Xu Hui-Fang, Liu Yin, Luo Yan-Lin, Zhao Dong-Mei, Jia Man-Man, Chen Pei-Pei, Li Meng-Jie, Sun Xing-Ai, Liu Shu-Zheng, Sun Xi-Bin, Zhang Shao-Kai
Department of Cancer Epidemiology, Henan International Joint Laboratory of Cancer Prevention, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Henan Engineering Research Center of Cancer Prevention and Control, Zhengzhou, China.
Department of Gynecology and Oncology, Henan International Joint Laboratory of Cancer Prevention, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Henan Engineering Research Center of Cancer Prevention and Control, Zhengzhou, China.
Front Oncol. 2021 Oct 4;11:716762. doi: 10.3389/fonc.2021.716762. eCollection 2021.
To evaluate the clinical performance and utility for risk stratification of DH3 HPV assay in women (≥30 years) with NILM cytology.
A prospective cohort was established in Central China between November 8 to December 14, 2016 which consisted of 2180 women aging 30-64 years with NILM cytology. At baseline, all women were screened using DH3 HPV assay. HPV 16/18 positive women would be assigned to colposcopy and biopsied if necessary. Then, hr-HPV positive women without CIN2+ lesions would be followed up by cytology every 12 months for two years. In the 3 year of follow up, all women that were not biopsy proven CIN2+ would be called back and screened by cytology again. In follow-up period, women with ASC-US and above were referred to colposcopy and biopsied if clinically indicated. CIN2+ was the primary endpoint in analysis. The clinical performance and utility for risk stratification of DH3 HPV assay were assessed by SPSS 22.0 and SAS 9.4.
Of 2180 qualified women, the prevalence of hr-HPV was 8.5% (185/2180), 45(2.1%) were HPV 16/18 positive. The clinical performance for HPV16/18 was 91.7% for sensitivity, 98.4% for specificity, respectively against CIN2+ detection at baseline. In four years of study, the corresponding rates of HPV 16/18 were 51.5% and 98.7%, respectively. The cumulative absolute risk for the development of CIN2+ was as high as 37.8% for HPV 16/18 positive women, followed by hr-HPV positive (14.6%), other hr-HPV positive (11.0%) and HPV negative (0.3%) in three years. The relative risk was 125.6 and 3.4 for HPV 16/18 positive group when compared with HPV negative and other hr-HPV positive group, respectively.
DH3 HPV assay demonstrated excellent clinical performance against CIN2+ detection in cervical cancer screening and utility of risk stratification by genotyping to promote scientific management of women with NILM cytology.
评估DH3 HPV检测对非典型鳞状细胞意义不明确（NILM）细胞学结果的30岁及以上女性的临床性能及风险分层效用。
2016年11月8日至12月14日在中国中部地区建立了一个前瞻性队列，纳入2180名年龄在30 - 64岁、细胞学结果为NILM的女性。基线时，所有女性均采用DH3 HPV检测进行筛查。HPV 16/18阳性的女性如有必要将接受阴道镜检查及活检。然后，HPV高危型（hr-HPV）阳性且无高级别鳞状上皮内病变（CIN2+）的女性将每12个月进行一次细胞学随访，为期两年。在随访的第3年，所有未经活检证实为CIN2+的女性将被召回并再次进行细胞学筛查。在随访期间，非典型鳞状细胞不能明确意义（ASC-US）及以上的女性，如有临床指征，将被转诊至阴道镜检查及活检。CIN2+是分析的主要终点。采用SPSS 22.0和SAS 9.4评估DH3 HPV检测的临床性能及风险分层效用。
在2180名符合条件的女性中，hr-HPV的患病率为8.5%（185/2180），45名（2.1%）为HPV 16/18阳性。HPV16/18检测针对基线时CIN2+检测的临床性能，敏感性为91.7%，特异性为98.4%。在4年的研究中，HPV 16/18的相应比率分别为51.5%和98.7%。HPV 16/18阳性女性发生CIN2+的累积绝对风险高达37.8%，其次是hr-HPV阳性（14.6%）、其他hr-HPV阳性（11.0%）和HPV阴性（0.3%），为期3年。与HPV阴性和其他hr-HPV阳性组相比，HPV 16/18阳性组的相对风险分别为125.6和3.4。
DH3 HPV检测在宫颈癌筛查中对CIN2+检测显示出优异的临床性能，并且通过基因分型进行风险分层有助于促进NILM细胞学结果女性的科学管理。
