Massad L Stewart, Clarke Megan A, Perkins Rebecca B, Garcia Francisco, Chelmow David, Cheung Li C, Darragh Teresa M, Egemen Didem, Lorey Thomas S, Nayar Ritu, Newman Morgan, Risley Carolann, Smith Robert A, Wentzensen Nicolas
Division of Gynecologic Oncology, Washington University School of Medicine, St. Louis, MO.
Division of Cancer Epidemiology & Genetics, National Cancer Institute, Rockville, MD.
J Low Genit Tract Dis. 2025 Apr 1;29(2):134-143. doi: 10.1097/LGT.0000000000000865. Epub 2025 Jan 10.
The Enduring Consensus Cervical Cancer Screening and Management Guidelines Committee developed recommendations for the use of extended genotyping results in cervical cancer prevention programs.
Risks of cervical intraepithelial neoplasia grade 3 or worse were calculated using data obtained with the Onclarity HPV Assay from large cohorts. Management recommendations were based on clinical action thresholds developed for the 2019 American Society for Colposcopy and Cervical Pathology Risk-Based Management Consensus Guidelines. Risk estimates were reviewed in relation to clinical action thresholds and used as the basis for draft recommendations. After an open comment period, recommendations were finalized and ratified through a vote by the Consensus Stakeholder Group.
Colposcopy is recommended after positive tests for human papillomavirus (HPV) types 16 and 18. For those positive for HPV 45, 33/58, 31, 52, 35/39/68, or 51 but negative for 16 or 18, triage with cytology or dual stain testing is recommended. When screening with primary HPV testing, for patients who test positive for HPV types 56/59/66 and no other carcinogenic types, repeat HPV testing in 1 year is recommended. When screening with cotesting, for those who test positive for HPV types 56/59/66 and no other carcinogenic types, 1-year return is recommended for negative for intraepithelial lesion or malignancy, atypical squamous cells of undetermined significance, and low-grade squamous intraepithelial lesion, and colposcopy is recommended for atypical squamous cells cannot exclude high-grade squamous intraepithelial lesion (ASC-H), atypical glandular cells, high-grade squamous intraepithelial lesion, or carcinoma. When patients without prior high-grade cytology (atypical squamous cells cannot exclude high-grade squamous intraepithelial lesion, atypical glandular cells, high-grade squamous intraepithelial lesion, or carcinoma) or histology (cervical intraepithelial neoplasia [CIN]2, CIN3, or adenocarcinoma in situ) are being followed, use of extended genotyping results is acceptable. When high-grade cytology or histology results are present, or when patients are being followed after treatment of CIN2+, management using the 2019 guidelines is recommended.
Human papillomavirus extended genotyping can guide clinical management in the setting of a positive HPV test result.
持久共识宫颈癌筛查与管理指南委员会制定了在宫颈癌预防项目中使用扩展基因分型结果的建议。
使用从大型队列中通过Onclarity HPV检测获得的数据计算宫颈上皮内瘤变3级或更高级别病变的风险。管理建议基于为2019年美国阴道镜和宫颈病理学会基于风险的管理共识指南制定的临床行动阈值。根据临床行动阈值对风险估计进行审查，并将其用作建议草案的基础。在公开征求意见期后，建议最终确定并经共识利益相关者小组投票批准。
对于人乳头瘤病毒（HPV）16型和18型检测呈阳性的患者，建议进行阴道镜检查。对于HPV 45、33/58、31、52、35/39/68或51型检测呈阳性但16型或18型检测呈阴性的患者，建议采用细胞学或双染检测进行分流。当采用HPV初筛时，对于HPV 56/59/66型检测呈阳性且无其他致癌型别的患者，建议1年后重复进行HPV检测。当采用联合检测时，对于HPV 56/59/66型检测呈阳性且无其他致癌型别的患者，对于上皮内病变或恶性肿瘤、意义不明确的非典型鳞状细胞以及低级别鳞状上皮内病变检测结果为阴性的患者，建议1年后复诊，对于不能排除高级别鳞状上皮内病变（ASC-H）、非典型腺细胞、高级别鳞状上皮内病变或癌的非典型鳞状细胞患者，建议进行阴道镜检查。对于既往无高级别细胞学检查结果（不能排除高级别鳞状上皮内病变的非典型鳞状细胞、非典型腺细胞、高级别鳞状上皮内病变或癌）或组织学检查结果（宫颈上皮内瘤变[CIN]2、CIN3或原位腺癌）的患者进行随访时，使用扩展基因分型结果是可以接受的。当存在高级别细胞学或组织学检查结果时，或当患者在CIN2+治疗后进行随访时，建议采用2019年指南进行管理。
人乳头瘤病毒扩展基因分型可在HPV检测结果为阳性的情况下指导临床管理。
