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Validation of intra- and inter-laboratory reproducibility of the Xpert HPV assay according to the international guidelines for cervical cancer screening
BACKGROUND: Cervical cancer screening with assays detecting DNA of high-risk human papillomavirus (hrHPV) types is more effective than cytology-based screening. This study completes the diagnostic accuracy assessment conducted previously within the framework of VALGENT-2 (Validation of HPV genotypin...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6206920/ https://www.ncbi.nlm.nih.gov/pubmed/30373616 http://dx.doi.org/10.1186/s12985-018-1076-6 |
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author | Akbari, Ajmal Vanden Broeck, Davy Benoy, Ina Padalko, Elizaveta Bogers, Johannes Arbyn, Marc |
author_facet | Akbari, Ajmal Vanden Broeck, Davy Benoy, Ina Padalko, Elizaveta Bogers, Johannes Arbyn, Marc |
author_sort | Akbari, Ajmal |
collection | PubMed |
description | BACKGROUND: Cervical cancer screening with assays detecting DNA of high-risk human papillomavirus (hrHPV) types is more effective than cytology-based screening. This study completes the diagnostic accuracy assessment conducted previously within the framework of VALGENT-2 (Validation of HPV genotyping Tests) and aims to determine whether the reproducibility of Xpert HPV is in line with international validation criteria. METHODS: Validation of new hrHPV DNA assays requires demonstration of good reproducibility and non-inferior clinical accuracy for cervical precancer compared to a standard comparator assay. The international reproducibility criteria are: lower bound of 95% confidence interval of the intra- and inter-laboratory agreement regarding detection of high-risk HPV DNA exceeding 87% with kappa ≥0.5. RESULTS: The Xpert HPV assay showed high intra-laboratory reproducibility with an overall positivity/negativity agreement of 96.9% and a kappa of 0.925. Inter-laboratory testing showed an agreement of 97.8% with a kappa of 0.948. CONCLUSIONS: The Xpert HPV assay fulfills the HPV test reproducibility criterion requirement for use in cervical cancer screening. |
format | Online Article Text |
id | pubmed-6206920 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-62069202018-10-31 Validation of intra- and inter-laboratory reproducibility of the Xpert HPV assay according to the international guidelines for cervical cancer screening Akbari, Ajmal Vanden Broeck, Davy Benoy, Ina Padalko, Elizaveta Bogers, Johannes Arbyn, Marc Virol J Research BACKGROUND: Cervical cancer screening with assays detecting DNA of high-risk human papillomavirus (hrHPV) types is more effective than cytology-based screening. This study completes the diagnostic accuracy assessment conducted previously within the framework of VALGENT-2 (Validation of HPV genotyping Tests) and aims to determine whether the reproducibility of Xpert HPV is in line with international validation criteria. METHODS: Validation of new hrHPV DNA assays requires demonstration of good reproducibility and non-inferior clinical accuracy for cervical precancer compared to a standard comparator assay. The international reproducibility criteria are: lower bound of 95% confidence interval of the intra- and inter-laboratory agreement regarding detection of high-risk HPV DNA exceeding 87% with kappa ≥0.5. RESULTS: The Xpert HPV assay showed high intra-laboratory reproducibility with an overall positivity/negativity agreement of 96.9% and a kappa of 0.925. Inter-laboratory testing showed an agreement of 97.8% with a kappa of 0.948. CONCLUSIONS: The Xpert HPV assay fulfills the HPV test reproducibility criterion requirement for use in cervical cancer screening. BioMed Central 2018-10-29 /pmc/articles/PMC6206920/ /pubmed/30373616 http://dx.doi.org/10.1186/s12985-018-1076-6 Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Research Akbari, Ajmal Vanden Broeck, Davy Benoy, Ina Padalko, Elizaveta Bogers, Johannes Arbyn, Marc Validation of intra- and inter-laboratory reproducibility of the Xpert HPV assay according to the international guidelines for cervical cancer screening |
title | Validation of intra- and inter-laboratory reproducibility of the Xpert HPV assay according to the international guidelines for cervical cancer screening |
title_full | Validation of intra- and inter-laboratory reproducibility of the Xpert HPV assay according to the international guidelines for cervical cancer screening |
title_fullStr | Validation of intra- and inter-laboratory reproducibility of the Xpert HPV assay according to the international guidelines for cervical cancer screening |
title_full_unstemmed | Validation of intra- and inter-laboratory reproducibility of the Xpert HPV assay according to the international guidelines for cervical cancer screening |
title_short | Validation of intra- and inter-laboratory reproducibility of the Xpert HPV assay according to the international guidelines for cervical cancer screening |
title_sort | validation of intra- and inter-laboratory reproducibility of the xpert hpv assay according to the international guidelines for cervical cancer screening |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6206920/ https://www.ncbi.nlm.nih.gov/pubmed/30373616 http://dx.doi.org/10.1186/s12985-018-1076-6 |
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