HPV E6/E7 mRNA、HPV DNA和TCT检测在宫颈上皮内瘤变筛查中的应用

目的分析人乳头瘤病毒(human papillomavirus,HPV)E 6/E 7 mRNA、第二代杂交捕获技术(hybrid Capture,HCⅡ)和薄层液基细胞学技术(thinprep cytology test,TCT)在宫颈上皮内瘤变(cervical intraepithelial neoplasia,CIN)筛查中的效能,选择适宜的分流筛查方案。方法采用病例-对照研究设计,80例CINⅠ~+的病例样本为HCⅡ或TCT筛查阳性并经组织学诊断;132例正常或炎症标本包括:组织学诊断正常或炎症的标本;HCⅡ阴性,TCT阴性且HPV E 6/E 7 mRNA均为阴性的标本。检测方法分别为:TCT进行细胞学检测、用b-DNA技术检测其HPV E 6/E 7 mRNA和用HCⅡ检测HPV DNA。结果在212例正常或宫颈炎和CIN标本中,HCⅡ的阳性率(37.74%)显著高于HPV E 6/E 7 mRNA的阳性率(25.94%)(P0.05);与TCT的阳性率(31.60%)比较差异无统计学意义(P0.05)。TCT的检出率高于HPV E 6/E 7mRNA的检出率,但差异无统计学意义(P0.05)。HPV E 6/E 7 mRNA与HCⅡ的符合率最高,Kappa为0.733,P=0.000;其次为HC II和TCT的符合率,Kappa为0.564,P=0.000;HPV E 6/E 7 mRNA与TCT的符合率,Kappa仅为0.519,P=0.000。并且,在HCⅡ检测结果阳性的67例CINⅠ~+样本中,HPV E 6/E 7 mRNA检测或TCT检测结果皆为阳性。而在HCⅡ阳性的13例正常或炎症样本中,HPVE 6/E 7 mRNA+或TCT结果阳性仅有7例(53.85%)。结论在CINⅠ~+分流筛查方案中,HPV E 6/E 7 mRNA和TCT共同作为HCⅡ阳性分流筛查的方法,可有效降低HCⅡ的假阳性。

The application of HPV E6/E7 mRNA,HPV DNA and TCT in screeningfor cervical intraepithelial neoplasia

Objective Assessing the efficacy of human papillomavirus (HPV) E6/E7 mRNA, hybrid capture Ⅱ (HCⅡ) and thinprep cytology test (TCT) screening for cervical intraepithelial neoplasia (CIN), and modified the screening program.Methods A case-control study was designed, including 80 patients with CINⅠ+ HCⅡ or TCT screening positive and histologically diagnosed, and 132 cases of negative control specimens including histological diagnosis of normal or inflammatory specimens;HC Ⅱ negative, TCT negative and HPV E6 / E7 mRNA were negative specimens.Every cervical cell sample was tested by all tests of the TCT, HCⅡ and b-DNA for HPV E6/E7 mRNA.Results The positive rate of HCⅡ detected (37.74％) was significantly higher than that of HPV E 6 / E 7 mRNA (25.94％) in 212 normal or cervicitis and CIN specimens (P <0.05), but was not significantly different from TCT positive rate (31.60％)(P>0.05).And the positive rate of TCT was not significant difference from HPV E6 / E7 mRNA (P>0.05).The concordance between HPV E6/E7 mRNA and HCⅡ was highest, and Kappa value was 0.733,P=0.000.The next was HCⅡ and TCT, Kappa value was 0.564, P=0.000.The concordance between HPV E6/E7 mRNA and TCT was lowest, and Kappa value was 0.519, P=0.000.Additionally, in 67 CINⅠ + cases with HCⅡ positive, HPV E6 / E7 mRNA or TCT test result was positive.Furthermore, in 13 CIN1 negative cases with HCⅡ positive, there were 7 (53.85％) cases with HPV E6 / E7 mRNA or TCT positive.Conclusion Screening for CINⅠ+, TCT and HPV E6/E7 mRNA tiage for HCⅡ positive could significantly decrease the false positive rate.