Multicenter Evaluation of the BD Max GBS Assay for Detection of Group B Streptococci in Prenatal Vaginal and Rectal Screening Swab Specimens from Pregnant Women†

A new integrated extraction and real-time PCR-based system for the detection of group B streptococci in antepartum screening samples enriched in Lim broth was compared to the CDC-recommended culture method. The BD Max GBS assay exhibited acceptable sensitivity (95%) and specificity (96.7%) compared to those of the culture method in this multisite evaluation. The number of neonatal group B streptococcus (GBS) in-fections has decreased significantly over the past 4 decades; however, GBS still remains one of the most common causes of neonatal sepsis in the United States (3). Current management guidelines recommend that all pregnant women be screened for vaginal/rectal GBS colonization at 35 to 37 weeks of ges-tation, with those found to be colonized receiving intrapartum antibiotic prophylaxis. While culture-based methods have historically been the gold standard for demonstrating GBS colonization, several recent studies have demonstrated the utility of PCR-based detectio