The GenomEra® GBS assay, performed on the GenomEra® CDX system, is a qualitative in vitro diagnostic (IVD) nucleic acid test for the detection of group B Streptococcus (Straptococcus agalactiae, GBS) from Vaginal-rectal swab samples collected into Copan ESwab transport medium from pregnant intrapartum or antepartum women and from Enrichment broth cultures from vaginal-rectal swab samples collected from antepartum women. Cultures are performed by incubating the swab samples preferably for 4 h or 18–24h, or until growth is detected, in selective enrichment broth medium.
GenomEra® GBS assay testing is indicated for rapid identification of antepartum and intrapartum GBS colonization.
Available in 40 and 200 test kits, and also available without the eSwabs.