Human papillomavirus DNA versus papanicolaou screening tests for cervical cancer
Human papillomavirus DNA versus papanicolaou screening tests for cervical cancer
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DOI：
10.1056/nejmoa071430
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发表时间：
2007-10-18
影响因子：
158.5
通讯作者：
Franco, Eduardo L.
中科院分区：
文献类型：
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作者：
Mayrand, Marie-Helene;Duarte-Franco, Eliane;Franco, Eduardo L.
背景：为了确定检测致癌的人乳头瘤病毒（HPV） DNA是否优于巴氏试验（Pap）筛查宫颈癌，我们进行了一项比较两种方法的随机试验。方法：我们比较HPV检测，使用经食品和药物管理局批准的检测方法，与传统的巴氏涂片检测作为筛查方法，在加拿大蒙特利尔和圣约翰的30至69岁妇女中识别高级别宫颈上皮内瘤变。巴氏试验结果异常或HPV检测阳性（每毫升至少1 pg高危HPV DNA）的妇女接受阴道镜检查和活组织检查，随机抽样检测阴性的妇女也是如此。对敏感性和特异性估计值进行验证偏倚校正。结果共有10154名妇女被随机分配到测试中。这两项测试都是在同一时段随机分配的顺序对所有女性进行的。HPV检测对2级或3级宫颈上皮内瘤变的敏感性为94.6%(95%可信区间[CI]， 84.2至100)，而Pap检测的敏感性为55.4% （95% CI， 33.6至77.2；P=0.01）。HPV检测的特异性为94.1% (95% CI, 93.4 ~ 94.8), 96.8% （95% CI, 96.3 ~ 97.3）
BackgroundTo determine whether testing for DNA of oncogenic human papillomaviruses (HPV) is superior to the Papanicolaou (Pap) test for cervical-cancer screening, we conducted a randomized trial comparing the two methods.MethodsWe compared HPV testing, using an assay approved by the Food and Drug Administration, with conventional Pap testing as a screening method to identify high-grade cervical intraepithelial neoplasia in women ages 30 to 69 years in Montreal and St. John's, Canada. Women with abnormal Pap test results or a positive HPV test (at least 1 pg of high-risk HPV DNA per milliliter) underwent colposcopy and biopsy, as did a random sample of women with negative tests. Sensitivity and specificity estimates were corrected for verification bias.ResultsA total of 10,154 women were randomly assigned to testing. Both tests were performed on all women in a randomly assigned sequence at the same session. The sensitivity of HPV testing for cervical intraepithelial neoplasia of grade 2 or 3 was 94.6% (95% confidence interval [CI], 84.2 to 100), whereas the sensitivity of Pap testing was 55.4% (95% CI, 33.6 to 77.2; P=0.01). The specificity was 94.1% (95% CI, 93.4 to 94.8) for HPV testing and 96.8% (95% CI, 96.3 to 97.3; P