导流杂交HPV检测在宫颈病变筛查中的价值

Application of Hybri Max human papillomavirus testing in cervical lesion screening

目的评价应用导流杂交技术（凯普导流杂交）HPV检测法（Hybri Max）行宫颈癌及癌前病变筛查的效果及作为首选筛查方法的可行性。方法统计分析2013年12月至2015年12月采用导流杂交技术,检测HR-HPV亚型的女性共7056例,分为5个年龄段：≤29岁;30~39岁;40~49岁;50~59岁;≥60岁。研究HR-HPV各亚型感染情况,不同年龄的HPV感染状况。计算导流杂交检测结果对筛查CIN2及以上病变的灵敏度、特异度、阳性预测值及阴性预测值,评价其作为宫颈癌及癌前病变初筛方法的可能性。所有数据采用SPSS13.0软件进行统计分析,P〈0.05定义为统计学有显著差异。结果 HR-HPV感染率总体呈现随年龄增长而增高趋势,各年龄段HR-HPV感染率总体比较差异有显著性意义（χ2=23.61,P〈0.05）。以病理诊断为金标准,与宫颈高级别病变（≥CIN2）最密切的亚型是HPV16、58和33型,占所有≥CIN2病变的70.86%（124/175）;导流杂交技术HPV检测对筛查宫颈癌及癌前病变的敏感度为95.30%,特异度为40.64%,阳性预测值为39.01%,阴性预测值为95.59%。结论中老年女性HR-HPV感染比例高,不能忽视该人群HPV筛查及感染情况;导流杂交技术有较好的敏感度及阴性预测值,在筛查宫颈癌及癌前病变中有指导意义;作为宫颈筛查方法仍需联合TCT等细胞学筛查进一步分流或按目前指南进行联合筛查。

Objective To evaluate the clinical efficacy of flow- through hybridization and gene chip（ Hybri Max） in cervical cancer and its precancerous lesion screening,and to discuss its feasibility as the prime initial screening methods. Methods Totally 7056 women received cervical lesion screening in Dalian Municipal Central Hospital during Dec2013 to Dec 2015. The statistical data were analyzed. Infection status of different HR- HPV genotypes was investigated according to the results of Hybri Max testing technology. And the effect of age on the HPV infection and the accuracy of high- level lesions（ CIN2 and above） diagnosis were analyzed. The sensitivity,specificity,positive predictive value and negative predictive value of the CIN2 and above lesions using Hybri Max testing were calculated and the feasibility of Hybri Max testing as the prime initial screening methods was evaluated. We analyzed all the data using the SPSS 13. 0,and P〈0. 05 had statistical significance. Results In 7056 women who received Hybri Max,the HPV genotypes 16,55 and 33 had the most close relationship with high- level cervical lesions（ CIN2 or above）,which were diagnosed pathologically and accounted for 70. 86%（ 124 /175） in all cervical lesions（ CIN2 or above）. The sensitivity,specificity,positive predictive value and negative predictive value of the CIN2 and above lesions using Hybri Max testing are95. 30%,40. 64%,39. 01%,and 95. 59%,respectively. Conclusion We should pay more attention on the middle-aged women because of the high HR- HPV infection rate. Hybri Max test has great values in cervical cancer and its precancerous lesion screening with the high sensitivity and negative predictive value. However,as a screening method of cervical cancer,it should also be associate with the TCT or cytology diagnosis due to the low specificity and positive predictive value.