流式荧光杂交法检测高危型人乳头瘤病毒的临床价值  

The clinical value of using xMAP technology for detection of high-risk human papillomavirus

作　　者：廖光东[1] 刘彬[2] 陈凤[2] 刘新伏[2] 崔剑峰[2] 王秀荣[2] 陈汶[2] 罗子国[1] 乔友林[2] 

机构地区：[1]重庆医科大学基础医学院电镜室,重庆400016 [2]中国医学科学院北京协和医学院肿瘤研究所流行病学室,北京100021

出　　处：《肿瘤》2008年第5期431-435,共5页Tumor

摘　　要：目的:探索流式荧光杂交法检测高危型人乳头瘤病毒的临床价值。方法:收集山西省子宫颈癌高发区妇女的宫颈脱落细胞样本638例,应用流式荧光杂交法和第二代杂交捕获实验(Hybrid Capture(2 Assay,hc2)进行检测分型,根据病理诊断对检测结果进行评价,对该人群中高危型人乳头瘤病毒(human papillomavirus,HPV)的感染情况和型别分布进行统计学分析,并对这2种方法作一致性检验。结果:流式荧光杂交法检测的灵敏度、特异度、准确度分别为77.78%、93.59%和92.42%,阴、阳性预测值分别为98.13%和49.30%。该人群中高危型HPV的感染率为11.7%,非瘤样病变和子宫颈上皮内瘤变(cervical intraepithelial neoplasia,CIN)1级(CIN1)中,HPV16和HPV52型为主要感染型别;子宫颈上皮内瘤变2级(CIN2)中,HPV16和HPV58型较为常见;子宫颈上皮内瘤变3级(CIN3)和子宫颈癌以HPV16型感染为主;HPV16、52、58型的感染率与病变进展呈正相关(P<0.01)。将流式荧光杂交法与hc2的检测结果作一致性检验:Κ=0.60。结论:流式荧光杂交法检测高危型HPV的特异度很高,灵敏度达77.78%,与hc2相比,两者的一致性较好;但还需进一步改进方法以提高检测的灵敏度,增加可分型的HPV亚型数。Objective： To explore the clinical values of using flexible multi-analyte profiling （xMAP） technology for detection of high-risk human papillomavirus （HR-HPV）. Methods. Six hundred and thirty eight cervical exfoliated cell samples were collected from women who lived in the region with high-incidence of cervical cancer in Shanxi province. The samples were tested with xMAP technology and Hybrid Capture 2 Assay （hc2）. Pathological diagnosis was used as a hallmark to evaluate the detection results. HR-HPV infection rate and its genotyping distribution were analyzed and the coincidence of two methods above was assessed. Results： The sensitivity, specificity and accuracy of xMAP technology were 77.78% , 93.59% and 92.42% , respectively. The negative and positive predictive values were 98.13% and 49.30% , respectively. The prevalence rate of HR-HPV was 11.7%. HPV16 and 52 were the dominant types in non-neoplastic disease and cervical intraepithelial neoplasia （ CIN ） grade 1 ; HPV16 and 58 were the most common types in CIN2 samples; HPV16 was the most frequent type in CIN3 and cervical cancer. The lesion progress was positively related to the infection rate of HPV16, 52 or 58 （P 〈0.01 ）. The Kappa value for agreement between xMAP technology and hc2 was 0.60. Conclusions：Compared with the hc2 test, the xMAP technology was highly specific, and the sensitivity is 77.78%. The agreement of these two methods is satisfactory. More improvements should be made to elevate the sensitivity of xMAP method and to increase the numbers of genotypes that can be detected.

关 键 词：宫颈肿瘤 人乳头瘤病毒 流式荧光杂交法 第二代杂交捕获实验 

分 类 号：R737.33[医药卫生—肿瘤] R373.9[医药卫生—临床医学]