Diagnostic value of p16/mcm2 dual staining in cervical intraepithelial neoplasia and its association with high-risk HPV infection / 中华流行病学杂志

ABSTRACT

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％CI9.59-26.51) and 10.53 (95％CI7.41-14.98),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.