Applying Results of Extended Genotyping to Management of Positive Cervicovaginal Human Papillomavirus Test Results: Enduring Guidelines

L Stewart Massad,Megan A Clarke，Nicolas Wentzensen, Enduring Consensus Cervical Cancer Screening and Management Guidelines Committee

Journal of lower genital tract disease（2025）

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Abstract

Objective The Enduring Consensus Cervical Cancer Screening and Management Guidelines Committee developed recommendations for the use of extended genotyping results in cervical cancer prevention programs. Methods 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. Results 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. Conclusions Human papillomavirus extended genotyping can guide clinical management in the setting of a positive HPV test result.

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【要点】：本文提出了一项关于在宫颈癌预防项目中使用扩展基因分型结果的临床管理指南，旨在优化宫颈癌的筛查与治疗策略。

【方法】：通过分析Onclarity HPV Assay的大规模队列数据，计算了患宫颈上皮内瘤变3级或更严重病变的风险，并根据2019年美国宫颈镜和宫颈病理学会风险基础管理共识指南制定的临床行动阈值，提出了管理建议。

【实验】：研究基于大规模队列数据，使用Onclarity HPV Assay进行基因分型，最终形成了针对不同HPV类型阳性的患者管理建议。结果建议对HPV 16和18阳性者进行宫颈镜检查；对HPV 45、33/58、31、52、35/39/68或51阳性但16和18阴性者进行细胞学或双染测试；对仅HPV 56/59/66阳性者进行一年后复检。在联合筛查中，针对特定情况，建议一年后复查或进行宫颈镜检查。对于无高级别细胞学或组织学结果的患者，使用扩展基因分型结果是可接受的。在高级别结果或治疗后的患者中，建议按照2019年指南进行管理。