ArticleFrontiers in oncology2026
Adjunctive role of p16/Ki-67 dual-stain cytology in colposcopy referral pathways for cervical precancer and persistent high-risk HPV infection.
Article in Frontiers in oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: This study aimed to evaluate the adjunctive triage performance of p16/Ki-67 dual staining (DS) cytology for cervical lesions in a colposcopy-referred cohort, to analyze its correlation with lesion severity, and to explore its predictive value for persistent high-risk human papillomavirus (HR-HPV) infection. Methods: A total of 109 patients undergoing colposcopic cervical biopsy (recruited via standard HPV+TCT referral criteria) were included. We evaluated the incremental diagnostic performance of adding p16/Ki-67 dual-stain (DS) triage to the standard HPV+TCT referral workflow for detection of CIN2+ and CIN3 +. Among 66 HR-HPV-positive patients with CIN1 or lower lesions, p16/Ki-67 DS cytology was performed, and the patients were followed up for 6 months to assess the predictive value for persistent infection. Results: The positivity rate of p16/Ki-67 DS cytology gradually increased with the progression of cervical lesion severity (P<0.001). Further triage with p16/Ki-67 DS on the basis of combined HPV+TCT cervical cancer screening yielded sensitivity, specificity, accuracy and AUC of 77.8%, 88.6%, 84.4% and 0.822 ± 0.052 (95%CI: 0.721-0.923) for the diagnosis of CIN2+, and 93.3%, 81.3%, 81.7% and 0.823 ± 0.056 (95%CI: 0.713-0.933) for CIN3+, respectively. Among HR-HPV-positive CIN1/lower lesions, 87.1% of DS-positive patients had persistent infection compared to 62.9% of DS-negative patients (P = 0.025), with an odds ratio of 4.515 (P = 0.028). Conclusions: In this colposcopy-referred cohort defined by HPV and/or TCT-based referral criteria, p16/Ki-67 dual-stain (DS) cytology exhibited satisfactory adjunctive triage efficacy for identifying CIN2+ and CIN3+, and independently predicted persistent HR-HPV infection among patients with ≤CIN1 lesions. Notably, all analyses in this study are limited to diagnostic efficacy in this referral cohort; any potential clinical applications, including possible reductions in unnecessary procedures, remain exploratory hypotheses that require prospective clinical validation.
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