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Prevalence of Human Papillomavirus in 5,072 Consecutive Cervical SurePath Samples Evaluated with the Roche Cobas HPV Real-Time PCR Assay

New commercially available Human Papillomavirus (HPV) assays need to be evaluated in a variety of cervical screening settings. Cobas HPV Test (cobas) is a real-time PCR-based assay allowing for separate detection of HPV genotypes 16 and 18 and a bulk of 12 other high-risk genotypes. The aim of the p...

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Autores principales: Preisler, Sarah, Rebolj, Matejka, Untermann, Anette, Ejegod, Ditte Møller, Lynge, Elsebeth, Rygaard, Carsten, Bonde, Jesper
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2013
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3606112/
https://www.ncbi.nlm.nih.gov/pubmed/23533648
http://dx.doi.org/10.1371/journal.pone.0059765
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author Preisler, Sarah
Rebolj, Matejka
Untermann, Anette
Ejegod, Ditte Møller
Lynge, Elsebeth
Rygaard, Carsten
Bonde, Jesper
author_facet Preisler, Sarah
Rebolj, Matejka
Untermann, Anette
Ejegod, Ditte Møller
Lynge, Elsebeth
Rygaard, Carsten
Bonde, Jesper
author_sort Preisler, Sarah
collection PubMed
description New commercially available Human Papillomavirus (HPV) assays need to be evaluated in a variety of cervical screening settings. Cobas HPV Test (cobas) is a real-time PCR-based assay allowing for separate detection of HPV genotypes 16 and 18 and a bulk of 12 other high-risk genotypes. The aim of the present study, Horizon, was to assess the prevalence of high-risk HPV infections in an area with a high background risk of cervical cancer, where women aged 23–65 years are targeted for cervical screening. We collected 6,258 consecutive cervical samples from the largest cervical screening laboratory in Denmark serving the whole of Copenhagen. All samples were stored in SurePath media. In total, 5,072 samples were tested with cobas, Hybrid Capture 2 High Risk HPV DNA test (HC2) and liquid-based cytology. Of these, 27% tested positive on cobas. This proportion decreased by age, being 43% in women aged 23–29 years and 10% in women aged 60–65 years. HC2 assay was positive in 20% of samples, and cytology was abnormal (≥ atypical squamous cells of undetermined significance) for 7% samples. When only samples without recent abnormalities were taken into account, 24% tested positive on cobas, 19% on HC2, and 5% had abnormal cytology. The proportion of positive cobas samples was higher than in the ATHENA trial. The age-standardized cobas positivity vs. cytology abnormality was 3.9 in our study and 1.7 in ATHENA. If in Copenhagen the presently used cytology would be replaced by cobas in women above age 30 years, an extra 11% of women would based on historical data be expected to have a positive cobas test without an underlying cervical intraepithelial lesion grade 3 or worse. Countries with a high prevalence of HPV infections should therefore proceed to primary HPV-based cervical screening with caution.
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spelling pubmed-36061122013-03-26 Prevalence of Human Papillomavirus in 5,072 Consecutive Cervical SurePath Samples Evaluated with the Roche Cobas HPV Real-Time PCR Assay Preisler, Sarah Rebolj, Matejka Untermann, Anette Ejegod, Ditte Møller Lynge, Elsebeth Rygaard, Carsten Bonde, Jesper PLoS One Research Article New commercially available Human Papillomavirus (HPV) assays need to be evaluated in a variety of cervical screening settings. Cobas HPV Test (cobas) is a real-time PCR-based assay allowing for separate detection of HPV genotypes 16 and 18 and a bulk of 12 other high-risk genotypes. The aim of the present study, Horizon, was to assess the prevalence of high-risk HPV infections in an area with a high background risk of cervical cancer, where women aged 23–65 years are targeted for cervical screening. We collected 6,258 consecutive cervical samples from the largest cervical screening laboratory in Denmark serving the whole of Copenhagen. All samples were stored in SurePath media. In total, 5,072 samples were tested with cobas, Hybrid Capture 2 High Risk HPV DNA test (HC2) and liquid-based cytology. Of these, 27% tested positive on cobas. This proportion decreased by age, being 43% in women aged 23–29 years and 10% in women aged 60–65 years. HC2 assay was positive in 20% of samples, and cytology was abnormal (≥ atypical squamous cells of undetermined significance) for 7% samples. When only samples without recent abnormalities were taken into account, 24% tested positive on cobas, 19% on HC2, and 5% had abnormal cytology. The proportion of positive cobas samples was higher than in the ATHENA trial. The age-standardized cobas positivity vs. cytology abnormality was 3.9 in our study and 1.7 in ATHENA. If in Copenhagen the presently used cytology would be replaced by cobas in women above age 30 years, an extra 11% of women would based on historical data be expected to have a positive cobas test without an underlying cervical intraepithelial lesion grade 3 or worse. Countries with a high prevalence of HPV infections should therefore proceed to primary HPV-based cervical screening with caution. Public Library of Science 2013-03-22 /pmc/articles/PMC3606112/ /pubmed/23533648 http://dx.doi.org/10.1371/journal.pone.0059765 Text en © 2013 Preisler et al http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited.
spellingShingle Research Article
Preisler, Sarah
Rebolj, Matejka
Untermann, Anette
Ejegod, Ditte Møller
Lynge, Elsebeth
Rygaard, Carsten
Bonde, Jesper
Prevalence of Human Papillomavirus in 5,072 Consecutive Cervical SurePath Samples Evaluated with the Roche Cobas HPV Real-Time PCR Assay
title Prevalence of Human Papillomavirus in 5,072 Consecutive Cervical SurePath Samples Evaluated with the Roche Cobas HPV Real-Time PCR Assay
title_full Prevalence of Human Papillomavirus in 5,072 Consecutive Cervical SurePath Samples Evaluated with the Roche Cobas HPV Real-Time PCR Assay
title_fullStr Prevalence of Human Papillomavirus in 5,072 Consecutive Cervical SurePath Samples Evaluated with the Roche Cobas HPV Real-Time PCR Assay
title_full_unstemmed Prevalence of Human Papillomavirus in 5,072 Consecutive Cervical SurePath Samples Evaluated with the Roche Cobas HPV Real-Time PCR Assay
title_short Prevalence of Human Papillomavirus in 5,072 Consecutive Cervical SurePath Samples Evaluated with the Roche Cobas HPV Real-Time PCR Assay
title_sort prevalence of human papillomavirus in 5,072 consecutive cervical surepath samples evaluated with the roche cobas hpv real-time pcr assay
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3606112/
https://www.ncbi.nlm.nih.gov/pubmed/23533648
http://dx.doi.org/10.1371/journal.pone.0059765
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