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使用商业采集富集装置通过聚合酶链反应(PCR)比较自我采集和医护人员采集的直肠阴道拭子在孕期检测B族链球菌中的应用。

Comparison of self-collected and healthcare worker-collected rectovaginal swabs for group B streptococcus detection in pregnancy using PCR with a commercial collection-enrichment device.

作者信息

Kukovica Iva, Omahen Neža, Klobučar Nika, Bučar Martina, Franko Rutar Anita, Perme Tina, Lučovnik Miha, Jeverica Samo

机构信息

Department of Perinatology, University Medical Centre Ljubljana, Ljubljana, Slovenia.

National Laboratory of Health, Environment and Food, Maribor, Slovenia.

出版信息

Front Microbiol. 2025 Feb 5;16:1541319. doi: 10.3389/fmicb.2025.1541319. eCollection 2025.

Abstract

INTRODUCTION

Universal screening for the detection of group B streptococcus (GBS) colonization in pregnant women was recently introduced in Slovenia. The aim of our study was to determine whether self-collection of rectovaginal swabs is a valid alternative to collection by healthcare workers (HCWs).

METHODS

A prospective, multicenter study was conducted between June and November 2023. A total of 227 pregnant women (aged 20 to 44 years) from the University Medical Center Ljubljana ( = 136), the Novo mesto Community Health Center ( = 48) and the Trebnje Community Health Center ( = 43) were included. Two swabs were taken: swab A by the HCWs using standard semi-solid Amies transport medium (Meus; current standard) and swab B by the pregnant woman following visual instructions using a commercial LIM Broth (Copan). Swabs were inoculated onto ChromID Strepto B (STRB) agars directly and after overnight enrichment in LIM broth. The NeuMoDx GBS assay was performed from the enrichment broth. A self-assessment questionnaire was completed after sampling. Performance characteristics were calculated and compared between different diagnostics test algorithms using McNemar's test for paired samples.

RESULTS

Overall, GBS was detected in 18% (95% CI 13-23%;  = 40) of swabs A and 19% (95% CI 14-25%;  = 43) of swabs B. PCR was superior in both groups. In the group of swabs collected by HCWs, 4 (40 vs. 36; 11.1% difference;  = 0.046) and 3 (40 vs. 37; 8.1% difference;  = 0.083) additional positives were detected with PCR compared to direct and enrichment culture, respectively; in the group of self-collected swabs, 4 (43 vs. 39; 10.3% difference;  = 0.046) and 6 (43 vs. 36; 16.2% difference;  = 0.014) additional positives were detected with PCR compared to direct and enrichment culture, respectively. Self-collection showed a trend towards a higher diagnostic yield. PCR after enrichment from self-collected samples was found to be the most sensitive method overall. 58.5% ( = 124/212; 95% CI 52-65%) of women would prefer the swabs taken by HCWs.

DISCUSSION

Self-collection of rectovaginal swabs during pregnancy is a good alternative to HCW-collected swabs. PCR from enrichment broth was better for the detection of GBS compared to enrichment culture. Majority of women preferred swabs taken by HCWs.

摘要

引言

斯洛文尼亚最近开始对孕妇进行普遍筛查以检测B族链球菌(GBS)定植情况。我们研究的目的是确定孕妇自行采集直肠阴道拭子是否是医护人员采集的有效替代方法。

方法

于2023年6月至11月进行了一项前瞻性多中心研究。纳入了来自卢布尔雅那大学医学中心(n = 136)、新梅斯托社区卫生中心(n = 48)和特尔布涅社区卫生中心(n = 43)的227名孕妇(年龄20至44岁)。采集两份拭子:拭子A由医护人员使用标准半固体阿氏运输培养基(Meus;现行标准)采集,拭子B由孕妇按照视觉指示使用商用LIM肉汤(Copan)自行采集。拭子直接接种到ChromID Strepto B(STRB)琼脂上,并在LIM肉汤中过夜富集后接种。从富集肉汤中进行NeuMoDx GBS检测。采样后完成一份自我评估问卷。使用配对样本的McNemar检验计算并比较不同诊断测试算法之间的性能特征。

结果

总体而言,拭子A中18%(95%CI 13 - 23%;n = 40)检测到GBS,拭子B中19%(95%CI 14 - 25%;n = 43)检测到GBS。两组中PCR检测效果均更佳。在医护人员采集的拭子组中,与直接培养和富集培养相比,PCR分别多检测到4例(40例对36例;差异11.1%;p = 0.046)和3例(40例对37例;差异8.1%;p = 0.083)阳性;在自行采集的拭子组中,与直接培养和富集培养相比,PCR分别多检测到4例(43例对39例;差异10.3%;p = 0.046)和6例(43例对36例;差异16.2%;p = 0.014)阳性。自行采集显示出诊断阳性率更高的趋势。总体而言,自行采集样本富集后进行PCR是最敏感的方法。58.5%(n = 124/212;95%CI 52 - 65%)的女性更喜欢医护人员采集的拭子。

讨论

孕期自行采集直肠阴道拭子是医护人员采集拭子的良好替代方法。与富集培养相比,从富集肉汤中进行PCR检测GBS效果更好。大多数女性更喜欢医护人员采集的拭子。

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