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Abstract
The aim of the study was to evaluate the diagnostic accuracy of p16/Ki-67 dual immunostaining (p16/ Ki-67 DS) in cervical cytology and the number of positive p16/Ki-67 cells to diagnose high grade cervical intraepithelial neoplasia (CIN2+) in colposcopy population. We performed an analysis on a subset cohort of 174 women enrolled within a large-scale randomised controlled human papillomavirus (HPV) self-sampling project organised as part of the population-based Cervical Cancer Screening Programme ZORA in Slovenia. This subset cohort of patients was invited to the colposcopy clinic, underwent p16/Ki-67 DS cervical cytology and had the number of p16/Ki-67 positive cells determined. Among analysed women, 42/174 (24.1%) had histologically confirmed CIN2+. The risk for CIN2+ was increasing with the number of positive cells (p < 0.001). The sensitivity of p16/Ki-67 DS for detection of CIN2+ was 88.1%, specificity was 65.2%, positive predictive value was 44.6% and negative predictive value was 94.5%. Dual p16/Ki-67 immunostaining for the detection of CIN2+ has shown high sensitivity and high negative predictive value in our study, which is comparable to available published data. The number of p16/Ki-67 positive cells was significantly associated with the probability of CIN2+ detection. We observed a statistically significant and clinically relevant increase in specificity if the cut-off for a positive test was shifted from one cell to three cells.
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Details
1 Department of Obstetrics and Gynecology, General Hospital Celje, Celje, Slovenia
2 University Department of Gynecology and Perinatology, University Medical Center Maribor, Maribor, Slovenia
3 University Department of Gynecology and Perinatology, University Medical Center Maribor, Maribor, Slovenia; Department of Gynecology and Obstetrics, Faculty of Medicine, University of Maribor, Maribor, Slovenia
4 National Cervical Cancer Screening Programme and Registry ZORA, Cancer Screening Department, Institute of Oncology Ljubljana, Ljubljana, Slovenia; Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
5 National Cervical Cancer Screening Programme and Registry ZORA, Cancer Screening Department, Institute of Oncology Ljubljana, Ljubljana, Slovenia
6 Department of Pathology and Cytology, General Hospital Celje, Celje, Slovenia