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A Comparative Study on the Accuracy and Efficacy Between Dalton and CINtec(®) PLUS p16/Ki-67 Dual Stain in Triaging HPV-Positive Women

BACKGROUND: CINtec(®) PLUS p16/Ki-67 dual-stained cytology (DS) is an alternative test to cytology in triaging human papillomavirus (HPV)-positive women. Dalton p16/Ki-67 Dual Stain kit employs the similar immunocytochemical detection and operating procedures with CINtec(®) PLUS, but its accuracy an...

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Autores principales: Li, Ying, Fu, Yunfeng, Cheng, Bei, Xie, Xing, Wang, Xinyu
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8818758/
https://www.ncbi.nlm.nih.gov/pubmed/35141154
http://dx.doi.org/10.3389/fonc.2021.815213
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author Li, Ying
Fu, Yunfeng
Cheng, Bei
Xie, Xing
Wang, Xinyu
author_facet Li, Ying
Fu, Yunfeng
Cheng, Bei
Xie, Xing
Wang, Xinyu
author_sort Li, Ying
collection PubMed
description BACKGROUND: CINtec(®) PLUS p16/Ki-67 dual-stained cytology (DS) is an alternative test to cytology in triaging human papillomavirus (HPV)-positive women. Dalton p16/Ki-67 Dual Stain kit employs the similar immunocytochemical detection and operating procedures with CINtec(®) PLUS, but its accuracy and efficacy in triaging HPV-positive women need to be evaluated. METHODS: A total of 717 HPV-positive specimens of cervical exfoliated cells were included. Cytology, Dalton, and CINtec(®) PLUS were subsequently performed, and two DS tests were separately completed in each of the same specimens. The results of two DS tests were head-to-head compared, and their efficacies to identify high-grade cervical intraepithelial neoplasia (CIN) were evaluated, using histopathology of biopsy as the golden standard. RESULTS: The overall positive rate of two DS tests were 28.31% for Dalton and 33.89% for CINtec(®) PLUS (p < 0.05); both rose with the increased severity of histopathological and cytological abnormalities. Compared to CINtec(®) PLUS, the positive rate of Dalton was significantly lower in the normal histopathology group (p < 0.05) and lower, but not significantly, in mild abnormal histopathology and cytology NILM and LSIL groups. Two DS tests showed a good consistency (Kappa value, 0.63; 95% CI, 0.557–0.688), with 100% of consistency in the cytology HSIL group. Inconsistency occurred mainly in the cytology NILM and LSIL groups, with more Dalton negative but CINtec(®) PLUS positive. Compared to CINtec(®) PLUS, Dalton showed similar sensitivity (94.59% vs. 91.89%), but significantly higher specificity (75.29% vs. 69.26%, p = 0.013) and accuracy (76.29% vs. 70.43%, p = 0.012), with a larger area under the curve (AUC) of 0.849 (95% CI, 0.800–0.899) for identifying CIN3+. The similar results were observed when identifying CIN2+. CONCLUSIONS: Dalton presents the lower false positive rate and better efficacy in identifying high-grade CIN than CINtec(®) PLUS, suggesting that Dalton may be superior to CINtec(®) PLUS and an alternative technique for triaging primary HPV-positive women in cervical cancer screening.
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spelling pubmed-88187582022-02-08 A Comparative Study on the Accuracy and Efficacy Between Dalton and CINtec(®) PLUS p16/Ki-67 Dual Stain in Triaging HPV-Positive Women Li, Ying Fu, Yunfeng Cheng, Bei Xie, Xing Wang, Xinyu Front Oncol Oncology BACKGROUND: CINtec(®) PLUS p16/Ki-67 dual-stained cytology (DS) is an alternative test to cytology in triaging human papillomavirus (HPV)-positive women. Dalton p16/Ki-67 Dual Stain kit employs the similar immunocytochemical detection and operating procedures with CINtec(®) PLUS, but its accuracy and efficacy in triaging HPV-positive women need to be evaluated. METHODS: A total of 717 HPV-positive specimens of cervical exfoliated cells were included. Cytology, Dalton, and CINtec(®) PLUS were subsequently performed, and two DS tests were separately completed in each of the same specimens. The results of two DS tests were head-to-head compared, and their efficacies to identify high-grade cervical intraepithelial neoplasia (CIN) were evaluated, using histopathology of biopsy as the golden standard. RESULTS: The overall positive rate of two DS tests were 28.31% for Dalton and 33.89% for CINtec(®) PLUS (p < 0.05); both rose with the increased severity of histopathological and cytological abnormalities. Compared to CINtec(®) PLUS, the positive rate of Dalton was significantly lower in the normal histopathology group (p < 0.05) and lower, but not significantly, in mild abnormal histopathology and cytology NILM and LSIL groups. Two DS tests showed a good consistency (Kappa value, 0.63; 95% CI, 0.557–0.688), with 100% of consistency in the cytology HSIL group. Inconsistency occurred mainly in the cytology NILM and LSIL groups, with more Dalton negative but CINtec(®) PLUS positive. Compared to CINtec(®) PLUS, Dalton showed similar sensitivity (94.59% vs. 91.89%), but significantly higher specificity (75.29% vs. 69.26%, p = 0.013) and accuracy (76.29% vs. 70.43%, p = 0.012), with a larger area under the curve (AUC) of 0.849 (95% CI, 0.800–0.899) for identifying CIN3+. The similar results were observed when identifying CIN2+. CONCLUSIONS: Dalton presents the lower false positive rate and better efficacy in identifying high-grade CIN than CINtec(®) PLUS, suggesting that Dalton may be superior to CINtec(®) PLUS and an alternative technique for triaging primary HPV-positive women in cervical cancer screening. Frontiers Media S.A. 2022-01-24 /pmc/articles/PMC8818758/ /pubmed/35141154 http://dx.doi.org/10.3389/fonc.2021.815213 Text en Copyright © 2022 Li, Fu, Cheng, Xie and Wang https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Oncology
Li, Ying
Fu, Yunfeng
Cheng, Bei
Xie, Xing
Wang, Xinyu
A Comparative Study on the Accuracy and Efficacy Between Dalton and CINtec(®) PLUS p16/Ki-67 Dual Stain in Triaging HPV-Positive Women
title A Comparative Study on the Accuracy and Efficacy Between Dalton and CINtec(®) PLUS p16/Ki-67 Dual Stain in Triaging HPV-Positive Women
title_full A Comparative Study on the Accuracy and Efficacy Between Dalton and CINtec(®) PLUS p16/Ki-67 Dual Stain in Triaging HPV-Positive Women
title_fullStr A Comparative Study on the Accuracy and Efficacy Between Dalton and CINtec(®) PLUS p16/Ki-67 Dual Stain in Triaging HPV-Positive Women
title_full_unstemmed A Comparative Study on the Accuracy and Efficacy Between Dalton and CINtec(®) PLUS p16/Ki-67 Dual Stain in Triaging HPV-Positive Women
title_short A Comparative Study on the Accuracy and Efficacy Between Dalton and CINtec(®) PLUS p16/Ki-67 Dual Stain in Triaging HPV-Positive Women
title_sort comparative study on the accuracy and efficacy between dalton and cintec(®) plus p16/ki-67 dual stain in triaging hpv-positive women
topic Oncology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8818758/
https://www.ncbi.nlm.nih.gov/pubmed/35141154
http://dx.doi.org/10.3389/fonc.2021.815213
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