两种筛查宫颈肿瘤方法的比较:ELISA检测宫颈脱落细胞p16^(INK4a)蛋白与FQ-PCR检测8种共用型HPV DNA

Comparison of two methods for screening of cervical carcinoma:detecting p16^(INK4a) in cervical exfoliative cells with ELISA and detecting HR-HPV DNA with FQ-PCR

目的:探讨用ELISA方法检测p16INK4a蛋白在宫颈脱落细胞的表达,筛查宫颈癌。方法:选取宫颈组织活检标本1523例,活检前用棉拭子从标本中获取宫颈脱落细胞。用荧光定量聚合酶链反应(FQ-PCR)法检测宫颈活检组织中8种亚型HR-HPV DNA,用ELISA方法检测宫颈脱落细胞中p16INK4a蛋白的表达。结果:HR-HPV DNA阳性率在CINⅠ、Ⅱ、Ⅲ及宫颈癌中,分别为91.9%,92.8%,94.4%,91.7%,其阳性率与宫颈病变严重程度无显著相关(P=0.893);非肿瘤性病变人群HR-HPV DNA阳性率16.3%;FQ-PCR方法的特异性83.7%。ELISA方法检测宫颈脱落细胞中p16INK4a表达用于筛查宫颈癌及CIN的总体敏感性和特异性分别为87.4%和92.4%,且宫颈病变级别越高,p16INK4a表达越强(r=0.773,P<0.001)。结论:FQ-PCR检测HR-HPV DNA用于筛查宫颈癌及CIN,敏感度高但特异性较低;ELISA检测p16INK4a蛋白表达具有较高的灵敏度和特异性,有望成为宫颈癌新的筛查方法在临床推广使用。

Objection：To explore cervical carcinoma with ELISA to detecting p16^INK4a expression in cervical exfoliative cells. Methods ：1523 specimens who under biopsy were selected. Before biopsy,a cotton swab was used to turning twice at the ectocervical and endocervical parts of the cervix to gather exfoliative cells. Fluorescent quantitated polymerase chain reaction （FQ-PCR） was used to detect HR-HPV（ HPV-16,18,31,33,45,52,56,58） DNA of biopsy; ELISA was employed to measure p16^INK4a protein in exfoliatiave cells. Results：The positive rate of HR-HPV in cervical intraepithelial neoplasia（CIN） Ⅰ , Ⅱ,Ⅲand carcinoma was 91.9% , 92.8% ,94.4% ,91.7% ,respectively. There was no significant relationship between infection rate of HR-HPV and severity of cervical lesion. The specificity of FQ-PCR for screening of cervical cancer and CIN was 83.7%. The sensitivity and specificity of ELISA for screening out significant cervical disease was 87.4% and 92.4% respectively. p16^INK4a expression was correlated with the severity of cervical damage （ r = 0. 773, P〈0. 001 ）. Conclusions ： Detecting HRHPV is sensitive for screening out significant cervix lesion but also with low specificity of 83. 7%. Measuring p16^INK4a witll ELISA for screening out significant cervix lesion is sensitive andspecify. It is prospective to be applied as a new screening tool for cervical carcinoma.