Implementation of P16/Ki67 Dual Staining Cytology for Detecting Cervical Dysplasia

Cervical cancer is the fourth most common cancer among women worldwide. Vaccination against oncogenic human papillomaviruses (HPV) and effective screening have made cervical cancer preventable. Current screening methods, including cytology, HPV testing, and a combination of both, have limitations, highlighting the need for additional markers to identify high-grade cervical lesions (CIN2+). p16/Ki67 dual immunocytochemistry staining is a biomarker with high sensitivity and specificity for detecting CIN2+ lesions. Incorporating this biomarker in triage, alongside cytology and HPV testing, can help avoid unnecessary referrals for colposcopy and biopsy. This study, conducted at the University Clinic for Gynecology and Obstetrics in Skopje over a one-year period, involved 40 female patients aged 21 to 65 years, all of whom underwent HPV DNA testing, cytological testing (LB) and p16/Ki67 dual staining. The study found a significant association between High-Grade Squamous Intraepithelial Lesion (HSIL) and p16/Ki67 dual staining (p=0.012), while no significant association was observed between Low-Grade Squamous Intraepithelial Lesion (LSIL) and p16/Ki67 staining (p=1.0).