p16INK4a / Ki67 dual staining immunocytochemistry to refer women infected by HR-HPV for colposcopy.

Background: Cervical cancer is still a significant global health issue, espacially in low- and middle-income countries. Human papillomavirus (HPV) infection is known to be the primary etiological factor in the development of cervical cancer. The identification of high-risk HPV infections in cervical screening is becoming crucial for early detection and management of cervical pre-neoplasia. However, HPV testing requires triage markers since HR HPV infections are widespread in the target population, of which only a small fraction requires detailed clinical work-up by colposcopy.

Summary: p16INK4a is a tumor suppressor protein that has emerged as a promising surrogate marker for HPV infection. In combination with a proliferation marker Ki67 in one diagnostic test kit referred to as CINtecPlus®- or dual stain (DS) it revealed excellent sensitivity and specificity profiles to detect clinically relevant CIN2+ lesions among HPV-infected women in large screening cohorts.

Key message: This review examines the role of the cytology CINtecPlus®-test (Dual Stain (DS)-test) as a triage marker to identify patients with CIN2+ lesions among HPV + tested women and summarizes the most recent recommendations for its clinical use.