p16/Ki67 dual staining improves the detection specificity of high‐grade cervical lesions

AIM: The goal of this study was to analyze the specificity of p16/Ki67 dual staining in the detection of high-grade cervical lesions. METHODS: A total of 223 patients with an average age of 39 years old were enrolled in this study. All samples were analyzed by p16/Ki67 immunocytochemical dual staining, liquid-based cytology and high-risk human papillomavirus (HR-HPV) test. Diagnosis of each patient was verified by histopathological test. RESULTS: The specificity of p16/Ki67 dual staining was 68.33%, which was significantly higher than that of cytology (38.33%) and HR-HPV test (21.67%) (P < 0.05) for CIN2+ detection. p16/Ki67 dual staining had similar sensitivity with HR-HPV test for CIN2+ detection (90.18% vs 93.87%, P = 0.286). In atypical squamous cells of undetermined significance (ASC-US) and low-grade squamous intraepithelial lesion (LSIL) cases, the specificity of p16/Ki67 dual staining was significantly higher than that of HPV test (66.67% vs 3.70%, P < 0.05) and its sensitivity was similar to that of HPV test for CIN2+ detection. The sensitivity and specificity of dual staining for CIN2+ detection in HR-HPV positive women were 90.85% and 70.21%, respectively, which were higher than those of cytology (83.01% and 42.55%) and HPV16/18 test (70.59% and 44.68%). CONCLUSIONS: p16/Ki67 dual staining could improve the specificity of high-grade cervical lesions detection and have similar sensitivity to HPV test for CIN2+ detection. When triaging women with ASC-US or LSIL liquid-based cytology, compared with positive HR-HPV, the specificity of CIN2+ lesion detection was increased by p16/Ki67 dual staining. p16/Ki67 dual staining could reduce colposcopy referrals and avoid excessive diagnosis and treatment.