Jiang Li, Zeng Yan, Li Jiarui, Wang Hong, Xia Yingying, Fang Xuhong, Zhang Ping
Department of Gynecology, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Asian Pac J Cancer Prev. 2011;12(11):2963-7.
This study aimed to evaluate the role of high risk HPV DNA testing in identifying Chinese younger women with abnormal cytology at risk of harboring cervical intraepithelial neoplasia at grade 2 (CIN2) or worse so as to popularize an effective triage strategy for younger women.
A total of 246 younger women aged 25 - 36 years old with abnormal cytology were recruited in our study. All were assessed by liquid-based cytology, high-risk HPV DNA test, and colposcopy with directed biopsy and endocervical curettage as necessary. Residual specimens from liquid-based cytology were subjected to real-time PCR testing to identify the presence of 10 high-risk HPV types that are prevalent in China.
Among the 246 abnormal cytology samples, 97 (39.4%) were found to be positive for high risk HPV. A clear association was observed between cytological findings and the proportion of patients with positive high risk HPV DNA: namely 29.8% HPV positivity in the ASCUS group; 43.5% in LSIL group; and 90.0% in HSIL group (p<0.01). Overall, high risk HPV test achieved a high specificity (79.8%) and PPV (86.5%) for an endpoint of CIN2+, and higher sensitivity (91.3%) and NPV (98.7%) for an endpoint of CIN3+. For younger women with ASCUS+ cytology, high risk HPV test achieved a higher NPV for CIN2+ and CIN3+ (96.0%, 99.0%). For LISL+ cytology, high risk HPV testing had a high sensitivity with LSIL (90.0%) and HSIL (100%), but there was also a corresponding decrease in specificity.
The results indicate that high risk HPV DNA testing is highly sensitive and moderately specific for CIN grade 2 or worse in women younger than 36 years. LBC primary testing followed by high risk HPV DNA triage improved sensitivity and the false-positive rate for cervical cancer screening and are suitable for developed regions in China.
本研究旨在评估高危型人乳头瘤病毒（HPV）DNA检测在识别中国年轻细胞学异常且有患2级及以上宫颈上皮内瘤变（CIN2）风险的女性中的作用，从而推广针对年轻女性的有效分流策略。
本研究共纳入246名年龄在25至36岁之间细胞学异常的年轻女性。所有患者均接受了液基细胞学检查、高危型HPV DNA检测以及必要时的阴道镜检查及直视下活检和宫颈管搔刮术。对液基细胞学检查的剩余标本进行实时聚合酶链反应（PCR）检测，以确定中国常见的10种高危型HPV的存在情况。
在246例细胞学异常样本中，97例（39.4%）高危型HPV检测呈阳性。细胞学结果与高危型HPV DNA阳性患者比例之间存在明显关联：即非典型鳞状细胞不能明确意义（ASCUS）组中HPV阳性率为29.8%；低度鳞状上皮内病变（LSIL）组为43.5%；高度鳞状上皮内病变（HSIL）组为90.0%（p<0.01）。总体而言，高危型HPV检测对于CIN2+终点具有较高的特异性（79.8%）和阳性预测值（PPV，86.5%），对于CIN3+终点具有较高的敏感性（91.3%）和阴性预测值（NPV，98.7%）。对于ASCUS+细胞学的年轻女性，高危型HPV检测对于CIN2+和CIN3+具有较高的NPV（分别为96.0%和99.0%）。对于LSIL+细胞学，高危型HPV检测对LSIL（90.0%）和HSIL（100%）具有较高的敏感性，但特异性相应降低。
结果表明，高危型HPV DNA检测对于36岁以下女性的CIN2级及以上病变具有高度敏感性和中等特异性。以液基细胞学初筛，随后进行高危型HPV DNA分流可提高宫颈癌筛查的敏感性和降低假阳性率，适用于中国的发达地区。
