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A rapid, high-volume cervical screening project using self-sampling and isothermal PCR HPV testing

OBJECTIVE: Rapid, high-volume screening programs are needed as part of cervical cancer prevention in China. METHODS: In a 5-day screening project in Inner Mongolia, 3345 women volunteered following a community awareness campaign, and self-swabbed to permit rapid HPV testing. Two AmpFire™ HPV detecti...

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Autores principales: Goldstein, Andrew, Lei, Yang, Goldstein, Lena, Goldstein, Amelia, Bai, Qiao Xu, Felix, Juan, Lipson, Roberta, Demarco, Maria, Schiffman, Mark, Egemen, Didem, Desai, Kanan T., Bedell, Sarah, Gersten, Janet, Goldstein, Gail, O’Keefe, Karen, O’Keefe, Casey, O’Keefe, Tierney, Sebag, Cathy, Lobel, Lior, Zhao, Anna, Lu, Yan Ling
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7579849/
https://www.ncbi.nlm.nih.gov/pubmed/33106753
http://dx.doi.org/10.1186/s13027-020-00329-0
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author Goldstein, Andrew
Lei, Yang
Goldstein, Lena
Goldstein, Amelia
Bai, Qiao Xu
Felix, Juan
Lipson, Roberta
Demarco, Maria
Schiffman, Mark
Egemen, Didem
Desai, Kanan T.
Bedell, Sarah
Gersten, Janet
Goldstein, Gail
O’Keefe, Karen
O’Keefe, Casey
O’Keefe, Tierney
Sebag, Cathy
Lobel, Lior
Zhao, Anna
Lu, Yan Ling
author_facet Goldstein, Andrew
Lei, Yang
Goldstein, Lena
Goldstein, Amelia
Bai, Qiao Xu
Felix, Juan
Lipson, Roberta
Demarco, Maria
Schiffman, Mark
Egemen, Didem
Desai, Kanan T.
Bedell, Sarah
Gersten, Janet
Goldstein, Gail
O’Keefe, Karen
O’Keefe, Casey
O’Keefe, Tierney
Sebag, Cathy
Lobel, Lior
Zhao, Anna
Lu, Yan Ling
author_sort Goldstein, Andrew
collection PubMed
description OBJECTIVE: Rapid, high-volume screening programs are needed as part of cervical cancer prevention in China. METHODS: In a 5-day screening project in Inner Mongolia, 3345 women volunteered following a community awareness campaign, and self-swabbed to permit rapid HPV testing. Two AmpFire™ HPV detection systems (Atila Biosystems) were sufficient to provide pooled 15-HPV type data within an hour. HPV+ patients had same-day digital colposcopy (DC) performed by 1 of 6 physicians, using the EVA™ system (MobileODT). Digital images were obtained and, after biopsy of suspected lesions for later confirmatory diagnosis, women were treated immediately based on colposcopic impression. Suspected low- grade lesions were offered treatment with thermal ablation (Wisap), and suspected high-grade lesions were treated with LLETZ. RESULTS: Of 3345 women screened, 624 (18.7%) were HPV+. Of these, 88.5% HPV+ women underwent same-day colposcopy and 78 were treated. Later consensus histology results obtained on 197 women indicated 20 CIN2+, of whom 15 were detected and treated/referred at screening (10 by thermal ablation, 4 by LLETZ, 1 by referral). CONCLUSIONS: Global control of cervical cancer will require both vaccination and screening of a huge number of women. This study illustrates a cervical screening strategy that can be used to screen-and-treat large numbers of women. HPV self-sampling facilitates high-volume screening. Specimens can be tested rapidly, promoting minimal loss-to-follow-up. Specifically, the AmpFire™ system used in this study is highly portable, simple, rapid (92 specimens per 65 min per unit), and economical. Visual triage can be performed on HPV+ women with a portable digital colposcope that provides magnification, lighting, and a recorded image. Diagnosis and appropriate treatment remain the most subjective elements. The digital image is under study for deep-learning based automated evaluation that could assist the management decision, either by itself or combined with HPV typing.
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spelling pubmed-75798492020-10-23 A rapid, high-volume cervical screening project using self-sampling and isothermal PCR HPV testing Goldstein, Andrew Lei, Yang Goldstein, Lena Goldstein, Amelia Bai, Qiao Xu Felix, Juan Lipson, Roberta Demarco, Maria Schiffman, Mark Egemen, Didem Desai, Kanan T. Bedell, Sarah Gersten, Janet Goldstein, Gail O’Keefe, Karen O’Keefe, Casey O’Keefe, Tierney Sebag, Cathy Lobel, Lior Zhao, Anna Lu, Yan Ling Infect Agent Cancer Research Article OBJECTIVE: Rapid, high-volume screening programs are needed as part of cervical cancer prevention in China. METHODS: In a 5-day screening project in Inner Mongolia, 3345 women volunteered following a community awareness campaign, and self-swabbed to permit rapid HPV testing. Two AmpFire™ HPV detection systems (Atila Biosystems) were sufficient to provide pooled 15-HPV type data within an hour. HPV+ patients had same-day digital colposcopy (DC) performed by 1 of 6 physicians, using the EVA™ system (MobileODT). Digital images were obtained and, after biopsy of suspected lesions for later confirmatory diagnosis, women were treated immediately based on colposcopic impression. Suspected low- grade lesions were offered treatment with thermal ablation (Wisap), and suspected high-grade lesions were treated with LLETZ. RESULTS: Of 3345 women screened, 624 (18.7%) were HPV+. Of these, 88.5% HPV+ women underwent same-day colposcopy and 78 were treated. Later consensus histology results obtained on 197 women indicated 20 CIN2+, of whom 15 were detected and treated/referred at screening (10 by thermal ablation, 4 by LLETZ, 1 by referral). CONCLUSIONS: Global control of cervical cancer will require both vaccination and screening of a huge number of women. This study illustrates a cervical screening strategy that can be used to screen-and-treat large numbers of women. HPV self-sampling facilitates high-volume screening. Specimens can be tested rapidly, promoting minimal loss-to-follow-up. Specifically, the AmpFire™ system used in this study is highly portable, simple, rapid (92 specimens per 65 min per unit), and economical. Visual triage can be performed on HPV+ women with a portable digital colposcope that provides magnification, lighting, and a recorded image. Diagnosis and appropriate treatment remain the most subjective elements. The digital image is under study for deep-learning based automated evaluation that could assist the management decision, either by itself or combined with HPV typing. BioMed Central 2020-10-22 /pmc/articles/PMC7579849/ /pubmed/33106753 http://dx.doi.org/10.1186/s13027-020-00329-0 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
Goldstein, Andrew
Lei, Yang
Goldstein, Lena
Goldstein, Amelia
Bai, Qiao Xu
Felix, Juan
Lipson, Roberta
Demarco, Maria
Schiffman, Mark
Egemen, Didem
Desai, Kanan T.
Bedell, Sarah
Gersten, Janet
Goldstein, Gail
O’Keefe, Karen
O’Keefe, Casey
O’Keefe, Tierney
Sebag, Cathy
Lobel, Lior
Zhao, Anna
Lu, Yan Ling
A rapid, high-volume cervical screening project using self-sampling and isothermal PCR HPV testing
title A rapid, high-volume cervical screening project using self-sampling and isothermal PCR HPV testing
title_full A rapid, high-volume cervical screening project using self-sampling and isothermal PCR HPV testing
title_fullStr A rapid, high-volume cervical screening project using self-sampling and isothermal PCR HPV testing
title_full_unstemmed A rapid, high-volume cervical screening project using self-sampling and isothermal PCR HPV testing
title_short A rapid, high-volume cervical screening project using self-sampling and isothermal PCR HPV testing
title_sort rapid, high-volume cervical screening project using self-sampling and isothermal pcr hpv testing
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7579849/
https://www.ncbi.nlm.nih.gov/pubmed/33106753
http://dx.doi.org/10.1186/s13027-020-00329-0
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