Diagnostic Accuracy of p16(INK4a)/Ki-67 Dual Immunostaining for Detection of High-Grade Cervical Intraepithelial Neoplasia in Women Involved in Cervical Cancer Screening in Georgia

BACKGROUND: Despite the widespread introduction of primary and secondary preventative measures, death rates for cervical cancer are still significantly high among females, especially in developing countries. Pap cytology and human papillomavirus-based screening often lead to unnecessary additional testing. The aim of this study is to analyze diagnostic accuracy of p16(INK4a)/Ki-67 dual immunostaining (DS) in cervical smear for identifying high-grade cervical intraepithelial neoplasia (CIN2+). MATERIALS AND METHODS: We studied the diagnostic performance of p16(INK4a)/Ki-67 DS in cervical smear of those women, who enrolled in cervical cancer screening due to abnormal previous screening results and compared it with Pap test results in identifying CIN2+. The reference standard was histopathology results. p16(INK4a)/Ki-67 DS and Pap test results for 162 women and histopathology results for 29 women were available, respectively. RESULTS: In our study, sensitivity, specificity, positive predictive value, and negative predictive value of p16(INK4a)/Ki-67 DS, irrespective of the morphology of stained cells to detect CIN2+ were 100%, 89%, 85%, and 100% (p < 0.01), respectively. The diagnostic accuracy of p16(INK4a)/Ki-67 DS is superior to that of existing cervical screening tests in the detection of CIN2+. CONCLUSION: The findings of cervical cancer screening based on Pap cytology highlight the importance of assessing the cost-effectiveness of integrating p16(INK4a)/Ki-67 biomarkers in cervical cancer cytology. Furthermore, these findings emphasize the need to enhance support for preventive programs for cervical cancer in Georgia.