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Diagnostic Performance of p16/Ki-67 Dual Immunostaining at Different Number of Positive Cells in Cervical Smears in Women Referred for Colposcopy
BACKGROUND: 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. SUBJECTS AND METHODS:...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Sciendo
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8647795/ https://www.ncbi.nlm.nih.gov/pubmed/34821133 http://dx.doi.org/10.2478/raon-2021-0043 |
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author | Gajsek, Ursula Salobir Dovnik, Andraz Takac, Iztok Ivanus, Urska Jerman, Tine Zatler, Simona Sramek Fokter, Alenka Repse |
author_facet | Gajsek, Ursula Salobir Dovnik, Andraz Takac, Iztok Ivanus, Urska Jerman, Tine Zatler, Simona Sramek Fokter, Alenka Repse |
author_sort | Gajsek, Ursula Salobir |
collection | PubMed |
description | BACKGROUND: 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. SUBJECTS AND METHODS: 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. RESULTS: 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%. CONCLUSIONS: 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. |
format | Online Article Text |
id | pubmed-8647795 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Sciendo |
record_format | MEDLINE/PubMed |
spelling | pubmed-86477952021-12-20 Diagnostic Performance of p16/Ki-67 Dual Immunostaining at Different Number of Positive Cells in Cervical Smears in Women Referred for Colposcopy Gajsek, Ursula Salobir Dovnik, Andraz Takac, Iztok Ivanus, Urska Jerman, Tine Zatler, Simona Sramek Fokter, Alenka Repse Radiol Oncol Research Article BACKGROUND: 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. SUBJECTS AND METHODS: 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. RESULTS: 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%. CONCLUSIONS: 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. Sciendo 2021-11-19 /pmc/articles/PMC8647795/ /pubmed/34821133 http://dx.doi.org/10.2478/raon-2021-0043 Text en © 2021 Ursula Salobir Gajsek, Andraz Dovnik, Iztok Takac, Urska Ivanus, Tine Jerman, Simona Sramek Zatler, Alenka Repse Fokter, published by Sciendo https://creativecommons.org/licenses/by-nc-nd/4.0/This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License. |
spellingShingle | Research Article Gajsek, Ursula Salobir Dovnik, Andraz Takac, Iztok Ivanus, Urska Jerman, Tine Zatler, Simona Sramek Fokter, Alenka Repse Diagnostic Performance of p16/Ki-67 Dual Immunostaining at Different Number of Positive Cells in Cervical Smears in Women Referred for Colposcopy |
title | Diagnostic Performance of p16/Ki-67 Dual Immunostaining at Different Number of Positive Cells in Cervical Smears in Women Referred for Colposcopy |
title_full | Diagnostic Performance of p16/Ki-67 Dual Immunostaining at Different Number of Positive Cells in Cervical Smears in Women Referred for Colposcopy |
title_fullStr | Diagnostic Performance of p16/Ki-67 Dual Immunostaining at Different Number of Positive Cells in Cervical Smears in Women Referred for Colposcopy |
title_full_unstemmed | Diagnostic Performance of p16/Ki-67 Dual Immunostaining at Different Number of Positive Cells in Cervical Smears in Women Referred for Colposcopy |
title_short | Diagnostic Performance of p16/Ki-67 Dual Immunostaining at Different Number of Positive Cells in Cervical Smears in Women Referred for Colposcopy |
title_sort | diagnostic performance of p16/ki-67 dual immunostaining at different number of positive cells in cervical smears in women referred for colposcopy |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8647795/ https://www.ncbi.nlm.nih.gov/pubmed/34821133 http://dx.doi.org/10.2478/raon-2021-0043 |
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