Abstract:Objective To explore the clinical value of p16/Ki-67 double immunocytochemical staining (namely dual-staining) of cervical exfoliative cells combined with quantitative DNA analysis in cervical cancer screening. Methods Women with suspicious lesions who visited Huaian Second Peoples Hospital from January 2020 to December 2020 were selected as the research subjects. The cervical exfoliated cells were collected from 220 women for p16/Ki-67 dual staining, DNA quantitative analysis and pathological diagnosis of cervical biopsy. Based on cervical histopathology results of chronic cervicitis (56 cases), low-grade squamous intraepithelial neoplasia (LSIN, 36 cases), high-grade squamous intraepithelial neoplasia (HSIN,119 cases) and cervical cancer (9 cases), the screening efficiency of p16/Ki-67 double staining combined with DNA quantitative analysis was evaluated in detecting HSIN of cervical exfoliated cells. Results The positive rates of p16/Ki-67 dual-stain, DNA quantitative analysis and combined detection of two methods for cervical exfoliated cells statistically increased with the severity of cervical lesions, namely from chronic cervicitis, LSIL, HSIL to cervical cancer（P＜0.01). In HSIL group, the positive rates of combined detection, p16/Ki-67 dual-stain and DNA quantitative analysis were 91.60%, 82.35%, 76.47%, respectively(χ²=10.031，P＜0.01). Based on the pathological results, the sensitivities of combined detection, p16/Ki-67 dual-stain and DNA quantitative analysis to screen HSIL and above-grade lesions were 92.19%, 83.59%, 78.13%, respectively,and there were statistical differences in them (P＜0.05). However, there were no significant differences in specificity (71.74% vs 76.09% vs 67.61%, P＞0.05). Conclusions The combined detection of p16/Ki-67 dual-stain and DNA quantitative analysis of cervical exfoliated cells possess higher screening efficiency for HSIL and above-grade lesions, which is suitable for application in primary hospitals.