Departamento de Salud Pública, Pontificia Universidad Católica de Chile, Santiago, Chile.
Int J Cancer. 2013 Feb 15;132(4):916-23. doi: 10.1002/ijc.27662. Epub 2012 Jun 26.
Cervical cancer mortality in Chile is four times higher than in developed countries. We compared the accuracy of human papillomavirus (HPV) DNA testing and conventional Papanicolaou (Pap) testing to detect prevalent precancerous and cancerous lesions in the routine clinical practice of the public health system. Women aged 25 years and older residing in the area covered by three primary care centers of Santiago, Chile, were invited to participate. Eligible women received both HPV DNA (Hybrid Capture 2) and Pap testing. Women positive by either test (Pap: ASCUS+, HC2: RLU/CO ≥ 1.0) underwent colposcopy and biopsy, as did a sample of double-negative women with an abnormal cervix at visual inspection or with risk factors for cervical lesions. Crude and verification bias-corrected sensitivities and specificities were estimated. In total, 8,265 women (98.8% of eligible) had complete screening results. Of these, 10.7% were HPV positive, 1.7% were Pap positive and 1.1% were positive by both tests. In all, 931 (11.3%) women were screen-positive, of whom 94.3% attended colposcopy. Additionally, 295 control women were invited for colposcopy, of whom 78% attended. In all, 42 CIN2, 45 CIN3 and 9 cancers were identified. Verification bias-corrected sensitivity for CIN2+ (95% confidence interval) was 92.7% (84.4-96.8) for HPV and 22.1% (16.4-29.2) for Pap; corresponding specificities were 92.0% (91.4-92.6) and 98.9% (98.7-99.0). In conclusion, in routine clinical practice in a developing country, HPV testing was four times more sensitive for CIN2+ than Pap testing, identifying three times more CIN2+ lesions; HPV testing was easily implemented in our established cervical cancer prevention program.
智利的宫颈癌死亡率是发达国家的四倍。我们比较了人乳头瘤病毒（HPV）DNA 检测和传统巴氏涂片（Pap）检测在智利公共卫生系统常规临床实践中检测普遍癌前病变和癌症的准确性。邀请年龄在 25 岁及以上的居住在圣地亚哥三个初级保健中心覆盖区域的女性参加。符合条件的女性均接受 HPV DNA（杂交捕获 2）和 Pap 检测。任何一种检测结果阳性的女性（Pap：ASCUS+，HC2：RLU/CO≥1.0）均行阴道镜检查和活检，同时对视觉检查宫颈异常或有宫颈癌前病变危险因素的双阴性女性进行随机抽样检查。估计了粗灵敏度和校正验证偏倚的特异度。共有 8265 名女性（合格女性的 98.8%）完成了完整的筛查结果。其中，10.7%的女性 HPV 阳性，1.7%的女性 Pap 阳性，1.1%的女性两种检测均阳性。共有 931 名（11.3%）女性筛查阳性，其中 94.3%接受了阴道镜检查。此外，还邀请了 295 名对照女性进行阴道镜检查，其中 78%的女性接受了检查。共发现 42 例 CIN2、45 例 CIN3 和 9 例癌症。校正验证偏倚后的 CIN2+灵敏度（95%置信区间）HPV 为 92.7%（84.4-96.8），Pap 为 22.1%（16.4-29.2）；相应的特异性分别为 92.0%（91.4-92.6）和 98.9%（98.7-99.0）。总之，在发展中国家的常规临床实践中，HPV 检测对 CIN2+的敏感性比 Pap 检测高 4 倍，可检测出 3 倍的 CIN2+病变；HPV 检测很容易在我们现有的宫颈癌预防计划中实施。
