Validation of the GenePOC GBS Assay for the Detection of the Cfb Gene From Streptococcus Agalactiae Strains

NCT ID: NCT02718157

Last Updated: 2021-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 771 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-10
• Study Completion Date: 2017-02-07

Brief Summary

The primary purpose of this clinical investigation is to verify the performance of the GenePOC GBS Assay on the GenePOC Instrument. This will be achieved by comparing the Assay to the a Culture, a conventional method for detection of Streptococcus agalactiae in vaginal/rectal swab specimens from antepartum women.

Detailed Description

The GenePOC GBS Test performed on the GenePOC System is a qualitative in vitro diagnostic (IVD) test designed to detect Group B Streptococcus (GBS) DNA from vaginal/rectal swabs from antepartum women following enrichment in Lim broth for 18-24 hours.

The GenePOC GBS Test utilizes automated sample preparation and real-time polymerase chain reaction (PCR) to detect a cfb gene sequence specific to the Streptococcus agalactiae genome. The GenePOC GBS Test is indicated for the identification of antepartum GBS colonization and does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.

The GenePOC GBS is an IVD system is comprised of the GenePOC Diagnostics System and the GenePOC Group B Step [GBS] Test, the components of which are:

1. Instrument

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

3. GBS Sample Buffer Tube (SBT)

4. Sample Transfer Device (STD).

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.

Lim Broth is used for the selective enrichment of group B streptococci (Streptococcus agalactiae). An aliquot of the broth is mixed with GenePOC Sample Buffer Tube Reagent (SBT), after which a sample is transferred to the GenePOC GBS PIE. The GenePOC GBS 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 four (4) Clinical Centers to obtain a total of 150 specimens positive for GBS 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

Streptococcus Agalactiae 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

Antepartum women swab specimen incubated in Lim Broth will be tested with the GenePOC GBS test on the GenePOC Instrument. The results will be compared to Reference Method defined as incubated Lim broth subcultured onto blood agar plate for observation of a Streptococcus agalactiae strain.

Interventions

Comparison between GenePOC PCR and Reference Method

Antepartum women swab specimen incubated in Lim Broth will be tested with the GenePOC GBS test on the GenePOC Instrument. The results will be compared to Reference Method defined as incubated Lim broth subcultured onto blood agar plate for observation of a Streptococcus agalactiae strain.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Antepartum pregnant women
• 18 years old and more
• Being at a gestation period of 35 to 37 weeks.
• Vaginal/rectal swab specimen
• Transport and storage times, and conditions (e.g. room temperature and/or refrigerated) within the labeled indications.

• Fresh specimens available to be tested with the GenePOC GBS System within 96 hours (4 days) of collection if kept at 2-25°C
• Fresh specimens must be tested with the Reference Method within 96 hours (4 days) of collection if kept at 2-25°C
• The GenePOC GBS System and the Reference Method will be performed according to the GenePOC GBS Investigation Documents.
• Materials use within their expiration date

• The GenePOC GBS System and the Reference Method not performed according to the GenePOC GBS Investigation Documents.

Exclusion Criteria

• Non pregnant women
• Less than 18 years old
• Gestation not between 35-37 weeks
• Transport and storage times and conditions that exceed these Study Protocol requirements
• The GenePOC GBS System and the Reference Method not performed according to the GenePOC GBS Investigation Documents
• Materials used beyond their expiration date

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• 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

Detroit Medical Center University Laboratories

Detroit, Michigan, United States

Tricore Laboratory University of New Mexico

Albuquerque, New Mexico, United States

Mount Sinai Hospital Joseph and Wolf Lebovic Health Complex

Toronto, Ontario, Canada

CHU de Québec - Université Laval

Québec, , Canada

Countries

United States; Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

GenePOC-GBS_clinical-01

Identifier Type: -

Identifier Source: org_study_id