摘要
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)用于宫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(≤CINⅠ)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宫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。
ObjectiveTo 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. MethodsThe 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. ResultsThe 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）. ConclusionDH3 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.
作者
尚乐乐
胡杰锋
王月清
朱茵茵
蒯守刚
SHANG Lele;HU Jiefeng;WANG Yueqing;ZHU Yinyin;KUAI Shougang(Wuxi Huishan District Hospital, Wuxi, Jiangsu, 214000;Hangzhou De Tong Biological Technology Corporation Limited, Hangzhoo, Zhejiang, 310053)
出处
《实用临床医药杂志》
CAS
2017年第19期99-102,共4页
Journal of Clinical Medicine in Practice
基金
江苏省自然科学基金项目(BK2012564)
关键词
人乳头状瘤病毒
癌前病变
宫颈癌
筛查
human papillomavirus
human papillomavirus
cervical cancer
screening
