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

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.