Background

High-risk human papillomavirus (hrHPV) detection in self-collected urine samples (SeCUS) may be a promising alternative for cervical cancer screening because of its greater acceptability, as long as it can offer comparable sensitivity to clinician-collected cervical samples (CCoS) for detecting precancer lesions.

Objective

To evaluate the performance of the SeCUS compared to that of the CCoS for cervical intraepithelial neoplasia grade 3 (CIN3) detection among hrHPV-positive women receiving colposcopy in Mexico City using different specific extended HPV typing procedures: HPV16/18, HPV16/18/35/39/68 or HPV16/18/35/39/68/31.

Methods

From March 2017 to August 2018, 4,158 female users of the cervical cancer screening program at Tlalpan Sanitary Jurisdiction in Mexico City were invited to participate in the FRIDA-Tlalpan study. All participants provided ≥ 30 mL of SeCUS, and then a CCoS was obtained with Cervex-Brush®, which was used for hrHPV typing. Participants who tested positive for hrHPV in CCoS were referred for colposcopy for diagnostic confirmation, and all SeCUS of these women were also tested for hrHPV typing.

Results

In total, 561 hrHPV-positive women were identified by CCoS via colposcopy, and 82.2% of the SeCUS of these women were also hrHPV positive. From both CCoS and SeCUS, 7 cases of CIN3 were detected. Considering HPV16/18 typing, CCoS and SeCUS detected 4 cases of CIN3, but after HPV16/18/35/39/68/31 extension typing, both CCoS and SeCUS detected all 7 of the CIN3 cases among the hrHPV-positive women.

Conclusions

Using extended hrHPV typing based on HPV16/18/35/39/68/31, our results suggest that the performance of SeCUS may be equivalent to that of CCoS for detecting CIN3 lesions. Although our results are inconclusive, they support the hypothesis that SeCUS may be an attractive alternative worthy of further research.

中文翻译：

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在墨西哥城阴道镜诊所就诊的 HPV 阳性女性中，尿液样本与宫颈样本在检测癌前病变方面的性能比较

背景

自收集尿液样本 (SeCUS) 中的高危人乳头瘤病毒 (hrHPV) 检测可能是宫颈癌筛查的一种有前途的替代方案，因为它具有更高的可接受性，只要它能够提供与临床医生收集的宫颈样本 (CCoS) 相当的灵敏度用于检测癌前病变。

客观的

评估 SeCUS 与 CCoS 相比，在墨西哥城接受阴道镜检查的 hrHPV 阳性女性中，使用不同的特定扩展 HPV 分型程序（HPV16/18、HPV16/18/35）检测 3 级宫颈上皮内瘤变 (CIN3) 的性能/39/68 或 HPV16/18/35/39/68/31。

方法

2017年3月至2018年8月，墨西哥城特拉尔潘卫生管辖区宫颈癌筛查项目的4,158名女性用户受邀参加FRIDA-特拉尔潘研究。所有参与者均提供 ≥ 30 mL 的 SeCUS，然后使用 Cervex-Brush® 获得 CCoS，用于 hrHPV 分型。CCoS 中 hrHPV 检测呈阳性的参与者被转诊进行阴道镜检查以进行诊断确认，并且这些女性的所有 SeCUS 也接受了 hrHPV 分型检测。

结果

CCoS 通过阴道镜检查总共鉴定出 561 名 hrHPV 阳性女性，这些女性的 SeCUS 中 82.2% 也为 hrHPV 阳性。从 CCoS 和 SeCUS 中均检测到 7 例 CIN3。考虑到HPV16/18分型，CCoS和SeCUS检测到4例CIN3，但在HPV16/18/35/39/68/31延伸分型后，CCoS和SeCUS在hrHPV阳性女性中检测到全部7例CIN3。

结论

使用基于 HPV16/18/35/39/68/31 的扩展 hrHPV 分型，我们的结果表明 SeCUS 的性能可能与 CCoS 检测 CIN3 病变的性能相当。尽管我们的结果尚无定论，但它们支持这样的假设：SeCUS 可能是一种值得进一步研究的有吸引力的替代方案。