Validation of the GenePOC CDiff Assay for the Detection of the Toxin B Gene From Toxigenic Clostridium Difficile Strains
Validation of the GenePOC CDiff Assay for the Detection of the Toxin B Gene From Toxigenic Clostridium Difficile Strains
The primary purpose of this clinical investigation is to verify the performance of the
 GenePOC CDiff test on the GenePOC instrument. This will be achieved by comparing the GenePOC
 CDiff test to the Toxigenic Culture (TC) and cell cytotoxicity neutralisation assay (CCNA), a
 conventional method considered as gold standard for detection of toxigenic Clostridium
 difficile in stool specimens.
The GenePOC CDiff test performed on the GenePOC™ instrument is a qualitative in vitro
 diagnostic (IVD) test that utilizes automated sample preparation and real-time polymerase
 chain reaction (rtPCR) to detect the toxin B (tcdB) gene of toxigenic Clostridium difficile
 (C. difficile) in unformed (liquid or soft) stool specimens obtained from patients suspected
 of having C. difficile infection (CDI).

 The GenePOC CDiff system comprises the GenePOC instrument and the GenePOC CDiff test, which
 consists of:

 1. Transfer Loop (TL)

 2. CDiff disposable microfluidic cartridges (PIE) (described in this document as PIEs
 because of the shape of the cartridge)

 3. CDiff Sample Buffer Tube (SBT)

 4. Disposable Transfer Tool (DTT).

 The GenePOC Instrument is fully automated and integrates sample lysis, dilution,
 amplification and detection of the target sequence in complex samples using real-time
 Polymerase chain reaction (rtPCR). User intervention is only required for discharging the
 patient sample into the SBT (sample Buffer Tube), transferring the sample into the PIE and
 for loading/unloading the PIEs into the instrument. The GenePOC instrument consists of a
 rotor to spin the PIEs, temperature control, fluorescence detection, a tactile user-friendly
 interface, two barcode readers, and integrated firmware and software to deliver results to
 the user. The PIE is a closed system that prevents the risk of contamination.

 An unformed (soft or liquid) stool specimen is collected using standard stool collection
 device. Using a disposable 5µL inoculating loop (transfer loop) dipped into the homogenized
 stool specimen, stool material is transferred into SBT and vortexed. Sample is then
 transferred to the GenePOC CDiff PIE. The GenePOC CDiff PIE is then automatically processed
 by the GenePOC Instrument. 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 GenePOC instrument per site will be allocated. The purpose of the clinical investigation
 is to enroll sufficient specimens from up to 7 Clinical Centers to obtain a total of 150
 specimens positive for CDiff based on the Reference Method final result.

 Subject Informed consent is not required for this clinical trial as the testing will be
 performed on excess de-identified specimens only.
Inclusion Criteria:

 -  Unformed Stool specimens from patients suspected of having CDI for whom diagnostic
 tests are indicated and ordered;

 -  At least 1.25mL of unformed stool specimen (defined as specimen assuming the shape of
 its container);

 -  Only one (1) specimen per patient will be included in the study;

 -  Materials use within their expiration date;

 -  Transport, storage times, and conditions (e.g. room temperature and/or refrigerated)
 within requested indications.

 Exclusion Criteria:

 -  Specimens from patients for whom CDI diagnostic tests have not been ordered;

 -  Transport and storage times and conditions that exceed these Study Protocol
 requirements;

 -  Formed or hard stool specimens or rectal swabs.