Obstetrics and Gynecology Department, Cairo University, Giza Governorate, Egypt.
Int J Gynaecol Obstet. 2018 Jun;141(3):332-336. doi: 10.1002/ijgo.12453. Epub 2018 Feb 18.
To assess the sensitivity of a urine test for high-risk HPV DNA genotypes in the detection of high-grade squamous intra-epithelial lesion (HSIL) and its correlation with pathologic precancerous lesions.
The present prospective cross-sectional study included women referred to Kasr AlAiny Medical School, Cairo, Egypt, for cervical smear anomalies, a history of cervical smear anomalies, or for suspicious cervix between May 1, 2015, and April 30, 2017. Paired urine tests and cervical smears were performed. HPV DNA was detected in urine using polymerase chain reaction and cervical smears were performed with a cervical spatula and a cytobrush. Agreement between urine test results and pathology was examined.
In total, 1375 women were included. Urine test for high-risk HPV DNA demonstrated 97.8% (95% confidence interval [CI] 92.1%-99.7%) sensitivity and 100% (95% CI 99.7%-100.0%) specificity for HSIL. Overall, 87 women had a positive urine test for high-risk HPV; of these, 82 (94.3%, 95% CI 87.1%-98.1%) had pathologic findings of cervical intra-epithelial neoplasia 2 or 3 (CIN2/3). Similarly, 89 women had HSIL cytology; again, 82 had CIN2/3 (92.1%; 95% CI, 84.3%-96.4%).
There was good agreement between a positive urine test for high-risk HPV DNA genotypes and pathologic findings of CIN2/3.
评估高危型人乳头瘤病毒(HPV)DNA 基因型尿液检测在发现高级别鳞状上皮内病变(HSIL)及与病理癌前病变的相关性方面的敏感性。
本前瞻性病例对照研究纳入了 2015 年 5 月 1 日至 2017 年 4 月 30 日期间因宫颈涂片异常、宫颈涂片异常史或可疑宫颈而前往埃及开罗 Kasr AlAiny 医学院就诊的女性。进行了配对的尿液检测和宫颈涂片检查。采用聚合酶链反应检测尿液中的 HPV DNA,用宫颈刮板和宫颈刷进行宫颈涂片。检查了尿液检测结果与病理学的一致性。
共纳入 1375 例女性。高危型 HPV DNA 尿液检测对 HSIL 的敏感性为 97.8%(95%置信区间 [CI]:92.1%-99.7%),特异性为 100%(95% CI:99.7%-100.0%)。总的来说,87 例女性的高危型 HPV 尿液检测呈阳性;其中 82 例(94.3%,95% CI:87.1%-98.1%)有宫颈上皮内瘤变 2 或 3(CIN2/3)的病理发现。同样,89 例女性的宫颈细胞学检查为 HSIL;同样,82 例为 CIN2/3(92.1%;95% CI,84.3%-96.4%)。
高危型 HPV DNA 基因型尿液检测阳性与 CIN2/3 的病理发现有较好的一致性。