The Kit is designed for the qualitative detection of the nucleic acid of Streptococcus agalactiae (Group B Streptococcus (GBS)) in eluates from biological specimens. The assay is an in vitro diagnostic medical device and intended to be used by professional users in a laboratory environment. It can be performed manually or using an automated platform. The assay serves as an aid in the diagnosis, screening and monitoring of Streptococcus agalactiae (Group B Streptococcus).
