Clinical Validation of the Molecular-Based GenePOC Carba Assay for the Detection and Differentiation of Carbapenemase Genes 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:

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.

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