Abstract
BackgroundGroup B Streptococcal (GBS) infections in the United States are a leading cause of meningitis and sepsis in newborns. The CDC therefore recommends GBS screening for all pregnant women at 35–37 weeks of gestation and administration of intrapartum prophylaxis (in those that tested positive) as an effective means of controlling disease transmission. Several FDA approved molecular diagnostic tests are available for rapid and accurate detection of GBS in antepartum women.MethodIn this study, we report a clinical comparison of the Xpert GBS LB assay and a novel FDA-cleared test, Revogene GBS LB assay. A total of 250 vaginal-rectal swabs from women undergoing prenatal screening were submitted to the University of Wisconsin’s clinical microbiology laboratory for GBS testing.ResultsWe found 96.8% of samples were concordant between the two tests, while 3.2% were discordant with a positive percent agreement of 98.0% and a negative percent agreement of 96.5% between the Revogene GBS LB assay and the GeneXpert GBS LB assay.ConclusionOverall, we report that both assays perform well for the detection of GBS colonization in pregnant women.
Highlights
Group B Streptococcal (GBS) infections in the United States are a leading cause of meningitis and sepsis in newborns
We found 96.8% of samples were concordant between the two tests, while 3.2% were discordant with a positive percent agreement of 98.0% and a negative percent agreement of 96.5% between the Revogene GBS LB assay and the GeneXpert GBS LB assay
Overall, we report that both assays perform well for the detection of GBS colonization in pregnant women
Summary
Group B Streptococcal (GBS) infections in the United States are a leading cause of meningitis and sepsis in newborns. Due to the high neonatal mortality rate caused by GBS infections, the Centers for Disease Control (CDC) implemented a universal guideline in 1996 which recommended screening of all pregnant women at 35–37 weeks of gestation and administration of intrapartum prophylaxis in pregnant women that tested positive [1, 5]. Despite these guidelines, infection with GBS remains a leading cause of morbidity in neonates born in the United States and the implementation of more rapid and sensitive screening techniques for GBS detection may further reduce transmission of GBS infection intrapartum [1, 6, 7]. Bacterial culture requires an experienced technician to further identify and test characteristics of GBS such as agglutination and beta hemolysis [1]
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