Solution reagent kit diarellaGBS

diagnosticfor RT-PCRfor DNA qualification

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). 2 Pathogen Information Streptococci mainly colonise mucous membranes in humans. Beta-hemolyzing streptococci of serogroup B (GBS) in the maternal genital tract can be transmitted to the child during birth. The Transmission may lead to early onset illness within the first hours up to 3 days after birth with serious systemic infection and pneumonia. Aetiopathology with shock symptoms and neurologic long-term damages may occur. Late onset illness can be cuased by transmission by the mother or e.g. nursing staff. Early onset infection occurs within app. 1 of 2.000 newborns. The affected majority (app. 80 %) are mature newborns. App. 4 % of the diseased children die. The following factors promote the transmission of GBS: •Presence of GBS in high titers in the maternal genital tract at birth. •Period of more than 18 h between rupture of membranes and confinement. •Maternal fever during birth. •Preterm birth before week 37 of pregnancy. •GBS present in maternal urine during pregnancy. •Previous birth of a child with GBS infection. In order to minimize the risk of GBS-transmission to newborns, pregnant women should be examined between week 35 and 37 of pregnancy.