ArticleRadiology and oncology2021
Diagnostic performance of p16/Ki-67 dual immunostaining at different number of positive cells in cervical smears in women referred for colposcopy.
Article in Radiology and oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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Who cites it
6 citing papers in PubMed, 8 citations in OpenAlex.
- Adjunctive role of p16/Ki-67 dual-stain cytology in colposcopy referral pathways for cervical precancer and persistent high-risk HPV infection.Frontiers in oncology · 2026Article
- Comparative Diagnostic Performance of DNA Ploidy Analysis and p16/Ki67 Dual-Staining with Cytology in hrHPV-Defined Subgroups: A Single-Center Evaluation.Cancer management and research · 2026Article
- Enhancing Cervical Cancer Screening: Review of p16/Ki-67 Dual Staining as a Promising Triage Strategy.Diagnostics (Basel, Switzerland) · 2024Review
- The Role of p16/Ki67 Dual Staining in Cervical Cancer Screening.Current issues in molecular biology · 2023Review
- Diagnostic Accuracy of p16Analytical cellular pathology (Amsterdam) · 2023Article
- Which is the best management for women with normal cervical cytologic findings despite positivity for non-16/18 high risk human papillomaviruses?Frontiers in public health · 2022Review
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Authors and funding
7 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe aim of the study was to evaluate the diagnostic accuracy of p16/Ki-67 dual immunostaining (p16/ Ki-67 DS) in cervical cytology and the number of positive p16/Ki-67 cells to diagnose high grade cervical intraepithelial neoplasia (CIN2+) in colposcopy population. SUBJECTS AND
methodsWe performed an analysis on a subset cohort of 174 women enrolled within a large-scale randomised controlled human papillomavirus (HPV) self-sampling project organised as part of the population-based Cervical Cancer Screening Programme ZORA in Slovenia. This subset cohort of patients was invited to the colposcopy clinic, underwent p16/Ki-67 DS cervical cytology and had the number of p16/Ki-67 positive cells determined.
resultsAmong analysed women, 42/174 (24.1%) had histologically confirmed CIN2+. The risk for CIN2+ was increasing with the number of positive cells (p < 0.001). The sensitivity of p16/Ki-67 DS for detection of CIN2+ was 88.1%, specificity was 65.2%, positive predictive value was 44.6% and negative predictive value was 94.5%.
conclusionsDual p16/Ki-67 immunostaining for the detection of CIN2+ has shown high sensitivity and high negative predictive value in our study, which is comparable to available published data. The number of p16/Ki-67 positive cells was significantly associated with the probability of CIN2+ detection. We observed a statistically significant and clinically relevant increase in specificity if the cut-off for a positive test was shifted from one cell to three cells.
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