ArticleModern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc2017
Evaluation of p16/Ki-67 dual-stained cytology as triage test for high-risk human papillomavirus-positive women.
Article in Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.
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Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it.
- The Diagnostic Value of p16/Ki67 Dual Immunostaining for Anal Intraepithelial Neoplasia: A Meta-Analysis.American journal of men's healthPooled it
- Risk-Stratified versus Cytology-Based Triage of Non-HPV 16/18-Positive for Detection of High-Grade Cervical Intraepithelial Neoplasia: Protocol of a Non- Inferiority Randomized Controlled Trial.Research square · 2026Article
- Article
- Cervical Cancer Screening in Transition: Global Challenges and Local Realities.International journal of women's health · 2026Review
- p16/ki-67 dual stain triage of individuals positive for HPV to detect cervical precancerous lesions.International journal of cancer · 2025Review
- Immunocytochemical staining for p16, Ki-67, and MCM2 in the detection of cervical lesions and cancer: a prospective observational study.Translational cancer research · 2025Article
- Article
- Adjunctive use of p16 immunohistochemistry for optimizing management of CIN lesions in a high-risk human papillomavirus-positive population.Acta obstetricia et gynecologica Scandinavica · 2022Article
- Cervical Cancer Elimination Is Dependent on Women's Self-Tests for Primary Human Papillomavirus Testing Triaged by Methylation Status.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022Article
- False Negative Results in Cervical Cancer Screening-Risks, Reasons and Implications for Clinical Practice and Public Health.Diagnostics (Basel, Switzerland) · 2022Review
- Targeted RNA next generation sequencing analysis of cervical smears can predict the presence of hrHPV-induced cervical lesions.BMC medicine · 2022Article
- Is Primary HPV with Secondary p16/Ki67 Dual-Stain an Alternative HSIL-Risk Detection Strategy in Cervical Cancer Screening for Women under 30 Years?Diagnostics (Basel, Switzerland) · 2021Article
- Liquid-Based Screening Tests Results: HPV, Liquid-Based Cytology, and P16/Ki67 Dual-Staining in Private-Based Opportunistic Cervical Cancer Screening.Diagnostics (Basel, Switzerland) · 2021Article
- Cervical Cancer Screening Postpandemic: Self-Sampling Opportunities to Accelerate the Elimination of Cervical Cancer.International journal of women's health · 2021Review
- Novel biomarkers with promising benefits for diagnosis of cervical neoplasia: a systematic review.Infectious agents and cancer · 2020Review
- The Association of Molecular Biomarkers in the Diagnosis of Cervical Pre-Cancer and Cancer and Risk Factors in Senegalese.Asian Pacific journal of cancer prevention : APJCP · 2020Article
- Implementation of p16/Ki67 dual stain cytology in a Danish routine screening laboratory: Importance of adequate training and experience.Cancer medicine · 2020Article
- Approaches to triage optimization in HPV primary screening: Extended genotyping and p16/Ki-67 dual-stained cytology-Retrospective insights from ATHENA.International journal of cancer · 2020Article
- FHIT and C-MYC expression in cervical histology and cytology as biomarkers for detecting high-grade intraepithelial neoplasia in human papillomavirus-positive women.Cancer biomarkers : section A of Disease markers · 2020Article
- Combining HPV DNA load with p16/Ki-67 staining to detect cervical precancerous lesions and predict the progression of CIN1-2 lesions.Virology journal · 2019Article
Corrections and comments
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Authors and funding
16 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The aim of this study was to evaluate the clinical utility of p16/Ki-67 dual staining, for the identification of CIN in high-risk HPV-positive women from a non-responder screening cohort. P16/Ki-67 dual staining, Pap cytology, and HPV16/18 genotyping were performed on physician-taken liquid-based samples from 495 women who tested high-risk HPV positive on self-sampled material (PROHTECT-3B study). Different triage strategies involving p16/Ki-67 dual staining were evaluated for sensitivity, specificity, and predictive value for ≥CIN2 and ≥CIN3, and compared to Pap cytology with a threshold of atypical cells of undetermined significance. Centrally revised histology or an adjusted endpoint with combined high-risk HPV negative and cytology negative follow-up at 6 months was used as gold standard. Pap cytology (threshold atypical cells of undetermined significance) triage of high-risk HPV-positive samples showed a sensitivity of 93% (95% confidence interval: 85-98) with a specificity of 49% (95% confidence interval: 41-56) for ≥CIN3. Three triage strategies with p16/Ki-67 showed a significantly increased specificity with similar sensitivity. P16/Ki-67 triage of all high-risk HPV-positive samples had a sensitivity of 92% (95% confidence interval: 84-97) and a specificity of 61% (95% confidence interval: 54-69) for ≥CIN3. Applying p16/Ki-67 triage to only high-risk HPV-positive women with low-grade Pap cytology showed a similar sensitivity of 92% (95% confidence interval: 84-97), with a specificity for ≥CIN3 of 64% (95% confidence interval: 56-71). For high-risk HPV-positive women with low-grade and normal Pap cytology, triage with p16/Ki-67 showed a sensitivity of 96% (95% confidence interval: 89-99), and a specificity of 58% (95% confidence interval: 50-65). HPV16/18 genotyping combined with Pap cytology showed a sensitivity and specificity for ≥CIN3 similar to Pap cytology with an atypical cells of undetermined significance threshold. Because the quality of Pap cytology worldwide varies, and differences in sensitivity and specificity are limited between the three selected strategies, p16/Ki-67 triage of all high-risk HPV-positive samples would be the most reliable strategy in triage of high-risk HPV-positive women with an increased specificity and similar sensitivity compared with Pap cytology triage.
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