Cepheid has noted that a new article, Evaluation of Universal Antenatal Screening for Group B Streptococcus, published in the June 2009 issue of the New England Journal of Medicine concluded that rapid, PCR-based testing at the time of admission for delivery may improve the accuracy of Group B streptococcal (GBS) screening over the normal antepartum testing done at 35-37 weeks of gestation.
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 David Persing, MD, PhD, Cepheid’s Executive Vice President, Chief Medical & Technology Officer. "As indicated by the study authors, a more accurate way to identify colonization status and target antimicrobial therapy may be to perform a rapid test at or around the time of delivery."
Cepheid’s Xpert® 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 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.