Blatt Amy J, Kennedy Ronald, Luff Ronald D, Austin R Marshall, Rabin Douglas S
Quest Diagnostics, Madison, New Jersey.
Clinical Trials, Quest Diagnostics, Madison, New Jersey.
Cancer Cytopathol. 2015 May;123(5):282-8. doi: 10.1002/cncy.21544. Epub 2015 Apr 10.
In the United States, human papillomavirus (HPV) and Papanicolaou (Pap) testing (cotesting) for cervical screening in women ages 30 to 65 years is the preferred strategy, and cytology alone is acceptable. Recently, a proprietary automated test for identifying high-risk HPV types for primary cervical screening was approved by the US Food and Drug Administration. The objective of the current study was to document extensive cervical screening among these screening options.
To investigate the sensitivity of various testing options for biopsy-proven cervical intraepithelial neoplasia grade 3 or worse (≥ CIN3) and cancer, the authors reviewed 256,648 deidentified results from women ages 30 to 65 years at the time of cotest who had a cervical biopsy specimen obtained within 1 year of the cotest.
A positive cotest result was more sensitive (98.8%; 4040 of 4090 cotests) for diagnosing ≥ CIN3 than either a positive HPV-only test (94%; 3845 of 4090 HPV-only tests) or a positive Pap-only test (91.3%; 3734 of 4090 Pap-only tests; P < .0001). A positive Pap-only result was more specific (26.3%; 66,145 of 251,715 Pap-only tests) for diagnosing ≥ CIN3 than a positive HPV-only test (25.6%; 64,625 of 252,556 HPV-only tests) or a positive cotest (10.9%; 27,578 of 252,558 cotests; P < .0001). Of 526 cervical cancers, 98 (18.6%) were HPV-only negative, 64 (12.2%) were Pap-only negative, and 29 (5.5%) were cotest negative.
Compared with HPV-only testing, cotesting was more sensitive for the detection of ≥ CIN3 in women ages 30 to 65 years. The current data suggest that approximately 19% of women with cervical cancer may be misdiagnosed by an HPV-only cervical screen. It is important to consider these data as the guidelines for cervical cancer screening undergo revision. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
在美国，30至65岁女性进行人乳头瘤病毒（HPV）检测和巴氏（Pap）检测（联合检测）用于宫颈癌筛查是首选策略，单独进行细胞学检查也是可以接受的。最近，一种用于初级宫颈癌筛查的识别高危HPV类型的专利自动化检测方法获得了美国食品药品监督管理局的批准。本研究的目的是记录这些筛查选项中的广泛宫颈癌筛查情况。
为了调查各种检测选项对活检证实的宫颈上皮内瘤变3级或更严重病变（≥CIN3）及癌症的敏感性，作者回顾了256,648例30至65岁女性联合检测时的匿名结果，这些女性在联合检测后1年内获得了宫颈活检标本。
联合检测结果呈阳性对诊断≥CIN3的敏感性更高（98.8%；4090例联合检测中有4040例），高于单纯HPV检测结果呈阳性（94%；4090例单纯HPV检测中有3845例）或单纯Pap检测结果呈阳性（91.3%；4090例单纯Pap检测中有3734例；P<0.0001）。单纯Pap检测结果呈阳性对诊断≥CIN3的特异性更高（26.3%；251,715例单纯Pap检测中有66,145例），高于单纯HPV检测结果呈阳性（25.6%；252,556例单纯HPV检测中有64,625例）或联合检测结果呈阳性（10.9%；252,558例联合检测中有27,578例；P<0.0001）。在526例宫颈癌中，98例（18.6%）单纯HPV检测为阴性，64例（12.2%）单纯Pap检测为阴性，29例（5.5%）联合检测为阴性。
与单纯HPV检测相比，联合检测对30至65岁女性中≥CIN3的检测更敏感。目前的数据表明，约19%的宫颈癌女性可能会被单纯HPV宫颈筛查误诊。随着宫颈癌筛查指南的修订，考虑这些数据很重要。本文是一篇根据知识共享署名 - 非商业性使用 - 禁止演绎许可协议发布的开放获取文章，允许在任何媒介中使用和传播，前提是正确引用原始作品，使用是非商业性的，且不进行任何修改或改编。
