Jiang M Y, Feng R M, Wang L, Li T Y, Zhang A A, Cui J F, Pan Q J, Zhang X, Liu M L, Gao F, Chen W, Qiao Y L
Department of Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.
Department of Cancer Prevention Research, Sun Yat-sen University Cancer Center, Guangzhou 510060, China.
Zhonghua Zhong Liu Za Zhi. 2018 Oct 23;40(10):750-756. doi: 10.3760/cma.j.issn.0253-3766.2018.10.006.
To evaluate the clinical performance of HPV genotyping with cytology for detecting cervical precancer among women attending co-testing. A total of 2 883 females who participated in cervical cancer screening program were recruited from Erdos in 2016. All the participants were tested by cytology and HPV genotyping. In 2017, women with abnormal cytology results or HPV positive were followed up. Pathological cervical intraepithelial neoplasia (CIN) 2+ was the study end-point. Clinical performance indexes were calculated, including sensitivity, specificity, positive predictive value, negative predictive value, referral rate and missed cases. INNO-LiPA resulted in a detection rate of 18.87%(544/2 883) for the 14-type high risk HPV. HPV16 was the most common infectious genotype (4.06%), followed by HPV52 (3.61%), HPV51 (2.50%), HPV58 (1.98%), and HPV18 (1.56%). With more HPV genotypes added into the group, sensitivity increased and the specificity decreased. Addition of HPV16, 58, 33, 39, 52, 18, 31 for detection lead to the maximun value of area under the curve (AUC)=0.913 (95%: 0.882-0.944). Compared with traditional screening method by cytology, cotesting decreased the number of missed diagnosis. Meanwhile, the fifth method (co-testing: triage of women with HPV16/18+ , cytological minor abnormalities and HPV58, 33, 39, 52, 31+ or cytological high grade abnormalities) did not increase referral rate (8.99% vs. 8.71%, =0.525), with five cases of missed diagnosis (sensitivity of 92.1% and specificity of 93.2%). Co-testing with triage of women with HPV16/18+ , cytological minor abnormalities and HPV58, 33, 39, 52, 31+ or cytological high grade abnormalities would provide better clinical performance. In co-testing, triage of HPV16/18 was used in women with normal cytology; triage of HPV58, 33, 39, 52 and 31 was used in women with low-grade abnormal cytology; referral colposcopy was used in women with high-grade abnormal cytology, which would provide better clinical performance.
评估人乳头瘤病毒（HPV）基因分型联合细胞学检查在接受联合检测的女性中检测宫颈上皮内瘤变的临床性能。2016年从鄂尔多斯招募了2883名参与宫颈癌筛查项目的女性。所有参与者均接受了细胞学检查和HPV基因分型检测。2017年，对细胞学结果异常或HPV阳性的女性进行了随访。宫颈上皮内瘤变（CIN）2级及以上为研究终点。计算了临床性能指标，包括敏感性、特异性、阳性预测值、阴性预测值、转诊率和漏诊病例。INNO-LiPA法检测14种高危型HPV的检出率为18.87%（544/2883）。HPV16是最常见的感染基因型（4.06%），其次是HPV52（3.61%）、HPV51（2.50%）、HPV58（1.98%）和HPV18（1.56%）。随着检测的HPV基因型种类增加，敏感性上升，特异性下降。加入HPV16、58、33、39、52、18、31进行检测时曲线下面积（AUC）达到最大值，为0.913（95%：0.882-0.944）。与传统的细胞学筛查方法相比，联合检测减少了漏诊数量。同时，第五种方法（联合检测：对HPV16/18阳性、细胞学轻度异常以及HPV58、33、39、52、31阳性或细胞学高度异常的女性进行分流）并未增加转诊率（8.99%对8.71%，P=0.525），漏诊5例（敏感性为92.1%，特异性为93.2%）。对HPV16/18阳性、细胞学轻度异常以及HPV58、33、39、52、31阳性或细胞学高度异常的女性进行分流的联合检测具有更好的临床性能。在联合检测中，对细胞学正常的女性采用HPV16/18分流；对细胞学低度异常的女性采用HPV58、33、39、52和31分流；对细胞学高度异常的女性采用转诊阴道镜检查，这样会具有更好的临床性能。
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