Diagnostic sensitivity and specificity complex in women with intraepithelial lesions of the cervix utery

Aim - study the molecular and biological features of cervical intraepithelial lesions (SIL) using the immunocytochemical method of determining the oncoprotein p16ink4α and the proliferation marker Ki67 in order to further develop a highly effective method for the early diagnosis cervical cancer. Materials and methods. Examined 150 women with a histologically verified diagnosis of SIL, of which the group 1 - 74 women with low-grade squamous intraepithelial lesion of the uterine cervix (LSIL) and the group 2 - 76 women with high-grade squamous intraepithelial lesion of the uterine cervix (HSIL). The control group included 70 women without morphological changes negative for cervical intraepithelial lesion (NILM). The average age of the patients is 32.7±0.5 years. Liquid cytology was taken from all patients and an immunocytochemical method (ICH) was performed to determine the expression of the oncoprotein p16ink4α and the proliferation marker Ki67 and complex genotyping of HPV DNA of 28 types. Statistical processing of research results was carried out using standard Microsoft Excel 5.0 and Statistical 6.0 programs. Results. The expression of the oncoprotein p16ink4α in patients of the group 1 (LSIL) was 27.2% of atypical squamous cells in the smear, the proliferation marker Ki67 was 11.6%. In women of the group 2 (HSIL), expression of oncoprotein p16ink4α - 58.9%, proliferation marker Ki67 - 30.7%. In patients of the control group (NILM), individual p16ink4α - positive cells were found in 0.72%, while they lacked the expression of the proliferation marker Ki67, which allowed to classify them as "senescent" cells. For p16ink4α, diagnostic sensitivity was 97.4%, diagnostic specificity was 76.8%. For the proliferation marker Ki67, diagnostic sensitivity was 100%, diagnostic specificity was 92.8%. Conclusions. The most informative method for detecting SIL is p16ink4α/Ki67 coexpression: diagnostic sensitivity - 98.5%, specificity - 100% compared to liquid cytology and HPV test. The research was conducted according to principles of Declaration of Helsinki. Protocol of research was proved by local ethical committee, mentioned in institution’s work. A informed sonsennt was collected in order to carry out the research. The author is stating no conflict of interests is declared.