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. 2023 Jun 5:2023:7988323.
doi: 10.1155/2023/7988323. eCollection 2023.

Diagnostic Accuracy of p16INK4a/Ki-67 Dual Immunostaining for Detection of High-Grade Cervical Intraepithelial Neoplasia in Women Involved in Cervical Cancer Screening in Georgia

Sopio Kakaliashvili-Dzagnidze  1   2 , Omar Khardzeishvili  3 , Sergo Tabagari  2
Affiliations

Diagnostic Accuracy of p16INK4a/Ki-67 Dual Immunostaining for Detection of High-Grade Cervical Intraepithelial Neoplasia in Women Involved in Cervical Cancer Screening in Georgia

Sopio Kakaliashvili-Dzagnidze et al. Anal Cell Pathol (Amst). .

Abstract

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 p16INK4a/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 p16INK4a/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. p16INK4a/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 p16INK4a/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 p16INK4a/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 p16INK4a/Ki-67 biomarkers in cervical cancer cytology. Furthermore, these findings emphasize the need to enhance support for preventive programs for cervical cancer in Georgia.

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Conflict of interest statement

The author(s) declare(s) that they have no conflicts of interest.

Figures

Figure 1
Figure 1
Positive p16INK4a/Ki-67 DS cells. (a) Magnification ×400. (b) Magnification ×100.
Figure 2
Figure 2
Negative p16INK4a/Ki-67 DS cells, magnification ×100.
Figure 3
Figure 3
p16 IHC staining. (a) Negative p16 IHC, magnification ×100. (b) Positive p16 IHC, magnification ×100.
See this image and copyright information in PMC

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