一种用于检测人乳头瘤病毒和宫颈上皮内瘤变的专用尿液检测方法的临床性能
Clinical Performance of a Dedicated Urine-Based Assay for the Detection of Human Papillomavirus and Cervical Intraepithelial Neoplasia.
作者信息
Zhao Yun, Zhao Lijun, Wang Zhaohuang, Cui Shuhui, Ren Chenchen, Yang Li, Bai Yang, Zhu Yuanhang, Xie Jingyan, Li Yujuan, Wu Xiaoqing, Feng Jing, Man Shanqing, Huang Longmei, Li Xiaoqi, Yu Xiaotian, Wang Jianliu
机构信息
Department of Obstetrics and Gynecology, Peking University People's Hospital, Beijing, People's Republic of China.
Department of Obstetrics and Gynecology, The Third Affiliated Hospital of Zhengzhou University, National Clinical Research Center for Obstetrics and Gynecology, Zhengzhou Key Laboratory of Cervical Disease, Zhengzhou Key Laboratory of Endometrial Disease Prevention and Treatment, Zhengzhou, Henan, People's Republic of China.
出版信息
Int J Womens Health. 2023 Dec 4;15:1909-1916. doi: 10.2147/IJWH.S424621. eCollection 2023.
OBJECTIVE
The objective of this study is to assess the clinical performance of a urine-based high-risk human papillomavirus (hrHPV) test for the detection of cervical intraepithelial neoplasia grade 2 or higher (CIN2+).
METHODS
Between September and December 2021, women aged 20 to 65 years referred to colposcopy clinic were prospectively recruited at three clinical centers in China. Paired urine and cervical specimens from all enrolled women were obtained for hrHPV DNA fluorescence quantitative PCR test. The results of liquid-based cytology (LBC), colposcopy and diagnostic biopsies were collected. We evaluated the sensitivity and specificity for CIN and assessed the agreement/kappa value.
RESULTS
A total of 732 women (median age, 40 years) with valid results were included in the study, and 130 (17.8%) women were histologically confirmed as CIN2+. The sensitivity of urine and cervical test for CIN2+ and CIN3+ were 87.69% and 85.45%, respectively. The specificity of urine test performed better than cervical test in women with <CIN 2. The overall agreement of hrHPV detection between urine and cervical specimens was 80.74%, with higher agreement for types 16 and 18 (91.67% and 96.58%).
CONCLUSION
The data suggested that the urine-based hrHPV test may be an alternative approach for cervical cancer screening.
目的
本研究旨在评估基于尿液的高危型人乳头瘤病毒（hrHPV）检测用于检测宫颈上皮内瘤变2级或更高级别（CIN2+）的临床性能。
方法
2021年9月至12月期间，在中国三个临床中心前瞻性招募了20至65岁转诊至阴道镜诊所的女性。收集所有入组女性的配对尿液和宫颈标本，进行hrHPV DNA荧光定量PCR检测。收集液基细胞学（LBC）、阴道镜检查和诊断性活检的结果。我们评估了对CIN的敏感性和特异性，并评估了一致性/卡帕值。
结果
共有732名（中位年龄40岁）结果有效的女性纳入研究，其中130名（17.8%）女性经组织学确诊为CIN2+。尿液检测和宫颈检测对CIN2+和CIN3+的敏感性分别为87.69%和85.45%。在CIN<2的女性中，尿液检测的特异性优于宫颈检测。尿液和宫颈标本之间hrHPV检测的总体一致性为80.74%，16型和18型的一致性更高（分别为91.67%和96.58%）。
结论
数据表明，基于尿液的hrHPV检测可能是宫颈癌筛查的一种替代方法。
Zotero 插件