HPV testing with 16/18 genotyping for risk stratification among women with normal cytology: a multicenter prospective cohort study from China

To evaluate the clinical performance of Hybribio’s 14-type HPV real-time PCR with 16/18 genotyping (HBRT-H14) and its risk stratification utility among women with normal cytology (NILM). From 2017 to 2020, a multicenter cohort enrolled 8,401 women aged 30–64 years with NILM cytology. Baseline HPV testing used HBRT-H14. Women positive for HPV 16/18 were referred for colposcopy; follow-up was annual for 3 years or until the detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+). Analyses included 6,679 women who completed follow-up. Overall HPV positivity was 11.4%, including 2.3% HPV 16/18. Over 3 years, sensitivity and specificity of HPV positivity for CIN2+ were 92.3% (95% confidence interval [CI]: 84.2–96.4) and 89.6% (88.8–90.3). For HPV 16/18 positivity, sensitivity and specificity were 41.0% (30.8–52.1) and 98.2% (97.8–98.5). Three-year cumulative CIN2+ risk was 20.9% (15.2–28.1) for HPV 16/18-positive women, 6.6% (4.9–8.9) for other types, and 0.1% (0.04–0.2) for HPV-negative women. HBRT-H14 shows strong clinical performance for detecting CIN2+, and HPV 16/18 genotyping provides effective risk stratification among women with NILM cytology. Findings support integration of HBRT-H14 into HPV-based screening pathways with HPV 16/18 genotyping and cytology triage of other types.