tetano
Editor, Senior Moderator
J Virol Methods
. 2021 Feb 25;114111.
doi: 10.1016/j.jviromet.2021.114111. Online ahead of print.
Multiplexed, Microscale, Microarray-based Serological Assay for Antibodies Against All Human-Relevant Coronaviruses
Erica D Dawson[SUP] 1 [/SUP], Laura R Kuck[SUP] 2 [/SUP], Rebecca H Blair[SUP] 2 [/SUP], Amber W Taylor[SUP] 2 [/SUP], Evan Toth[SUP] 2 [/SUP], Vijaya Knight[SUP] 3 [/SUP], Kathy L Rowlen[SUP] 2 [/SUP]
Affiliations
Abstract
Rapid, sensitive, and precise multiplexed assays for serological analysis during candidate COVID-19 vaccine development would streamline clinical trials. The VaxArray Coronavirus (CoV) SeroAssay quantifies IgG antibody binding to 9 pandemic, potentially pandemic, and endemic human CoV spike antigens in 2 hours with automated results analysis. IgG antibodies in serum bind to the CoV spike protein capture antigens printed in a microarray format and are labeled with a fluorescent anti-species IgG secondary label. The assay demonstrated excellent lower limits of quantification ranging from 0.3 - 2.0 ng/mL and linear dynamic ranges of 76 to 911-fold. Average precision of 11% CV and accuracy (% recovery) of 92.5% over all capture antigens were achieved over 216 replicates representing 3 days and 3 microarray lots. Clinical performance on 263 human serum samples (132 SARS-CoV-2 negatives and 131 positives based on donor-matched RT-PCR and/or date of collection) produced 98.5% PPA and 100% NPA.
Keywords: COVID-19; SARS-CoV-2; VaxArray; human coronavirus; immunoassay; serology.
. 2021 Feb 25;114111.
doi: 10.1016/j.jviromet.2021.114111. Online ahead of print.
Multiplexed, Microscale, Microarray-based Serological Assay for Antibodies Against All Human-Relevant Coronaviruses
Erica D Dawson[SUP] 1 [/SUP], Laura R Kuck[SUP] 2 [/SUP], Rebecca H Blair[SUP] 2 [/SUP], Amber W Taylor[SUP] 2 [/SUP], Evan Toth[SUP] 2 [/SUP], Vijaya Knight[SUP] 3 [/SUP], Kathy L Rowlen[SUP] 2 [/SUP]
Affiliations
- PMID: 33640374
- DOI: 10.1016/j.jviromet.2021.114111
Abstract
Rapid, sensitive, and precise multiplexed assays for serological analysis during candidate COVID-19 vaccine development would streamline clinical trials. The VaxArray Coronavirus (CoV) SeroAssay quantifies IgG antibody binding to 9 pandemic, potentially pandemic, and endemic human CoV spike antigens in 2 hours with automated results analysis. IgG antibodies in serum bind to the CoV spike protein capture antigens printed in a microarray format and are labeled with a fluorescent anti-species IgG secondary label. The assay demonstrated excellent lower limits of quantification ranging from 0.3 - 2.0 ng/mL and linear dynamic ranges of 76 to 911-fold. Average precision of 11% CV and accuracy (% recovery) of 92.5% over all capture antigens were achieved over 216 replicates representing 3 days and 3 microarray lots. Clinical performance on 263 human serum samples (132 SARS-CoV-2 negatives and 131 positives based on donor-matched RT-PCR and/or date of collection) produced 98.5% PPA and 100% NPA.
Keywords: COVID-19; SARS-CoV-2; VaxArray; human coronavirus; immunoassay; serology.