out of all negative results (true negative/true negative +false negative.).
| percentage of specimens | Accuracy Testing - Fresh Specimen | Accuracy Testing - Frozen Specimen |
|---|---|---|
| PPV | 82.0 (73.6 to 88.6) | 83.1 (77.7 to 87.7) |
| NPV | 96.8 (95.2 to 98.0) | 98.0 (97.2 to 98.7) |
To estimate the rate of unresolved results for the GenePOC CDiff System due to Sample Processing control failure (unresolved sample results).
| percentage of Unresolved | Accuracy Testing - Fresh Specimen | Accuracy Testing - Frozen Specimen |
|---|---|---|
| Unresolved Sample Results | 1.1 (0.52 to 2.13) | 0.8 (0.42 to 1.33) |
To estimate the rate of indeterminate results for the GenePOC CDiff Test due to an Instrument failure (indeterminate sample results).
| percentage of Indeterminates | Accuracy Testing - Fresh Specimen | Accuracy Testing - Frozen Specimen |
|---|---|---|
| Indeterminate Sample Results | 1.6 (1.16 to 2.20) | 1.5 (0.78 to 2.61) |
Collected over Adverse event were assessed at the time of individual patient enrollment and participation, which lasts approximately 1-2 minutes at most.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Accuracy Testing | 0/2,461 (0%) | 0/2,461 (0%) | 0/2,461 (0%) |
all specimens were included
| Age, Categorical(Participants) | Accuracy Testing - Fresh Specimen | Accuracy Testing - Frozen Specimen | Total |
|---|---|---|---|
| <=18 years | 34 | 80 | 114 |
| Between 18 and 65 years | 399 | 800 | 1199 |
| >=65 years | 364 | 784 | 1148 |
| Sex/Gender, Customized(Participants) | Accuracy Testing - Fresh Specimen | Accuracy Testing - Frozen Specimen | Total |
|---|---|---|---|
| All Genders | — | — | 0 |
| Race and Ethnicity Not Collected(Participants) | Accuracy Testing - Fresh Specimen | Accuracy Testing - Frozen Specimen | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Accuracy Testing - Fresh Specimen | Accuracy Testing - Frozen Specimen | Total |
|---|---|---|---|
| Canada | 79 | 0 | 79 |
| United States | 718 | 1664 | 2382 |
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Meridian Bioscience, Inc.