Diagnostic accuracy of p16/Ki-67 dual-stain cytology for detecting CIN2+ and CIN3+ in HPV-positive women: A systematic review and meta-analysis.
Dual-staining cytology shows good potential to improve cervical cancer screening by better identifying high-risk women.
This systematic review and meta-analysis of 27 studies (24,519 HPV-positive women) evaluated the diagnostic accuracy of p16/Ki-67 dual-stained cytology as a triage test for cervical intraepithelial neoplasia. The pooled results demonstrate high sensitivity (~84–86%) with moderate specificity (~61–64%) for detecting CIN2+ and CIN3+, supporting its potential role as a reflex triage test in HPV-based screening programs, while cautioning about very low certainty of evidence due to study heterogeneity.
What the study was
- Study design
- systematic review + meta-analysis (bivariate random-effects Reitsma model, 27 studies, n=24,519)
- Category
- Diagnostics
- Maturity
- Validated
- Journal
- European Journal of Obstetrics, Gynecology, and Reproductive Biology
Why it surfaced
Large meta-analysis (24k+ HPV-positive women) providing the most comprehensive accuracy data yet for p16/Ki-67 dual-stain as cervical cancer triage; directly relevant to T5 precision oncology (biomarker-guided screening) and major global cervical cancer prevention unmet need.
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