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

Meridian Bioscience

Status: Unknown

Conditions: Carbapenem-Resistant Enterobacteriaceae

Treatments: Device: Rectal swab collection

Study type: Interventional

Funder types: Industry

Identifiers

NCT03680898

GPC04-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 2+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,200 participants in 2 patient groups

revogene Testing

Experimental group

Description:

The swab will be used for the testing on the revogene using the GenePOC Carba assay.

Treatment:

Device: Rectal swab collection

Reference Method

Active Comparator group

Description:

The other swab will be used in the Reference Method.

Treatment:

Device: Rectal swab collection