导流杂交基因芯片、实时定量PCR检测人乳头瘤病毒的临床价值

摘要

Objective To evaluate the accordance of flow-through hybridization gene chip and real-time quantitative PCR in human papillomavirus(HPV) testing compared with HC Ⅱ , and to evaluate the clinical significance for screening cervical lesions above CIN Ⅱ. Methods The cervical cell samples of 103 females were collected into this research. All smears were detected for HPV by flow-through hybridization gene chip, real-time quantitative PCR and Hybrid Capture Ⅱ. Then, the cervical biopsies were taken through colposcopy for histology. We evaluate the accordance of HybriMax and RT-qPCR compared with HC Ⅱ in human papillomavirus (HPV) testing. The sensitivity and negative predictive value of HybriMax and RT-qPCR for cervical lesions above CIN Ⅱ were calculated according to histology, which were considered as a golden standard. Results The accordance of HybriMax and HC Ⅱ for HPV detecting were excellent, with total according rate of 86.41％; and the results of RT-qPCR and HC Ⅱ also had good correlation, with an according rate of 96. 12％. The sensitivity and specificity of HybriMax for cervical lesions above CIN Ⅱ was 96. 30％ and 50. 00％, while the positive predictive value and negative predictive value was 40. 63％ and 97. 44％; and the sensitivity by RT-qPCR was 100％, while the negative predictive value was 100％. Conclusions HybriMax and RT-qPCR have good accordance in HPV testing compared with HC Ⅱ , and also have high sensitivity and negative predictive value in screening cervical lesions above CIN Ⅱ. Furthermore, HybriMax can detect HPV subtypes and RT-qPCR is able to quantitate HPVDNA. The further study with more samples is needed to verify their values.%目的 评价导流杂交基因芯片(HybriMax)、实时定量PCR(RT-qPCR)在人乳头瘤病毒(HPV)分型和定量分析以及对筛查高级别宫颈上皮内瘤变(CIN)及宫颈癌的临床价值.方法 选取2007年5月至2007年10月103例在复旦大学附属妇产科医院宫颈疾病诊疗中心就诊妇女作为研究对象,取宫颈脱落细胞行杂交捕获二代(HCⅡ)、HybriMax及RT-qPCR检测HPV,同时在阴道镜引导下取宫颈活体组织行病理学检查.以HCⅡ检测结果为对照,分析并比较HybfiMax及RT-qPCR检测HPV感染与HCⅡ检测结果的一致性;以病理诊断为金标准,分析HybriMax及RT-qPCR对筛查CINⅡ以上病变的灵敏度、阴性预测值.结果 HybfiMax、RT-qPCR检测HPV与HCⅡ的符合率分别为86.41%、96.12%;HybriMax筛查CINⅡ以上病变的灵敏度、特异度、阳性预测值、阴性预测 值分别为96.30%、50.00%、40.63%、97.44%,RT-qPCR筛查CINⅡ以上病变的灵敏度、特异度、阳性预测值、阴性预测值分别为100%、56.58%、45.00%、100%,且HybriMax、RT-qPCR分别能够将HPV分型和定量.结论 导流杂交基因芯片、实时定量PCR检测HPV与HCⅡ比较有较好的一致性,对于CINⅡ以上病变有较高的 灵敏度和阴性预测值,且能行HPV分型及定量,可用于宫颈病变的初步筛查.