HPV testing with 16/18 genotyping for risk stratification among women with normal cytology: a multicenter prospective cohort study from China
This multicenter prospective study evaluated the Hybribio 14 high-risk HPV real-time PCR assay (HBRT-H14) in 8,401 women with normal (NILM) cytology under guideline-based follow-up. The assay showed high clinical sensitivity and a very low risk among HPV-negative women, and HPV 16/18 genotyping provided clear risk stratification. These findings deliver large-scale, practice-oriented evidence supporting integration of HBRT-H14 into HPV-based screening pathways that use HPV 16/18 genotyping with cytology triage of other types.
Authors
- Zhifang Li (ORCID: https://orcid.org/0000-0002-0060-8417)
- Xiangxian Feng
- Hong Wang (ORCID: https://orcid.org/0000-0002-6192-3082)
- Yin Liu (ORCID: https://orcid.org/0000-0003-0961-2276)
- YouLin Qiao (ORCID: https://orcid.org/0000-0001-6380-0871)
- Shaokai Zhang
- Xiping Luo
- Jiangong Zhang
- Wen Chen
- Hui Yang
Institutions
- Northwestern Polytechnical University (CN)
- Changzhi Medical College (CN)
- Chinese Academy of Medical Sciences & Peking Union Medical College (CN)
- Peking Union Medical College Hospital (CN)
- National Cancer Center (US)
- Henan Cancer Hospital (CN)
- Guangdong Province Women and Children Hospital (CN)
Publication Details
- Journal
- Journal of Clinical Microbiology
- Published
- 2026-02-19
- DOI
- https://doi.org/10.1128/jcm.01289-25
- Primary Topic
- Cervical Cancer and HPV Research
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- National Natural Science Foundation of China