Yan ChunX, Ma Jiong, Zheng Xia, Shu Jing, Wang XiaoJ, Chen XiaoY, Gao Feng, Li XiaoQ, M ShanQ, Huang LongM, Yu XiaoT, Chen XueJ
The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.
Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China.
Sci Rep. 2025 Jan 20;15(1):2513. doi: 10.1038/s41598-025-86943-7.
To assess the diagnostic accuracy of self-collected urine and vaginal samples for the identification of precancerous cervical lesions in the referral population using high-risk human papillomavirus (hrHPV) assays based on polymerase chain reaction (PCR). It was a prospective study carried out in China from June 2021 to March 2022. The vaginal and urine samples were collected and analyzed by using a newly developed specific hrHPV PCR test, and matched cervical samples were analyzed by using an approved hrHPV DNA test. The primary outcomes were sensitivity for cervical intraepithelial neoplasia 2 or greater (CIN2 +). The secondary outcome was the accuracy of hrHPV findings in urine and vaginal samples compared to cervical samples. A total of 1,701 women were recruited with 113 women excluded. Among 1,588 qualified participants, a total of 203 cases of the CIN2 + group were enrolled in the two centers. The sensitivity and specificity of HPV detection for CIN2 + in urine, vaginal and cervical samples were 86.70% and 36.46%, 90.64% and 30.54%, 93.60% and 26.14%, respectively. The urine sample performed lower sensitivity (p = 0.003) and higher specificity (p < 0.001) than the cervical sample. There was no difference in sensitivity between vaginal and cervical samples (p = 0.146), and the specificity of vaginal samples was higher than that in cervical samples (p < 0.001). The agreement was 78.15% of urine and cervical samples and 85.71% of vaginal and cervical samples. HPV testing on self-collected urine and vaginal samples has acceptable consistency compared with traditional cervical samples. It may be an alternative option for cervical cancer screening. Additional studies are still required to substantiate this issue.
为了评估基于聚合酶链反应（PCR）的高危型人乳头瘤病毒（hrHPV）检测方法，使用自行采集的尿液和阴道样本在转诊人群中识别宫颈癌前病变的诊断准确性。这是一项于2021年6月至2022年3月在中国开展的前瞻性研究。通过使用新开发的特异性hrHPV PCR检测方法对阴道和尿液样本进行采集和分析，并使用经批准的hrHPV DNA检测方法对匹配的宫颈样本进行分析。主要结局指标为宫颈上皮内瘤变2级或更高级别（CIN2+）的敏感性。次要结局指标为尿液和阴道样本中hrHPV检测结果与宫颈样本相比的准确性。共招募了1701名女性，排除了113名女性。在1588名合格参与者中，两个中心共纳入了203例CIN2+组病例。尿液、阴道和宫颈样本中HPV检测对CIN2+的敏感性和特异性分别为86.70%和36.46%、90.64%和30.54%、93.60%和26.14%。尿液样本的敏感性低于宫颈样本（p = 0.003），特异性高于宫颈样本（p < 0.001）。阴道样本和宫颈样本的敏感性无差异（p = 0.146），阴道样本的特异性高于宫颈样本（p < 0.001）。尿液和宫颈样本的一致性为78.15%，阴道和宫颈样本的一致性为85.71%。与传统宫颈样本相比，自行采集的尿液和阴道样本进行HPV检测具有可接受的一致性。它可能是宫颈癌筛查的一种替代选择。仍需要更多研究来证实这一问题。
