Carbapenem-Resistant Enterobacteriaceae
Conditions
Keywords
Carbapenem, rectal swab, infectious disease, infection
Brief summary
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
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: 1. Sample Buffer Tube (SBT) 2. Disposable Transfer Tool (DTT) 3. 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.
Interventions
DEVICERectal swab collection
Patient will provide a rectal swab by following hospital-provided instructions.
Sponsors
Meridian Bioscience, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance characteristics : Clinical sensitivity (true positive rate) in comparison to the Reference Method | up to 3 months | 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. |
| Performance characteristics : clinical specificity (true negative rate) in comparison to the Reference Method | up to 3 months | 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. |
Countries
Canada, United States
Outcome results
None listed