高危型人乳头瘤病毒核酸检测试剂盒-Care HPV用于宫颈癌及癌前病变筛查的临床价值

目的 评价care HPV用于宫颈癌及癌前病变筛查的临床价值。方法 收集2010年至2012年南京鼓楼医院妇科就诊的年龄在30~59岁之间的妇女宫颈样本,行care HPV、第二代杂交捕获技术（HC2）、HPV聚合酶链反应（HPV-PCR）及宫颈液基细胞学（TCT）检查,TCT≥ASC-US者行阴道镜宫颈活检及必要时宫颈管诊刮,以组织病理学为金标准。病理诊断≥CIN2者为高危病变组,炎症/CCIN 1为良性病变组。结果 共收集404例有效样本。高危组42例、良性组50例,正常组312例。care HPV和HC2检测结果 的一致性为Kappa=0.833（P〈0.0001）,一致率93.81%;care HPV和HPV-PCR检测结果 的一致性为Kappa=0.707（P〈0.0001）,一致率88.12%;care HPV检出≥CIN 2的灵敏度为85.71%,特异度为83.15%。结论 care HPV与HC2、HPV-PCR试剂具有高度一致性。care HPV在检出HPV感染上具有很好的灵敏度和特异性,检测耗时短,有望成为医疗资源相对贫乏地区子宫颈癌及癌前病变筛查的主要方法 。

Clinical value of high-risk HPV nucleic acid detection kit careHPV in screening of cervical cancer and precancerous lesions

Objective To assess the clinical value of careHPV test in screening of cervical cancer and precancerous lesions.Methods From 2010 to 2012 cervical specimens were collected from women aged 30-59 years old visiting department of gynecology of Nanjing Drum Tower Hospital between.They were detected by careHPV test, HC2, HPV-PCR test and TCT.Women with TCT≥ASC-US had colposcopy with directed biopsy and endocervical curettage if necessary.Based on the gold standard of histopathology, patients with CIN2 or higher belonged to high-risk group and those with inflammation/CIN1 belonged to benign group.Results Totally 404 valid samples were collected. There were 42 cases in high-risk group, 50 cases in benign group, and 312 cases in normal group.The value of Kappa was 0.833 in indicating the consistency of detection results between careHPV test and HC2 (P<0.0001) and the concordance rate was 93.81%.The value of Kappa was 0.707 in indicating the consistency of detection results between careHPV test and HPV-PCR (P<0.0001) and the concordance rate was 88.12%.The sensitivity and specificity of careHPV test in detecting lesions≥CIN 2 were 85.71% and 83.15%, respectively.Conclusion The careHPV test is highly consistent with HC2 and HPV-PCR test.CareHPV has good sensitivity and specificity in the detection of HPV infection with short time consuming, and is expected to be the main method for screening of cervical cancer and precancerous lesions in the areas with relatively insufficient medical resources.