流式荧光杂交法检测高危型人乳头瘤病毒的临床验证试验  

Clinical Evaluation of the xMAP Technology in Detection of High-risk Human Papillomavirus

作　　者：廖光东[1] 张小燕[2] 高玉华[3] 刘彬[1] 刘霞[2] 李联昆[3] 陈凤[1] 卞美璐[2] 陈汶[1] 乔友林[1] 

机构地区：[1]中国医学科学院北京协和医学院肿瘤研究所肿瘤流行病学研究室,北京100021 [2]中日友好医院妇产科,北京100029 [3]辽宁省肿瘤医院妇科,沈阳110042

出　　处：《中国医学科学院学报》2007年第5期603-607,共5页Acta Academiae Medicinae Sinicae

摘　　要：目的评估流式荧光杂交法检测高危型人乳头瘤病毒(HPV)的临床应用价值。方法随机选择1061名年龄在21～65岁间的妇女,采用流式荧光杂交法和第二代杂交捕获实验(hc2)检测其子宫颈脱落细胞,以病理诊断作为金标准对检测结果进行分析和评价,并对二者的检测结果作一致性检验。结果流式荧光杂交法检测的灵敏度和特异度分别为80.31%和85.83%。阳、阴性预测值分别为44.5%和96.9%。与hc2检测一致性检验结果显示Kappa=0.58。结论流式荧光杂交法检测高危型HPV的特异度与hc2相似,灵敏度低于hc2,但两者检测的一致性较好。Objective To evaluate the clinical application value of flexible multi-analyte profiling （xMAP） technology in detecting high-risk human papillomavirus （HR-HPV）. Methods Totally 1 061 women, aged 21-65 years, were randomly enrolled into the study. Cervical exfoliated cells were used in xMAP technology and hybrid capture Ⅱ （hc2）. Pathological diagnosis was used as golden standard. Consistency of these two methods was assessed. Results The sensitivity and specificity of xMAP technology were 80.31% and 85.83% , respectively. The positive and negative predictive values were 44.5% and 96.9% , respectively. The Kappa value for consistency between xMAP technology and hc2 was 0. 58. Conclusions The specificity of xMAP technology is similar to hc2 test, but the sensitivity is inferior to hc2. However, these two methods show good consistency in the detection of HR-HPV.

关 键 词：子宫颈癌 人乳头瘤病毒 检测分型 流式荧光杂交法 

分 类 号：R373.9[医药卫生—病原生物学] R737.33[医药卫生—基础医学]