ArticleJournal of clinical microbiology2026
HPV testing with 16/18 genotyping for risk stratification among women with normal cytology: a multicenter prospective cohort study from China.
Article in Journal of clinical microbiology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
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. IMPORTANCE: 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.
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