Department of Epidemiology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.
J Natl Cancer Inst. 2012 Feb 8;104(3):178-88. doi: 10.1093/jnci/djr532. Epub 2012 Jan 23.
Worldwide, one-seventh of cervical cancers occur in China, which lacks a national screening program. By evaluating the diagnostic accuracy of self-collected cervicovaginal specimens tested for human papillomavirus (HPV) DNA (Self-HPV testing) in China, we sought to determine whether Self-HPV testing may serve as a primary cervical cancer screening method in low-resource settings.
We compiled individual patient data from five population-based cervical cancer-screening studies in China. Participants (n = 13 140) received Self-HPV testing, physician-collected cervical specimens for HPV testing (Physician-HPV testing), liquid-based cytology (LBC), and visual inspection with acetic acid (VIA). Screen-positive women underwent colposcopy and confirmatory biopsy. We analyzed the accuracies of pooled Self-HPV testing, Physician-HPV testing, VIA, and LBC to detect biopsy-confirmed cervical intraepithelial neoplasia grade 2 or more severe (CIN2+) and CIN3+. All statistical tests were two-sided.
Of 13 004 women included in the analysis, 507 (3.9%) were diagnosed as CIN2+, 273 (2.1%) as CIN3+, and 37 (0.3%) with cervical cancer. Self-HPV testing had 86.2% sensitivity and 80.7% specificity for detecting CIN2+ and 86.1% sensitivity and 79.5% specificity for detecting CIN3+. VIA had statistically significantly lower sensitivity for detecting CIN2+ (50.3%) and CIN3+ (55.7%) and higher specificity for detecting CIN2+ (87.4%) and CIN3+ (86.9%) (all P values < .001) than Self-HPV testing, LBC had lower sensitivity for detecting CIN2+ (80.7%, P = .015), similar sensitivity for detecting CIN3+ (89.0%, P = .341), and higher specificity for detecting CIN2+ (94.0%, P < .001) and CIN3+ (92.8%, P < .001) than Self-HPV testing. Physician-HPV testing was more sensitive for detecting CIN2+ (97.0%) and CIN3+ (97.8%) but similarly specific for detecting CIN2+ (82.7%) and CIN3+ (81.3%) (all P values <.001) than Self-HPV testing.
The sensitivity of Self-HPV testing compared favorably with that of LBC and was superior to the sensitivity of VIA. Self-HPV testing may complement current screening programs by increasing population coverage in settings that do not have easy access to comprehensive cytology-based screening.
全世界有七分之一的宫颈癌发生在中国，但中国尚未建立全国性的筛查项目。本研究通过评估在中国进行的自行采集的宫颈阴道标本检测人乳头瘤病毒（HPV）DNA（自取样 HPV 检测）的诊断准确性，旨在确定自取样 HPV 检测是否可作为资源匮乏地区的宫颈癌初级筛查方法。
我们汇集了中国 5 项基于人群的宫颈癌筛查研究中的个体患者数据。参与者（n=13140 人）接受自取样 HPV 检测、医生采集的 HPV 检测（医生取样 HPV 检测）、液基细胞学（LBC）和醋酸白试验（VIA）。筛查阳性的女性接受阴道镜检查和确认性活检。我们分析了 pooled Self-HPV 检测、Physician-HPV 检测、VIA 和 LBC 对检测活检证实的宫颈上皮内瘤变 2 级或更高级别（CIN2+）和 CIN3+的准确性。所有统计检验均为双侧检验。
在纳入分析的 13004 名女性中，507 名（3.9%）被诊断为 CIN2+，273 名（2.1%）为 CIN3+，37 名（0.3%）患有宫颈癌。自取样 HPV 检测检测 CIN2+的敏感性为 86.2%，特异性为 80.7%；检测 CIN3+的敏感性为 86.1%，特异性为 79.5%。VIA 检测 CIN2+和 CIN3+的敏感性显著低于自取样 HPV 检测（分别为 50.3%和 55.7%），但特异性高于自取样 HPV 检测（分别为 87.4%和 86.9%）（所有 P 值均<.001）。LBC 检测 CIN2+的敏感性低于自取样 HPV 检测（80.7%，P=0.015），检测 CIN3+的敏感性与自取样 HPV 检测相似（89.0%，P=0.341），但检测 CIN2+和 CIN3+的特异性高于自取样 HPV 检测（分别为 94.0%和 92.8%）（所有 P 值均<.001）。医生取样 HPV 检测检测 CIN2+和 CIN3+的敏感性均显著高于自取样 HPV 检测（分别为 97.0%和 97.8%），但特异性与自取样 HPV 检测相似（分别为 82.7%和 81.3%）（所有 P 值均<.001）。
与 LBC 相比，自取样 HPV 检测的敏感性较好，优于 VIA。自取样 HPV 检测可能会增加无法获得全面基于细胞学筛查的人群的覆盖率，从而补充目前的筛查方案。
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