Real-World Performance of HPV DNA-Based Screening in Health Resource-Limited Areas of China: A Multicenter Implementation Study

在中国医疗资源匮乏地区,基于HPV DNA的筛查在实际应用中的表现:一项多中心实施研究

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Abstract

BACKGROUND: Cervical cancer remains a significant health burden in China. National policies now allow human papillomavirus (HPV) DNA as a primary screening test, but many health resource-limited counties have not adopted it because programs cannot fund reagents or laboratory platforms. We conducted a multicenter study in 10 pilot counties where HPV DNA screening was introduced with project-supported reagents, platforms, and training. METHODS: We analyzed data from 10 pilot counties designated by the National Cervical Cancer Prevention Program. A total of 63,223 women aged 35 to 64 years were screened with three strategies: (i) cytology alone, (ii) HPV DNA testing with cytology triage, and (iii) HPV DNA testing with visual inspection with acetic acid/Lugol iodine (VIA/VILI) triage. Key indicators included screen positivity rate, colposcopy rate, cervical intraepithelial neoplasia (CIN) 2+ detection, positive predictive value (PPV), and number needed to refer (NNR). Inverse probability weighting was used to adjust for loss to follow-up. RESULTS: HPV-based strategies were superior to cytology across all indicators. CIN2+ detection was two to three times higher, with the highest PPV in the HPV + cytology group (21.9%) and the lowest NNR (5.73), indicating higher referral efficiency. Loss to follow-up rate was also significantly reduced under the HPV + VIA/VILI strategy. These advantages were most prominent among women aged ≥45 years. CONCLUSIONS: Within the first year of implementation, HPV DNA-based screening is feasible and more effective in health resource-limited areas of China and flexible triage models can be adapted. IMPACT: The findings support the integration of HPV DNA testing into national cervical cancer screening programs and highlight needs for robust follow-up systems in underserved populations.

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