Abstract Purpose: This head-to-head comparative study of the screening efficacy of p16 single staining versus p16/Ki-67 dual staining in parallel to analyze the effectiveness of the two tests in triaging patients with cytological abnormalities or high-risk human papillomavirus (HR-HPV) positivity. Methods: Women who were HR-HPV positive or had cytological abnormalities and were screened at the local hospital in Xinjiang between January and December 2023 were recruited. Gynecologists collected the cervical exfoliated cells from eligible women for LBC, p16 and p16/Ki⁃67 dual staining. Pathological diagnostic results were used as the standard to compare the sensitivity, specificity, positive predictive values (PPVs) and negative predictive values (NPVs) and corresponding 95% confidence intervals (CI) in response to the diagnostic performance of each triage strategy between p16/Ki-67 and p16 staining as a triage measure for screening high-risk HPV DNA-positive individuals or cytology-positive individuals, and to analyze the correlation between positive rates and positive results of p16/Ki-67 and p16 staining. Results: Among 260 women, five low-grade squamous intraepithelial lesions (LSIL) and two high-grade squamous intraepithelial lesions (HSIL) were diagnosed by biopsy. p16 testing screened for CIN2+ with a high sensitivity of 100% (95% CI: 19. 79% to 100%) and the specificity was 94. 57% (95%CI: 90. 86%∼96. 89%), positive predictive value was 12. 50% (95%CI: 2. 20%∼39. 59%), and negative predictive value was 100% (95%CI: 98. 10%∼100%). p16/Ki-67 assay had a slightly higher specificity of 99. 23% when compared with p16 assay (95%CI: 96. 92%∼99. 87%). In cytological screening results, p16/Ki-67 and p16 staining of LBC specimens at all levels were associated with the severity of the type of cytological diagnosis (P0. 001), with all HSIL cases testing positive. Conclusion: The p16 test has a higher sensitivity and negative predictive value than the p16/Ki-67 dual staining test for CIN2 and above lesions, but a positive p16/Ki-67 dual staining test and a positive p16 test result can still be used as a warning factor in patients with HSIL and as a potential triage of high-risk individuals in cytological LSIL or as primary screening. Citation Format: Hayuehashi Tali, Yan Wang. Efficacy of p16 Staining Versus p16/Ki-67 Dual Staining in Cervical Cancer Screening abstract. In: Proceedings of the 13th Annual Symposium on Global Cancer Research; 2025 Sep 16. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2025;34 (12Suppl): Abstract nr 8.
Tali et al. (Mon,) studied this question.