Clinical Research and R&D Department, Laboratoire Européen, Alphabio - Biogroup, Marseille, France.
FCRIN INSERM US015, CHU de Toulouse, Hôpital PURPAN, Toulouse, France.
PLoS One. 2021 Nov 18;16(11):e0260021. doi: 10.1371/journal.pone.0260021. eCollection 2021.
BACKGROUND & AIM: Screening for genital infection (GI) such as bacterial vaginosis (BV) and yeast infection, for sexually transmitted infection (STI), and for asymptomatic carriage of group B streptococcus (GBS) in pregnant women are common reason for medical appointments. The diagnosis and control of GIs, STIs, and GBS are major issues, for fertility and overall well-being of affected women. Conventional testing is performed using vaginal/cervical classical sampling (VCS); this procedure requires pelvic examination performed by health care professionals which raises concerns among women. Vaginal-self-sampling (VSS), as an alternative to VCS, might capture more women. The aim was first to show non-inferiority of VSS compared with VCS to screen for GIs, STIs, and GBS; second to determine the feasibility of VSS.
VSS and VCS from 1027 women were collected by health care professionals and simultaneously carried out on each patient. GIs, STIs, and GBS were systematically screened in both paired VSS and VCS samples. Non-inferiority of VSS compared with VCS was assessed using z statistic for binomial proportions.
Prevalence of GIs were 39.7% using VSS and 38.1% using VCS (p = 0.0016). Prevalence of STIs was 8.5% (VSS) vs 8.1% (VCS) (p = 0.0087). Prevalence of GBS was 13.4% (VSS) and 11.5% (VCS) (p = 0.0001). Most participants (84%) recommended the use of VSS.
This study shows that VSS was not inferior to VCS for the detection of GIs, STIs, and GBS. This study provides evidence that VSS can be used as a universal specimen for detection of lower genital tract infections in women.
ID-RCB 2014-A01250-4.
筛查孕妇的生殖道感染（GI），如细菌性阴道病（BV）和酵母菌感染、性传播感染（STI）以及 B 组链球菌（GBS）无症状携带，是妇产科就诊的常见原因。GI、STI 和 GBS 的诊断和控制是影响女性生育和整体健康的主要问题。传统的检测方法是使用阴道/宫颈经典采样（VCS）；该程序需要由医疗保健专业人员进行盆腔检查，这引起了女性的担忧。阴道自我采样（VSS）作为 VCS 的替代方法，可能会捕获更多的女性。本研究的目的首先是证明 VSS 筛查 GI、STI 和 GBS 与 VCS 相比不劣效；其次是确定 VSS 的可行性。
由医护人员收集 1027 名女性的 VSS 和 VCS，并同时对每位患者进行采样。系统地对 VSS 和 VCS 配对样本进行 GI、STI 和 GBS 筛查。使用二项式比例的 z 统计量评估 VSS 与 VCS 相比的非劣效性。
使用 VSS 的 GI 患病率为 39.7%，使用 VCS 的 GI 患病率为 38.1%（p=0.0016）。STI 的患病率为 8.5%（VSS）与 8.1%（VCS）（p=0.0087）。GBS 的患病率为 13.4%（VSS）和 11.5%（VCS）（p=0.0001）。大多数参与者（84%）推荐使用 VSS。
本研究表明，VSS 在检测 GI、STI 和 GBS 方面并不逊于 VCS。本研究提供了证据，证明 VSS 可作为女性下生殖道感染的通用标本。
ID-RCB 2014-A01250-4。
