Zhao Xuye, Cui Yong, Jiang Shufang, Meng Yuanguang, Liu Aijun, Wei Linping, Liu Tongyu, Han Haiqiong, Liu Xiaosu, Liu Fuhong, Li Yali
Chinese PLA General Hospital & Chinese PLA Medical School, Beijing 100853, China.
Email:
Zhonghua Yi Xue Za Zhi. 2014 Nov 25;94(43):3432-5.
To determine the performance of HR-HPV E6/E7 massager RNA (mRNA) test for detecting high-grade cervical intraepithelial neoplasia in cervical cancer screening and compare the clinical performance of HR-HPV E6/E7 mRNA test with HC-2 and Cervista HPV DNA tests for cross-sectional positivity in women with and without cervical neoplasia.
A total of 172 women underwent cytology, HR-HPV DNA test, HR-HPV E6/7 mRNA test, colposcopy and biopsy. We compared the clinical performance of HR-HPV E6/E7 mRNA test with Hybrid Capture 2 DNA test (HC-2) and Cervista HR-HPV DNA test on the cervical brush specimens during colposcopy and routine screening. The samples were histologically confirmed high-grade cervical intraepithelial neoplasia (CIN II) or worse (CIN II+) as an endpoint.
HR-HPV E6/E7 mRNA positive rate was 37.9% in NILM, 67.9% in ASCUS and LSIL, 88.5% in ASC-H+. HR-HPV E6/E7 mRNA positive rate was 38.6% in CIN I, 77.4% in CIN II-3 and 92.5% in SCC. HR-HPV E6/E7 mRNA test showed a higher specificity than HC-2 and Cervista HPV DNA tests for high-grade lesions (61.4%, 54.3%, 55.7%, respectively, P < 0.05) and also a higher positive predictive value (75.9%, 74.8%, 74.6% respectively). Among three tests, HR-HPV E6/E7 mRNA had the largest area of ROC curve and the best diagnostic value.
HR-HPV E6/E7 mRNA test has a performance more specific for detecting CIN II+ with the same sensitivity as HC-2 and Cervista HPV DNA tests. And it may serve as a more specific test for predicting the risk of progression and offer a viable tool for triage during cervical cancer screening.
确定高危型人乳头瘤病毒（HR-HPV）E6/E7信使核糖核酸（mRNA）检测在宫颈癌筛查中检测高级别宫颈上皮内瘤变的性能，并比较HR-HPV E6/E7 mRNA检测与HC-2和Cervista HPV DNA检测在有或无宫颈肿瘤女性中的横断面阳性率的临床性能。
共有172名女性接受了细胞学检查、HR-HPV DNA检测、HR-HPV E6/7 mRNA检测、阴道镜检查和活检。我们在阴道镜检查和常规筛查期间比较了HR-HPV E6/E7 mRNA检测与杂交捕获2 DNA检测（HC-2）和Cervista HR-HPV DNA检测在宫颈刷标本上的临床性能。样本经组织学证实为高级别宫颈上皮内瘤变（CIN II）或更严重（CIN II+）作为终点。
HR-HPV E6/E7 mRNA在无上皮内病变或恶性病变（NILM）中的阳性率为37.9%，在非典型鳞状细胞不能明确意义（ASCUS）和低度鳞状上皮内病变（LSIL）中为67.9%，在非典型鳞状细胞不排除高度鳞状上皮内病变（ASC-H+）中为88.5%。HR-HPV E6/E7 mRNA在CIN I中的阳性率为38.6%，在CIN II-III中的阳性率为77.4%，在鳞状细胞癌（SCC）中的阳性率为92.5%。HR-HPV E6/E7 mRNA检测对高级别病变的特异性高于HC-2和Cervista HPV DNA检测（分别为61.4%、54.3%、55.7%，P<0.05），阳性预测值也更高（分别为75.9%、74.8%、74.6%）。在三项检测中，HR-HPV E6/E7 mRNA的曲线下面积最大，诊断价值最佳。
HR-HPV E6/E7 mRNA检测在检测CIN II+方面具有更高的特异性，其敏感性与HC-2和Cervista HPV DNA检测相同。它可能作为一种更具特异性的检测方法来预测进展风险，并为宫颈癌筛查期间的分流提供一种可行的工具。
