Estimating clinical outcome of HPV induced cervical lesions by combination of capsid protein L1 and p16INK4a protein detection.

The aim of this study was to investigate whether is possible to predict clinical outcome of cervical lesion by immunoassaying performed on cervical smears. During the two year study period the cervical smears of 81 patients were collected. All patients were tested for human papillomavirus (HPV) infections using Amplycor HPV test. Sixty-six of them were tested as positive for high risk types (hrHPV) and squamous intraepithelial lesion, and in those patients repeated cervical smears were taken every six months. The rest were hrHPV negative patients with normal smears which were used as a negative control in immunoassays with HPV L1 and p16INK4a antibodies. The results of p16INK4a staining in 66 hrHPV positive patients showed impairment of the cervical lesion in 22 (33.3%) and unchanged cytological finding in 21 (31.9%) p16INK4a positive patients, respectively, while improving of cytological finding was seen only in three (4.5%) p16LNK4a positive patients. On the contrary, impairment of cytological finding was not seen in p16INK4a negative patients, while in 17 out of 20 patients from that group improving or normalisation of cytological finding were detected (p < 0.01). Correlation between L1/p16 pattern and cytological finding showed that only in L1-/p16+ cervical lesions was detected impairment of cytological finding during the study period. In L1 +/p16+ group the cytological finding was the same during the follow up in all 11 patients, while in L1 +/p16- group in most patients (9/11) downgrading or normalisation of Pap test were detected. The usage of p16 and HPV L1 markers can be useful in estimation of biologic potentiality and clinical outcome of cervical lesions.