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

Completed · Not applicable

Conditions studied: Streptococcus Agalactiae Infection

In brief

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.

Key facts

Study ID

NCT02718157

Run by

Meridian Bioscience, Inc.

People needed

771

Starts

2016-08-10

Expected to finish

2017-02-07

Last updated by the study team

2021-05-03

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Specimens without all test results required by this Study Protocol. Specimens that are inadvertently entered into the study that do not meet the specimen inclusion criteria will be made non-compliant.
• The GenePOC GBS System and the Reference Method not performed according to the GenePOC GBS Investigation Documents.

Where it is running

• 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

Full record on ClinicalTrials.gov

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