This study was designed to compare the performance of GeneXpert® and GenomEra® group B streptococcus (GBS) PCR assays, held up against standard culture of GBS performed with and without broth pre-enrichment. In Denmark, the strategy for preventing early onset GBS infection (EOGBS) is risk factor based. Three hundred and sixty six women fulfilling one or more of the criteria for presence of risk factors for EOGBS were prospectively included. Rectovaginal swab samples were taken intrapartum and tested bed-site by the GenomEra® and the GeneXpert® GBS PCR assays and cultured at the microbiology laboratory using Granada agar plates with and without prior growth of sampling material in selective enrichment broth. Among 366 participants tested intrapartum, 99 were GBS-positive by culture, 95 by GenomEra, and 95 by GeneXpert. Compared with culture, the GenomEra and the GeneXpert performed with a sensitivity of 91.8% and 91.7% and a specificity of 98.1% and 97.3%, respectively. A combined reference standard was established by defining true positives as either culture-positive samples or culture-negative samples where both the GeneXpert and the GenomEra GBS PCR assays were positive. Using this, the sensitivity increased to 92.2% and the specificity to 99.6% for GenomEra and to 92.0% and 96.8% for GeneXpert. The use of selective broth enrichment found only three additional GBS culture-positive samples. The performance of the two PCR methods examined was very similar and close to the findings by culture, and both PCR assays are thus applicable as rapid intrapartum bed-site tests.

这项研究旨在比较GeneXpert®和GenomEra®B组链球菌（GBS）PCR检测的性能，该检测与有或没有肉汤预富集的GBS标准培养物相提并论。在丹麦，预防早期发作GBS感染（EOGBS）的策略基于风险因素。前瞻性地纳入了三百六十六名符合EOGBS危险因素存在标准的妇女。产后采集阴道拭子样品，并通过GenomEra®和GeneXpert®GBS PCR测定法在病床现场进行测试，并在微生物实验室中使用Granada琼脂平板在有和没有事先在选择性富集肉汤中生长采样材料的情况下进行培养。在366名接受产后测试的参与者中，有99名文化培养的GBS阳性，95名GenomEra和95名GeneXpert。与文化相比 GenomEra和GeneXpert的灵敏度分别为91.8％和91.7％，特异性为98.1％和97.3％。通过将真阳性定义为GeneXpert和GenomEra GBS PCR检测均为阳性的培养阳性样品或培养阴性样品来建立组合参考标准。使用此方法，GenomEra的敏感性提高到92.2％，特异性提高到99.6％，GeneXpert的特异性提高到92.0％和96.8％。使用选择性肉汤富集仅发现了三个额外的GBS培养阳性样品。所检查的两种PCR方法的性能非常相似，并且与培养结果相近，因此这两种PCR方法都可以用作产时快速产地的快速检测。分别。通过将真阳性定义为GeneXpert和GenomEra GBS PCR检测均为阳性的培养阳性样品或培养阴性样品来建立组合参考标准。使用此方法，GenomEra的敏感性提高到92.2％，特异性提高到99.6％，GeneXpert的特异性提高到92.0％和96.8％。使用选择性肉汤富集仅发现了三个额外的GBS培养阳性样品。所检查的两种PCR方法的性能非常相似，并且与通过培养获得的结果非常接近，因此这两种PCR检测方法都可以用作产时快速产位检测。分别。通过将真阳性定义为GeneXpert和GenomEra GBS PCR检测均为阳性的培养阳性样品或培养阴性样品来建立组合参考标准。使用此方法，GenomEra的敏感性提高到92.2％，特异性提高到99.6％，GeneXpert的特异性提高到92.0％和96.8％。使用选择性肉汤富集仅发现了三个额外的GBS培养阳性样品。所检查的两种PCR方法的性能非常相似，并且与培养结果相近，因此这两种PCR方法都可以用作产时快速产地的快速检测。GenomEra的敏感性提高到92.2％，特异性提高到99.6％，GeneXpert的特异性提高到92.0％和96.8％。使用选择性肉汤富集仅发现了三个额外的GBS培养阳性样品。所检查的两种PCR方法的性能非常相似，并且与培养结果相近，因此这两种PCR方法都可以用作产时快速产地的快速检测。GenomEra的敏感性提高到92.2％，特异性提高到99.6％，GeneXpert的特异性提高到92.0％和96.8％。使用选择性肉汤富集仅发现了三个额外的GBS培养阳性样品。所检查的两种PCR方法的性能非常相似，并且与培养结果相近，因此这两种PCR方法都可以用作产时快速产地的快速检测。