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Diagnostics for filovirus detection: impact of recent outbreaks on the diagnostic landscape

Ebolaviruses and Marburg virus (MARV) both belong to the family Filoviridae and cause severe haemorrhagic fever in humans. Due to high mortality rates and potential for spread from rural to urban regions, they are listed on the WHO R&D blueprint of high-priority pathogens. Recent ebolavirus outb...

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Autores principales: Emperador, Devy M, Mazzola, Laura T, Wonderly Trainor, Betsy, Chua, Arlene, Kelly-Cirino, Cassandra
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6407532/
https://www.ncbi.nlm.nih.gov/pubmed/30899573
http://dx.doi.org/10.1136/bmjgh-2018-001112
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author Emperador, Devy M
Mazzola, Laura T
Wonderly Trainor, Betsy
Chua, Arlene
Kelly-Cirino, Cassandra
author_facet Emperador, Devy M
Mazzola, Laura T
Wonderly Trainor, Betsy
Chua, Arlene
Kelly-Cirino, Cassandra
author_sort Emperador, Devy M
collection PubMed
description Ebolaviruses and Marburg virus (MARV) both belong to the family Filoviridae and cause severe haemorrhagic fever in humans. Due to high mortality rates and potential for spread from rural to urban regions, they are listed on the WHO R&D blueprint of high-priority pathogens. Recent ebolavirus outbreaks in Western and Central Africa have highlighted the importance of diagnostic testing in epidemic preparedness for these pathogens and led to the rapid development of a number of commercially available benchtop and point-of-care nucleic acid amplification tests as well as serological assays and rapid diagnostic tests. Despite these advancements, challenges still remain. While products approved under emergency use licenses during outbreak periods may continue to be used post-outbreak, a lack of clarity and incentive surrounding the regulatory approval pathway during non-outbreak periods has deterred many manufacturers from seeking full approvals. Waning of funding and poor access to samples after the 2014–2016 outbreak also contributed to cessation of development once the outbreak was declared over. There is a need for tests with improved sensitivity and specificity, and assays that can use alternative sample types could reduce the need for invasive procedures and expensive equipment, making testing in field conditions more feasible. For MARV, availability of diagnostic tests is still limited, restricted to a single ELISA test and assay panels designed to differentiate between multiple pathogens. It may be helpful to extend the target product profile for ebolavirus diagnostics to include MARV, as the viruses have many overlapping characteristics.
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spelling pubmed-64075322019-03-21 Diagnostics for filovirus detection: impact of recent outbreaks on the diagnostic landscape Emperador, Devy M Mazzola, Laura T Wonderly Trainor, Betsy Chua, Arlene Kelly-Cirino, Cassandra BMJ Glob Health Analysis Ebolaviruses and Marburg virus (MARV) both belong to the family Filoviridae and cause severe haemorrhagic fever in humans. Due to high mortality rates and potential for spread from rural to urban regions, they are listed on the WHO R&D blueprint of high-priority pathogens. Recent ebolavirus outbreaks in Western and Central Africa have highlighted the importance of diagnostic testing in epidemic preparedness for these pathogens and led to the rapid development of a number of commercially available benchtop and point-of-care nucleic acid amplification tests as well as serological assays and rapid diagnostic tests. Despite these advancements, challenges still remain. While products approved under emergency use licenses during outbreak periods may continue to be used post-outbreak, a lack of clarity and incentive surrounding the regulatory approval pathway during non-outbreak periods has deterred many manufacturers from seeking full approvals. Waning of funding and poor access to samples after the 2014–2016 outbreak also contributed to cessation of development once the outbreak was declared over. There is a need for tests with improved sensitivity and specificity, and assays that can use alternative sample types could reduce the need for invasive procedures and expensive equipment, making testing in field conditions more feasible. For MARV, availability of diagnostic tests is still limited, restricted to a single ELISA test and assay panels designed to differentiate between multiple pathogens. It may be helpful to extend the target product profile for ebolavirus diagnostics to include MARV, as the viruses have many overlapping characteristics. BMJ Publishing Group 2019-02-07 /pmc/articles/PMC6407532/ /pubmed/30899573 http://dx.doi.org/10.1136/bmjgh-2018-001112 Text en © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: http://creativecommons.org/licenses/by/4.0
spellingShingle Analysis
Emperador, Devy M
Mazzola, Laura T
Wonderly Trainor, Betsy
Chua, Arlene
Kelly-Cirino, Cassandra
Diagnostics for filovirus detection: impact of recent outbreaks on the diagnostic landscape
title Diagnostics for filovirus detection: impact of recent outbreaks on the diagnostic landscape
title_full Diagnostics for filovirus detection: impact of recent outbreaks on the diagnostic landscape
title_fullStr Diagnostics for filovirus detection: impact of recent outbreaks on the diagnostic landscape
title_full_unstemmed Diagnostics for filovirus detection: impact of recent outbreaks on the diagnostic landscape
title_short Diagnostics for filovirus detection: impact of recent outbreaks on the diagnostic landscape
title_sort diagnostics for filovirus detection: impact of recent outbreaks on the diagnostic landscape
topic Analysis
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6407532/
https://www.ncbi.nlm.nih.gov/pubmed/30899573
http://dx.doi.org/10.1136/bmjgh-2018-001112
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