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.

Details

Title
Diagnostic performance of p16/Ki-67 dual immunostaining at different number of positive cells in cervical smears in women referred for colposcopy
Author
Gajsek, Ursula Salobir 1 ; Dovnik, Andraz 2 ; Takac, Iztok 3 ; Ivanus, Urska 4 ; Jerman, Tine 5 ; Simona Sramek Zatler 6 ; Fokter, Alenka Repse 6 

 Department of Obstetrics and Gynecology, General Hospital Celje, Celje, Slovenia 
 University Department of Gynecology and Perinatology, University Medical Center Maribor, Maribor, Slovenia 
 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 
 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 
 National Cervical Cancer Screening Programme and Registry ZORA, Cancer Screening Department, Institute of Oncology Ljubljana, Ljubljana, Slovenia 
 Department of Pathology and Cytology, General Hospital Celje, Celje, Slovenia 
Pages
426-432
Publication year
2021
Publication date
2021
Publisher
De Gruyter Poland
ISSN
13182099
e-ISSN
0485893X
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
2601729653
Copyright
© 2021. This work is published under http://creativecommons.org/licenses/by-nc-nd/4.0 (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.