Prospective Evaluation of Cytology, CINtec^® and PD-L1 for the Detection of Cervical Intraepithelial Neoplasia: A Single-Center Study.

ABSTRACT: Background/Objectives: This study evaluated the diagnostic accuracy of cervical cytology, CINtec^® (p16/Ki-67 dual staining), and PD-L1 immunohistochemistry, individually and in combination with high-risk HPV (HR-HPV) testing, for identifying histologically confirmed cervical lesions ranging from CIN1 to invasive carcinoma. Methods: We conducted a prospective cross-sectional study including 114 patients who underwent cervical cytology, CINtec^®, PD-L1 staining, HPV genotyping, and histopathologic confirmation at a tertiary clinical center between September 2024 and September 2025. Sensitivity, specificity, PPV, NPV, and ROC performance were calculated for each test across lesion categories. Multivariable logistic regression models incorporating HR-HPV stat

SUBMITTER: Hamod A 

PROVIDER: S-EPMC12897607 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature