Clinical Validation of the Molecular-Based GenePOC Carba Assay for the Detection and Differentiation of Carbapenemase Genes in Rectal Swab Samples.

Study Overview
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Brief Summary
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The primary purpose of this clinical investigation is to establish the performance of the GenePOC Carba assay on the revogene. This will be achieved by comparing the test to a conventional method for detection of Carbapenemase Producing Organisms (CPOs) in rectal swab samples.

Detailed Description
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The GenePOC Carba assay will be performed using the revogene instrument. The revogene instrument, used in conjunction with appropriate reagents, is capable of automated cell lysis, dilution of nucleic acids from multiple sample types as well as automated amplification and detection of target nucleic acid sequences. The GenePOC Carba assay reagents kits consist of: Sample Buffer Tube (SBT) Disposable Transfer Tool (DTT) Disposable microfluidic cartridges (PIE) The test is performed using the revogene™. The revogene automates sample homogenization, sample dilution, cells lysis, DNA amplification, and detection of the amplified PCR products. User intervention is only required for discharging the patient sample into the Sample Buffer Tube (SBT), transferring the sample into the PIE, and loading/unloading the PIEs into the revogene carousel. A dual swab sample is collected when ICF is signed by patient. One of the swab is transferred into the SBT and vortexed. Sample is then transferred to the GenePOC Carba PIE. The PIE is then automatically processed by the revogene. 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 revogene will be allocated per site. The purpose of this clinical trial is to enroll sufficient patients from up to 14 Clinical Centers to meet regulatory requirements, based on the Reference Method final results.

Official Title
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Prospective Study for Clinical Validation of the Molecular-Based GenePOC Carba Assay for the Detection and Differentiation of Carbapenemase Genes of Gram-negative Bacteria (blaIMP, blaKPC, blaNDM, blaOXA-48-like and blaVIM) in Rectal Swab Samples From Patients Suspected of Being Colonized. The Targeted Organisms Are Enterobacteriaceae, Acinetobacter Baumannii, and Pseudomonas Aeruginosa.

Conditions
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Carbapenem-Resistant Enterobacteriaceae

Intervention / Treatment
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* Device: Rectal swab collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Samples from patients who were previously diagnosed to be infected with CPOs, or were identified per hospital policies as being suspected or are at risk for CPO infection; Patient that signed the approved Informed Consent Form (if applicable) Patient older than 2 years of age (>24.0 months) Only one (1) compliant sample per patient is allowed Exclusion Criteria: Patient/sample not meeting inclusion criteria above

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: revogene Testing<br>The swab will be used for the testing on the revogene using the GenePOC Carba assay. | Device: Rectal swab collection<br>* Patient will provide a rectal swab by following hospital-provided instructions.<br>|
| Active Comparator: Reference Method<br>The other swab will be used in the Reference Method. | Device: Rectal swab collection<br>* Patient will provide a rectal swab by following hospital-provided instructions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance characteristics : Clinical sensitivity (true positive rate) in comparison to the Reference Method | To establish the performance characteristics of the GenePOC Carba assay for its use in determining the presence of CPO/CPE in rectal swab samples obtained from patients suspected of being infected, or considered at risk. Sensitivity will be estimated as the proportion of positives that are correctly identified by the Carba assay when compared to the Reference Method. | up to 3 months | 
| Performance characteristics : clinical specificity (true negative rate) in comparison to the Reference Method | To establish the performance characteristics of the GenePOC Carba assay for its use in determining the presence of CPO/CPE in rectal swab samples obtained from patients suspected of being infected, or considered at risk. Sensitivity will be estimated as the proportion of positives that are correctly identified by the Carba assay when compared to the Reference Method. | up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carbapenem, rectal swab, infectious disease, infection