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目的评价多聚酶链反应(PCR)基础上的人乳头瘤病毒(HPV)DNA检测方法与杂交捕获Ⅱ代(HC-Ⅱ)在宫颈HPV感染检测及宫颈病变诊断中的应用价值。方法选取2005年8月至2008年4月间于中日友好医院就诊的3个特定的机会性筛查人群,分别为310例、600例和1012例,分别用三种PCR基础上的检测方法(简称PCR方法),即导流杂交基因芯片技术(HybriMax)、实时荧光定量PCR法(FQ-PCR)和流式荧光杂交法进行宫颈细胞标本HPVDNA检测。用HC-Ⅱ检测作为对照。比较PCR方法与HC-Ⅱ的检测结果符合率和Kappa指数(KI),以及对≥宫颈上皮内瘤变(CIN)Ⅱ病变的敏感度、特异度、阳性预测值(PPV)和阴性预测值(NPV)。结果 HybriMax、FQ-PCR、流式荧光杂交法和HC-Ⅱ检测HPVDNA结果的总符合率分别为92.3%、86.7%、86.1%,KI分别为0.796、0.722、0.721,一致性好。流式荧光杂交法与HC-Ⅱ比较,前者敏感度、特异度、PPV、NPV(88.8%、66.6%、54.2%和91.7%)均低于后者(93.1%、74.2%、60.1%和96.5%),差异均有统计学意义(P<0.05),另两种方法与HC-Ⅱ相似。结论三种PCR方法检测HPVDNA结果与HC-Ⅱ一致性好。对诊断≥CINⅡ宫颈病变的敏感度、特异度、PPV、NPV,HybriMax和FQ-PCR与HC-Ⅱ相似,而流式荧光杂交法逊于HC-Ⅱ。
Objective To evaluate the diagnostic value of human papillomavirus (HPV) DNA detection based on polymerase chain reaction (PCR) and hybrid capture Ⅱ (HC-Ⅱ) in the detection of cervical HPV infection and cervical lesions. Methods Three specific opportunistic screening patients at the China-Japan Friendship Hospital between August 2005 and April 2008 were selected, which were 310, 600 and 1012, respectively. Three types of PCR-based detection methods (PCR), HybriMax, FQ-PCR and flow cytometry (FCM) were used to detect HPV DNA in cervical cells. HC-Ⅱ test as a control. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (PPV) were compared between the detection results of HCT-PCR and HC-Ⅱ and the Kappa index (KI), and for cervical intraepithelial neoplasia (CIN) NPV). Results The overall coincidence rates of HybriMax, FQ-PCR, flow cytometry and HC-Ⅱ were 92.3%, 86.7% and 86.1%, respectively. The KI were 0.796, 0.722 and 0.721, respectively. The sensitivity, specificity, PPV, NPV (88.8%, 66.6%, 54.2% and 91.7%) in the former group were lower than those in the latter group (93.1%, 74.2%, 60.1% and 96.5 %), The differences were statistically significant (P <0.05), the other two methods and HC-Ⅱ similar. Conclusion The results of three PCR methods for detecting HPVDNA are consistent with HC-Ⅱ. The sensitivity, specificity, PPV, NPV, HybriMax and FQ-PCR for diagnosing cervical lesions ≥ CINⅡ were similar to those for HC-Ⅱ, whereas flow-fluorescent hybridization was inferior to HC-Ⅱ.