Application Of P16/Ki-67 Immunocytochemistry In Triage Of Patients With ASC-US

[Objective]To investigate the clinical value of p16/Ki-67 immunocytochemistry in patients with atypical squamous cells of undetermined significance(ASC-US).[Materials and Methods]181 cases of thin-prep cytology test(TCT)diagnosed ASC-US underwent p16/Ki-67 immunocytochemistry and all patients had colposcopy and biopsy from March 2015 to January 2016.10 patients of ASC-US were ruled out because the number of cells were too small.Thus,there were 171 patients of ASC-US in our study,and 90 of the 171 cases had underwent high-risk HPV test at the same time.The test results were analyzed statistically by SPASS22.0 software.The detection of sensitivity,specificity,positive predictive value,negative predictive value and ROC area under the curve of the two methods were compared to evaluate the value of the triage by p16/Ki-67 immunocytochemistry in patients of ASC-US.[Results]1.There were 67 patients(39.2%)with cervical histopathological results of CIN2+in 171 patients of ASC-US.In which CIN2 has a total of 30 patients,CIN3 in 36 patients,adenocarcinoma in 1 patients.2.In 171 patients with ASC-US,the positive rate of p16/Ki-67 immunocytochemistry was 43.9%,and the sensitivity,specificity,positive predictive value(PPV)and negative predictive value(NPV)for CIN2+ were 77.6%(95%CI:65.8%-86.9%),77.9%(95%CI:68.7%-85.4%),69.3%(95%CI:56.7%-79.5%),and 84.4%(95%CI:75.5%-91.0%),respectively;In 90 patients with ASC-US who were detected by high-risk HPV test at the same time,the positive rate of p16/Ki-67 immunocytochemistry was 41.1%,and the sensitivity,specificity,PPV and NPV for CIN2+ were 70.6%(95%CI:52.5%-84.9%),76.8%(95%CI:63.6%-87.0%),64.9%(95%CI:47.2%-80.0%),and 81.1%(95%CI:67.9%-90.6%),respectively,the area of ROC curve was 0.737.3.The positive rate of high-risk HPV test was 93.3%,and the sensitivity,specificity,PPV and NPV for CIN2+were were 100.0%(95%CI:89.7%-100.0%),10.7%(95%CI:4.0%-21.9%),40.5%(95%CI:29.9%-51.7%),and 100%(95%CI:54.1%-100.0%),respectively,the area of ROC curve was 0.554.[Conclusions]P16/Ki-67 immunocytochemistry showed lower sensitivity than high-risk HPV test in diagnosing CIN2+,the difference was statistically significant(P=0.003<0.05);the specificity was higher than high-risk HPV test,and there were significant differences(P<0.05).Superior performance was observed for pl6/Ki-67 immunocytochemistry,it had an area under the ROC curve of 0.737(P<0.05).BUT the ROC curve area of high-risk HPV test was 0.554(P>0.05).P16/Ki-67 immunocytochemistry can maintain a high sensitivity,and has a higher specificity,it is a good triage test for identifying CIN2+ in ASC-US specimens.