Application Value Of P16/Ki-67 Double Staining In Cervical Cancer Screening

[Objectives]To analyze the sensitivity and specificity of p16/Ki-67 dual staining in the detection of high-grade cervical lesions and investigate the clinical value of pl6/Ki-67 dual staining in cervical intraepithelial neoplasia(CIN)and cervical Cancer screening.[Methods]A retrospective study was performed on 359 cases with diagnosis of endometrial cancer in the biopsy treated at the Department of Obstetrics and Gynecology,Wuxi Maternal and Child Health Care Hospital,between Jan,2017 and Oct,2018.All samples were tested by pl6/Ki-67 immunocytochemical dual staining,liquid-based cytology and high-risk human papillomavirus(HR-HPV)test.Diagnosis of each patient was verified by histopathological test.[Results](1)For patients with pathological diagnosis of CIN2 or greater,the Sensitivity,Specificity,PVP and NPV of pl6/Ki67dual staining was 89.73%(95%CI:83.59%-95.30%),68.75%(95%CI:55.35%-78.79%),70.97%(95%CI:61.45%-84.05%)and 88.72%(95%CI:84.23%-94.69%).The specificity of pl6/Ki67dual staining was significantly higher than cytology(39.58%,p=0.02)and HR-HPV test(22.92%,p=0.01)for CIN2+detection,while no significant differences of sensitivity between p16/Ki-67 dual staining,cytology and HR-HPV test for CIN2+detection were found(p>0.01).(2)In atypical squamous cells of undetermined significance(ASC-US)and low-grade squamous intraepithelial lesion(LSIL)cases,the specificity of p16/Ki-67 dual staining was significantly higher than HPV test(65.12%vs 11.63%,p<0.05)and its sensitivity was similar to HPV test for CIN2+detection.(3)The sensitivity and specificity of dual staining for CIN2+detection in HR-HPV positive women were 89.85%and 69.81%,respectively,which were higher than those of cytology(82.79%and 42.18%)and HPV16/18 test(70.45%and 44.59%).[Conclusions](1)p16/Ki-67 dual staining could improve the specificity of high-grade cervical lesions detection and was similar to the sensitivity of HPV test for CIN2+detection.(2)When triaging women with ASC-US or LSIL liquid-based cytology,p16/Ki-67 dual staining could increase the specificity of CIN2+lesion detection compared with positive HR-HPV.(3)In the triaging management of patients with initial high-risk HPV screening,p16/Ki-67 dual staining could improve the sensitivity and specificity and reduce the misdiagnosis compared with the cytological triaging.P16/Ki-67 dual staining could avoid excessive diagnosis and treatment.