The Value Of P16 Immunocytochemical Staining In The Screening Of Cervical Precancerous Lesions

Objective:（1）The results of p16 immunocytochemistry were compared with the degree of cervical lesions in cytology and histology.（2）To compare the diagnostic value of p16 immunocytochemical staining,HPV detection and TCT in high-grade cervical lesions（including cervical intraepithelial neoplasia CIN Ⅱ and CIN Ⅲ）.（3）To analyze the diagnostic value of p16 immunocytochemical staining as cytological results of ASCUS,LSIL and ASC-H in detecting high-grade cervical lesions（including cervical intraepithelial neoplasia CIN Ⅱ and CIN Ⅲ）,so as to evaluate the value of p16 immunocytochemical staining as an index of referral colposcopy biopsy or cervical conization shunt.Methods:A total of 5377 patients were collected from the gynecological clinic of our hospital because of cervical cancer screening in other medical institutions and abnormal TCT or HPV results,or because of contact bleeding,symptoms of unexplained vaginal bleeding or simple gynecological health examination.Among them,1205 patients underwent cervical biopsy or cervical LEEP or hospitalized cervical cold knife surgery（CKC）due to abnormal cytology,macroscopic cervical ulcer,tumor or suspicious lesion,and abnormal iodine test under colposcopy.A total of 901 patients were included in the study and tested by p16 immunocytochemical staining.Taking histological and pathological diagnosis as the "gold standard",the screening value of p16 immunocytochemical staining,HPV and TCT for high-grade cervical intraepithelial neoplasia and the shunt value of cytology for ASCUS,LSIL and ASC-H were analyzed.Research results:（1）In different degrees of cervical lesions,the positive rate of p16 immunocytochemical staining increased with the increase of cytology and histology.The results of p16 immunocytochemical staining were consistent with the degree of cervical lesions in cytology and histology.The sensitivity,specificity,positive predictive value（PPV）,negative predictive value（NPV）,positive odds ratio（+ LR）,negative likelihood ratio（-LR）,yoden index and kappa value of P16 immunocytochemical staining for CINII+were 91.43%,81.06%,72.18%,94.62%,4.83,0.11,0.72 and 0.68 respectively.Area under ROC curve（AUC）0.86.The sensitivity and negative predictive value（NPV）of P16,12 hrhpv,HPV16 / 18 and TCT were the highest;The negative likelihood ratio（-LR）was the lowest;Jordan index and kappa value are the largest;The specificity,positive predictive value（PPV）and positive odds ratio（+ LR）of P16 were lower than those of TCT.The ROC curve area（AUC）of P16 index is the largest.（2）When screening the accuracy of CINII+,compared with high-risk HPV detection and TCT,p16 immunocytochemical staining had the highest sensitivity and NPV-LR minimum.The specificity,PPV and + LR of p16 were only lower than those of TCT.The yoden index and kappa value of p16 are the largest.Among the three screening indexes,the ROC curve area（AUC）of p16 index is the largest,and the curve is closer to the upper left corner.（3）For cervical samples with ASCUS,LSIL and ASC-H cytology,when p16 immunocytochemical staining and HPV examination were used to predict the accuracy of CINII+,p16 had the highest sensitivity,specificity,PPV,NPV and + LR,-LR minimum.The yoden index and kappa value of p16 are the largest.Among the three screening indexes,the ROC curve area（AUC）of p16 index is the largest,and the curve is the most convex and close to the upper left corner.Conclusion:（1）The results of p16 immunocytochemical staining were consistent with the degree of cervical lesions in cytology and histology.（2）Compared with high-risk HPV detection and TCT,p16 immunocytochemical staining has the advantage of early screening of cervical cancer.（3）P16 immunocytochemical staining can be used as an auxiliary means of cervical cytological smear and biopsy histology to evaluate cervical lesions,and identify women whose cytological results are unclear and need to be referred for colposcopy and potential treatment.（4）P16 immunocytochemical staining provides a better screening index for the population diversion of ASCUS,LSIL and ASC-H.