Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina.
Department of Obstetrics and Gynecology, Duke University School of Medicine, Durham, North Carolina.
Cancer Epidemiol Biomarkers Prev. 2020 Dec;29(12):2651-2661. doi: 10.1158/1055-9965.EPI-20-0674. Epub 2020 Sep 17.
Primary high-risk human papillomavirus (hr-HPV) testing of self-collected cervico-vaginal swabs could increase cervical cancer screening coverage, although triage strategies are needed to reduce unnecessary colposcopies. We evaluated the use of extended hr-HPV genotyping of self-collected samples for cervical cancer screening.
We recruited women ages 25-65 years at two colposcopy clinics in North Carolina between November 2016 and January 2019, and obtained self-collected cervico-vaginal samples, provider-collected cervical samples, and cervical biopsies from all enrolled women. Self- and provider-collected samples were tested for 14 hr-HPV genotypes using the Onclarity Assay (Becton Dickinson). We calculated hr-HPV genotype-specific prevalence and assessed agreement between results in self- and provider-collected samples. We ranked the hr-HPV genotypes according to their positive predictive value (PPV) for the detection of cervical intraepithelial neoplasia (CIN) grade 2 or higher (CIN2+).
A total of 314 women participated (median age, 36 years); 85 women (27%) had CIN2+. More women tested positive for any hr-HPV on self-collected (76%) than on provider-collected samples (70%; = 0.009) with type-specific agreement ranging from substantial to almost perfect. HPV-16 was the most common genotype in self-collected (27%) and provider-collected samples (20%), and HPV-16 prevalence was higher in self- than provider-collected samples ( < 0.001). In self- and provider-collected samples, HPV-16 had the highest PPV for CIN2+ detection.
Overall sensitivity for CIN2+ detection was similar for both sample types, but the higher HPV-16 prevalence in self-collected samples could result in increased colposcopy referral rates.
Additional molecular markers might be helpful to improve the triage of women who are hr-HPV positive on self-collected samples.
自我采集的宫颈阴道拭子的原发性高危型人乳头瘤病毒（hr-HPV）检测可以增加宫颈癌筛查的覆盖率，但需要采用分流策略来减少不必要的阴道镜检查。我们评估了自我采集样本的 HPV 基因分型扩展检测在宫颈癌筛查中的应用。
我们于 2016 年 11 月至 2019 年 1 月在北卡罗来纳州的两家阴道镜检查诊所招募了 25-65 岁的女性，并为所有入组女性采集了自我采集的宫颈阴道样本、医务人员采集的宫颈样本和宫颈活检。使用 Onclarity 检测试剂盒（Becton Dickinson）对自我和医务人员采集的样本进行了 14 种 hr-HPV 基因型的检测。我们计算了 hr-HPV 基因型的特定流行率，并评估了自我和医务人员采集样本结果之间的一致性。我们根据其对检测宫颈上皮内瘤变（CIN）2 级或更高级别（CIN2+）的阳性预测值（PPV）对 HPV 基因型进行了排序。
共有 314 名女性参与（中位年龄 36 岁），85 名女性（27%）患有 CIN2+。自我采集样本的 HPV 阳性检出率（76%）高于医务人员采集样本（70%； = 0.009），且一致性从高度一致到几乎完美。自我采集样本和医务人员采集样本中最常见的 HPV 基因型均为 HPV-16（分别为 27%和 20%），且自我采集样本中 HPV-16 的检出率高于医务人员采集样本（ < 0.001）。自我采集样本和医务人员采集样本中，HPV-16 对 CIN2+的检测均具有最高的 PPV。
两种样本类型对 CIN2+的总体检出率相似，但自我采集样本中 HPV-16 的高检出率可能会导致阴道镜检查的转诊率增加。
额外的分子标志物可能有助于改善对自我采集样本 HPV 阳性女性的分流。
