A sensitive cell-based assay for the detection of residual infectious West Nile virus

Autor: Lewis John Alfred, Jaap Goudsmit, Giuseppe Marzio, C. Ophorst, Martin H. Koldijk, Gerrit Jan Weverling, F. Uytdehaag, Linda Gijsbers, Johannes A. Bogaards, Stefan Kostense, M Ter Haak, Just P. J. Brakenhoff, M de Vocht, J.Y. Guichoux
Přispěvatelé: Amsterdam institute for Infection and Immunity, General Internal Medicine, Epidemiology and Data Science
Jazyk: angličtina
Rok vydání: 2007
Předmět:
Zdroj: Koldijk, M H, Bogaards, J A, Kostense, S, de Vocht, M, Gijsbers, L, ter Haak, M, Ophorst, C, Brakenhoff, J P J, Weverling, G J, Guichoux, J Y, UytdeHaag, F, Lewis, J, Goudsmit, J & Marzio, G 2007, ' A sensitive cell-based assay for the detection of residual infectious West Nile virus ', Vaccine, vol. 25, no. 39-40, pp. 6872-6881 . https://doi.org/10.1016/j.vaccine.2007.07.011
Vaccine, 25(39-40), 6872-6881. Elsevier BV
ISSN: 0264-410X
DOI: 10.1016/j.vaccine.2007.07.011
Popis: Ensuring complete viral inactivation is critical for the safety of vaccines based on an inactivated virus. Detection of residual infectious virus is dependent on sensitivity of the assay, sample volume analyzed and the absence of interference with viral infection. Here we describe the development and qualification of a sensitive cell-based assay for the detection of residual infectious West Nile Virus (WNV). The results of the assay are in good agreement with the assumption that at low concentrations the number of infectious units in relatively small samples follows a Poisson distribution. The assay can detect 1 infectious unit with a confidence of 99%, provides statistical controls for interference and can easily be scaled up to test large amounts of vaccine material. Furthermore, we show equivalence in sensitivity between the cell-based assay and an in vivo assay for detection of infectious WNV. Finally, the assay has been used for successful release testing of clinical lots of inactivated WNV vaccine. Given the principle and generic setup of the method we envision broad applicability to the detection of very low concentrations of infectious virus.
Databáze: OpenAIRE