高危型人乳头瘤病毒E6/E7 mRNA检测在宫颈癌筛查中的意义

Comparative study of HR HPV E6/E7 mRNA and HR-HPV DNA in cervical cancer screening

目的 比较高危型人乳头瘤病毒（HR-HPV） E6/E7 mRNA与HR-HPV DNA检测（HC-2、Cervista）方法在宫颈病变中的诊断性能,探讨其在宫颈病变筛查中的作用及意义.方法 选取201 1年10月至2012年12月就诊于解放军总医院妇产科172例妇女,分别做宫颈脱落细胞的液基细胞学检查（TCT）、HC-2、Cervista、HR-HPV E6/E7 mRNA检测,阴道镜检查及宫颈活体组织检查,以组织学证实的高级别宫颈上皮内瘤变（CIN）Ⅱ或更高（Ⅱ＋）为研究终点.结果 HR-HPV E6/E7mRNA阳性率在未见上皮内病变或恶性（NILM）中为37.9％,在意义不明的非典型鳞状细胞（ASCUS）和低度鳞状上皮内病变（LSIL）中为67.9％（36/53）,在非典型鳞状细胞不能排除高度鳞状上皮内病变（ASC-H＋）中为88.5％ （54/61）.HR-HPV E6/E7 mRNA阳性率在CIN I-中为38.6％,在CINⅡ～Ⅲ为77.4％,在SCC中为92.5％.在CINⅡ＋人群中HR-HPV E6/E7 mRNA检测特异度明显高于HC-2、Cervista（61.4％和54.3％,55.7％,P＜0.05）,并具有更高的阳性预测值（75.9％、74.8％及74.6％）.比较HR-HPV E6/E7 mRNA、HC-2和Cervista的ROC曲线,HR-HPV E6/E7 mRNA曲线下面积最大,诊断效能最佳.结论 HR-HPV E6/E7 mRNA检测在宫颈病变筛查中比HC-2和Cervista检测具有更高特异性,为预测宫颈病变进展及宫颈癌筛查分流提供了新思路.

Objective 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.Methods 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.Results 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.Conclusion 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.