日本妇女自取尿液/阴道样本中的 HPV 基因型检测法在癌症筛查中的实用性。

IF 2 4区 医学 Q2 OBSTETRICS & GYNECOLOGY
Mika Mizuno, Masaki Kamio, Mika Sakihama, Shintaro Yanazume, Shinichi Togami, Tadao Kakizoe, Hiroaki Kobayashi
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引用次数: 0

摘要

目的 在未接受癌症筛查的人群中,浸润性宫颈癌的发病率很高,这是一个严重的问题。本研究旨在探讨将自取尿液和阴道样本中的 HPV 检测结果作为筛查工具的实用性。设计 研究分两步进行。首先,验证适当的储存容器、温度和时间直至尿液 HPV 检测结果。其次,比较在这些条件下的尿液定点检测结果以及妇科医生采集的宫颈样本和自取的阴道样本,以验证对宫颈细胞学异常者使用 BD Onclarity® HPV 检测的可行性。参与者/材料、环境、方法 参与者为 121 名宫颈细胞学检查异常的女性。使用 BD Onclarity® HPV 检测法对自取的尿液和阴道样本以及妇科医生采集的宫颈样本进行 HPV 检测。通过比较不同条件下的 HPV 检测率,确定了尿液样本的最佳储存条件。结果发现,室温下在 BD Probe Tec™ (QxUPT) 中储存少于 72 小时的尿液 HPV 阳性率最高。在这些条件下,对尿液、宫颈和阴道样本中的 HPV 检测率进行了检测。在 41.7% 的宫颈样本中检测到了 HPV 16 型,10% 检测到了 18 型,31 型和 52 型各占 12.6%。临床医生采集的宫颈样本和尿液样本之间的 HPV 检测吻合率为 63.9%(kappa 0.34;95% CI:0.21-0.47),临床医生采集的宫颈样本和自我采集的阴道样本之间的吻合率为 77.8%(kappa 0.68;95% CI:0.53-0.83),表明吻合度良好。在HPV相关病变/肿瘤发病率约为70%的人群中,宫颈、尿液和阴道样本的HPV检测灵敏度分别为82.7%、46.4%和75.7%。局限性 主要的局限性是点滴尿液样本中 HPV 的检测率低于其他样本类型,这表明检测方法还有改进的余地。研究结果是基于特定人群得出的,这可能会限制研究结果的普遍性。结论 我们研究了自取尿液检测的最佳时间和温度。自取阴道和尿液的 HPV 检测与临床医生采集的宫颈 HPV 检测显示出中等-高度的一致性,这表明它们对未定期接受癌症筛查的妇女具有潜在的实用性。不过,定点尿液的灵敏度不高。因此,需要进一步的大规模研究来验证这些发现,并优化检测方法,以鼓励更多的人参与癌症筛查项目。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The Utility of an Human Papillomavirus Genotype Assay for Cancer Screening in Self-Collected Urine and Vaginal Samples from Japanese Women.

Objectives: The high incidence of invasive cervical cancer among those who have not undergone cancer screening is a serious problem. This study aimed to investigate the utility of human papillomavirus (HPV) test results from self-collected urine and vaginal samples as screening tools.

Design: The study was conducted in two steps. First, the appropriate storage container, temperature, and time until urine HPV assay performance were verified. Second, the results of spot urine testing under those conditions and of gynecologist-collected cervical and self-collected vaginal samples were compared to verify the feasibility of using the BD Onclarity® HPV assay for individuals with abnormal cervical cytology.

Participants/materials, setting, methods: The participants were 121 women with abnormal cervical cytology. Self-collected urine and vaginal samples, along with gynecologist-collected cervical samples, were tested for HPV using the BD Onclarity® HPV assay. The optimal conditions for urine sample storage were identified by comparing the HPV detection rates under various conditions.

Results: Urine stored in a BD Probe Tec™ (QxUPT) for less than 72 h at room temperature was found to have the highest HPV positivity rate. Under these conditions, the detection rates of HPV in urine, cervical, and vaginal samples were examined. HPV type 16 was detected in 41.7% of the cervical samples, type 18 in 10%, and types 31 and 52 in 12.6% each. The concordance rate for HPV testing between clinician-collected cervical and urine samples was 63.9% (kappa: 0.34; 95% CI: 0.21-0.47), and that between clinician-collected cervical and self-collected vaginal samples was 77.8% (kappa: 0.68; 95% CI: 0.53-0.83), indicating good concordance. In a population with an HPV-related lesion/tumor prevalence of approximately 70%, the sensitivity of HPV testing was 82.7% for the cervix, 46.4% for urine, and 75.7% for vaginal samples.

Limitations: The primary limitation is the lower detection rate of HPV in spot urine samples than in other sample types, indicating room for methodological improvement. The study's findings are based on a specific population, which may limit generalizability.

Conclusions: We investigated the optimal self-collected urine-to-testing time and temperature. Self-collected vaginal and urine HPV tests show moderate-high concordance with clinician-collected cervical HPV tests, suggesting their potential utility for women who do not undergo regular cancer screening. However, the sensitivity was not high in spot urine. Therefore, further large-scale studies are needed to verify these findings and optimize testing methods to encourage broader participation in cancer screening programs.

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来源期刊
CiteScore
4.20
自引率
4.80%
发文量
44
审稿时长
6-12 weeks
期刊介绍: This journal covers the most active and promising areas of current research in gynecology and obstetrics. Invited, well-referenced reviews by noted experts keep readers in touch with the general framework and direction of international study. Original papers report selected experimental and clinical investigations in all fields related to gynecology, obstetrics and reproduction. Short communications are published to allow immediate discussion of new data. The international and interdisciplinary character of this periodical provides an avenue to less accessible sources and to worldwide research for investigators and practitioners.
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