摘要
目的评价careHPV16/18/45快速检测作为宫颈癌初筛阳性妇女阴道镜转诊分流方法的应用价值。方法招募山西省阳城县宫颈癌高发乡镇年龄在25～65岁,符合宫颈癌筛查纳入标准的妇女。获得知情同意后,进行问卷调查、妇科检查并取样。采用第二代杂交捕获试验(HC2)、careHPV、Avantage HPV E6和醋酸染色后肉眼观察(VIA)的方法对妇女进行宫颈癌初筛;初筛阳性的妇女做第2次VIA和阴道镜检查。其中,careHPV初筛阳性者也进行careHPV16/18/45分流检测。在阴道镜下可见病变处直接取活检,病理诊断结果为宫颈上皮内瘤样病变2级(CIN2)及以上病变者按照规范进行治疗。结果在自我取样和医生取样标本中,使用careHPV16/18/45分流,可使阴道镜转诊率分别下降至3.2%和3.1%;灵敏度、特异度和阳性预测值可分别达到50.0%、97.6%和26.7%,以及63.0%、97.9%和34.0%。结论careHPV16/18/45可以作为资源欠缺地区careHPV初筛阳性妇女的转诊工具。
Objective To evaluate the clinical performance of careHPV16/18/45 DNA testing of cervical specimens as a triage testing for women with positive findings during the cervical cancer screening. Methods Eligible women aged 25-65 years were enrolled from two high-risk communities in Yangcheng County, Shanxi Province. After providing written informed consent on a voluntary base, women underwent questionnaire-based interview, gynecological examination, and sample collection. Hybrid capture 2 technology （HC2）, careHPV, Avantage HPV E6 test, and visual inspection with acetic acid （VIA） were conducted as the primary screening tests at the enrollment visit. Women with any positive finding were invited to receive a second VIA and colposcopy, careHPV16/18/45 was performed as a triage testing. Any visible lesion under colposcopy was directly biopsied. Women with pathology confirmed cervical intraepithelial neoplasia grade 2 and worse （CIN2 ＋ ） were treated with standard procedures. Results For the self-collected and doctor-collected samples, the application of careHPV16/18/45 as a triage testing decreased the colposcopy referral to 3. 2% and 3. 1%, respectively. Meanwhile, the sensitivity, specificity, and positive predictive value （ PPV ） for CIN2 ＋ were 50. 0%, 97. 6%, and 26. 7% for women with positive self-sampling careHPV results and 63.0%, 97.9%, and 34. 0% for women with positive doctor-sampling careHPV results. Conclusion careHPV16/18/45 is promising as a triage testing among women with positive screening findings in low-resource settings.
出处
《中国医学科学院学报》
CAS
CSCD
北大核心
2013年第3期254-259,共6页
Acta Academiae Medicinae Sinicae
基金
比尔和梅琳达.盖茨基金会(GAT.1386-08734-CTA)~~
