Abstract: Objective To investigate the correlation between P16 protein and thin-layer liquid-based cytology(TCT)and high-risk human papillomavirus(HR-HPV), and to explore its diagnostic efficacy for different cervical lesions. Methods A total of 1,096 female patients treated during July 2018 and Dec. 2020 were randomly selected as the research objects. Cervical cell samples were collected and TCT was detected by PAP staining. According to the TCT results, the patients were divided into no intraepithelial or malignant lesions(NILM)group, atypical squamous cells of unknown significance(ASC-US)group, high grade squamous intraepithelial lesions were not excluded(ASC-H)group, low grade squamous intraepithelial neoplasia(LSIL)group, high grade squamous intraepithelial neoplasia(HSIL)group and squamous cell carcinoma(SCC)group. HR-HPV was detected by hybridization capture method. According to the HR-HPV results, the patients were divided into HR-HPV negative group, HR-HPV and other 12 subtypes positive group, and HR-HPV16/18 subtypes positive group. The P16 protein was detected with SP two-step staining. The correlation between P16, TCT and HR-HPV was analyzed. Among all patients, 272 underwent colposcopic pathological biopsy, and the pathological biopsy results were taken as the gold standard to compare the diagnostic efficacies of P16, TCT and HR-HPV alone and in combination for lesions above HSIL. Results (1) The positive rate of P16 protein increased with the level of TCT diagnosis(χ2=75.17, P<0.001). The positive rate of P16 protein in ASC-US, ASC-H, LSIL, HSIL and SCC groups was significantly higher than that in NILM group(P<0.001). (2) There was a rising tendency of positive rate of P16 protein from the HR-HPV negative group, to HR-HPV and other 12 subtypes positive group and to HR-HPV 16/18 subtypes positive group(χ2=137.77, P<0.001). There was significant difference in the positive rate of P16 protein between HR-HPV 16/18 subtypes positive group and HR-HPV and other 12 subtypes positive group(χ2=12.26, P<0.001), and HR-HPV negative group(χ2=112.77, P<0.001). (3) The positive rate of P16 protein increased with the level of cervical pathological diagnosis(χ2=47.58, P<0.001). The positive rate of P16 protein in HSIL and SCC groups was significantly higher than that in chronic cervicitis LSIL group(P<0.001). (4) When age was taken as an influencing factor, there was significant difference in expression of P16 protein among patients with different cervical lesions(χ2=9.15, P=0.03). (5) The combined detection method had the highest sensitivity; TCT had the highest coincidence rate; P16 detection had the largest Youden index. Conclusion The expression of P16 protein is correlated with the results of TCT and HR-HPV; P16 detection has high diagnostic efficiency for lesions above HSIL.

Key words: P16 protein, Immunocytochemistry, Thin layer liquid based cytology, High-risk human papillomavirus, Low/high grade squamous intraepithelial neoplasia