cobas 4800与careHPV用于人乳头瘤病毒检测的对比研究

[目的]比较cobas 4800检测和careHPV人乳头瘤病毒（human papillomavirus,HPV）检测方法用于宫颈癌筛查的有效性和一致性。[方法]本研究纳入856名研究对象,采用cobas4800和careHPV检测方法对宫颈脱落细胞标本进行HPV DNA检测。以病理组织学为金标准,评估careHPV和cobas 4800检出宫颈上皮内瘤变2（cervical intraepithelial neoplasia grade 2,CIN2）及以上病人的有效性和准确性。采用McNemar检验对两种检测方法进行一致性检验。[结果]最终853例妇女的有效检测结果纳入统计分析。careHPV和cobas 4800检出HPV DNA阳性率分别是37.1%（316/853）和39.3%（335/853）。cobas 4800检测和careHPV检出HPV DNA一致率为83.2%（710/853）,Kappa=0.65（95%CI：0.59-0.70）。careHPV和cobas 4800检出CIN2＋的敏感度和特异性分别为94.4%（95%CI：81.3%-99.2%）和65.5%（95%CI：62.1%-68.7%）,94.4%（95%CI：81.3%-99.2%）和63.2%（95%CI：59.7%-66.5%）。在最后纳入统计分析的853名妇女中HPV16和HPV 18的感染率分别为13.1%和2.6%,而在36例CIN2＋的病人中,HPV16和HPV18的感染率分别为77.8%和2.8%。[结论]careHPV和cobas4800作为初筛方法检出CIN2＋的一致性较好,然而两种方法又有其不同的优势,应该根据当地的经济水平来选择用于筛查的HPV DNA检测方法。     

山西省襄垣县采用careHPV检测技术进行宫颈癌初筛的效果分析

[目的]评价careHPV检测技术在农村宫颈癌筛查中的应用情况.[方法]对山西襄垣县2270名35～64岁妇女采用careHPV检测技术进行官颈癌初筛,初筛阳性者接受液基细胞学分流,分流阳性者召回阴道镜检查及活检,以病理结果为金标准.[结果]参加筛查的妇女平均年龄45.7±6.8岁,careHPV阳性率为12.9％(292/2270),阴道镜转诊率为4.8％(109/2270),CIN1、CIN2+检出率分别为1.4％(31/2270)和1.7％(38/2270).在既往筛查史上,参加过筛查的妇女CIN2+的检出率要低于从未参加过筛查的妇女(x2=4.50,P=0.042).[结论]careHPV检测技术初筛细胞学分流的筛查策略有助于在降低阴道镜转诊率的同时,提高宫颈病变的检出率,扩大筛查覆盖面.该策略适用于资源相对贫乏的农村地区.     

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 。     

Lower cost strategies for triage of human papillomavirus DNA‐positive women

Using human papillomavirus (HPV) testing for cervical cancer screening in lower‐resource settings (LRS) will result in a significant number of screen‐positive women. This analysis compares different triage strategies for detecting cervical precancer and cancer among HPV‐positive women in LRS. This was a population‐based study of women aged 25–65 years living in China (n = 7,541). Each woman provided a self‐collected and two clinician‐collected specimens. The self‐collected and one clinician‐collected specimen were tested by two HPV DNA tests—careHPV? and Hybrid Capture 2; the other clinician‐collected specimen was tested for HPV16/18/45 E6 protein. CareHPV?‐positive specimens were tested for HPV16/18/45 DNA. HPV DNA‐positive women underwent visual inspection with acetic acid (VIA) and then colposcopic evaluation with biopsies. The performance for detection of cervical intraepithelial neoplasia grade 3 or cancer (CIN3+) among HPV DNA‐positive women was assessed for different triage strategies: HPV16/18/45 E6 or DNA detection, VIA, colposcopic impression, or higher signal strength (≥10 relative light units/positive control [rlu/pc]). The percent triage positive ranges were 14.8–17.4% for VIA, 17.8–20.9% for an abnormal colposcopic impression; 7.9–10.5% for HPV16/18/45 E6; 23.4–28.4% for HPV16/18/45 DNA; and 48.0–62.6% for higher signal strength (≥10 rlu/pc), depending on the HPV test/specimen combination. The positivity for all triage tests increased with severity of diagnosis. HPV16/18/45 DNA detection was approximately 70% sensitive and had positive predictive values (PPV) of approximately 25% for CIN3+. HPV16/18/45 E6 detection was approximately 50% sensitive with a PPV of nearly 50% for CIN3+. Different triage strategies for HPV DNA‐positive women provide important tradeoffs in colposcopy or treatment referral percentages and sensitivity for prevalent CIN3+.