Xue Shaolong, Zeng Xi, Li Jing, Kang Leni, Xi Mingrong, Xu Lian, Fu Ping, Zhou Min, Ao Mengyin, Yao Xiaoxi, Li Dongmei, Liao Guangdong
Department of Gynecology, West China Second University Hospital, Sichuan University, Chengdu, China.
Key Laboratory of Birth Defects and Related Diseases of Women and Children, Ministry of Education, Sichuan University, Chengdu, China.
Front Public Health. 2025 Apr 23;13:1524796. doi: 10.3389/fpubh.2025.1524796. eCollection 2025.
Cervical cancer, driven by persistent high-risk human papillomavirus (hrHPV) infection, remains a global health challenge, especially in low- and middle-income areas such as western China. Despite the critical role of HPV testing in early detection, coverage in China remains low due to cultural, psychological, and other barriers. Self-collected urine and vaginal samples offer alternative methods for sample collection. This study aimed to evaluate the feasibility and acceptability of detecting hrHPV and cervical intraepithelial neoplasia grade 2 or worse (CIN2+) via urine and vaginal self-sampling compared with clinician sampling in urban areas of western China.
A cross-sectional survey was conducted from November 2022 to March 2023 in urban areas of western China. The participants provided self-collected urine and vaginal samples for hrHPV testing and completed questionnaires on acceptability of self-sampling. The HPV positivity, agreement, and kappa value were calculated to assess concordance between self- and clinician sampling. The sensitivity, specificity, agreement, predictive values, and likelihood ratios were used to evaluate the clinical performance of both methods for detecting CIN2+.
A total of 2,228 female subjects aged 21-71 years were recruited, and self-collected urine samples, vaginal samples, and clinician-collected cervical samples were obtained. The sensitivity of clinician sampling, urine self-sampling and vaginal self-sampling were 80.00% (95% CI: 44.22-96.46), 70.00% (95% CI: 35.37-91.91) and 90.00% (95% CI: 54.12-99.48) for CIN2+; the specificity for <CIN2 were 98.33% (95% CI: 97.68-98.81), 98.23% (95% CI: 97.56-98.72) and 98.50% (95% CI: 97.87-98.95%); and the agreements for CIN2+ were 98.25% (95% CI: 97.59-98.74), 98.83 (95% CI: 98.26-99.22) and 98.82 (95% CI: 98.25-99.21). All methods yielded high negative predictive values, high positive likelihood ratios, and low negative likelihood ratios. Additionally, participants reported high acceptability of self-sampling, citing less discomfort and embarrassment than clinician sampling.
Self-collected urine and vaginal samples for the detection of hrHPV and CIN2+ demonstrate high diagnostic accuracy and acceptability, making them viable alternatives to clinician-collected samples. Self-sampling methods may improve screening accessibility and compliance, especially in resource-limited settings, thereby supporting the prevention and early detection of CIN2+.
由持续性高危型人乳头瘤病毒(hrHPV)感染引发的宫颈癌仍是一项全球性的健康挑战,在中国西部等低收入和中等收入地区尤为如此。尽管HPV检测在早期检测中起着关键作用,但由于文化、心理和其他障碍,其在中国的覆盖率仍然很低。自行采集尿液和阴道样本为样本采集提供了替代方法。本研究旨在评估与在中国西部城市地区由临床医生采样相比,通过尿液和阴道自行采样检测hrHPV及宫颈上皮内瘤变2级或更严重病变(CIN2+)的可行性和可接受性。
于2022年11月至2023年3月在中国西部城市地区开展了一项横断面调查。参与者自行采集尿液和阴道样本进行hrHPV检测,并完成关于自行采样可接受性的问卷调查。计算HPV阳性率、一致性和kappa值,以评估自行采样与临床医生采样之间的一致性。采用灵敏度、特异度、一致性、预测值和似然比来评估两种检测CIN2+方法的临床性能。
共招募了2228名年龄在21至71岁之间的女性受试者,获取了自行采集的尿液样本、阴道样本以及临床医生采集的宫颈样本。临床医生采样、尿液自行采样和阴道自行采样检测CIN2+的灵敏度分别为80.00%(95%置信区间:44.22 - 96.46)、70.00%(95%置信区间:35.37 - 91.91)和90.00%(95%置信区间:54.12 - 99.48);检测<CIN2的特异度分别为98.33%(95%置信区间:97.68 - 98.81)、98.23%(95%置信区间:97.56 - 98.72)和98.50%(95%置信区间:97.87 - 98.95);检测CIN2+的一致性分别为98.25%(95%置信区间:97.59 - 98.74)、98.83(95%置信区间:98.26 - 99.22)和98.82(95%置信区间:98.25 - 99.21)。所有方法均具有较高的阴性预测值、较高的阳性似然比和较低的阴性似然比。此外,参与者报告自行采样的可接受性较高,称与临床医生采样相比,不适感和尴尬感更少。
自行采集尿液和阴道样本用于检测hrHPV及CIN2+具有较高的诊断准确性和可接受性,使其成为临床医生采集样本的可行替代方法。自行采样方法可能会提高筛查的可及性和依从性,尤其是在资源有限的环境中,从而有助于CIN2+的预防和早期检测。