OBJECTIVE: 

To assess concordance and acceptability of a modified menstrual pad compared with a clinician-collected high-risk human papillomavirus (HPV) sample.

METHODS: 

This was a prospective observational study. Women presenting for either cervical cancer screening or with a history of high-risk HPV positivity were eligible. Three samples were requested from participants: 1) clinician-collected cervical specimens; 2) self-collected vaginal swabs; and 3) a modified menstrual pad, which was taken home for use during the next menstruation. All samples were processed using the Cobas HPV test. Menstrual pad dried blood spots were eluted, then similarly processed.

RESULTS: 

Of 153 women enrolled in the study, 106 provided menstrual pad samples and clinician-collected cervical specimens for high-risk HPV analysis. For samples in which the interval between the clinician-collected specimen and the menstrual pad sample was less than 2 months, the concordance was 94% (95% CI 83–98). For women who tested positive for high-risk HPV who presented for general screening and those with more than cervical intraepithelial neoplasia 2, menstrual pad and clinician-collected specimen agreement was 100% (95% CI 32.5–100). Among participants, 22.9% expressed discomfort with the self-collected vaginal swabs and opted out of collection. Overall, 94.0% of participants preferred the menstrual pad over clinician-collected sampling. Twelve patients were found to be positive for HPV on the menstrual pad sample but negative on the clinician-collected specimen.

CONCLUSION: 

Among women who tested positive for HPV, the menstrual pad showed highly concordant results compared with clinician-collected sampling. This collection approach shows promise for integration into cervical cancer prevention programs.

中文翻译：

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使用被动自采经血筛查高危人乳头瘤病毒

客观的： 

评估改良月经垫与临床医生收集的高危人乳头瘤病毒 (HPV) 样本相比的一致性和可接受性。

方法： 

这是一项前瞻性观察研究。接受宫颈癌筛查或有高危 HPV 阳性病史的女性符合条件。要求参与者提供三个样本：1）临床医生收集的宫颈标本；2）自行采集阴道拭子；3) 改良的月经垫，带回家下次月经时使用。所有样本均使用 Cobas HPV 测试进行处理。洗脱干血点的月经垫，然后进行类似处理。

结果： 

在参加该研究的 153 名女性中，有 106 名提供了月经垫样本和临床医生收集的宫颈样本用于高危 HPV 分析。对于临床医生采集的样本与月经垫样本之间的间隔小于 2 个月的样本，一致性为 94%（95% CI 83–98）。对于接受一般筛查的高危 HPV 检测呈阳性的女性和宫颈上皮内瘤变超过 2 的女性，月经垫和临床医生收集的标本一致性为 100%（95% CI 32.5–100）。在参与者中，22.9% 的人表示对自行收集的阴道拭子感到不适，并选择不收集。总体而言，94.0% 的参与者更喜欢月经垫而不是临床医生收集的样本。

结论： 

在 HPV 检测呈阳性的女性中，与临床医生收集的样本相比，月经垫显示出高度一致的结果。这种收集方法有望融入宫颈癌预防计划。