Validation of CINtec® PLUS cytology kit in the diagnosis of persistent HPV infections - Cohort study in the Portuguese population

Context: The use of the CINtec® PLUS Cytology Kit as a complementary method of diagnosis is intended to contribute to a risk assessment of CIN II+ cervical lesions development, thus avoiding unnecessary colposcopy in negative cases. This method has proved to be effective in the follow-up of cervical...

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Main Authors: Ângela L Abreu, Regina A Silva, Sílvia Fernandes
Format: Article
Language:English
Published: Wolters Kluwer Medknow Publications 2021-01-01
Series:Journal of Cytology
Subjects:
Online Access:http://www.jcytol.org/article.asp?issn=0970-9371;year=2021;volume=38;issue=2;spage=94;epage=100;aulast=Abreu
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author Ângela L Abreu
Regina A Silva
Sílvia Fernandes
author_facet Ângela L Abreu
Regina A Silva
Sílvia Fernandes
author_sort Ângela L Abreu
collection DOAJ
description Context: The use of the CINtec® PLUS Cytology Kit as a complementary method of diagnosis is intended to contribute to a risk assessment of CIN II+ cervical lesions development, thus avoiding unnecessary colposcopy in negative cases. This method has proved to be effective in the follow-up of cervical lesions, although there is need for consistency in the approach of equivocal or negative cytological results, with persistent positive High-Risk Human Papillomavirus (HR-HPV) test. Aims: The present study intends to retrospectively evaluate the capacity of the CINtec® to add information to the clinical practice within the screening and follow-up of cervical lesions. Additionally, this study intends to define criteria for CINtec® referral in order to maximize its utilization in the Portuguese context. Materials and Methods: For this purpose, 225 cases with CINtec® PLUS Cytology Kit and histology results were used, and data were analysed and compared according to the cytology and HR-HPV molecular test results. Results: The data of this study show that CINtec® PLUS Cytology Kit is a valid test for the diagnosis of persistent HPV lesions (p = 0.0005), with excellent sensitivity and reliable values of specificity. Relevant patient groups to apply the kit are in agreement with the manufacturer recommendations: women with ASC-US/LSIL result and NILM cytology with HPV-positive test, essentially over 30 years old. Conclusions: Although clinical data and previous cytological information must help guiding, authors considered that CINtec® is a really valid test for the prognosis of persistent HPV infections in the female population.
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spelling doaj.art-b450809dfc9845d79997a4f0f5a125ef2022-12-21T22:45:55ZengWolters Kluwer Medknow PublicationsJournal of Cytology0970-93712021-01-013829410010.4103/JOC.JOC_173_20Validation of CINtec® PLUS cytology kit in the diagnosis of persistent HPV infections - Cohort study in the Portuguese populationÂngela L AbreuRegina A SilvaSílvia FernandesContext: The use of the CINtec® PLUS Cytology Kit as a complementary method of diagnosis is intended to contribute to a risk assessment of CIN II+ cervical lesions development, thus avoiding unnecessary colposcopy in negative cases. This method has proved to be effective in the follow-up of cervical lesions, although there is need for consistency in the approach of equivocal or negative cytological results, with persistent positive High-Risk Human Papillomavirus (HR-HPV) test. Aims: The present study intends to retrospectively evaluate the capacity of the CINtec® to add information to the clinical practice within the screening and follow-up of cervical lesions. Additionally, this study intends to define criteria for CINtec® referral in order to maximize its utilization in the Portuguese context. Materials and Methods: For this purpose, 225 cases with CINtec® PLUS Cytology Kit and histology results were used, and data were analysed and compared according to the cytology and HR-HPV molecular test results. Results: The data of this study show that CINtec® PLUS Cytology Kit is a valid test for the diagnosis of persistent HPV lesions (p = 0.0005), with excellent sensitivity and reliable values of specificity. Relevant patient groups to apply the kit are in agreement with the manufacturer recommendations: women with ASC-US/LSIL result and NILM cytology with HPV-positive test, essentially over 30 years old. Conclusions: Although clinical data and previous cytological information must help guiding, authors considered that CINtec® is a really valid test for the prognosis of persistent HPV infections in the female population.http://www.jcytol.org/article.asp?issn=0970-9371;year=2021;volume=38;issue=2;spage=94;epage=100;aulast=Abreucervical cytologycervical intraepithelial neoplasiahigh gradeimmunocytochemistrytriage
spellingShingle Ângela L Abreu
Regina A Silva
Sílvia Fernandes
Validation of CINtec® PLUS cytology kit in the diagnosis of persistent HPV infections - Cohort study in the Portuguese population
Journal of Cytology
cervical cytology
cervical intraepithelial neoplasia
high grade
immunocytochemistry
triage
title Validation of CINtec® PLUS cytology kit in the diagnosis of persistent HPV infections - Cohort study in the Portuguese population
title_full Validation of CINtec® PLUS cytology kit in the diagnosis of persistent HPV infections - Cohort study in the Portuguese population
title_fullStr Validation of CINtec® PLUS cytology kit in the diagnosis of persistent HPV infections - Cohort study in the Portuguese population
title_full_unstemmed Validation of CINtec® PLUS cytology kit in the diagnosis of persistent HPV infections - Cohort study in the Portuguese population
title_short Validation of CINtec® PLUS cytology kit in the diagnosis of persistent HPV infections - Cohort study in the Portuguese population
title_sort validation of cintec r plus cytology kit in the diagnosis of persistent hpv infections cohort study in the portuguese population
topic cervical cytology
cervical intraepithelial neoplasia
high grade
immunocytochemistry
triage
url http://www.jcytol.org/article.asp?issn=0970-9371;year=2021;volume=38;issue=2;spage=94;epage=100;aulast=Abreu
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