D4 Julkaistu kehittämis- tai tutkimusraportti tai -selvitys
Report on the WHO collaborative study to establish the 1st International Standard for anti-EV-D68 serum (Human)
Tekijät: Pegg Elaine, Jason Hockley Jason; EV-D68 Study Group, Rigsby Peter, Martin Javier, Tedcastle Alison
Kustantaja: World Health Organization
Julkaisuvuosi: 2022
Aloitussivu: 1
Lopetussivu: 49
Verkko-osoite: https://www.who.int/publications/m/item/who-bs-2022.2418
Enterovirus D68 (EV-D68), a member of the Picornaviridae family of enteroviruses, was isolated in the US in 1962. Infrequent infections of EV-D68 were initially reported until a large outbreak in the US in 2014. Since then the incidence of EV-D68 infection has grown worldwide. EV-D68 infection causes severe respiratory symptoms and is associated with acute flaccid myelitis (AFM) in children, a neurogenic disease which results in limb weakness and paralysis.
There has been some interest in recent years in the development of a vaccine for EV-D68, there is therefore a need to produce reagents to support this research and development.
A new collaborative study, reported here, was conducted with the aim to establish the 1st international standard for anti-human enterovirus D68 (EV-D68) serum. The establishment of an IS for anti EV-D68 serum is intended to help laboratories standardize virus neutralization methods to measure antibody levels against EV-D68 in human sera. These assays might be suitable for the evaluation of the immunogenicity of EV-D68 vaccines and for the assessment of the seroprevalence of human populations against EV-D68 virus.
The collaborative study showed that between laboratory variations in neutralization titres were significantly reduced when values were expressed relative to those of either of the two candidate sera. Based on the results of the collaborative study and the stability data candidate 20/172 is proposed as the 1st International Standard for anti-EV-D68 serum (Human).