Support timely screening with a molecular in vitro diagnostic test designed for the qualitative detection of Group B Streptococcus DNA in rectal swabs, vaginal swabs, or combined rectal/vaginal swab samples from pregnant women.

The test is intended for use at 35–37 weeks of gestation in women with relevant risk factors, and at other stages of pregnancy when clinical conditions such as premature rupture of membranes or threatened preterm labor are present. Results should be interpreted by qualified healthcare professionals together with clinical findings and applicable testing guidelines.