Department of Obstetrics and Gynecology, Korea University Guro Hospital, College of Medicine, Korea University, Seoul, Republic of Korea.
Department of Obstetrics and Gynecology, Korea University Ansan Hospital, College of Medicine, Korea University, Ansan, Republic of Korea.
J Virol Methods. 2019 Jul;269:77-82. doi: 10.1016/j.jviromet.2019.04.012. Epub 2019 Apr 15.
Human papillomavirus (HPV) is well established as the main cause of cervical cancer. Non-invasive self-collected urine and vaginal sampling have the potential advantage of increasing patient compliance with cervical cancer screening.
Self-collected vaginal and urine samples and clinician-collected cervical samples were collected from 101 patients, including 84 patients with high grade squamous intraepithelial lesion and 17 patients with benign ovarian disease. Each sample was evaluated with RealTime HR-S HPV, Anyplex™ II HPV, and Cobas HPV assays. The concordance of urine and of self-collected vaginal samples with cervical samples was assessed using the kappa (k) statistic.
In any high-risk HPV (hrHPV), the concordance of self-collected vaginal and urine samples compared to cervical samples was moderate (k 0.49-0.58) and fair to moderate (k 0.33-0.51), respectively. In HPV 16/18, the concordance of vaginal and urine samples compared to cervical samples was almost perfect (k 0.81-0.86) and moderate to substantial (k 0.59-0.63), respectively. Among the three methods for HPV detection, RealTime HR-S showed the highest concordance with vaginal (k: any hrHPV 0.58, HPV 16/18 0.86) and urine samples (k: any hrHPV 0.51, HPV 16/18 0.63) compared to cervical samples.
HPV tests using self-collected vaginal samples and urine showed substantial and moderate agreement compared with cervical samples, respectively, although HPV tests using these samples were still inferior to clinician-collected cervical samples. Further research is needed on the clinical performance of HPV testing using urine and self-collected vaginal samples as the screening method.
人乳头瘤病毒（HPV）已被充分确认为宫颈癌的主要病因。非侵入性的自我采集尿液和阴道样本采集方法具有提高患者宫颈癌筛查依从性的潜在优势。
从 101 名患者中采集了自我采集的阴道和尿液样本以及临床医生采集的宫颈样本，包括 84 名高级别鳞状上皮内病变患者和 17 名良性卵巢疾病患者。每个样本均使用 RealTime HR-S HPV、Anyplex™ II HPV 和 Cobas HPV 检测方法进行评估。使用 Kappa（k）统计量评估尿液样本和自我采集的阴道样本与宫颈样本的一致性。
在任何高危型 HPV（hrHPV）中，自我采集的阴道和尿液样本与宫颈样本的一致性为中度（k 值为 0.49-0.58）和中等到中度（k 值为 0.33-0.51）。在 HPV 16/18 中，与宫颈样本相比，阴道和尿液样本的一致性几乎是完美的（k 值为 0.81-0.86）和中度到显著（k 值为 0.59-0.63）。在 HPV 检测的三种方法中，RealTime HR-S 与阴道样本（k：任何 hrHPV 0.58，HPV 16/18 0.86）和尿液样本（k：任何 hrHPV 0.51，HPV 16/18 0.63）的一致性最高，与宫颈样本相比。
与宫颈样本相比，自我采集的阴道样本和尿液样本的 HPV 检测分别显示出显著和中度的一致性，尽管使用这些样本的 HPV 检测仍不如临床医生采集的宫颈样本。需要进一步研究使用尿液和自我采集的阴道样本作为筛查方法的 HPV 检测的临床性能。
