A Study On The Relationship Between Hr HPV, L1 Protein, P16 Protein And Cervical Lesions And Their Diagnostic Value In Clinic

Objective:The aims of this study were to detect the load of high risk HPV, the expression of L1 capsid protein and p16 in cervical lesions, and to study the relation between hr HPV, L1 capsid protein, p16 and cervical lesions and their diagnostic efficiency in clinic. The study can provide reliable diagnostic indicators for early diagnosis of cervical cancers.Methods:From January 1,2008 to June 30,2008, the patients with cytological test and biopsy were in study. Hybrid Capture 2 was used to detect the load of hr HPV, and immunochemical method was used to detect the expression of L1 capsid protein and p16 protein. The result of histopathologic test was used as gold standard. The persons with the biopsy result "≥CIN2" were considered as cases.χ2 test, spearman's rank correlation and Mantel trend analysis were used for statistical analysis. The diagnostic sensitivity, specificity, Youden's index, positive likelihood ratio (+LR), negative likelihood ratio (-LR), percent agreement, positive predictive values (PPV), negative predictive values (NPV) and the area under the Receive Operating Characteristic (ROC) curve (denoted by Az) were calculated. The Receive Operating Characteristic (ROC) curves were drawn with Medcalc v 11.0.0. All the statistical tests were two-sides at the 5% level of significance.Results:1. Hr HPV infection increased (P<0.001), L1 expression decreased (P<0.001), but p16 expression increased (P<0.001) with histopathologic diagnosis (CIN and SCC) increasing.2. The postive rates of hr HPV in CIN1 were lower than in CIN3, SCC. The expression rates of L1 protein in CIN1 were higher than in normal cervix, CIN3, SCC. The expression rates of p16 protein in CIN1 were lower than in CIN2, CIN3, SCC. The expressions of L1(-)/p16(+), L1(-)/p16(-) in CIN2, CIN3, and SCC were statistically different from those in CIN1 (P<0.001).3. Diagnostic value:In alone diagnosis, p16 protein had a better diagnostic value than hr HPV alone, L1 protein alone (P<0.05). Hr HPV had a better diagnostic value (except:sensitivity) than L1 protein alone (P<0.05). The specificity,+LR, PPV and AZ of combing L1 and p16 were higher than alone diagnosis (P<0.05). The specificity of combing L1 and hr HPV was higher than alone diagnosis (P<0.05). The AZ of combing hr HPV and p16 was higher than alone diagnosis (P<0.05).Conclusions:1. Hr HPV, L1 and p16 are useful biomarkers for the early diagnosis of cervical lesions.2. In alone diagnosis, the diagnostic value of high to low is arranged as following:p16 protein, hr HPV, L1 capsid protein.3. The indictors of p16 protein, hr HPV, L1 capsid protein have higher sensitivity, and can be screening indiactors for cervical cancer and high grade squamous intraepithelial lesions.4. The combination indicators have higher specificity and diagnostic efficacy than alone diagnosis.