Large-cohort screening projects in seven regions of China demonstrate the efficacy of extended HPV genotyping in triaging HPV-positive women.

OBJECTIVE: To assess the triage efficacy of extended HPV genotyping for human papillomavirus (HPV)-positive women, using data from 5 large population-based cohort screening studies across seven regions in China. METHODS: We analyzed 7,821 HPV-positive cases among 116,042 screening attendees. The incidence of cervical intraepithelial neoplasia (CIN) grades 3+ was evaluated for single HPV infections. HPV genotypes conferring high CIN3+ risks as single infections were selected for triaging HPV-positive cases and compared with strategy recommended in current screening guidelines. RESULTS: The top five HPV subtypes were HPV-16, 52, 58, 51, and 18. Single HPV16 infection carried the highest risk of CIN3+ incidence. Single infections with HPV31, 33, 52, and 58 also exhibited elevated CIN3+ rates. Using CIN3+ as the primary endpoint, we evaluated extended genotyping-based triage strategies without relying on cytology. The results showed that the extended genotyping strategies (HPV-16/18/31/33/35/45/52/58 and HPV-16/18/31/33/52/58) were non-inferior to the standard strategy (HPV-16/18 combined with cytology) in CIN3+ detection (97.7% vs. 97.1%, p = 0.1540; 97.3% vs. 97.1%, p = 0.1485, respectively). CONCLUSION: Extended HPV genotyping is a promising triage strategy for HPV-positive women, which reduces the reliance on cytology while maintaining non-inferior diagnostic effectiveness for CIN3+ detection, and is suitable for population-based cervical cancer screening.