在首次排空尿液中进行 HPV 检测对 CIN2+ 的检出灵敏度与临床医生取样或刷子自采样相当：来自分层人群的横断面数据。
HPV testing in first-void urine provides sensitivity for CIN2+ detection comparable with a smear taken by a clinician or a brush-based self-sample: cross-sectional data from a triage population.
机构信息
DDL Diagnostic Laboratory, ER Rijswijk, the Netherlands.
Faculty of Medicine-University 9 of Barcelona, Institute of Gynaecology, Obstetrics and Neonatology, Hospital Clínic-Institut d'Investigacions Biomèdiques August Pi I 8 Sunyer (IDIBAPS), Barcelona, Spain.
出版信息
BJOG. 2017 Aug;124(9):1356-1363. doi: 10.1111/1471-0528.14682.
OBJECTIVE
To compare the sensitivity of high-risk human papillomavirus (hrHPV) and genotype detection in self-collected urine samples in the morning (U1), and later on (U2), brush-based self-samples (SS), and clinician-taken smears (CTS) for detecting cervical intraepithelial neoplasia grade 2+ (CIN2+) in a colposcopic referral population.
DESIGN
Cross-sectional single-centre study.
SETTING
A colposcopy clinic in Spain.
POPULATION
A cohort of 113 women referred for colposcopy after an abnormal Pap smear.
METHODS
Women undergoing colposcopy with biopsy for abnormal Pap smears were sent a device (Colli-Pee™, Novosanis, Wijnegem, Belgium) to collect U1 on the morning of colposcopy. U2, CTS, and SS (Evalyn brush™, Rovers Medical Devices B.V., Oss, the Netherlands) were also analysed. All samples were tested for HPV DNA using the analytically sensitive SPF10-DEIA-LiPA25 assay and the clinically validated GP5+/6+-EIA-LMNX.
MAIN OUTCOME MEASURES
Histologically confirmed CIN2+ and hrHPV positivity for 14 high-risk HPV types.
RESULTS
Samples from 91 patients were analysed. All CIN3 cases (n = 6) tested positive for hrHPV in CTS, SS, U1, and U2 with both HPV assays. Sensitivity for CIN2+ with the SPF10 system was 100, 100, 95, and 100%, respectively. With the GP5+/6+ assay, sensitivity was 95% in all sample types. The sensitivities and specificities for both tests on each of the sample types did not significantly differ. There was 10-14% discordance on hrHPV genotype.
CONCLUSIONS
CIN2+ detection using HPV testing of U1 shows a sensitivity similar to that of CTS or brush-based SS, and is convenient. There was substantial to almost excellent agreement between all samples on genotype with both hrHPV assays. There was no advantage in testing U1 compared with U2 samples.
TWEETABLE ABSTRACT
Similar CIN2+ sensitivity for HPV testing in first-void urine, physician-taken smear and brush-based self-sample.
目的
比较高危型人乳头瘤病毒（hrHPV）和基因型检测在晨尿（U1）、随后的尿样（U2）、基于刷子的自我采样（SS）和临床医生采集的涂片（CTS）中检测宫颈上皮内瘤变 2+（CIN2+）的敏感性，用于在阴道镜转诊人群中。
设计
横断面单中心研究。
地点
西班牙的一个阴道镜检查诊所。
人群
因巴氏涂片异常而接受阴道镜检查的 113 名女性队列。
方法
对因巴氏涂片异常而接受阴道镜检查和活检的女性，在阴道镜检查当天早晨，她们会收到一个设备（Colli-Pee™，Novosanis，Wijnegem，比利时）以收集 U1。还分析了 U2、CTS 和 SS（Evalyn 刷子™，Rovers Medical Devices B.V.，Oss，荷兰）。所有样本均使用分析敏感的 SPF10-DEIA-LiPA25 检测法和临床验证的 GP5+/6+-EIA-LMNX 检测 HPV DNA。
主要观察结果
组织学证实的 CIN2+和 14 种高危 HPV 类型的 hrHPV 阳性。
结果
对 91 名患者的样本进行了分析。两种 HPV 检测法均显示，所有 CIN3 病例（n=6）的 CTS、SS、U1 和 U2 中均检测到 hrHPV 阳性。SPF10 系统检测 CIN2+的敏感性分别为 100、100、95 和 100%。使用 GP5+/6+检测法，所有样本类型的敏感性均为 95%。两种检测方法在每种样本类型上的敏感性和特异性均无显著差异。在 hrHPV 基因型方面，有 10-14%的不一致性。
结论
使用 U1 的 HPV 检测，CIN2+的检测具有与 CTS 或基于刷子的 SS 相似的敏感性，并且方便。两种 HPV 检测法的所有样本在基因型上的一致性均为高度一致到几乎完全一致。与 U2 样本相比，U1 样本检测没有优势。
推文摘要
U1 尿液、医生采集的涂片和基于刷子的自我采样的 HPV 检测，CIN2+的敏感性相似。
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