Antibody anti-p16(INK4a) in cervical cytology.

ABSTRACT

OBJECTIVE: To evaluate sensitivity, specificity and positive and negative predictive values (PPV, NPV) of anti-p16(INK4a) in cervical cytology. STUDY DESIGN: A case-control study was conducted in a reference center for cervical pathology. Cytology slides were collected in a standard way with Ayre spatula and Cytobrush. The slides were interpreted by 2 independent pathologists (P1, P2). The cases (n = 61) represented all cervical examinations that had resulted in a biopsy with the diagnosis of CIN 1, 2 or 3 or squamous cell carcinoma. Controls (n = 87) included all examinations with negative cytology (Papanicolaou) and negative colposcopy. RESULTS: The sensitivity for the histologic diagnosis of CIN 2, 3 (n = 23) was 100% and 95.7% (P1, P2), respectively. The NPV for CIN 2 or worse was 100% (P1) and 98.9% (P2). The sensitivity for the diagnosis of CIN 1 was 77.8% (P1) and 58.3% (P2). The NPV for CIN 1 or worse was 90.6% (P1) and 82% (P2). The K index between the 2 pathologists was 0.74. CONCLUSIONS: Our results suggest that the antibody anti-p16(INK4a) could contribute as an adjuvant tool in the follow-up of cervical intraepithelial lesions when the cytology sample is collected in the standard way.