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Comparison of the AmpFire® Multiplex HPV Assay to the Xpert® HPV Assay for detection of human papillomavirus and cervical disease in women with human immunodeficiency virus: a pragmatic performance evaluation

BACKGROUND: Low- and middle-income countries (LMICs) account for nearly 85% of the global cervical cancer burden, yet have the least access to high-performance screening. International guidelines recommend human papillomavirus testing (HPV) as primary screening, yet implementation is inhibited by th...

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Autores principales: Moyo, Sikhulile, Ramogola-Masire, Doreen, Moraka, Natasha O., Tawe, Leabaneng, Noubary, Farzad, Motsumi, Kesego, Manowe, Godiraone, Zuze, Boitumelo, Radibe, Botshelo, Hungwe, Faith T. T., Mohammed, Terence, Maphorisa, Comfort, Shapiro, Roger, Gaseitsiwe, Simani, Luckett, Rebecca
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10170707/
https://www.ncbi.nlm.nih.gov/pubmed/37165397
http://dx.doi.org/10.1186/s13027-023-00504-z
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author Moyo, Sikhulile
Ramogola-Masire, Doreen
Moraka, Natasha O.
Tawe, Leabaneng
Noubary, Farzad
Motsumi, Kesego
Manowe, Godiraone
Zuze, Boitumelo
Radibe, Botshelo
Hungwe, Faith T. T.
Mohammed, Terence
Maphorisa, Comfort
Shapiro, Roger
Gaseitsiwe, Simani
Luckett, Rebecca
author_facet Moyo, Sikhulile
Ramogola-Masire, Doreen
Moraka, Natasha O.
Tawe, Leabaneng
Noubary, Farzad
Motsumi, Kesego
Manowe, Godiraone
Zuze, Boitumelo
Radibe, Botshelo
Hungwe, Faith T. T.
Mohammed, Terence
Maphorisa, Comfort
Shapiro, Roger
Gaseitsiwe, Simani
Luckett, Rebecca
author_sort Moyo, Sikhulile
collection PubMed
description BACKGROUND: Low- and middle-income countries (LMICs) account for nearly 85% of the global cervical cancer burden, yet have the least access to high-performance screening. International guidelines recommend human papillomavirus testing (HPV) as primary screening, yet implementation is inhibited by the cost of HPV testing. Atila AmpFire® HPV Assay (AmpFire) is both affordable and easy to use, and offers individual genotyping. The objective of this study was to compare the performance of the AmpFire HPV assay to the Xpert® HPV assay in detection of both HPV and clinically significant cervical disease. METHODS: We utilized stored cervical specimens from a prospective cohort study of women living with human immunodeficiency virus (HIV) in Botswana conducted from May to July 2018. Positive and negative percent agreement was calculated for the AmpFire and Xpert assays, as was detection of high-grade cervical dysplasia. RESULTS: 63 stored cervical specimens had detectable DNA after thawing and were included in the analysis. The positive percent agreement was 91.2% (95%CI 76.3–98.1) and negative percent agreement was 79.3% (95% CI 60.3–92.0). Six cases positive by AmpFire but negative by Xpert were HPV genotypes 35, 52 (n = 2), 58, 68, and co-infection with HPV 45 and 68. Both Xpert and AmpFire assays detected HPV in all 10 samples of women who had high-grade cervical dysplasia. CONCLUSIONS: The AmpFire HPV assay demonstrated excellent analytic performance in both detection of HPV and clinically significant cervical disease. AmpFire HPV is a promising option to increase access to affordable, type-specific HPV screening for cervical cancer in LMICs.
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spelling pubmed-101707072023-05-11 Comparison of the AmpFire® Multiplex HPV Assay to the Xpert® HPV Assay for detection of human papillomavirus and cervical disease in women with human immunodeficiency virus: a pragmatic performance evaluation Moyo, Sikhulile Ramogola-Masire, Doreen Moraka, Natasha O. Tawe, Leabaneng Noubary, Farzad Motsumi, Kesego Manowe, Godiraone Zuze, Boitumelo Radibe, Botshelo Hungwe, Faith T. T. Mohammed, Terence Maphorisa, Comfort Shapiro, Roger Gaseitsiwe, Simani Luckett, Rebecca Infect Agent Cancer Brief Report BACKGROUND: Low- and middle-income countries (LMICs) account for nearly 85% of the global cervical cancer burden, yet have the least access to high-performance screening. International guidelines recommend human papillomavirus testing (HPV) as primary screening, yet implementation is inhibited by the cost of HPV testing. Atila AmpFire® HPV Assay (AmpFire) is both affordable and easy to use, and offers individual genotyping. The objective of this study was to compare the performance of the AmpFire HPV assay to the Xpert® HPV assay in detection of both HPV and clinically significant cervical disease. METHODS: We utilized stored cervical specimens from a prospective cohort study of women living with human immunodeficiency virus (HIV) in Botswana conducted from May to July 2018. Positive and negative percent agreement was calculated for the AmpFire and Xpert assays, as was detection of high-grade cervical dysplasia. RESULTS: 63 stored cervical specimens had detectable DNA after thawing and were included in the analysis. The positive percent agreement was 91.2% (95%CI 76.3–98.1) and negative percent agreement was 79.3% (95% CI 60.3–92.0). Six cases positive by AmpFire but negative by Xpert were HPV genotypes 35, 52 (n = 2), 58, 68, and co-infection with HPV 45 and 68. Both Xpert and AmpFire assays detected HPV in all 10 samples of women who had high-grade cervical dysplasia. CONCLUSIONS: The AmpFire HPV assay demonstrated excellent analytic performance in both detection of HPV and clinically significant cervical disease. AmpFire HPV is a promising option to increase access to affordable, type-specific HPV screening for cervical cancer in LMICs. BioMed Central 2023-05-10 /pmc/articles/PMC10170707/ /pubmed/37165397 http://dx.doi.org/10.1186/s13027-023-00504-z Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/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/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://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 Brief Report
Moyo, Sikhulile
Ramogola-Masire, Doreen
Moraka, Natasha O.
Tawe, Leabaneng
Noubary, Farzad
Motsumi, Kesego
Manowe, Godiraone
Zuze, Boitumelo
Radibe, Botshelo
Hungwe, Faith T. T.
Mohammed, Terence
Maphorisa, Comfort
Shapiro, Roger
Gaseitsiwe, Simani
Luckett, Rebecca
Comparison of the AmpFire® Multiplex HPV Assay to the Xpert® HPV Assay for detection of human papillomavirus and cervical disease in women with human immunodeficiency virus: a pragmatic performance evaluation
title Comparison of the AmpFire® Multiplex HPV Assay to the Xpert® HPV Assay for detection of human papillomavirus and cervical disease in women with human immunodeficiency virus: a pragmatic performance evaluation
title_full Comparison of the AmpFire® Multiplex HPV Assay to the Xpert® HPV Assay for detection of human papillomavirus and cervical disease in women with human immunodeficiency virus: a pragmatic performance evaluation
title_fullStr Comparison of the AmpFire® Multiplex HPV Assay to the Xpert® HPV Assay for detection of human papillomavirus and cervical disease in women with human immunodeficiency virus: a pragmatic performance evaluation
title_full_unstemmed Comparison of the AmpFire® Multiplex HPV Assay to the Xpert® HPV Assay for detection of human papillomavirus and cervical disease in women with human immunodeficiency virus: a pragmatic performance evaluation
title_short Comparison of the AmpFire® Multiplex HPV Assay to the Xpert® HPV Assay for detection of human papillomavirus and cervical disease in women with human immunodeficiency virus: a pragmatic performance evaluation
title_sort comparison of the ampfire® multiplex hpv assay to the xpert® hpv assay for detection of human papillomavirus and cervical disease in women with human immunodeficiency virus: a pragmatic performance evaluation
topic Brief Report
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10170707/
https://www.ncbi.nlm.nih.gov/pubmed/37165397
http://dx.doi.org/10.1186/s13027-023-00504-z
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