to investigate the clinical value of p16/Ki-67 immunocytochemical dual staining (abbreviated as p16/Ki-67 dual staining) in cervical intraepithelial neoplasia (CIN) and cervical cancer screening.

From July to November 2015, a total of 980 women attending cervical cancer screening and receiving high-risk human papillomavirus (HR-HPV) test and thinprep cytologic test (TCT) were included in the study. p16/Ki-67 immunocytochemical dual staining was performed on residual cytologic specimens and compared with histopathology results.

The expression risks of p16/Ki-67 in HPV16/18 group and another HR-HPV group were higher than HPV negative group, with an odds ratio of 10.64 (95%CI: 5.66~20.02) and 5.40 (95%CI: 3.62~8.04), respectively. The positive rate of p16/Ki-67 increased with the grade of TCT and histologic diagnosis, and was higher in both CIN2 and CIN3 groups than normal group (P<0.05). The sensitivity of p16/Ki-67 to detect CIN2+ and CIN3+ lesions was 89.3% and 94.1%, respectively, and the specificity was 69.3% and 66.8%, respectively. The sensitivity of TCT to detect CIN2+ and CIN3+ lesions was 60.7% and 64.7%, respectively, and the specificity was 49.3% and 49.1%, respectively.

Compared with TCT, p16/Ki-67 dual staining has higher sensitivity and specificity. It can identify high-grade cervical lesions and guide the classification of CIN. p16/Ki-67 dual staining in conjunction with HPV test may be considered as an efficient method for cervical cancer screening.

p16/Ki-67; Cervical intraepithelial neoplasia; Human papillomavirus; Cervical cancer screening