N/A
Completed N=2,461
Validation of the GenePOC CDiff Assay for the Detection of the Toxin B Gene From Toxigenic Clostridium Difficile Strains
Source: ClinicalTrials.gov NCT02968758 ↗Enrolled (actual)
2,461
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcomePrimary: Performance Characteristics : Clinical Sensitivity (True Positive Rate) and Clinical Specificity (True Negative Rate) in Comparison to the Reference Method — 95.5; 95.2; 93.4; 95.3 percentage of specimens
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Performance Characteristics : Clinical Sensitivity (True Positive Rate) and Clinical Specificity (True Negative Rate) in Comparison to the Reference Method |
95.5; 95.2; 93.4; 95.3 | — |
| SECONDARY Positive and Negative Predictive Values (PPV and NPV) |
82.0; 83.1; 96.8; 98.0 | — |
| SECONDARY Unresolved Sample Results |
1.1; 0.8 | — |
| SECONDARY Indeterminate Sample Results |
1.6; 1.5 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02968758). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.