PandemieGrippaleV1, Ncbi, Checkpoint, bibRecord, 001E77

VaxArray potency assay for rapid assessment of “pandemic” influenza vaccines

Identifieur interne : 001E77 ( Ncbi/Checkpoint ); précédent : 001E76; suivant : 001E78

VaxArray potency assay for rapid assessment of “pandemic” influenza vaccines

Auteurs : Rose T. Byrne-Nash ; David F. Miller ; Katie M. Bueter ; Jacob H. Gillis ; Laura R. Kuck ; Kathy L. Rowlen

Source :

NPJ Vaccines [ 2059-0105 ] ; 2018.

RBID : PMC:6175820

Abstract

The VaxArray Influenza Pandemic HA (VXI-pHA) potency assay is a multiplexed sandwich immunoassay that consists of nine broadly reactive yet subtype-specific monoclonal capture antibodies printed in microarray format and a suite of fluor-labeled secondary antibodies that were selected to probe conserved HA epitopes. VXI-pHA was designed to optimize the probability that the ready-to-use assay would work for the most concerning, emergent influenza A strains, eliminating the need for the time-consuming process of reference reagents production. The performance of this new potency test was evaluated using a panel of 48 potentially pandemic strains of influenza viruses and vaccines spanning 16 years of antigenic drift, including the most recent pre-pandemic vaccine being developed against the “5^th wave” A/H7N9 virus. The VXI-pHA assay demonstrated coverage of 93%, 92%, and 100% for H5, H7, and H9 antigens, respectively. The assay demonstrated high sensitivity with linear dynamic ranges of more than 150-fold and quantification limits ranging from 1 to 5 ng/mL. For three production lots of H7N9 monobulk drug substance, the assay exhibited excellent accuracy (100 ± 6%) and analytical precision (CV 6 ± 2%). The high assay sensitivity enabled robust detection and quantification of hemagglutinin in crude in-process samples and low-dose, adjuvanted vaccines with an accuracy of 100 ± 10%.

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6175820

DOI: 10.1038/s41541-018-0080-6
PubMed: 30323954
PubMed Central: 6175820

Affiliations:

Links to Exploration step

PMC:6175820

Le document en format XML

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<front><div type="abstract" xml:lang="en"><p id="Par1">The VaxArray Influenza Pandemic HA (VXI-pHA) potency assay is a multiplexed sandwich immunoassay that consists of nine broadly reactive yet subtype-specific monoclonal capture antibodies printed in microarray format and a suite of fluor-labeled secondary antibodies that were selected to probe conserved HA epitopes. VXI-pHA was designed to optimize the probability that the ready-to-use assay would work for the most concerning, emergent influenza A strains, eliminating the need for the time-consuming process of reference reagents production. The performance of this new potency test was evaluated using a panel of 48 potentially pandemic strains of influenza viruses and vaccines spanning 16 years of antigenic drift, including the most recent pre-pandemic vaccine being developed against the “5<sup>th</sup>
 wave” A/H7N9 virus. The VXI-pHA assay demonstrated coverage of 93%, 92%, and 100% for H5, H7, and H9 antigens, respectively. The assay demonstrated high sensitivity with linear dynamic ranges of more than 150-fold and quantification limits ranging from 1 to 5 ng/mL. For three production lots of H7N9 monobulk drug substance, the assay exhibited excellent accuracy (100 ± 6%) and analytical precision (CV 6 ± 2%). The high assay sensitivity enabled robust detection and quantification of hemagglutinin in crude in-process samples and low-dose, adjuvanted vaccines with an accuracy of 100 ± 10%.</p>
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Serveur d'exploration sur les pandémies grippales

VaxArray potency assay for rapid assessment of “pandemic” influenza vaccines

VaxArray potency assay for rapid assessment of “pandemic” influenza vaccines

Source :

Abstract

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Links to Exploration step

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