人乳头状瘤病毒核酸检测试剂盒用于宫颈癌及癌前病变筛查的临床价值

摘要

Objective To analyze the clinical value of the second generation hybrid capture nucleic acid detection kit (DH3) of human papillomavirus (HPV) in screening cervical cancer and precancerous lesions.Methods The cervical exfoliated cell samples of 480 women in gynecologic clinic were collected and detected by DH3,TCT and HPV-PCR.Colposcopic pathological examination was performed in women with TCT ≥ ASC-US.With the pathological results as the golden standard,the diagnostic value of DH3 was analyzed.Results The pathological results showed that 370 cases were normal (77.08％),59 cases had benign lesions (≤CIN Ⅰ) (12.29％) and 51 were high-risk cases (≥CIN Ⅱ) (10.63％).The positive diagnostic rates of TCT,HPV-PCR and DH3 were 26.04％,32.08％ and 27.08％,respectively.The concordancerate of DH3 and TCT was 94.79％ (P ＜ 0.01),and the concordance rate with HPV-PCR was 93.13％ (P ＜ 0.01).The sensitivity,specificity,positive predictive value,negative predictive value and accuracy rate of DH3 were 98.18％,87.57％,70.13％,99.39％ and 90％,respectively.The ROC area of detection of high-risk (CIN Ⅱ) was Z =0.887 (95 ％ CI 0.785 ～ 0.918,P ＜ 0.01).Conclusion DH3 kit has a high degree of consistency with TCT and HPV-PCR in the detection of HPV cervical cancer and precancerous lesions.The sensitivity,specificity and accuracy are high,and it is easy to operate.%目的 分析人乳头状瘤病毒(HPV)杂交捕获·化学发光法核酸检测试剂盒(DH3)用于官颈癌及癌前病变筛查的临床价值.方法 收集480例妇科门诊妇女宫颈脱落细胞样本,分别采用DH3、TCT和HPV-PCR检测,对TCT≥ASC-US者行阴道镜下病理检测,以病理学结果为金标准,分析DH3诊断价值.结果 病理学结果显示,正常者370例(77.08％),良性病变者(≤CIN Ⅰ)59例(12.29％),高危者(≥CINⅡ)51例(10.63％);TCT、HPV-PCR和DH3诊断阳性率分别为26.04％、32.08％和27.08％;DH3与TCT检测一致率为94.79％ (P ＜0.01),与HPV-PCR检测一致率为93.13％ (P ＜0.01);DH3灵敏度98.18％,特异度87.57％,阳性预测值70.13％,阴性预测值99.39％,准确率为90％,检出高危型(≥CINⅡ)的ROC曲线面积Z=0.887(95％ CI为0.785 ～0.918,P＜0.01).结论 DH3试剂盒与TCT、HPV-PCR在检出HPV富颈癌及癌前病变具有高度一致性,灵敏度、特异度和准确率高,操作便捷,临床筛查意义显著.