Wang Yangzhen, Gao Shanshan, Wang Yuxia, Chen Fuchun, Deng Hailong, Lu Yongfang
Department of Central Laboratory, Longyan First Hospital Affiliated to Fujian Medical University, Longyan, People's Republic of China.
Department of Gynecology, Longyan First Hospital Affiliated to Fujian Medical University, Longyan, People's Republic of China.
Cancer Manag Res. 2020 Jul 1;12:5265-5275. doi: 10.2147/CMAR.S254330. eCollection 2020.
To evaluate the performance of different high-risk human papillomavirus (HR-HPV) genotype models in triaging women with cytological diagnosis of atypical squamous cells of undetermined significance (ASCUS).
A total of 36,679 Chinese women who underwent cytology and HR-HPV genotyping assessments during cervical cancer screening were enrolled in this study. Women with cytology-proven ASCUS were referred for further screening by colposcopy and biopsy. The study endpoint was histological detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) at any of the follow-up visits. The sensitivity, specificity, positive predictive values (PPVs), negative predictive values (NPVs), positive likelihood ratio (PLR) and negative likelihood ratio (NLR) of different HR-HPV genotype combination models were estimated.
In all, 1675 (4.9%) women were identified as having ASCUS, 1454 women underwent colposcopy and biopsy, and 6.0% (87/1454) women were identified as having CIN2+ lesions. Among those with ASCUS who were identified as having CIN2+, the HR-HPV infection rate was 97.7%, and the prevalence rates of HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 were 48.3%, 8.0%, 6.9%, 4.6%, 1.1%, 2.3%, 3.4%, 3.4%, 26.4%, 1.1%, 17.2%, 2.3%, 0.0% and 0.0%, respectively. Compared to other HR-HPV-type combination models, the HPV16/18/31/33/52/58 model achieved a higher sensitivity [93.1 (87.8-98.4)], specificity [73.0 (70.7-75.4)], PPV [18.0 (14.5-21.5)], NPV [99.4 (98.9-99.9)], PLR [3.7 (3.1-3.8)] and NLR [0.06 (0.03-0.18)] for the triage of ASCUS patients, but the colposcopy referral rate (30.9%) was significantly lower than that of the recommended HR-HPV model (44.0%).
This study confirms that the specific HR-HPV genotype HPV16/18/31/33/52/58 is an alternative strategy for ASCUS triage and can effectively reduce the high burden of colposcopy referrals in China.
评估不同的高危型人乳头瘤病毒（HR-HPV）基因型模型在对细胞学诊断为意义不明确的非典型鳞状细胞（ASCUS）的女性进行分流时的性能。
本研究纳入了36679名在宫颈癌筛查期间接受了细胞学和HR-HPV基因分型评估的中国女性。经细胞学证实为ASCUS的女性被转诊接受阴道镜检查和活检以进一步筛查。研究终点为在任何一次随访中组织学检测到宫颈上皮内瘤变2级或更严重病变（CIN2+）。估计了不同HR-HPV基因型组合模型的敏感性、特异性、阳性预测值（PPV）、阴性预测值（NPV）、阳性似然比（PLR）和阴性似然比（NLR）。
总共1675名（4.9%）女性被诊断为ASCUS，1454名女性接受了阴道镜检查和活检，其中6.0%（87/1454）的女性被诊断为CIN2+病变。在被诊断为CIN2+的ASCUS患者中，HR-HPV感染率为97.7%，HPV-16、-18、-31、-33、-35、-39、-45、-51、-52、-56、-58、-59、-66和-68的感染率分别为48.3%、8.0%、6.9%、4.6%、1.1%、2.3%、3.4%、3.4%、26.4%、1.1%、17.2%、2.3%、0.0%和0.0%。与其他HR-HPV类型组合模型相比，HPV16/18/31/33/52/58模型在对ASCUS患者进行分流时具有更高的敏感性[93.1（87.8 - 98.4）]、特异性[73.0（70.7 - 75.4）]、PPV[18.0（14.5 - 21.5）]、NPV[99.4（98.9 - 99.9）]、PLR[3.7（3.1 - 3.8）]和NLR[0.06（0.03 - 0.18）]，但阴道镜转诊率（30.9%）显著低于推荐的HR-HPV模型（44.0%）。
本研究证实特定的HR-HPV基因型HPV16/18/31/33/52/58是ASCUS分流的一种替代策略，并且可以有效减轻中国阴道镜转诊的高负担。
