What question did this study set out to answer?

This study aims to evaluate the effectiveness of dual stain and genotyping for managing HPV-positive women in cervical cancer screening.

February 19, 2026

Long-Term Prospective Cohort Study of Cervical Cancer Screening Using Triage of Women who Are Human Papillomavirus–Positive With Dual Stain and Human Papillomavirus Genotyping

Key Points

This study aims to evaluate the effectiveness of dual stain and genotyping for managing HPV-positive women in cervical cancer screening.
Included 9,645 HPV-positive women in cervical screening from 2015 to 2017.
Estimated absolute risk and clinical performance of dual stain and cytology for detecting CIN3+.
Used a prevalence-incidence mixture model for modeling cumulative risk over five years.
CIN3+ baseline risk was 9.4% for dual stain positives and significantly lower for negatives (0.8%).
Dual stain showed greater sensitivity, specificity, and predictive values for CIN3+ detection compared to cytology.
Women with HPV16 had a higher risk for CIN3+ compared to those who were HPV16-positive but dual stain-negative.

Abstract

PURPOSE Primary human papillomavirus (HPV) testing has the best tradeoff of benefits and harms for cervical screening but requires triage to determine management among HPV positives. We conducted a prospective observational study to evaluate triage of women who are HPV-positive using dual stain (DS) and HPV genotyping. MATERIALS AND METHODS We included 9,645 consecutive women who are HPV-positive undergoing cervical screening in two periods between 2015 and 2017 in the organized cervical screening program at Kaiser Permanente Northern California. Absolute risk and clinical performance of DS and cytology for detection of cervical intraepithelial neoplasia grade 3 and greater (CIN3+) were estimated overall and by HPV genotype and by age. Cumulative absolute risk of CIN3+ was modeled over 5 years using a prevalence-incidence mixture model, which allows estimating risk accounting for differences in disease ascertainment, surveillance intervals, and compliance. RESULTS The baseline risk of CIN3+ was 9.4% and 0.8% for women testing positive and negative for DS, respectively, and 6.9% and 2.0% for women testing positive and negative for cytology, respectively. Sensitivity, specificity, and predictive values for CIN3+ detection were better for DS compared with cytology over 5 years ( P < .001 for all comparisons). Risk in women with HPV16-positive/negative for intraepithelial lesion or malignancy was substantially higher than the risk in women with HPV16-positive/DS-negative (7.5% v 2.9%, P < .001). DS had better triage performance compared with cytology in all age groups and in women positive for HPV types other than HPV16 or HPV18. CONCLUSION Long-term reassurance of low risk among DS negatives suggests that DS detects molecular changes earlier in the carcinogenic pathway than cytology. DS has better risk stratification than cytology overall, within HPV risk strata, and across all screening age groups and is a better option for triage of vaccinated populations.

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