In 2017, the South African National Department of Health (NDoH) Cervical Cancer Prevention and Control Policy was revised. Human papillomavirus (HPV) testing on self-collected samples may offer improved screening uptake. The objectives of the study were to compare the positivity of high-risk (hr)-HPV deoxyribonucleic acid (DNA) and hrHPV viral messenger ribonucleic acid (mRNA) between healthcare worker-collected cervical and self-collected vaginal samples and investigate the accuracy of the applicator-tampon-based self-collected samples in detecting hrHPV DNA and hrHPV mRNA. A total of 527 women aged 18 years and older and seeking gynecology services at a tertiary hospital in Pretoria, South Africa, were enrolled. Vaginal samples were self-collected using SelfCerv applicator tampon, followed by cervical samples collected by a healthcare worker using a Cervex Brush® Combi. Both samples were tested with the Abbott m2000 analyzer for 14-hrHPV types and 285 paired samples were tested for hrHPV E6/E7 mRNA using the Aptima HR-HPV mRNA assay. The prevalence of hrHPV DNA and hrHPV E6/E7 mRNA was estimated and the positivity between the two collection methods was compared for the total group as well as per age group. HrHPV prevalence was 48.0% (95% CI 43.7–52.4) among healthcare worker collected samples and 47.6% (95% CI 43.3–52.0) among self-collected samples. There was no difference in positivity between healthcare worker collection (48.0%) and applicator-tampon-based self-collection, 47.6% (p-value = 0.90). The proportions of hrHPV were equal between the age groups as shown by the McNemar test (p = 0.9036) results for correlated proportions. The prevalence of hrHPV mRNA was 78.6% (95% CI 73.4–83.2) and 58.6% (95% CI 52.6–64.4) for healthcare worker- and self-collection, respectively. The McNemar test for correlated proportions was highly significant (p < 0.0001), indicating that the hrHPV mRNA proportions are not comparable, although this differed between age groups. Applicator-tampon-based self-collection has a comparable hrHPV DNA positivity rate as healthcare worker collection but different positivity rates for hrHPV mRNA. Self-sampling showed high concordance with healthcare worker-collected sampling for hrHPV DNA detection, especially regarding HPV 16/18 detection. HrHPV DNA was equally detected between the total group as well as per age group. Implementation of self-sampling using an applicator tampon as a primary screening tool may be considered.

中文翻译：

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与医护人员在南非比勒陀利亚一家三级医院妇科诊所就诊的妇女中收集的宫颈样本相比，在自行收集的阴道样本中检测到高风险人乳头瘤病毒

2017年，南非国家卫生部（NDoH）宫颈癌防控政策进行了修订。对自行收集的样本进行人乳头瘤病毒 (HPV) 检测可能会提高筛查率。该研究的目的是比较医护人员采集的宫颈样本和自行采集的阴道样本中高危 (hr)-HPV 脱氧核糖核酸 (DNA) 和 hrHPV 病毒信使核糖核酸 (mRNA) 的阳性率，并调查其准确性。基于涂抹器-卫生棉条的自收集样本用于检测 hrHPV DNA 和 hrHPV mRNA。共有 527 名年龄在 18 岁及以上并在南非比勒陀利亚的三级医院寻求妇科服务的女性被纳入研究。使用 SelfCer 涂抹器卫生棉条自行收集阴道样本，然后是医护人员使用 Cervex Brush® Combi 采集的宫颈样本。两个样本均使用 Abbott m2000 分析仪检测 14-hrHPV 类型，并使用 Aptima HR-HPV mRNA 测定法检测 285 个配对样本的 hrHPV E6/E7 mRNA。估计了hrHPV DNA和hrHPV E6/E7 mRNA的流行率，并比较了总组和每个年龄组的两种收集方法之间的阳性率。HrHPV 患病率在医护人员收集的样本中为 48.0% (95% CI 43.7–52.4)，在自行收集的样本中为 47.6% (95% CI 43.3–52.0)。医护人员收集 (48.0%) 和基于涂抹器-卫生棉条的自我收集之间的阳性率没有差异，为 47.6% (p 值 = 0.90)。McNemar 检验显示不同年龄组间 hrHPV 的比例相等（p = 0. 9036) 相关比例的结果。医护人员和自我收集的 hrHPV mRNA 的患病率分别为 78.6% (95% CI 73.4–83.2) 和 58.6% (95% CI 52.6–64.4)。相关比例的 McNemar 检验非常显着（p < 0.0001），表明 hrHPV mRNA 比例不具有可比性，尽管这在年龄组之间有所不同。基于涂抹器-卫生棉条的自我收集具有与医护人员收集相当的 hrHPV DNA 阳性率，但 hrHPV mRNA 的阳性率不同。自我采样与医护人员收集的用于 hrHPV DNA 检测的采样高度一致，特别是在 HPV 16/18 检测方面。HrHPV DNA 在总组之间以及每个年龄组中均被检测到。