Streptococcus IVDs

Intended purpose

The Revogene® GBS DS assay performed on the Revogene® instrument is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from vaginal/rectal swabs obtained from pregnant women. The Revogene GBS DS assay utilizes automated sample processing and real-time polymerase chain reaction (PCR) to detect a cfb gene sequence specific to the Streptococcus agalactiae genome. Revogene GBS DS assay is indicated for the identification of intrapartum GBS colonization and does not provide susceptibility results.It is not intended to diagnose or monitor treatment of GBS infection. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.