Division of Cancer Epidemiology, McGill University, Montreal, Canada.
Gynecologic Cancer Service, McGill University Health Centre - Glen Site Cedars Cancer Centre, Montreal, Canada.
Cancer Epidemiol Biomarkers Prev. 2019 Jul;28(7):1134-1140. doi: 10.1158/1055-9965.EPI-18-1338. Epub 2019 Apr 23.
Self-sampling has become an attractive proposition now that human papillomavirus (HPV) primary testing is being incorporated into cervical cancer screening programs worldwide. We compared predictive values of HPV testing based on self- and physician-collected samples, and cytology, in detecting high-grade cervical intraepithelial neoplasia (CIN).
The Cervical And Self-Sample In Screening (CASSIS) study enrolled 1,217 women ages 16-70 years prior to scheduled colposcopies. Vaginal specimens were self-collected using the validated HerSwab device. Cervical specimens were collected by gynecologists. Specimens were tested for presence of high-risk HPV (hrHPV) by the Cobas 4800 HPV test. We estimated positive predictive values (PPV) and negative predictive values (NPV) and 95% confidence intervals (CI) for a subset of women ( = 700) who underwent cervical biopsy and cytology at the actual CASSIS visit.
hrHPV was detected in 329 women (47%) with HerSwab and in 327 (46.7%) with physician sampling. Respective values for HPV16/18 were 119 (17%) and 121 (17.3%). On histology, 134 women had CIN1, 49 had CIN2, 48 had CIN3, 5 had CIN2/CIN3, and 3 had cancers. PPVs for CIN2 of any hrHPV were 28% (95% CI, 23.2-33.1) and 29.7% (95% CI, 24.8-34.9) for HerSwab and physician samples, respectively. Corresponding values for HPV16/18 were 43.7% (95% CI, 34.6-53.1) and 43.8% (95% CI, 34.8-53.1). PPV of cytology (ASC-US+) was 26.6% (95% CI, 21.6-32.0). Corresponding NPVs (same order as PPVs) were 96.4% (95% CI, 93.9-98.1), 97.8% (95% CI, 95.6-99), 90.9% (95% CI, 88.2-93.1), 91% (95% CI, 88.4-93.2), and 94.7% (95% CI, 91.8-96.8).
Our results confirm that HPV self-sampling has comparable performance with a physician-collected sample in detecting cervical lesions.
HPV self-sampling has the potential to increase coverage in cervical cancer screening.
由于人乳头瘤病毒（HPV）初筛检测已被纳入全球宫颈癌筛查计划，因此自我采样已成为一种极具吸引力的选择。我们比较了基于自我和医生采集样本的 HPV 检测在检测高级别宫颈上皮内瘤变（CIN）方面的预测值。
在计划行阴道镜检查前，Cervical And Self-Sample In Screening（CASSIS）研究纳入了 1217 名年龄在 16-70 岁的女性。使用经过验证的 HerSwab 设备对阴道标本进行自我采集。由妇科医生采集宫颈标本。使用 Cobas 4800 HPV 检测试剂盒检测标本中高危型 HPV（hrHPV）的存在情况。我们对实际 CASSIS 就诊时接受宫颈活检和细胞学检查的部分女性（=700 名）的阳性预测值（PPV）和阴性预测值（NPV）及其 95%置信区间（CI）进行了估计。
用 HerSwab 检测到 329 名女性（47%）和用医生采样检测到 327 名女性（46.7%）存在 hrHPV。HPV16/18 的相应值分别为 119 名（17%）和 121 名（17.3%）。在组织学检查中，134 名女性患有 CIN1，49 名女性患有 CIN2，48 名女性患有 CIN3，5 名女性患有 CIN2/CIN3，3 名女性患有癌症。任何 hrHPV 的 CIN2 的 PPV 分别为 28%（95%CI，23.2-33.1）和 29.7%（95%CI，24.8-34.9），用于 HerSwab 和医生样本。HPV16/18 的相应值分别为 43.7%（95%CI，34.6-53.1）和 43.8%（95%CI，34.8-53.1）。细胞学检查（ASC-US+）的 PPV 为 26.6%（95%CI，21.6-32.0）。相应的 NPV（与 PPV 相同顺序）分别为 96.4%（95%CI，93.9-98.1）、97.8%（95%CI，95.6-99）、90.9%（95%CI，88.2-93.1）、91%（95%CI，88.4-93.2）和 94.7%（95%CI，91.8-96.8）。
我们的研究结果证实，HPV 自我采样在检测宫颈病变方面与医生采集样本具有相当的性能。
HPV 自我采样有可能提高宫颈癌筛查的覆盖率。
