HPV 16/18 Genotyping by Real-Time PCR Provides Clear Risk Stratification in Women with Normal Cytology
A multicenter prospective cohort of 6,679 Chinese women with normal cervical cytology showed that HPV 16/18 positivity by the HBRT-H14 real-time PCR assay carried a 20.9% three-year cumulative risk of CIN2+, compared to 6.6% for other high-risk types and 0.1% for HPV-negative women. The assay achieved 92.3% sensitivity and 89.6% specificity for detecting CIN2+ over the follow-up period. These data provide strong evidence for integrating HPV 16/18 genotyping into primary cervical screening programs to guide risk-appropriate triage.
The original study
HPV testing with 16/18 genotyping for risk stratification among women with normal cytology: a multicenter prospective cohort study from China.
- Authors
- Zhang J, Wang H, Liu Y, Li Z, Feng X, Luo X, et al.
- Journal
- Journal of clinical microbiology
- Type
- Journal Article, Multicenter Study
- PMID
- 41711488
Original abstract
UNLABELLED: 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.