Department of Pathology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.
Department of Pathology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
Cancer Cytopathol. 2022 Apr;130(4):248-258. doi: 10.1002/cncy.22536. Epub 2021 Dec 7.
Extended high-risk human papillomavirus (hrHPV) genotype testing (hrHPVGT) has emerged as a new strategy to help optimize the efficiency of hrHPV triage.
Women with an atypical squamous cells of undetermined significance (ASC-US) cervical Papanicolaou test result who underwent hrHPVGT between October 2017 and May 2021 at the Obstetrics and Gynecology Hospital of Fudan University in Shanghai, China, were studied. For hrHPVGT, a proprietary multiplex real-time polymerase chain reaction assay was used. hrHPVGT and viral load test results in selected patients were correlated with histopathologic follow-up findings available within 6 months.
In total, 17,235 women with ASC-US cytology who had hrHPVGT results were identified in the Obstetrics and Gynecology Hospital of Fudan University database. The hrHPV-positive rate was 61.8%, and the most prevalent hrHPV genotypes were type 52 (HPV52) (16%), HPV16 (11.3%), HPV58 (10.2%), and HPV53 (8.4%). Single hrHPV genotypes were detected in 65.9% of women with hrHPV-positive results, and multiple genotypes were detected in 34.1%. Histopathologic cervical findings within 6 months were available in 5627 hrHPV-positive women and 2223 hrHPV-negative women. High-grade cervical intraepithelial lesions or cervical cancer (cervical intraepithelial neoplasia 2 or greater [CIN2+]) were identified in 7.5% of hrHPV-positive women who had ASC-US cytology and in 0.9% of hrHPV-negative women who had ASC-US cytology. The greatest risk for CIN2+ was in single hrHPV genotype infections with HPV16 (21.1%), HPV33 (15.2%), HPV82 (10%), and HPV18 (9.9%). hrHPVGT for genotypes HPV16, HPV33, HPV82, HPV18, HPV31, HPV45, HPV58, and HPV52 identified 95% of CIN2+ cases with 90.8% sensitivity, 53.8% specificity, a positive predictive value of 10.2%, and a negative predictive value of 99%. A significantly increased viral load was associated only with women who had HPV16-related CIN2+.
hrHPVGT for women who have ASC-US cytology allows for risk stratification capable of optimizing the efficiency of triage for hrHPV-positive women.
扩展高危型人乳头瘤病毒（hrHPV）基因型检测（hrHPVGT）已成为一种新策略，有助于优化 hrHPV 分流的效率。
本研究纳入了 2017 年 10 月至 2021 年 5 月在中国上海复旦大学妇产科医院进行 hrHPVGT 的因非典型鳞状细胞意义不明确（ASC-US）宫颈巴氏涂片检查结果异常的女性。hrHPVGT 采用专有的多重实时聚合酶链反应检测。在 6 个月内获得了 hrHPVGT 和病毒载量检测结果与组织病理学随访结果的相关性。
在复旦大学妇产科医院数据库中，共确定了 17235 例 ASC-US 细胞学检查的 hrHPV 阳性女性。hrHPV 阳性率为 61.8%，最常见的 hrHPV 基因型为 HPV52（16%）、HPV16（11.3%）、HPV58（10.2%）和 HPV53（8.4%）。65.9%的 hrHPV 阳性女性检测到单一的 hrHPV 基因型，34.1%的女性检测到多种基因型。在 5627 例 hrHPV 阳性女性和 2223 例 hrHPV 阴性女性中，在 6 个月内获得了组织病理学宫颈发现。在 ASC-US 细胞学检查结果异常的 hrHPV 阳性女性中，有 7.5%的女性发现高级别宫颈上皮内瘤变或宫颈癌（宫颈上皮内瘤变 2 级或更高级别[CIN2+]），在 ASC-US 细胞学检查结果正常的 hrHPV 阴性女性中，有 0.9%的女性发现 CIN2+。在 HPV16（21.1%）、HPV33（15.2%）、HPV82（10%）和 HPV18（9.9%）单一基因型感染的女性中，CIN2+的风险最高。针对 HPV16、HPV33、HPV82、HPV18、HPV31、HPV45、HPV58 和 HPV52 基因型的 hrHPVGT 检测可发现 95%的 CIN2+病例，敏感性为 90.8%，特异性为 53.8%，阳性预测值为 10.2%，阴性预测值为 99%。仅与 HPV16 相关的 CIN2+女性的病毒载量显著增加有关。
针对 ASC-US 细胞学检查的 hrHPVGT 可进行风险分层，从而优化 hrHPV 阳性女性的分流效率。
