HPV DNA testing in cervical cancer screening - Results from women in a high-risk province of Costa Rica
HPV DNA testing in cervical cancer screening - Results from women in a high-risk province of Costa Rica
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DOI：
10.1001/jama.283.1.87
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发表时间：
2000-01-05
影响因子：
120.7
通讯作者：
Lorincz, AT
中科院分区：
文献类型：
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作者：
Schiffman, M;Herrero, R;Lorincz, AT
背景 已知人乳头瘤病毒 (HPV) 会导致全世界大多数宫颈癌，但 HPV DNA 检测在宫颈癌预防中的效用尚未确定。目的 提供不同分析灵敏度水平下最常见致癌类型 HPV 检测筛查性能的全面数据。设计 1993-1995 年间进行的实验室分析，使用 3 种细胞学技术和 宫颈造影，然后对宫颈发现异常的女性进行阴道镜检查，以检测所有高级上皮内病变和癌症（有临床意义的疾病的参考标准）。随后进行了 HPV 检测，并掩盖了临床结果。以哥斯达黎加瓜纳卡斯特省为年龄调整后宫颈癌发病率较高的地区。参与者随机选择了 11742 名女性，其中 8554 名未进行子宫切除术的非妊娠、性活跃女性使用原始混合捕获管测试进行了初步 HPV DNA 检测；使用分析更灵敏的第二代检测（Hybrid Capture II 检测）对 1119 份样本的分层子样本进行重新检测。主要结果测量基于不同的阳性切点，通过 HPV DNA 检测对宫颈高级上皮内病变和癌症进行接收者操作特征分析。结果使用第二代检测的 1.0 pg/mL 分析灵敏度将允许检测 138 例高级别病变和癌症中，88.4%（所有 12 种癌症均为 HPV 阳性），其中 12.3% 的女性进行了阴道镜转诊。使用意义未定的非典型鳞状细胞作为转诊切点进行巴氏测试，结果敏感性为 77.7%，特异性为 94.2%，转诊率为 6.9%。第二代检测对高级别病变和癌症阳性的特异性为 89.0%，其余 HPV DNA 阳性受试者中 33.8% 具有低级别或模棱两可的显微镜下明显病变。原始检测中使用的较高检测阈值 10 pg/mL 的灵敏度为 74.8%，特异性为 93.4%，第二代检测的检测水平较低（
Context Human papillomaviruses (HPVs) are known to cause most cervical cancer worldwide, but the utility of HPV DNA testing in cervical cancer prevention has not been determined.Objective To provide comprehensive data on the screening performance of HPV testing for the most common carcinogenic types, at different levels of analytic sensitivity.Design Laboratory analysis conducted during 1993-1995, using 3 cytologic techniques and cervicography, followed by colposcopic examination of women with any abnormal cervical finding, to detect all high-grade intraepithelial lesions and cancer (reference standard of clinically significant disease). The HPV testing was performed subsequently with masking regarding clinical findings.Setting Guanacaste Province, Costa Rica, a region with a high age-adjusted incidence of cervical cancer.Participants Of 11742 randomly selected women, 8554 nonpregnant, sexually active women without hysterectomies underwent initial HPV DNA testing using the original Hybrid Capture Tube test; a stratified subsample of 1119 specimens was retested using the more analytically sensitive second generation assay, the Hybrid Capture II test.Main Outcome Measures Receiver operating characteristic analysis of detection of cervical high-grade intraepithelial lesions and cancer by HPV DNA testing based on different cut points of positivity.Results An analytic sensitivity of 1.0 pg/mL using the second generation assay would have permitted detection of 88.4% of 138 high-grade lesions and cancers (all 12 cancers were HPV-positive), with colposcopic referral of 12.3% of women. Papanicolaou testing using atypical squamous cells of undetermined significance as a cut point for referral resulted in 77.7% sensitivity and 94.2% specificity, with 6.9% referred. Specificity of the second generation assay for positivity for high-grade lesions and cancer was 89.0%, with 33.8% of remaining HPV DNA-positive subjects having low-grade or equivocal microscopically evident lesions. The higher detection threshold of 10 pg/mL used with the original assay had a sensitivity of 74.8% and a specificity of 93.4%, Lower levels of detection with the second generation assay (