Department of Obstetrics and Gynecology, School of Medicine, Stanford University, Stanford, and Qurasense Inc., Medical Team, Palo Alto, California; and TriCore Laboratories, Albuquerque, New Mexico.
Obstet Gynecol. 2022 Sep 1;140(3):470-476. doi: 10.1097/AOG.0000000000004904. Epub 2022 Aug 3.
To assess concordance and acceptability of a modified menstrual pad compared with a clinician-collected high-risk human papillomavirus (HPV) sample.
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.
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.
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.
评估改良卫生巾与临床医生采集的高危型人乳头瘤病毒（HPV）样本的一致性和可接受性。
这是一项前瞻性观察性研究。符合条件的参与者为因宫颈癌筛查就诊或有高危 HPV 阳性史的女性。研究要求参与者提供 3 种样本：1）临床医生采集的宫颈标本；2）自我采集的阴道拭子；3）改良的卫生巾，供参与者在下一次月经期间使用。所有样本均采用 Cobas HPV 检测进行处理。对卫生巾干血斑进行洗脱，然后进行同样的处理。
在纳入研究的 153 名女性中，有 106 名提供了用于高危 HPV 分析的卫生巾样本和临床医生采集的宫颈标本。对于间隔时间小于 2 个月的样本，一致性为 94%（95%CI83-98）。对于因一般筛查就诊且 HPV 高危检测阳性的女性，以及患有宫颈上皮内瘤变 2 级以上的女性，卫生巾和临床医生采集标本的一致性为 100%（95%CI32.5-100）。在参与者中，22.9%的人对自我采集的阴道拭子感到不适，因此选择不采集。总体而言，94.0%的参与者更喜欢使用卫生巾而不是临床医生采集样本。有 12 名患者在卫生巾样本中检测到 HPV 阳性，但在临床医生采集的标本中检测为阴性。
在 HPV 检测阳性的女性中，与临床医生采集的样本相比，改良卫生巾显示出高度一致的结果。这种采集方法有望纳入宫颈癌预防计划。
