Group B Strep direct molecular assay
Designed for use on the LIAISON MDX instrument, the highly sensitive SimplexaTM Group B Strep direct assay enables the direct in vitro detection of Group B Streptococcus (GBS DNA). GBS infection is a significant challenge in the health management of women and newborns. The new assay is more specific than traditional testing methods and features an efficient, fast workflow. This assay has also been submitted to the FDA under their Premarket Notification process, to obtain 510(k) clearance. GBS infection is a leading cause of early-onset neonatal sepsis. An estimated one in five pregnant women around the world carries GBS bacteria, which is a major, yet preventable, cause of maternal and infant infection globally. Vertical transmission of GBS to the newborn can result in an invasive infection known as early onset disease (EOD). Infants with EOD will present with fever, lethargy, sepsis, pneumonia and, more rarely, meningitis within the first 24 to 48 hours of life. The World Health Organization estimates that GBS causes 150,000 preventable stillbirths and infant deaths every year.