BACKGROUND Group 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. METHOD In 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. RESULTS 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. CONCLUSION Overall, we report that both assays perform well for the detection of GBS colonization in pregnant women.

中文翻译：

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Revogene GBS LB测定法与GeneXpert GBS LB测定法在产前筛查样本中检测B组链球菌的比较研究。

背景技术在美国，B组链球菌（GBS）感染是新生儿脑膜炎和败血症的主要原因。因此，疾病预防控制中心建议对所有妊娠35-37周的孕妇进行GBS筛查，并进行产前预防（在检测为阳性的孕妇中），作为控制疾病传播的有效手段。有几种FDA批准的分子诊断测试可用于快速，准确地检测产前女性的GBS。方法在本研究中，我们报告了Xpert GBS LB测定法与FDA批准的新型测试Revogene GBS LB测定法的临床比较。总共250例接受产前筛查的女性阴道直肠拭子已提交威斯康星大学临床微生物学实验室进行GBS检测。结果我们发现96。两次测试之间有8％的样品一致，而Revogene GBS LB测定和GeneXpert GBS LB测定之间的3.2％不一致，正百分比一致性为98.0％，负百分比一致性为96.5％。结论总的来说，我们报告说这两种检测方法在检测孕妇GBS定植方面表现良好。