An interventional study of Rectal swab collection in Carbapenem-Resistant Enterobacteriaceae, sponsored by Meridian Bioscience, Inc.. Status unknown at 3 sites in 2 countries. Open to participants aged 2 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-30.
Sponsored by Meridian Bioscience, Inc. · Not applicable, Interventional, and Diagnostic
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.
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:
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.
Meridian Bioscience, Inc. is the lead sponsor of 27 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The swab will be used for the testing on the revogene using the GenePOC Carba assay.
Device: Rectal swab collection
The other swab will be used in the Reference Method.
Device: Rectal swab collection
Patient will provide a rectal swab by following hospital-provided instructions.
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.
Time frame: 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.
Time frame: up to 3 months
Plan to share: No
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This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Meridian Bioscience, Inc.