[Diagnostic value of p16/mcm2 dual staining in cervical intraepithelial neoplasia and its association with high-risk HPV infection].

Objective: To study the expression of p16/mcm2 immunocytochemical dual staining in cervical lesions and its association with high-risk HPV infection, and discuss its clinical value in cervical cancer screening. Methods: From May to December 2015, a total of 1 127 women receiving cervical cancer screening, high-risk HPV (HR-HPV) test and liquid-based cytology test were included in the study. p16/mcm2 immunocytochemical dual staining was performed on residual cytology specimens and the results were compared with histopathology results. Results: p16/mcm2 had a higher expression risk in HPV16/18 group and other HR-HPV group compared with HPV negative group, with OR of 15.95 (95%CI: 9.59-26.51) and 10.53 (95%CI: 7.41-14.98), respectively. The positive rate of p16/mcm2 increased with cervical intraepithelial neoplasia (CIN) severity, and was higher in both CIN2 group and CIN3 group than in benign lesion group (P<0.05). The overall sensitivity of p16/mcm2 to detect CIN2+and CIN3+lesions were 86.1% and 92.0%, respectively, and the overall specificity were 46.1% and 44.4%, respectively. In group with cytologic diagnoses of atypical squamous cells (ASC) and low-grade squamous intraepithelial lesion (LSIL), the sensitivity to detect CIN2+and CIN3+lesions were 85.7% and 87.5%, respectively, and the specificity were 45.5% and 44.1%, respectively. Conclusions: p16/mcm2 dual staining has higher sensitivity than cytology test and better specificity than HPV test. It can identify high-grade cervical lesions and guide the classification of CIN. p16/mcm2 might be used as an innovative biomarker for cervical cancer screening.