美国一项自行收集尿液与临床收集宫颈样本检测HPV和宫颈上皮内瘤变2级或更差的研究：横断面一致性和诊断准确性研究

IF 2.4 3区医学 Q2 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH

Preventive Medicine Reports Pub Date : 2025-08-30 DOI:10.1016/j.pmedr.2025.103222

Alisa P. Young , Marie Claire O'Dwyer , Roger Smith , Dongru Chen , Ananda Sen , Heather M. Walline , Diane M. Harper , MISSH1 study group

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引用次数: 0

摘要

目的尿液检测可为高危人乳头瘤病毒（hrHPV）感染提供一种无创筛查方法。我们的目的是比较hrHPV和宫颈上皮内瘤变2级或更糟（CIN2+）的检出率，使用首次空尿（FVU）和临床收集的宫颈样本。我们评估了收集FVU的时间是否影响hrHPV检测。方法：从2020年9月至2022年2月，我们招募了188名30-65岁的参与者，在他们进行阴道镜检查或常规筛查之前。每个人在同一天收集两次FVU：在家里和在预约前的诊所。我们使用流行校正偏倚校正kappa （PABAK）评分来比较hrHPV类型特异性的一致性，然后进行McNemar的精确测试。我们评估了绝对和相对敏感性和特异性，以评估收集技术预测hrHPV类型CIN2+的准确性。结果188例妇女中有70例（37.2%）hrHPV感染95例。FVU与窥镜检测hrHPV16的PABAK一致性为0.95 （95% CI: 0.91, 1.0）。家庭或诊所尿液采集与窥镜标本检测hrHPV的一致性几乎是完美的。临床首空标本与窥镜标本的敏感性比测定hrHPV16 CIN2+检测的准确性为1.00（0.62,6.20）。所有其他hrHPV类型的大多数特异性比锚定在1.0，具有狭窄的置信区间。一天中FVU的时间给出了相似的“任何hrHPV”检出率（27.5% vs 32%, p > 0.05）。结论fvu hrHPV检测为不能耐受其他集合的妇女提供了一种潜在的宫颈癌筛查选择。

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A United States study of self-collected urine vs clinician-collected cervical sample for HPV and cervical intraepithelial neoplasia grade two or worse detection: Cross-sectional agreement and diagnostic accuracy study

Objectives

Urine can provide a non-invasive screening method for high-risk human papillomavirus (hrHPV) infections. We aimed to compare detection rates of hrHPV and cervical intraepithelial neoplasia grade two or worse (CIN2+) using first-void urine (FVU) and clinician-collected cervical samples. We assessed whether the time of day of FVU collection impacts hrHPV detection.

Methods

We recruited 188 participants, 30–65 years, before their colposcopy or routine screening from September 2020 through February 2022. Each collected FVU twice on the same day: at home and in the clinic before their appointments. We used prevalence-adjusted bias-adjusted kappa (PABAK) scores to compare hrHPV type-specific agreement, followed by McNemar's Exact test. We assessed both absolute and relative sensitivity and specificity to evaluate the accuracy of the collection techniques in predicting CIN2+ by hrHPV type.

Results

95 hrHPV infections were detected in 70/188 (37.2 %) women. The PABAK agreement for hrHPV16 detection between FVU and the speculum was 0.95 (95 % CI: 0.91, 1.0). The agreement for hrHPV detection was almost perfect between home or clinic urine collection and the speculum specimen. The accuracy of CIN2+ detection measured by the sensitivity ratio of the clinic first-void specimen compared to the speculum specimen for hrHPV16 was 1.00 (0.62, 6.20). Most specificity ratios for all other hrHPV types were anchored at 1.0 with narrow confidence intervals. The time of day for FVU gave similar “any hrHPV” detection rates (27.5 % vs 32 %, p > 0.05).