Validation of the GenePOC CDiff Assay for the Detection of the Toxin B Gene From Toxigenic Clostridium Difficile Strains

NCT ID: NCT02968758

Last Updated: 2021-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2461 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-06
• Study Completion Date: 2017-08-10

Brief Summary

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.

Detailed Description

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.

Conditions

Clostridium Difficile Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Accuracy Testing

Comparison between GenePOC PCR and Reference Method

Group Type: EXPERIMENTAL

Comparison between GenePOC PCR and Reference Method

Intervention Type: DEVICE

Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain.

Interventions

Comparison between GenePOC PCR and Reference Method

Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meridian Bioscience, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrice Allibert

Role: STUDY_DIRECTOR

Meridian Bioscience, Inc.

Locations

Wishard Health Services

Indianapolis, Indiana, United States

John Hopkins University School of Medicine

Baltimore, Maryland, United States

Detroit Medical Center University Laboratories

Detroit, Michigan, United States

Tricore Laboratory University of New Mexico

Albuquerque, New Mexico, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Mount Sinai Hospital Joseph and Wolf Lebovic Health Complex

Toronto, Ontario, Canada

McGill University Health Centre

Montreal, Quebec, Canada

Countries

United States; Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

GenePOC CDiff_clinical-01

Identifier Type: -

Identifier Source: org_study_id