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An evaluation of solid versus liquid transport media for high-risk HPV detection and cervical cancer screening on self-collected specimens

BACKGROUND: The solid transport media is a small size card that allows fast, easy DNA extraction from a variety of biological samples. In 2016 we developed a solid media transport card; for that pilot study to control the self-collection we used a pseudo-self-collection technique. The current study...

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Autores principales: Du, Hui, Duan, Xianzhi, Liu, Yan, Shi, Bin, Zhang, Wei, Wang, Chun, Qu, Xinfen, Bao, Juncui, Li, Jingran, Zhao, Chao, Jiang, Jing, Liu, Juan, Wu, Kejia, Xiao, Aimin, Duan, Lvfang, Huang, Xia, Bian, Shuhuang, Zhang, Lijie, Luo, Hongxue, Wei, Lihui, Belinson, Jerome L., Wu, Ruifang
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7706049/
https://www.ncbi.nlm.nih.gov/pubmed/33292341
http://dx.doi.org/10.1186/s13027-020-00333-4
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author Du, Hui
Duan, Xianzhi
Liu, Yan
Shi, Bin
Zhang, Wei
Wang, Chun
Qu, Xinfen
Bao, Juncui
Li, Jingran
Zhao, Chao
Jiang, Jing
Liu, Juan
Wu, Kejia
Xiao, Aimin
Duan, Lvfang
Huang, Xia
Bian, Shuhuang
Zhang, Lijie
Luo, Hongxue
Wei, Lihui
Belinson, Jerome L.
Wu, Ruifang
author_facet Du, Hui
Duan, Xianzhi
Liu, Yan
Shi, Bin
Zhang, Wei
Wang, Chun
Qu, Xinfen
Bao, Juncui
Li, Jingran
Zhao, Chao
Jiang, Jing
Liu, Juan
Wu, Kejia
Xiao, Aimin
Duan, Lvfang
Huang, Xia
Bian, Shuhuang
Zhang, Lijie
Luo, Hongxue
Wei, Lihui
Belinson, Jerome L.
Wu, Ruifang
author_sort Du, Hui
collection PubMed
description BACKGROUND: The solid transport media is a small size card that allows fast, easy DNA extraction from a variety of biological samples. In 2016 we developed a solid media transport card; for that pilot study to control the self-collection we used a pseudo-self-collection technique. The current study expands this prior work using true self-collections and only the POI card, and aims to evaluate the solid media transport card to detect HR-HPV in self-samples compared to liquid transport media. METHODS: Ten thousand eight hundred eighty-five women between the ages of 30–59 with no screening for 3 years were enrolled. The self-collected sample was first applied to a new solid media transport card (Labeled as SC) then the brush placed in 6 ml ThinPrep liquid (Labeled as SL). Then a physician collected a direct endocervical specimen into ThinPrep liquid (Labeled as DL). Samples were tested with Cobas 4800 and the SeqHPV NGS assay for HR-HPV. Patients positive on any test were recalled for colposcopy and biopsy. RESULTS: Ten thousand three hundred thirty-nine participants had complete data. The mean age was 43.9 years. CIN 2+ rates were 1.4% (142/10339). The agreement in HPV detection between the two different self-sample collection media was also good (Cobas HPV kappa = 0.86; SeqHPV kappa = 0.98). Tested with Cobas, the sensitivity of Cobas-SL and Cobas-SC for CIN 2+ was95.07 and 94.37%; and for CIN3+ was 96.30, 96.30% respectively. The specificity of Cobas-SC, and Cobas-SL for CIN2+ was 88.74 and 87.35%; for CIN3 was 88.04and 86.65% respectively. Tested with SeqHPV, the sensitivity for CIN2+ of Seq-SC and Seq-SL was 95.77 and 96.48%; for CIN3+, both the SC and SL specimens had a sensitivity of 100%. The specificity for CIN2+ of Seq-SC and Seq-SL was 89.54 and 89.53%; for CIN3+ was 88.84,88.82% respectively. For both HR-HPV assays, the sensitivities were similar for the two self-sample media (SC vs SL, p = 1.00). CONCLUSIONS: The solid transport card for collecting vaginal self-samples as accurate as liquid transport media assayed by two different PCR based HR-HPV tests. The solid transport media is a suitable medium for collecting and storing vaginal self-samples. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13027-020-00333-4.
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spelling pubmed-77060492020-12-01 An evaluation of solid versus liquid transport media for high-risk HPV detection and cervical cancer screening on self-collected specimens Du, Hui Duan, Xianzhi Liu, Yan Shi, Bin Zhang, Wei Wang, Chun Qu, Xinfen Bao, Juncui Li, Jingran Zhao, Chao Jiang, Jing Liu, Juan Wu, Kejia Xiao, Aimin Duan, Lvfang Huang, Xia Bian, Shuhuang Zhang, Lijie Luo, Hongxue Wei, Lihui Belinson, Jerome L. Wu, Ruifang Infect Agent Cancer Research Article BACKGROUND: The solid transport media is a small size card that allows fast, easy DNA extraction from a variety of biological samples. In 2016 we developed a solid media transport card; for that pilot study to control the self-collection we used a pseudo-self-collection technique. The current study expands this prior work using true self-collections and only the POI card, and aims to evaluate the solid media transport card to detect HR-HPV in self-samples compared to liquid transport media. METHODS: Ten thousand eight hundred eighty-five women between the ages of 30–59 with no screening for 3 years were enrolled. The self-collected sample was first applied to a new solid media transport card (Labeled as SC) then the brush placed in 6 ml ThinPrep liquid (Labeled as SL). Then a physician collected a direct endocervical specimen into ThinPrep liquid (Labeled as DL). Samples were tested with Cobas 4800 and the SeqHPV NGS assay for HR-HPV. Patients positive on any test were recalled for colposcopy and biopsy. RESULTS: Ten thousand three hundred thirty-nine participants had complete data. The mean age was 43.9 years. CIN 2+ rates were 1.4% (142/10339). The agreement in HPV detection between the two different self-sample collection media was also good (Cobas HPV kappa = 0.86; SeqHPV kappa = 0.98). Tested with Cobas, the sensitivity of Cobas-SL and Cobas-SC for CIN 2+ was95.07 and 94.37%; and for CIN3+ was 96.30, 96.30% respectively. The specificity of Cobas-SC, and Cobas-SL for CIN2+ was 88.74 and 87.35%; for CIN3 was 88.04and 86.65% respectively. Tested with SeqHPV, the sensitivity for CIN2+ of Seq-SC and Seq-SL was 95.77 and 96.48%; for CIN3+, both the SC and SL specimens had a sensitivity of 100%. The specificity for CIN2+ of Seq-SC and Seq-SL was 89.54 and 89.53%; for CIN3+ was 88.84,88.82% respectively. For both HR-HPV assays, the sensitivities were similar for the two self-sample media (SC vs SL, p = 1.00). CONCLUSIONS: The solid transport card for collecting vaginal self-samples as accurate as liquid transport media assayed by two different PCR based HR-HPV tests. The solid transport media is a suitable medium for collecting and storing vaginal self-samples. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13027-020-00333-4. BioMed Central 2020-11-30 /pmc/articles/PMC7706049/ /pubmed/33292341 http://dx.doi.org/10.1186/s13027-020-00333-4 Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. 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 in a credit line to the data.
spellingShingle Research Article
Du, Hui
Duan, Xianzhi
Liu, Yan
Shi, Bin
Zhang, Wei
Wang, Chun
Qu, Xinfen
Bao, Juncui
Li, Jingran
Zhao, Chao
Jiang, Jing
Liu, Juan
Wu, Kejia
Xiao, Aimin
Duan, Lvfang
Huang, Xia
Bian, Shuhuang
Zhang, Lijie
Luo, Hongxue
Wei, Lihui
Belinson, Jerome L.
Wu, Ruifang
An evaluation of solid versus liquid transport media for high-risk HPV detection and cervical cancer screening on self-collected specimens
title An evaluation of solid versus liquid transport media for high-risk HPV detection and cervical cancer screening on self-collected specimens
title_full An evaluation of solid versus liquid transport media for high-risk HPV detection and cervical cancer screening on self-collected specimens
title_fullStr An evaluation of solid versus liquid transport media for high-risk HPV detection and cervical cancer screening on self-collected specimens
title_full_unstemmed An evaluation of solid versus liquid transport media for high-risk HPV detection and cervical cancer screening on self-collected specimens
title_short An evaluation of solid versus liquid transport media for high-risk HPV detection and cervical cancer screening on self-collected specimens
title_sort evaluation of solid versus liquid transport media for high-risk hpv detection and cervical cancer screening on self-collected specimens
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7706049/
https://www.ncbi.nlm.nih.gov/pubmed/33292341
http://dx.doi.org/10.1186/s13027-020-00333-4
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