Abstract: Objective To explore and analysis the values of fully automated immunocytochemical staining P16/Ki-67 double staining in cervical lesions screening. Methods From April 2022 to June 2023, 120 cases of patients who underwent cervical lesion screening at Jiagang Hospital were selected as the research subjects. All patients were underwent thinprep cytology test (TCT), pathological examination, and automatic immunocytochemical staining P16/Ki-67 double staining, and were to determine the screening results. Results There were 28 cases were positive for P16/Ki-67 double staining in the 120 cases, with a total positive rate of 23.3%. 67 cases of benign reactive cell changes, 37 cases of atypical squamous epithelial cells with unclear diagnostic significance in the cervix, 12 cases of low-level cervical squamous intraepithelial lesions, 4 cases of high-level cervical squamous intraepithelial lesions. The positive rates of P16/Ki-67 double staining were 16.4%、21.6%、41.6%、100.0%, respectively, with compared were significant differences (P<0.05). Pathological examination determined that 16 cases were normal, 85 cases of cervical intraepithelial neoplasia grade I, 14 cases of cervical intraepithelial neoplasia grade Ⅱ, 4 cases of cervical intraepithelial neoplasia grade Ⅲ, and 1 cases of cervical cancer. The positive rates of P16/Ki-67 double staining were 6.2%、15.3%、71.4%、75.0% and 100.0%, respectively, with compared were significant differences (P<0.05). Using pathological examination results as the gold standard, the sensitivity and specificity of P16/Ki-67 double staining in cervical lesions screening were 73.7%(14/19)and 86.1%(87/101), respectively. Receiver operating characteristic curve analysis showed that the area under the curve of automatic immunocytochemical staining P16/Ki-67 double staining in cervical lesion screening were 0.872, and the Kappa value was 0.824. Conclusion The sensitivity and specificity of P16/Ki-67 double staining in cervical lesions screening and diagnosis are relatively high, and it has good clinical value.

Key words: fully automated immunocytochemical staining, P16/Ki-67 double staining, cervical lesions, liquid based thin layer cytology examination, pathological examination