Byrne-Nash RT, et al. A neuraminidase potency assay for quantitative assessment of neuraminidase in influenza vaccines. NPJ Vaccines. 2019 Jan 22;4:3
Neuraminidase (NA) immunity leads to decreased viral shedding and reduced severity of influenza disease; however, NA content in influenza vaccines is currently not regulated, resulting in inconsistent quality and quantity of NA that can vary from manufacturer to manufacturer, from year to year, and from lot to lot. To address this problem, we have developed an assay for NA quantification that could be used by the industry to move toward developing influenza vaccines that induce a predictable immune response to NA. The VaxArray Influenza Seasonal NA Potency Assay (VXI-sNA) is a multiplexed sandwich immunoassay that relies on six subtype-specific monoclonal antibodies printed in microarray format and a suite of fluor-conjugated "label" antibodies. The performance of the assay as applied to a wide range of influenza vaccines is described herein. The assay demonstrated high NA subtype specificity and high sensitivity, with quantification limits ranging from 1 to 60?ng/mL and linear dynamic ranges of 24-500-fold. When compared to an enzymatic activity assay for samples exposed to thermal degradation conditions, the assay was able to track changes in protein stability over time and exhibited good correlation with enzyme activity. The assay also demonstrated excellent analytical precision with relative error ranging from 6 to 12% over day-to-day, user-to-user, and lot-to-lot variation. The high sensitivity and reproducibility of the assay enabled robust detection and quantification of NA in crude in-process samples and low-dose, adjuvanted vaccines with an accuracy of 100?±?10%.
See Also:
Latest articles in those days:
- Influenza hijacks myeloid cells to inflict type-I interferon-fueled damage in the heart 21 minute(s) ago
- MHC class II functions as a host-specific entry receptor for representative human and swine H3N2 influenza A viruses 22 minute(s) ago
- Longitudinal Surveillance of Influenza A Virus Exposure in Wild Boars (Sus scrofa) in Spain (2015-2023): Serologic and Virologic Evidence of Subtype Infections and H5N1 Spillover Risk 24 minute(s) ago
- [preprint]Emergence and antigenic characterisation of influenza A(H3N2) viruses with hemagglutinin substitutions N158K and K189R during the 2024/25 influenza season 20 hours ago
- Epitope specificity shapes the CD4+ T cell response to influenza virus infection in mice 20 hours ago
[Go Top] [Close Window]


