The Diagnostic Accuracy of Electrical Impedance Spectroscopy-Assisted Colposcopy, HPV mRNA Test, and P16/Ki67 Immunostaining as CIN2+ Predictors in Greek Population

Nikolaos Tsampazis; Eleftherios Vavoulidis; Chrysoula Margioula-Siarkou; Marianthi Symeonidou; Stergios Intzes; Alexios Papanikolaou; Konstantinos Dinas; Angelos Daniilidis

doi:10.3390/diagnostics14131379

The Diagnostic Accuracy of Electrical Impedance Spectroscopy-Assisted Colposcopy, HPV mRNA Test, and P16/Ki67 Immunostaining as CIN2+ Predictors in Greek Population

Diagnostics (Basel). 2024 Jun 28;14(13):1379. doi: 10.3390/diagnostics14131379.

Authors

Nikolaos Tsampazis¹, Eleftherios Vavoulidis¹, Chrysoula Margioula-Siarkou¹, Marianthi Symeonidou¹, Stergios Intzes¹, Alexios Papanikolaou¹, Konstantinos Dinas¹, Angelos Daniilidis²

Affiliations

¹ 2nd Department of Obstetrics & Gynecology, Medical Faculty, Aristotle University of Thessaloniki, Hippokration General Hospital, 56429 Thessaloniki, Greece.
² 1st Department of Obstetrics & Gynecology, Medical Faculty, Aristotle University of Thessaloniki, Papageorgiou General Hospital, 54124 Thessaloniki, Greece.

Abstract

Objective: To evaluate the diagnostic accuracy of Electrical Impedance Spectroscopy (EIS)-assisted colposcopy in detecting CIN2+ Greek women towards standalone colposcopy, HPV mRNA testing, and p16/Ki67 immunostaining.

Methods: We conducted a cross-sectional observational study at the Cervical Pathology Clinic of the 2nd Obstetrics-Gynecology University Department of Hippokration Hospital Thessaloniki involving 316 patients from January 2022 to August 2023. All participants provided liquid-based cervical samples for cytology, HPV mRNA testing, and p16/Ki67 immunostaining.

Main outcome measures: Subsequently, participants underwent both standalone colposcopy and EIS/ZedScan-assisted colposcopy, followed by cervical punch biopsies.

Results: The incorporation of EIS significantly enhanced the sensitivity of colposcopy, increasing it from 54.17% to 100%, equivalent to that of HPV mRNA testing and p16/Ki67 immunostaining, while achieving a high specificity (95.45%). The specificities observed with EIS/ZedScan-assisted and standalone colposcopy were notably superior to those of HPV-related biomarkers (HPV mRNA test and p16/Ki67 immunostaining). When compared to standalone colposcopy, HPV mRNA testing, and p16/Ki67 immunostaining, EIS/ZedScan-assisted colposcopy demonstrated the most favorable combination of Positive and Negative Predictive Values, at 90.57% and 100%, respectively. The inclusion of EIS/ZedScan in colposcopy led to the detection of 44 additional cases of true CIN2+ (100% of the total CIN2+ confirmed histologically) that were missed by standalone colposcopy. This discovery suggests a 45.83% increase in the detection of CIN2+ cases.

Conclusions: The integration of EIS with colposcopy has demonstrated effectiveness in detecting cervical lesions, resulting in a significant detection increase of CIN2+ cases while offering optimal levels of sensitivity, specificity, and predictive values for CIN2+ detection.

Keywords: CIN2 lesions; Greek patients; HPV mRNA test; P16/Ki67 immunostaining; ZedScan; electrical impedance spectroscopy.

Grants and funding

This research received no external funding.