首页> 美国卫生研究院文献>Journal of Clinical Microbiology >Multicenter Study Evaluating Performance of the Smart Group B Streptococcus (GBS) Assay Using an Enrichment Protocol for Detecting GBS Colonization in Patients in the Antepartum Period
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Multicenter Study Evaluating Performance of the Smart Group B Streptococcus (GBS) Assay Using an Enrichment Protocol for Detecting GBS Colonization in Patients in the Antepartum Period

机译:多中心研究评估智能B组链球菌(GBS)测定的性能该方法使用富集方案在产前检测患者GBS的定植

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摘要

Group B streptococcus (GBS) remains the leading cause of infectious morbidity and mortality in infants born in the United States, especially among black infants. Because a newborn can acquire GBS during and after delivery, the Centers for Disease Control and Prevention (CDC) recommends that pregnant women be screened for rectovaginal GBS colonization during the antepartum period between weeks 35 and 37 of gestation and, if they are colonized, that intrapartum antibiotic prophylaxis be administered. A prospective investigational study was undertaken from 2 May 2006 to 14 August 2006 at three sites to establish the performance characteristics of the Smart GBS LB assay on the SmartCycler II system for detecting GBS colonization in subjects in the antepartum period from combined vaginal/rectal swab-based specimens after broth enrichment. Results were compared to broth enrichment culture and to the predicate device, the BD GeneOhm StrepB direct assay. The collected specimens were randomized for swab testing order. Each swab sample was processed simultaneously by culture, Smart GBS LB assay, and the BD GeneOhm StrepB assay. A total of 310 subjects were enrolled, with 306 subject results included in the study. Compared to enrichment culture, the Smart GBS LB assay demonstrated a sensitivity, specificity, positive predictive value, and negative predictive value of 98.6%, 90.4%, 77.1%, and 99.5%, respectively. The Smart GBS LB assay demonstrated substantially equivalent or better performance than culture or the predicate device. Screening of broth enrichment fluids by nucleic acid amplification testing requires careful handling during sample processing to avoid possible contamination.
机译:B组链球菌(GBS)仍然是美国出生的婴儿,尤其是黑人婴儿中传染病发病率和死亡率的主要原因。由于新生儿在分娩期间和分娩后均可获得GBS,因此疾病控制与预防中心(CDC)建议在妊娠的第35至37周的产前期间筛查孕妇的阴道阴道GBS定植,如果定殖,给予产前抗生素预防。从2006年5月2日至2006年8月14日在三个地点进行了一项前瞻性研究,以建立SmartGBS LB检测在SmartCycler II系统上的性能特征,该系统可用于检测阴道/直肠联合拭子在产前期对象中GBS定植。肉汤富集后的基础标本。将结果与肉汤富集培养和谓词设备BD GeneOhm StrepB直接分析相比较。将收集的样本随机抽签进行拭子测试。通过培养,Smart GBS LB测定和BD GeneOhm StrepB测定同时处理每个拭子样品。总共招募了310名受试者,研究中包括306个受试者结果。与富集培养相比,Smart GBS LB检测的灵敏度,特异性,阳性预测值和阴性预测值分别为98.6%,90.4%,77.1%和99.5%。 Smart GBS LB测定法显示出与培养物或谓词装置基本相同或更好的性能。通过核酸扩增测试筛选肉汤浓缩液需要在样品处理过程中小心处理,以避免可能的污染。

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