Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT02718157
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
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
* 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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02718157
Study Brief:
Protocol Section:
NCT02718157