Efficacy of comprehensive diagnostics of cervical intraepithelial neoplasia using digital technologies

Aim: to evaluate efficacy of a comprehensive diagnostic approach for cervical intraepithelial neoplasia (CIN) based on a combination of colposcopy, cytology and human papillomavirus (HPV) testing using advanced digital technology, and to assess a role of p16INK4a/Ki-67 immunohistochemical markers in challenging cases of differential diagnosis.

Materials and Methods. A single-center prospective analysis covering the period from 2023 to 2026 was conducted. Data from 84,712 women who underwent visual screening were processed using a custom-developed digital module. There were enrolled 247 women identified as CIN suspected based on a positive result in at least one of three tests: colposcopy, cytology, or HPV DNA testing. They underwent an examination using the comprehensive diagnostic approach (CDА).

Results. CIN was excluded in 165 (66.8 %) cases, low-grade squamous intraepithelial lesion (LSIL) was detected in 63 (25.5 %), high-grade squamous intraepithelial lesion (HSIL) – in 14 (5.7 %) cases and stage I cervical cancer was diagnosed in 5 (2,0 %) women. While assessing accuracy, the HPV DNA test turned out to be the most optimal showing 93.1 % (sensitivity (Se) – 92.7 %; specificity (Sp) – 93.3 %), followed by cytology – 91.9 % (Se – 85.4 %; Sp – 95.2 %) and colposcopy – 78.5 % (Se – 96.3 %; Sp – 69.7 %). In 17 complex clinical cases, immunohistochemical (IHC) testing of p16/Ki-67 markers enabled clear differentiation between reactive lesions, such as LSIL with focal or weak p16/Ki-67 expression ≤ 20 % in the lower third of the epithelium, and pronounced precancerous transformation (HSIL) with diffuse p16/Ki-67 expression throughout the entire epithelium. This completely eliminated diagnostic uncertainty in challenging clinical situations.

Conclusion. CDА for CIN using three widely available tests (visual colposcopic, cytology, and HPV DNA testing) on a digital platform approaches the accuracy of histological diagnosis. In complex and controversial cases, IHC testing for p16/Ki-67 markers serves as an objective method for stratifying patients into mild (LSIL) and severe (HSIL) forms, eliminating over- and underdiagnosis as well as optimizing treatment.

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