子宫颈癌是危害妇女健康的主要杀手之一，它是全球最致命但最容易预防的女性癌症类型。在全球范围内，每年有超过27万人死于子宫颈癌，其中高达85%的死亡病例发生在发展中国家 [1]。据WHO估计我国是世界上浸润性宫颈癌(ICC)发病人数第二多的国家（每年约有45,000例新发病例和25,000例ICC相关性死亡病例）[2]。

数据来源于发表在Ca-Cancer J Clin的“2018年全球癌症统计数据”

   人乳头瘤病毒（HPV）是专性感染人表皮和粘膜的常见DNA病毒，是导致宫颈上皮内增生（CIN）和宫颈癌的主要因素。根据导致宫颈癌的危险度，HPV可分为低危型和高危型。高危型HPV主要导致宫颈非典型增生和宫颈癌，低危型HPV主要导致生殖器疣（如尖锐湿疣）。目前报道的HPV型超过100种，已知约35种涉及生殖道感染，其中15到20种为高危型或可能的高危型。对宫颈癌组织标本的研究发现，约99%的宫颈癌伴有HPV感染，其中HPV16和18的感染率最高，分别占到50%和20%，而HPV阴性者几乎不会发生宫颈癌。持续感染高危型HPV，尤其是HPV16、HPV18会导致高度子宫颈上皮内瘤变和宫颈癌的发生。对于具有正常细胞学宫颈但高危型HPV检测呈阳性的女性，4-7年内约有15%-30%的可能发生CIN2或CIN3。对于具有CIN3且未正规治疗的妇女，30年内有31.3%的患者成为宫颈癌。

   Clifford等在2003年分析了全球各大洲85项总计10058例用PCR方法鉴定宫颈癌组织(宫颈鳞癌8550例，腺癌1508例)的HPV感染型别的研究。结果显示，子宫颈鳞癌中HPV16感染率最高，为45.9%-62.6%，HPV18的感染率为10%-14%，在亚洲，HPV58 (5.8%)和52(4.4%)是感染率仅次于HPV16和18的型别。子宫颈腺癌中HPV18感染率最高，为37%-41%，HPV16所占比例为26%-36%，HPV45占到5%-7%。

   国际癌症研究机构（IARC）得出结论，宫颈癌筛查的基本手段除了细胞学检查外，HPV DNA检测是可以接受的选项。世界卫生组织（WHO）也建议利用HPV检测筛查预防女性子宫颈癌，对高危型HPV阳性感染者需要定期随访，而HPV阴性者，发病风险较低，可适当延长其筛查间隔。2013年美国宫颈和阴道镜病理协会(ASCCP)指南中更新了宫颈癌筛查流程，特别提出在HPV检测中应对 HPV16/18进行分型检测。因此高危HPV的诊断筛查以及HPV16、HPV18的分型检测，对于宫颈癌的预防与治疗有着非常重要的作用。

   随着宫颈癌机理的阐明以及检测技术的发展，HPV检测在宫颈癌筛查中的地也越来越重要，2015年ASCCP发布的宫颈癌筛查指南明确指出，HPV检测可单独用于宫颈癌初筛。

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