New England Journal of Medicine Study Highlights Need for Rapid, PCR-based Group B Streptococcus (GBS) Testing at Time of Admission for Labor and Delivery
GBS disease is one of the most common infections in the first week following birth and is a leading cause of infant mortality and serious neonatal infections such as sepsis, pneumonia and meningitis. Transmission of GBS occurs from colonized women to their babies during childbirth.
The new article points out that current U.S. Centers for Disease Control (CDC) guidelines for preventing neonatal GBS disease, which call for culture-based screening of expectant mothers at 35-37 weeks of gestation, have helped to reduce incidence of early-onset GBS disease since their implementation in 2002. However, the study also finds that 61.4% of full-term infants born with GBS disease were born to women who had previously screened negative during their 35-37 week gestation.
“This revealing study shows clearly that screening for GBS at 35 to 37 weeks gestation leaves many newborns at significant risk of GBS infection, presumably due to either false negative culture results or due to a change in GBS status, from negative to positive, over time,” said
Cepheid’s Xpert(R) GBS test is designed to run on a STAT basis, returning positive results in as little as 32 minutes. It is the only in vitro diagnostic test to fully meet current CDC criteria for rapid intrapartum GBS testing. Xpert GBS is also the only PCR-based antepartum and intrapartum GBS test to receive ‘Moderate Complexity’ CLIA categorization by the U.S. Food & Drug Administration (FDA), enabling healthcare professionals such as labor and delivery nurses to run the test near-patient — 24 hours a day, 365 days a year.
Xpert GBS runs on Cepheid’s GeneXpert(R) System, the world’s leading on-demand molecular diagnostic platform.
About the GeneXpert System Molecular Diagnostic Platform
The GeneXpert System is a closed, self-contained, fully-integrated and automated platform that represents a paradigm shift in the automation of molecular analysis, producing accurate results in a timely manner with minimal risk of contamination. The GeneXpert System is the only system to combine on-board sample preparation with real-time PCR (polymerase chain reaction) amplification and detection functions for fully integrated and automated nucleic acid analysis. The system is designed to purify, concentrate, detect and identify targeted nucleic acid sequences thereby delivering answers directly from unprocessed samples. Modular in design, the GeneXpert System has a variety of configurations to meet the broad range of testing demands of any clinical environment.
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