The Role of Reference Materials in the Research and Development of Diagnostic Tools and Treatments for Haemorrhagic Fever Viruses.
Viruses
; 11(9)2019 08 24.
Article
en En
| MEDLINE
| ID: mdl-31450611
ABSTRACT
Following the Ebola outbreak in Western Africa in 2013-16, a global effort has taken place for preparedness for future outbreaks. As part of this response, the development of vaccines, treatments and diagnostic tools has been accelerated, especially towards pathogens listed as likely to cause an epidemic and for which there are no current treatments. Several of the priority pathogens identified by the World Health Organisation are haemorrhagic fever viruses. This review provides information on the role of reference materials as an enabling tool for the development and evaluation of assays, and ultimately vaccines and treatments. The types of standards available are described, along with how they can be applied for assay harmonisation through calibration as a relative potency to a common arbitrary unitage system (WHO International Unit). This assures that assay metrology is accurate and robust. We describe reference materials that have been or are being developed for haemorrhagic fever viruses and consider the issues surrounding their production, particularly that of biosafety where the viruses require specialised containment facilities. Finally, we advocate the use of reference materials at early stages, including research and development, as this helps produce reliable assays and can smooth the path to regulatory approval.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Infecciones por Virus ARN
/
Vacunas
/
Fiebre Hemorrágica Ebola
/
Técnicas y Procedimientos Diagnósticos
/
Servicios de Información
Tipo de estudio:
Diagnostic_studies
/
Guideline
/
Prognostic_studies
País/Región como asunto:
Africa
Idioma:
En
Revista:
Viruses
Año:
2019
Tipo del documento:
Article
País de afiliación:
Reino Unido
Pais de publicación:
CH
/
SUIZA
/
SUÍÇA
/
SWITZERLAND