Department of Obstetrics and Gynecology, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea.
Department of Preventive Medicine, Korea University College of Medicine, Seoul, Korea.
J Gynecol Oncol. 2022 Jan;33(1):e4. doi: 10.3802/jgo.2022.33.e4. Epub 2021 Oct 7.
The human papillomavirus (HPV) test is an effective screening tool to prevent cervical cancer. Urinary sampling for HPV detection improves the accessibility and participation of screening services and reduces the cost and burden on physicians. The clinical accuracy of urinary HPV test has yet to be determined via meta-analysis. This study assessed the clinical accuracy of these tests to detect cervical intraepithelial neoplasia (CIN) 2 or worse.
Relevant studies were identified using the PubMed, Embase, and Cochrane databases. Research eligibility was based on the clinical accuracy of HPV test on clinician-collected samples as a comparator test, and urine as an index test. The reference standard was the presence of CIN2 or worse. The pooled absolute, relative sensitivity, and specificity of the urinary HPV test versus clinician-collected samples were assessed using a bivariate model.
The pooled sensitivity of urinary HPV test was significantly lower than that of clinician-collected samples (ratio=0.84, 95% confidence interval [CI]=0.78-0.91). However, some polymerase chain reaction (PCR)-based HPV test such as GP5+/6+ (relative sensitivity=0.98, 95% CI=0.91-1.05), SPF10 (relative sensitivity=0.98, 85% CI=0.88-1.08) and non GP5+/6+ PCR (relative sensitivity=1.00, 95% CI=0.88-1.14) showed similar sensitivity in both the urine and clinician-collected samples.
Our findings indicate that HPV test with some PCR-based assay on urine versus clinician-collected samples demonstrate similar clinical accuracy to detect CIN2 or worse. It suggests that urinary HPV test may present itself as a decent alternative screening tool for the detection of cervical pre-cancer.
PROSPERO identifier: CRD42021227901.
人乳头瘤病毒（HPV）检测是预防宫颈癌的有效筛查工具。HPV 尿样检测提高了筛查服务的可及性和参与度，同时降低了医生的成本和负担。HPV 尿样检测的临床准确性尚未通过荟萃分析确定。本研究评估了这些检测方法在检测宫颈上皮内瘤变（CIN）2 级及以上病变中的临床准确性。
使用 PubMed、Embase 和 Cochrane 数据库检索相关研究。研究纳入标准为 HPV 检测以临床医生采集的样本为对照试验，尿液为指标试验，评估 HPV 检测在临床上对 CIN2 或更高级别病变的检测准确性。参考标准为 CIN2 或更高级别病变的存在。使用双变量模型评估尿 HPV 检测与临床医生采集样本的汇总绝对、相对敏感性和特异性。
尿 HPV 检测的汇总敏感性明显低于临床医生采集样本（比值=0.84，95%置信区间[CI]=0.78-0.91）。然而，一些基于聚合酶链反应（PCR）的 HPV 检测，如 GP5+/6+（相对敏感性=0.98，95% CI=0.91-1.05）、SPF10（相对敏感性=0.98，85% CI=0.88-1.08）和非 GP5+/6+PCR（相对敏感性=1.00，95% CI=0.88-1.14）在尿液和临床医生采集的样本中均显示出相似的敏感性。
我们的研究结果表明，基于一些 PCR 的 HPV 检测在尿液与临床医生采集的样本中的检测性能相似，均能达到检测 CIN2 或更高级别病变的临床准确性。这表明尿 HPV 检测可能是一种有价值的宫颈癌前病变筛查工具。
PROSPERO 标识符：CRD42021227901。
